Record Review of OIF/OEF Veterans Discharged in 2006 with

Chapter 513 Personality Disorder (PD) Separations

I. Executive Summary

Members of the media and Congress have alleged that Soldiers have been
inappropriately discharged under Army Regulation (AR) 635-200. Chapter 5-13,
Separation Because of Personality Disorder (PO). when they should have been afforded
the opportunity to undergo Medical Evaluation Boards (MEBs). The Acting Surgeon
General (ATSG) directed a review of all Soldiers discharged under Chapter 5..13 in
2006 who had served in Operation Iraqi Freedom (OIF) or Operation Enduring Freedom
(OEF). Numerous variables were assessed in the record reviews, to include diagnOSiS,
severity of symptoms. eligibility for a MEBI the presence of other psychological and
medical conditions, and the credentials of the evaluator. From the available records,
there is no affirmable evidence that indicated that Soldiers were misdiagnosed with PO
when they should have been diagnosed with a different medical condition. However, In
some cases Soldiers had multiple diagnoses but were discharged for personality
disorder. In 13% of cases, existing documentation did not adequately support an AxIs /I
diagnosis of PD. Of the remainder, 56% of reviewed records had sufficient
documentary support for diagnosis of PO, and 31% did not have adequate
documentation to either confirm or dismiss diagnosis of PD. Axis II Is used to report
Personality Disorders and mental Retardation. Axis" may also be used to note
prominent maladaptive personality features. In the case of Soldiers, the most common
maladaptive features are suicidal and homicidal ideation. Problems with the adequacy
of the documentation are outlined In the report. Many of the cases are notable for
having a variety of psychiatric pathologies, often unrelated 10 the effects of combat.
Healthcare providers, unit Commanders. and Army leadership should take actions to
strengthen the process for executing PO separations.
II. Introduction

In July 2007, the ATSG directed a review of all records of Soldiers discharged for PO in
2006 who had served in OIF or OEF. The Army G1ldentified 294 active component
Soldiers with service In OIF/OEF who were separated in 2006 under Army Regulation
AR 635200. Chapter 513. The Office of the Surgeon General (OTSG) requested
administrative files, medical records and mental health records for each Soldier. A team
of Army behavioral health providers and healthcare admInistrators conducted the review
in the Washington D.C. area and St. Louis, Missouri between 25 July 2007 and 2
August 2007.
1. Definitions: Chapter 513 PO and Related Chapters

a. AR 635-200, Chapter 513, Separation Because of Personality Disorder (PO) is

commonly referred to as aChapter &.13 and is derived from goveming Department of

Defense (DoD) Policy (000 Directive 1332.14). It Is a subset of Chapter 5, Separation

for Convenience of the Government.
b. Chapter 513 is one of several administrative separations Included in AR 635-200
that may be used to separate Soldiers from active duty service. Other relevant
administrative separations include: Chapter 13, Separation for Unsatisfactory
Performance; Chapter 14, Patterns of Misconduct; and Chapter 517, Other Designated
Physical or Mental Conditions. Chapter 517 covers other physical or mental conditions
not amounting to disability and excluding conditions appropriate for separation
processing under provision of Chapter 5-11 or Chapter 5-13 that potentially Interfere
with a Soldier's assignment or his ability to perform his duties. The service of a Soldier
separated per Chapter 5-13 is characterized as honorable unless an entry-level
separation is required under Chapter 3 of the same regulation. Characterization of
service under honorable conditions may be awarded to a soldier who has been
convicted of an offense by general court-martial or who has been convicted by more
than one special court-martial in the current enlistment, period of obligated service, or
any extension thereof. The service of a Soldier separated per Chapter 14 is normally
characterized as under other than honorable, although the separation authority may
direct a general discharge if such is merited by the Soldier'S overall record. The
characterization of service and benefits Involved with a Chapter 5-17 separation are
very similar to those for separation under Chapter 5-13. Soldiers in their first six months
of service may be separated under Chapter 11, Entry Level Performance and Conduct.
c. All chapter separations are done through the Uniform Code of Military Justice
(UCMJ) chain of command. The SpeCial Court-Martial Convening Authority (brigade
level commander) Is the separation authority for Chapter 5-13 separations. Normally, a
Soldier's company commander Initiates the chapter paperwork and forwards it through
the chain of command to the battalion-level commander and Brigade Judge Advocate,
who review it and forward it to the brigade-level commander for approval.
d. Per AR 635-200, Chapter 2, Section I, all Soldiers are afforded the opportunity to
review their packet with an attorney, who advises the Soldiers of their administrative
rights, including their right to appeal the separation with the Army Discharge Review
Board or Anny Board for Correction of Military Records after their separation, if they
believe there is error or Injustice in their separation. Mental health providers make
separation recommendations to the commander after assessing for the presence or
absence of mental health conditions that: (1) make the person unable to appreciate the
wrongfulness of his/her conduct; (2) Impede the Soldier's capacity to partiCipate In
administrative process; (3) Includes a diagnosis that Is incompatible with military
service; and (4) are not likely to remit or improve with treatment or remediation. The
chain of command has the final authority to move forward with a separation action.
Mental health providers have no authority to initiate separation actions.
e. Unless the reason for separation requires a specific characterization of service. a
Soldier being separated for the convenience of the Government is awarded a
characterization of service of honorable, general under honorable conditions, or an

uncharactelized description of service if in an entry-level status.

2

f. In order to warrant a recommendation to separate for PO, the Soldier's condition

must be a deeply ingr~lned maladaptive pattem of behavior of long duration that
Interferes with the Soldier's ability to perform duty (combat exhaustion and other acute
situational maladjustments do not meet these criteria). A psychiatrist or doctoral-level
clinical psychologist, with necessary and appropriate professional credentials privileged
to conduct 000 evaluations, must establish the diagnosis of PO in accordance with the
Diagnostic and StatistIcal Manual of Mental Disorders-Text Revised (DSM IV-TR).

g. Soldiers with a mental illness or other medical Impairments that are medically
disqualifying are processed under AR40-501. Standards of Medical Fitness. and then
separated and processed for disability under the provisions of AR 635-40, Physical
Evaluation for Retention, Retirement, or Separation. A referral for a MEB does not
mean that the Soldier will necessarily receive disability. Generally only significant
mental disorders. such as schizophrenia and bipolar disorder, which cause SoldIers to
be unable to perform their military job receive a disability rating. If a cond~lon is judged
to have Existed Prior to Service (EPTS). the Soldier will not normally receive disability
for that condition.
2. Diagnostic and Statistical Manual of Mental Disorders- Text Revised (DSM IV
TR) MultlAxlal System

a. DSM IV4TR Is the widely-used diagnostic criteria manual of mental disorders.

Diagnoses are reported on a multi-axial system. Axis I addresses mental disorders.
ranging from relatively mild ones. such as adjustment disorders, to severe ones, such
as schizophrenia. Axis II covers longstanding conditions, including POs and mental
retardation. Axis III concerns relevant physical illnesses or Injuries in the patient. Axis
IV addresses the degree and types of stress a person is under. and Axis V assesses
level of functioning. described as the Global Assessment of Functioning (GAF) Scale.
This scale Is reported from 0 to 100.
b. In the OSM IV-TR. there are nine different POSt split into three clusters: (1)
Cluster A (odd/eccentric); (2) Cluster B (dramatIc/erratic); and (3) Cluster C
(anxious/fearful). There Is also a category called PO, not othelWise specified. ThIs is
for people who have traits from a number of different POSt but may not meet criteria for
a specific PO diagnosis.
c. There are no formal studies that show which type of PO Is most commonly
diagnosed in the military. However, AR 635-200 requires not only the presence of the
diagnosis of a PO, but that it Is of such severity as to preclude military service.
Persistent suicidal or homicidal ideation generally rises to that level of severity, since
these Impact on both the Soldier'S ability to perform his/her mission and on the Soldier's
unit. Typical examples of personality disorders in our Soldier population include
Antisocial. Bordertlne and Narcissistic PDs.

d. Suicidal Ideation may be a symptom of many different conditions, but if it Is a

component of a PO, it is often associated with a borderline PD. Please see DSM IV-TR
for the full diagnostic criteria. Homicidal Ideation is often consistent with Antisocial PD.
e. Post Traumatic Stress Disorder (PTSD) Is a specific psychiatric diagnosis on Axis
I In which an Individual Is exposed to a traumatic event. In order to meet the diagnosis
of PTSD, the following criteria must be present: A. The person has been exposed to a
traumatic event In which both of the following were present: (1) the person
experienced, witnessed, or was confronted with an event that involved actual or
threatened death, or serious injury, or a threat to the physical integrity of self and others;
and (2) the person's response involved intense fear, helplessness, or horror. B. The
traumatic event is persistently re-experienced in one (or more) of the following ways: (1)
recurrent and intrusive distressing recollections of the event (images, thoughts, or
perceptions); (2) recurrent dreams of the event; (3) acting or feeling as if the traumatic
event were recurring; (4) Intense psychological distress at exposure to Internal or
external cues that symbolize or resemble an aspect of the traumatic event; (5)
physiological reactivity upon exposure to internal or external cues that symbolizes or
resembles an aspect of the traumatic event. C. Persistent avoidance of stimuli
associated with the trauma of general responsiveness (not present before the trauma),
as indicated by three (or more) of the following: (1) efforts to avoid thoughts, feelings or
conversations associated with the trauma; (2) efforts to avoid activities, places. or
people that arouse recollections of the trauma; (3) Inability to recall an important aspect
of the trauma; (4) markedly diminished interest or participation in significant activities;
(5) feeling detached or estranged from others; (6) restricted range of affect; (7) sense of
foreshortened future. D. Persistent symptoms of increased arousal (not present before
the trauma). as Indicated by two (or more) of the following: (1) difficulty falling asleep;
(2) Irritability or outburst of anger; (3) difficulty concentrating; (4) hypervlgilence; (5)
exaggerated startle response; E. Duration of the disturbance (symptoms In Criteria B, C,
and D) Is more than one month. F. The disturbance causes clinically significant
distress or impairment in social, occupational, or other important area of functioning.
f. It Is normal for Soldiers who experience combat to have symptoms associated
with PTSD. but most do not develop PTSD. Data is now available from multiple sources
that indicate that 1015% of Soldiers returning from OIF develop PTSD. Another 10
15% experience significant symptoms of PTSD, depreSSion. or anxiety and may benefit
from care. Alcohol, aggreSSion. and family problems add to or exacerbate these
concerns. PTSD and PO may co-exist.
g. Soldiers and other persons may have a variety of co..axisting psychiatric disorders,
both on Axis I and Axis II. Soldiers with AxIs II personality disorders commonly have
other Axis I disorders, such as Attention Deficit HyperactivIty Disorder, or Adjustment
Disorder with Mixed Disturbance of cmotions and Conduct. In addition, the Axis I
psychiatric diagnoses may change over time. For example, an Adjustment Disorder
with Depressed Mood may evolve into Major Depression.
III. Record Review Methods

a. The Army G-1ldentified 294 OIF/OEF Soldiers separated In 2006 under Chapter
5-13. According to the statistics provided by Army G1, the Army separated a total of
1073 Soldiers in FY 2006 under Chapter 5~13. This number represents an increase of
approximately 20% from the early years of the decade but Is nearly identical to PO
separations in the year 2005.
b. OTSG requested the administrative files, medical records and the mental health
records for each Soldier identified. The review began 25 July 2007 and concluded 2
August 2007. Administrative records were available online. The medical records were
all hard copies, and were located In a VA facility In St. Louis, MO. Some of these were
printouts from the new electronic medical record, (AHLTA). The mental health records
came from a variety of sources, to include theater facilities, Landstuhl Regional Medical
Center in Germany, military treatment facilities (MTFs) in the US, and civilian facilities.
In the past, Army MTFs maintained mental health records (separate from other medical
records) In the behavioral health clinic. Over the past two years, the Army has gradually
transltJoned to the electronic medical record known as AHLTA, which consolidates the
medical and mental health records. The records with electronic documentation
generally were clearer and more complete than the paper records.
1. Administrative Record Review

All Soldiers had some administrative files available online and the vast majority
(275/294,94%) had adequate administrative Information available, which typIcally
included behavIoral health documents, such as the Report of Mental Status Evaluation,
to support the administrative actions recommended in the reviewed files.

2. Medical Record Review

a. A team flew to St. Louis, MO, and reviewed medical records in the Veterans
Affairs Record Management Center. 128 of 294 medical records were accessible.
Many other medical records had already been requested or were otherwise unavailable.
Available records were reviewed by two Army behavioral health officers, one of whom
was a physician. The comprehensiveness of these records with respect to mental
health documentation varied considerably. Many Included some mental health
information, especially the Report of Mental Status Evaluation.
b. Most records contained the Pre-Deployment Health Assessment screening form
(DO 2795) and the Post-Deployment Health Assessment screening form (PDHA; DO
2796). The Post Deployment Health Re-Assessment Form (PDHRA; DO 2900) was
rarely enclosed as expected. The PDHRA was still In the process of being fully
implemented In 2006, and it Is not deSigned to be administered until three-to-slx months
after deployment. Some Soldiers separated from service before they reached this
window. Both the PDHA and the PDHRA have a number of questions specific to PTSD
symptoms. The reviewers noted If any responses were posrtive. Reviewers also
specifically reviewed and documented the presence of Traumatic Brain Injury (Tel), as

well as other medical conditions.

5

3. Behavioral Health Record Review

a. Reviewers queried Regional Medical Commands (RMCs) for behavioral health
records. These records are maintained at the local medical faollity. The request to the
RMCs was for intake notes, discharge summaries, mental status evaluations, and any
other pertinent data. The RMCs submitted 202 behavioral health records for review.
b. The information available from the behavioral health records was highly variable.
Some of these records came from theater, from Landstuhl RMC andlor from medical
treatment facilities In the US. In some cases, records from complete Inpatient
psychiatric hospitalizations were forwarded. In other cases, there were only medical
evacuation summaries, Report of Mental Status Evaluations or other memoranda for the
command. However. in the majority of cases the Report of Mental Status Evaluation
was available in the administrative records.
c. Either a board-certified psychiatrist or licensed clinical doctoral-level psychologist
reviewed the behavioral health flies. A total of five psychiatrists or psychologists
participated In the reviews.
4. Review Criteria: Data points specifically Individually assessed and recorded were
the following:
a. Is there significant supporting clinical evidence for an Axis II diagnosis?
b. Is the severity of the PO condition documented in accordance with Army
Regulation 635-2007
c. Are other mental health conditions present?
d. Does the patient also meet criteria for a Medical Evaluation Board (MEB)?
e. Is there documentation of a head injury/TBt? If so, what is the severity?
f. What are the credentials of the providers listed on the Report of Mental Status
Evaluation?
g. Are there other significant medical conditions?
h. Military installation of discharge.

IV. Results of the 513 Records Review: Overview

a. This review focused on two processes: (1) conducting a quality review ofthe
record to include the following: a) mental health documents were in order, b) properly

signed by a board certified psychiatrist or alicensed clinical doctoral-level psychologist;

6

and (2) meeting the criterion established in DSM IV-TR for the personality disorder
which supports a Chap 5~13 versus another competing diagnoses.
b. It is important to note that the variables above were ascertained Independently.
Thus, a Soldier might meet the criteria for PO, but also have other mental health
conditions, such as an adjustment disorder with depressed mood. A Soldier might have
other medical conditions present, but not meet the criteria for a full MEB, which Is based
on fitness for duty considerations. A Soldier might have excellent documentation of his
past history, but it may not be signed by the appropriate provider. Therefore, the
number and percentages cited below do not add up neatly. Many Soldiers had
evidence of symptoms of both Axis I and Axis II disorders. In numerous cases there
was eVidence of drug use, which could confound the other diagnoses.
(1) Given that a PO is a chronic condition that usually exists prior to service
(EPTS), Chapter 5~13 should only be given to Soldiers who have shown an inability to
function effectively in a military environment. As such. discharge for PO is generally
Inappropriate for a Soldier on their second enlistment (one who had already completed
a full contract, received an honorable discharge, and offered a second tour of service), a
Soldier who was promoted to the grade of non~ommissioned officer (NCO), or a
Soldier who has received a series of awards for meritorious and effective service. All
these variables are strong indicators that at one time the individual had adapted well to
military service, and therefore the inability to adapt was acquired rather than innate.
(2) In some cases the 513 separation appeared to serve another function: it
provided a mechanism for an honorable that allowed Soldiers who did not otherwise
qualify for another chapter or a MEB to be released from service. In most of these
cases, records IndIcated that the Soldier requested the chapter.

V. Results of the Review: Individual Variable. Examined

a. Significant Support for Axis II (Personality Disorder) Diagnosis:
(1) A record was acceptable as showing significant support for a PO diagnosis if
there was an adequate description of behavioral hearth problems commonly associated
with PO (eg. self mutilation, suicide gestures or attempts, homIcidal ideation or actions).
(2) 203 of the 294 records (69%) had sufficient documentation In the medIcal
record to assess the clinical justification for the Axis II diagnosis. In 39 (13%) of cases,
there was not significant support for an Axis II diagnosis documented. In 164 (560/0)
there was sufficient support. and In the remaining 91 (310/0) there was not sufficient
documentation to make a judgment.
b. Severity level as to preclude Military Service Documented:
(1) AR 635-200 requIres not just the presence of the diagnosis of a PO, but that it
is of such severity as to preclude military service.

(2) In 35 (12%) cases the severity of the stated problems did not appear to rise to
the level of precluding military service. In 176 (60%) cases it did, and in the remaining
84 cases (32%) there was not sufficient documentation to make a judgment.
(3) 211 of the 294 records (72%) had sufficient documentation in the medical

record to assess whether the severity of the disorder rose to the level of precluding

military service. Of these, 176 records supported severity of the disorder sufficient to

preclude military service and 35 (12%) did not.

c. Criteria for MEB met and Other Mental Health Conditions Present:
(1) In 79 cases (27%) there was another Axis I diagnosis that might have led to
referral for a MES. In 125 (43%) there was not, and in 90 (31%) there was not sufficient
documentation to make a judgment.
(2) It is Important to note that even if these Soldiers were referred to a MEB,
they may not have received any disability rating, as many of these conditions existed
prior to service or were no't In themselves disabling. In one case, the Soldier was
referred to a PEB (Physical Evaluation Board), but the board found the Soldier
medically fit for duty. In four other cases, there was discussion of referral to an MES.
There was no documentation in the remaining 74 cases to indicate that the Soldiers'
commanders considered referral to an MEB. However, discussion of a MEB does not
mean the Soldier would have been found unfit and given disability by the MESIPEB
process.
(3) Symptoms of PTSD: some symptoms of PTSD were noted as diagnosed in
58 cases. In four cases it was documented as pre-exlstlng, e.g., from childhood sexual
trauma. (It should be noted that about 15% of combat veterans have symptoms of
PTSD; therefore, this finding Is actually consistent with the overall combat veteran
population.) In the remaining cases, there was no evidence that PTSD caused Soldiers'
behavioral problems that resulted in their administrative separation under Chapter 5-13.
(4) Presence and severity of head injury (TBI): reviewers specifically examined
medical records and mental health records to assess for a history of TBI. Such
evidence was only present in three cases. The relationship of the Injury to the
symptoms leading to the discharge was also assessed. There were not any cases of a
TBI being misdiagnosed as a PD.
d. Credentials: 13 mental health evaluations (5%) appear to have been signed by
Behavioral Health Staff not authorized by regulation to do so (I.e., social work officers,
non-psychiatric physicians, or nurses).
e. Any other Significant Medical Conditions:
(1) There were numerous other medical conditions, including low back pain and
various orthopediC injuries.

(2) These conditions generally did not appear to rise to the level of needing
referral to a MEB, based on the available medlcallnfonnatlon.

h. Installation Specific Infonnation:

Records were sorted based on the installation that completed the separation. It is
premature to assess patterns or draw conclusions of this one-year snapshot, since the
population of OIF/OEF veterans at each installation varies significantly from installation
to installation based on operational tempo and deployment cycles. As records are
reviewed over a longer tlmeframe It will become possible to seek local patterns.
Jablel

Discharge by Installation

Ft. Benning
Ft. Bliss
Ft. Bragg
Ft. Campbell
Ft. Carson
Ft. Drum
Ft. Eustis
Ft. Gordon
Hunter AF
Ft. Hood
Ft. Irwin
Ft. Jackson
Ft. Knox
Ft. Lee
Ft. Leonard Wood
Ft. Lewis
Okinawa
Ft. Polk
Ft. Richardson
Ft. Riley
Schofield
Ft. Stewart
Ft. Sill
Ft. Wainwright
WRAMC
Europe (total)
Unknown
Totals

2
20

22
41

25
1
4

2
62
3

1
1
1
2
12
1
3

5
4
21

6
6
1
43
2
294

VI. Conclusion

a. From the available records, there is no affirmable evidence that Indicated that

Soldiers were misdiagnosed with PD when they should have been diagnosed with

PTSD or TBI. However, in many cases SoldIers had multiple diagnoses but were

discharged for personality disorder.

b. Reviewers did not find evidence of comprehensive screening and documentation

for either PTSD or TBI in the medical records other than the PDHA and PDHRA
screening 10n118.
c. Existing policies, particularly conceming the level of credentialed provider
required to make a separation recommendation. need to be emphasized to the local
installations and better qu ality assurance reviews of records need to be performed.
Healthcare providers did not follow existing policies and guidelines pertaining to the
roles of privileged providers In mental health documentations suggesting inadequacy of
the quality assurance review process.
d. Better documentation of all the variables describe above is essential.

VII. Recommendations
a. For healthcare providers:
(1) Clearly document the reasons for the PO recommendation. Document the
DSM IV-TR criteria clearly and completely. If not possible, then document the reasons
why this is not possible and document as many criteria as possible.

(2) If there is an Axis I diagnosis, document why a chapter was selected.

(3) A psychologist or psychiatrist must make the recommendation. not a social
worker, non-psychiatric physician. or nurse.
(4) The Chief of Behavioral Health at every installation should review all
recommended Chapter 5-13 separation actions.
(5) Clearly document this pattem of behavior was evident eanier in life. If not
evident earlier In life, and the person has behavioral difficulties incompatible with military
service, a Chapter 5-17, Chapter 13 or 14 may be more appropriate.
(6) If in doubt as to Chapter 5-13 or MEB, recommend an MES.
(7) Document counseling and rehabilitation efforts, Including your counseling to
the Command regarding the needed rehabilitation. Document the Command's
adherence to your recommendations.
(8) If a Chapter 5-13 was recommended Instead of another chapter (e.g.,
misconduct, failure to adapt, etc.), then document your reasons.

10

(9) Make sure that PTSD Is not the reason for the behavioral difficulties. If It was,
consider a MEB or other therapeutic options. Screen and document more rigorously for
PTSD and TBI.
Note: These recommendations have already been provided to the field In a number of
forums. New policy from ATSG ensures that all Chapter 5-13 recommendations are
reviewed by the Chief of Behavioral health at that Installation.
b. For Soldier's command:
(1) Ensure all chapter packets are administratively complete.

(2) Ensure that each Soldier understands hislher rights. the impact of the
separation on his/her future and his/her avenues to appeal the decision.

c. For Army Leadership:

VIII. The Way Ahead

a. The TSG will send a personal letter to Soldiers who may have questions In
reference to their Chapter 5-13 discharge. The letter will clearly explain the guidelines
for submitting an appeal packet to the Army Board for Correction of Military Records.
b. In September 2007 OTSG performed a record review of all OIF/OEF Soldiers who
received a Chapter 5-13 from 2001 through 2005. The report of this review will be
completed shortly.
c. Chapter 5-13s will continue to be monitored both at the installation-level and
centrally at the Office of The Surgeon General to ensure that the recommendations
listed above are being folll
"

11

Record Review of OIF/OEF Veterans Discharged from 2001 through 2005 with

Chapter 5-13 Personality Disorder (PO) Separations

I. Executive Summary

Members of the media and Congress have alleged that Soldiers have been
inappropriately discharged under Army Regulation (AR) 635-200, Chapter 5-13,
Personality Disorder (PD). when they should have been afforded the opportunity to
undergo Medical Evaluation Boards (MEBs). The Acting The Surgeon General (ATSG)
directed a review of all Soldiers discharged under Chapter 5-13 from 2001 to 2005 who
had served in Operation Iraqi Freedom (OIF) or Operation Enduring Freedom (OEF). A
similar report was already completed for Soldiers discharged In 2006. Numerous
variables were assessed in the record reviews, to include diagnosis, severity of
symptoms, eligibility for other chapters or for a MEB. the presence of other
psychological and medical conditions. credentials of the provider and indications of
suicidal and homicidal ideation. In 27% of cases, there was not significant support for
an Axis II diagnosis documented. There were other Issues with the adequacy of the
documentation which are outlined in the report. Healthcare providers. unit
Commanders, and Army leadershfp should take actions to strengthen the process for
executing PD separations.
II. Introduction

The ATSG directed a review of all records of Soldiers discharged for PO from 2001
through 2005 who had served In OIF or OEF. 01 Identified 359 active component
Soldiers with service in OIF/OEF who were separated from 2001 through 2005 under
Chapter 5-13. OTSG requested administrative flies, medical records and mental health
records for each Soldier. A team of Army behavioral health providers and health care
administrators conducted the review in the Washington D.C. area and St. Louis,
Missouri in September 2007.
1. AR 635-200, Active Duty Enlisted AdministratIve Separations,

a. Authorfty to separate Soldiers for Personality Disorder (PO) under paragraph 513
of AR 635-200. derives from governing Department of Defense (000) Policy (000
Directive 1332.14). A separation action for PO under paragraph 5-13 Is commonly
referred to as a Chapter 5-13 separation. whIch is a subset of Chapter 5, Separation for
Convenience of the Government.
b. Chapter 5-1318 one of several administrative separations included In AR 635-200
that commanders use to separate Soldiers from active duty service. Other relevant
administrative separations Include: Chapter 13, Separation for Unsatisfactory
Performance; Chapter 14. Patterns of Misconduct; and Chapter 5-17, Other Designated
Physical or Mental CondHlons. Chapter f>..17 covers other physical or mental conditions
not amounting to disability and excluding conditions appropriate for separation

processing under provisions of Chapter 5-11 or Chapter 5-13 that potentially interfere
with a Soldier's assignment or his ability to perform his duties. A Soldier separated
under Chapter 5-13 normally receives an Honorable Discharge, or an uncharacterlzed
description of service if the Soldier Is in an entry-level status. If the Soldier has one or
more court-martial convictions, the Soldier may receive a General, under honorable
conditions discharge under Chapter 5-13. Soldiers separated under Chapter 14
normally receive either a General, under honorable conditions, or Other Than
Honorable Discharge. It is possible, though highly unusual, that a Soldier separated
under Chapter 14 could receive an Honorable Discharge. The characterization of
service and benefits Involved with a Chapter 5-17 separation are very similar to those
for separation under Chapter 5-13. Soldiers in their first six months of service may be
separated under Chapter 11, Entry Level Performance and Conduct.
c. All chapter separations are done through the Uniform Code of Military Justice
(UCMJ) chain of command. The Special Court-Martial Convening Authority (brigade
level commander) is the separation authority for Chapter 5-13 separations. Normally, a
Soldier's company commander Initiates the chapter paperwork and forwards It through
the chain of command to the battalion-level commander and Brigade Judge Advocate,
who review it and forward it to the brigade-level commander for approval.
d. All Soldiers are afforded the opportunity to review their packet with legal counsel,
who advises the Soldiers of theIr administrative rights, Including their right to appeal the
separation with the Army Boards of Review. Mental health providers make separation
recommendations to the commander after asseSSing for the presence or absence of
mental health conditions that: (1) make the person unable to appreciate the
wrongfulness of his/her conduct; (2) impede the Soldier'S capacity to participate in
administrative process; (3) Include a diagnosis that Is incompatible with military service;
and (4) are not likely to remit or improve with treatment or remediation. The chain of
command has the final authority to move forward with a separation action. Mental
health providers have no authority to Initiate separation actions.
e. Unless the reason for separation requires a specific characterization of service, a
Soldier being separated for the convenience of the Government is awarded a
characterization of service of honorable, under honorable conditions, or an
uncharacterlzed description of service if in an entry-level status.
f. In order to warrant a recommendation to separate for PO, the Soldier's condition
must be a deeply Ingrained maladaptive pattern of behavior of long duration that
Interferes with the Soldier's ability to perform duty (combat exhaustion and other acute
situational maladjustments do not meet these criteria). A psychiatrist or doctoral-level
clinical psychologist, with necessary and appropriate professional credentials privileged
to conduct 000 evaluations, must establish the diagnosis of PO In accordance with the
Diagnostic and Statistical Manual of Mental Disorders-Text Revised (DSM IV-TR).
g. Soldiers with a mental illness or other medical impairments that are medically
disqualifying are processed under AR 40-501, Standards of Medical Fitness, and then

separated and processed for disability under the provisions of AR 635-40, Physical
2

Evaluation for Retention, Retirement. or Separation. A referral for a MEB does not
mean that the Soldier will necessarily receive disability. Generally only significant
mental disorders, such as schizophrenia and bipolar disorder, which cause Soldiers to
be unable to perform their military job. receive a disability rating. If a condition is Judged
to have Existed Prior to Service (EPTS). the Soldier will not normally receive disability
for that condition.
2. Diagnostic and StatistIcal Manual of Mental Disorders- Text Revised (DSM IV
TR) Multi-Axial System
a. The DSM IV-TR is the widely-used diagnostic criteria manual of mental dIsorders.
Diagnoses are reported on a multi-axial system. AxIs I addresses mental disorders.
ranging from relatively mild ones, such as adjustment disorders, to severe ones. such
as schizophrenia. Axis II covers longstanding conditions, including PDs and mental
retardation. Axis III concerns relevant physical illnesses or injuries in the patient. Axis
IV addresses the degree and types of stress a person is under, and Axis V assesses
level of functioning. described as the Globa! Assessment of Functioning (GAF) Scale.
This scale Is reported from 0 to 100.

b. In the DSM IV..TR, there are nine different POSy split Into three clusters: (1)
Cluster A (odd/eccentric): (2) Cluster B (dramatic/erratic); and (3) Cluster C
(anxiouslfearful). There is also a category called "PersonalHy DIsorder, not othelWlse
specified." This is for people who have traits from a number of different PDs, but may
not meet criteria for a specific PO diagnosis.
c. There are no formal studies that show which type of PO is most commonly
diagnosed in the military. However. AR 635-200 requires not only presence of the
diagnosis of a PD. but that it is of such severity as to preclude military service.
Persistent suicidal or homicidal ideation generally rises to that level of severity. since
these impact on both the Soldier's ability to perform his/her mission and on the SoldIer's
unit.
d. Suicidal Ideation may be a symptom of many different conditions, but If it Is a
component of a PD. it is often associated with a borderline PO. (Please see OSM IV-TR
for the full diagnostic criteria). Homicidal ideatlon is often consistent with antisocial PD.
e. Post Traumatic Stress Disorder (PTSD) is a specific psychiatric diagnOSis on Axis
I In which an individual Is exposed to a traumatic event. In order to meet the diagnosis

of PTSD, the following criteria must be present: (1) The person has been exposed to a
traumatic event in which both of the fonowlng were present: (a) the person experienced,
witnessed, or was confronted with an event that Involved actual or threatened death, or
serious Injury. or a threat to the physIcal integrity of self and others; and (b) the person's
response Involved intense fear. helplessness, or horror. (2) The traumatic event Is
persistently re~experienced in one (or more) of the following ways: (a) recurrent and
intrusive distressing recollections of the event (images, thoughts. or perceptions); (b)
recurrent dreams of the event; (c) acting or feeling as if the traumatic event were
recurring; (d) Intense psychological distress at exposure to internal or external cues that

symbolize or resemble an aspect of the traumatic event; (e) physiological reactivity

upon exposure to Internal or external cues that symbolizes or resembles an aspect of
the traumatic event. (3) Persistent avoidance of stimuli associated with the trauma and
numbering of general responsiveness (not present before the trauma), as Indicated by
three (or more) of the following: (a) efforts to avoid thoughts, feelings or conversations
associated with the trauma; (b) efforts to avoid activities, places, or people that arouse
recollections of the trauma; (c) inability to recall an important aspect of the trauma; (d)
markedly diminished Interest or participation in significant activities; (e) feeling detached
or estranged from others; (f) restricted range of affect; (g) sense of foreshortened future.
(4) Persistent symptoms of Increased arousal (not present before the trauma), as
indicated by two (or more) of the following: (a) difficulty falling asleep; (b) irritability or
outbursts of anger; (c) difficUlty concentrating; (d) hypervlgllence; (e) exaggerated
startle response; (5) Duration of the disturbance (symptoms in Criteria 2, 3, and 4) is
more than one month. (6) The disturbance causes clinically significant distress or
impairment in social, occupational, or other Important areas of functioning.
f. While all Soldiers who experience combat are affected and It is normal to have
symptoms, most do not develop PTSD. Data is now available from multiple sources
that indicate that 10-15% of Soldiers returning from OIF develop PTSD. and that
another 10-15% experience significant symptoms of PTSD, depression, or anxiety and
may benefit from care. Alcohol. aggression, and family problems add to or exacerbate
these concerns. PTSD and PD may co-exist.
III. Record Review Methods

1. Background.
a. Anny G-1 identified 359 OEF/OIF Soldiers separated from 2001 through 2005
under Chapter 513. According to the statistics provided by Army G1, the Army
separated 4,545 Soldiers from FY 2001 through 2005 under Chapter 5-13.
b. OTSG requested the administrative files, the medical records and the mental
health records for each Soldier identified. The review took place in September 2007.
Administrative records were available online. The medical records were all hard copies,
and were located in a VA facility in St. Louis, MO. Some of these were printouts from
the new electronic medical record (AHLTA). The mental health records came from a
variety of sources, to Include theater facilities, Landstuhl Regional Medical Center in
Germany, military treatment facilities in the US, and civilian facilities. In the past, the
Army maintained mental health records, separate from other medical records, In the
behavioral health clinic. Over the past two years, the Army has gradually transltloned to
the electronic medical record known as AHLTA, which has medical and most mental
health records. The records with electronic documentation were, generally, much
clearer and more complete than the paper records.

2. Administrative Record Review

All Soldiers had some administrative files available online and the vast majority had
adequate administrative information available. Most had the appropriate documentation
from behavioral health to support the administrative actions, including the Chapter 5-13.
For example, the Report of Mental Status Evaluation, which is a document from the
provider to the command, was usually included in the administrative records.
3. Medical Record Review

a. A team flew to St. Louis, MO, and reviewed medical records in the Veterans
Affairs Record Management Center. 127 (36%) medical records were accessible.
Many medical records were othelWise unavailable because of previous requests.
Available records were reviewed by four Army behavioral health officers, one of whom
was a physician. The comprehensiveness of these records with respect to mental
health documentation varied considerably. Many included some mental health
information, especially the Report of Mental Status Evaluation.
b. Most records contained the Pre-Deployment Screening. (PDHA; DO Form 2795)
and the Post-Deployment Health Assessment. (PDHA; DD Form 2796). The Post
Deployment Health Re-Assessment (DO Form 2900) was rarely enclosed. The DO
Form 2900 was usually absent for two reasons: (1) the PDHRA was not implemented
until 2005. and (2) the PDHRA is normally not completed until 3-6 months after
redeployment and some Soldiers separate before they reach this window. Both the
PDHA and the PDHRA have a number of questions specific to PTSD symptoms. The
reviewers noted if any responses were positive. Reviewers also specifically reviewed
and documented the presence of Traumatic Brain Injury (TBI), as well as other medical
conditions.
4. Behavioral Health Record Review

a. Reviewers queried Regional Medical Commands (RMCs) for behavioral health

records. These records are maintained at the local medical facility. The request to the
RMCs was for intake notes, discharge summaries, mental status evaluations. and any
other pertinent data. The RMCs submitted 242 behavioral health records for review.
b. The information available from the behavioral health records was highly variable.
Some of these records came from theater OIF/OEF. from Landstuhl RMC and/or from
medical treatment facilities In the US. In some cases, records from complete inpatient
psychiatric hospitalizations were forwarded. In other cases, there were only medical
evacuation summaries, Report of Mental Status Evaluations or other memoranda from
the command. However, in most cases the Report of Mental Status Evaluation was
available In the administrative records.
c. Either a board-certified psychiatrist or licensed clinical doctora/-Ievel psychologist
reviewed the behavioral health flies. A total of five psychiatrists or psychologists
participated in the reviews.

5. Review Criteria: Data points specifically assessed and recorded were the following:
a, Is there significant supporting clinical evidence for an Axis II diagnosis?
b. Is the severity of the PO condition documented in accordance with Army

Regulation 635200?

c. Are other mental health conditions present?

d. Does the patient also meet criteria for a Medical Evaluation Board (MEB)?
e. Is there documentation of a head lnjuryrrBI? If so, what Is the severity?
f. Is another chapter (e.g., Chapter 14, 5-17) an altemative?
g. Are there UCMJ actions?
h. What are the credentials of the providers listed on the Report of Mental Status

Evaluation?

I. Are there other significant medical conditions?

j. Patient gender and ethnicity

k. Military installation of discharge
IV. Results of the 5-13 Records Review: Overview

a. This review focused on two processes: (1) a quality review of the record to
determine whether mental health documents were In order and properly signed by a
board-certified psychiatrist or licensed clinical doctoral-level psychologist; and (2)
whether the diagnosis met the criterion established In DSM IV-TR for the personality
disorder.
b. It is important to note that the varIables above were ascertained independently.
Thus, a Soldier might meet the criteria for PD, but also have other mental health
conditions. such as an adjustment disorder with depressed mood. A Soldier might have
other medical conditions present, but not meet the criteria for a full MEB, which is based
on fitness for duty considerations. A Soldier might have excellent documentation of his
or her past history. but it may not be signed by the appropriate provider. Therefore. the
number and percentages cited below do not add up neatly. Many Soldiers had
evidence of symptoms of both Axis I and Axis II disorders. In numerous cases there was
evidence of drug use, which could confound the other diagnoses. Finally, In some
cases where there were Insufficient documents, a judgment call was made as to
whether there was significant supporting evidence for a PD. In these cases, the issue
was discussed with the team.

(1) Given that a PO is a chronic condition that usually exists prior to service
(EPTS), Chapter 5-13 should only be given to Soldiers who have shown an Inability to
function effectively in a military environment. As such, it Is generally inappropriate for a
Soldier on his or her second enlistment (one who has already completed a full contract,
received an Honorable Discharge, and offered a second tour of service), a Soldier who
was promoted to the grade of non-commissioned officer (NCO). or a Soldier who has
received a series of awards for meritorious and effective service. All these variables are
strong indicators that at one time the Individual had adapted well to military service, and
therefore the Inability to adapt was acquired rather than innate.
(2) In some cases the Chapter 5-13 separation appeared to serve another
function: it provided a mechanism for an honorable discharge 'or the convenience of
the Government" that allowed Soldiers who did not otherwise qualify for another chapter
or an MEB to be released from service. In most of these cases t records indicated that
the Soldier welcomed their administrative separation from the service.
V. Results of the Review: Individual Varlab'es Examined

a. Significant Support for Axis II Diagnosis.

(1) A record was acceptable as showing significant support for a PD diagnosis If
there was an adequate description of behavioral health problems commonly associated
with PD (e.g., self mutilation. suicide gestures or attempts, homicidal Ideation or
actions).

(2) 200 (570/0) of the cases reviewed established the presence of a PD by

specifying a chronic pattern of maladjustment which predated military service. In 96
(27%) of cases, there was insufficient support for an Axis II diagnosis documented, and
In 56 (16%) cases there was not enough documentation to ascertain this Issue.
(3) Recent suiCidal ideation andlor attempts or recent homicidal ideation often
precipitated the request for a PD separation. In 191 (43%) cases of these discharges,
the records documented evidence of suicidal ideation andlor attempts. In another 70
(20%) cases the records documented homicidal Ideation andlor actions.
b. Severity level as to preclude Military Service Documented.
(1) Separation for PD under paragraph 513 of AR 635-200 requires not just
presence of the diagnosis of a PD, but a determination that the PO Is of such severity as
to preclude military service.
(2) In 255 (72%) of aU cases the severity of the psychiatriC condition is properly
documented. In 51 cases documentation was insufficient, and in 46 cases that
Information is unknown.

c. Criteria for MEB met and Other Mental Health Conditions Present:
(1) Soldiers in 46 (13%) cases had a Axis I condition documented which
appeared to meet criterion for an MEB. In some cases an MEB had been Initiated, but
was unsuccessful. This was particularly true for PTSO cases, whIch require
considerable documentation (i.e. witness statements) to establish a service connection
and severity rating.
(2) It Is Important to note that even if these Soldiers were referred to a MEB, they
may not have received any dIsability rating, as many of these conditions existed prior to
service or were not in themselves disabling. However, discussion of an MEB does not
mean the Soldier would have been found unfit and given disability by the MEB/PES
process.
(3) Symptoms of PTSO: some symptoms of PTSD were noted as diagnosed In
34 cases.
(4) Presence and severity of head injury or Traumatic Brain Injury (TBI):
Reviewers speciflcally examined medical records and mental health records to assess
for a history of TBI. Such evidence was only present In one case. The relationship of
the injury to the symptoms leading to the discharge was also assessed. There were no
cases of TBI misdiagnosed as POs.
d. Altemative administrative separations and UCMJ action:
(1) In 47 cases, the Soldiers were eligible for separations under other chapters;
e.g., Chapter 5-17. Other Physical or Mental Conditions Not Amounting to Disability. or
Chapter 14, Misconduct.
(2) In 50 cases, there was documentation of disciplinary action for misconduct
under the UCMJ. While Soldiers with PO are often disciplined under UCMJ, it is not
always clear why anyone Soldier was separated under Chapter 5-13 for PO in lieu of
Chapter 14 for misconduct. It may be that the Soldier's Command wanted the Soldier to
receive an Honorable Discharge. rather than a less favorable characterization of
service.
e. Credentials. There were two (O.SOfa) cases where It appeared that the mental
health documents were Signed by staff who were not authorized by regulation to do so
(I.e social work officers. nonpsychiatric physicians, or nurses).
f. Other Signiflcant Medical Conditions. In several cases documents indicated that
Soldiers suffered from other medical conditions, Including low back pain and various
orthopediC injuries; however, based on the available medical information. these
conditions generally did not appear to rise to the level of requiring referral to an MEB.
g. Gender and Ethnlcity:

(1) 82% were male. 18% female. This compares to the 15% female make-up of
the Army.
(2) It is not possible to determine the ethnlctty based on these records.
h. Installation Specific Information. Records were sorted based on the Installation
that completed the separation.
Tablet
Discharge by Installation
Ft Benning
5
Ft Bliss
21
Ft Bragg
15
Ft Campbell
16
Ft Carson
45
Ft Drum
16
Ft Eustis
7
Ft Gordon
5
Hunter AF
6
Ft Hood
32
Ft Irwin
4
FtJackson
0
Ft Knox
1
Ft Lee
5
Ft Leonard Wood
0
Ft Lewis
52
0
Okinawa
Ft Polk
27
Ft Richardson
1
Ft Riley
17
Schofield
1
Ft Stewart
30
FtSill
7
Ft Wainwright
1
WRAMC
0
Europe (total)
26
Other
12
Totals
352

VI. Conclusion

a. The fragmentary status of many of the mental health records confound the
conclusions below. Now that the electronic medical record has been widely
implemented. there will be a far greater ability to track the health care of Soldiers. From
the available records, there was no evidence that Soldiers were systematically
misdiagnosed. However, in many cases there were several Axis I and the Axis II
diagnoses. and In these index cases the Soldiers were discharged for the personality
disorder. Also not available for this review were the records of Soldiers not discharged
for this diagnosis.
b. Except on the PDHA and PDHRA, reviewers did not generally find evidence of
comprehensive screening and documentation for either PTSO or TBI in the medical
records.
c. Existing pOlicies. such as the new requirement for the Chief of Behavioral Health
to review all Chapter 5-13 separations and for licensed psychologists or psychiatrists to
sign all Chapter 513s, need to be emphasized to the local installations and better
quality assurance reviews of records need to be performed.
d. Better documentation of all the variables described above is essential.
VII. Recommendations

a. For healthcare providers:

(1) Clearly document the reasons for the PO recommendation. Document the
OSM IV-TR criteria clearly and completely.
(2) If there Is an Axis I diagnosis. document why the type of separation was

selected.
(3) A psychologist or psychiatrist must make the recommendation, not a social
worker, non-psychiatric physician, or nurse.
(4) The Chief of Behavioral Health at every Installation should review all
recommended Chapter 5-13 separation actions as a quality control measure.
(5) Clearly document historic patterns of behavior consistent with a PD. If not
evident earlier in life, and the person has behavioral difficulties incompatible with military
servIce, a Chapter 517. Chapter 13 or 14 may be more appropriate.
(6) If In doubt as to whether to separate a Soldier for PO under Chapter 513 or
to refer the Soldier to an MEB, recommend an MEB.

10

(7) Document counseling and rehabilitation efforts, including your counseling to

the Command regarding the needed rehabilitation. Document the Command's
adherence to your recommendations.
(8) If a Chapter 5-13 was selected Instead of another chapter {e.g. misconduct,
failure to adapt, etc.}, document the reasons.
(9) Make sure that PTSD Is not the reason for the behavioral difficulties. If It Is,
consider an MEB or other therapeutic options. Screen and document more rigorously
for PTSD and TBI.
Note: These recommendations have already been provided to the field in a number of
forums. New policy from ATSG ensures that all Chapter 5-13 recommendatrons are
reviewed by the ChIef of BehavIoral Health at that Installation.
b. For the Soldier's command:
(1) Ensure all chapter packets are administratively complete.
(2) Ensure that each Soldier understands hlslher rights, the impact of the
separation on his/her future and his/her avenues to appeal the decision.
c. For Army Leadership:
(1) Send a personal letter to Soldiers who may have questions In reference to
their Chapter 5-13 discharge. The letter should clearly explain the guidelines for
submitting an appeal packet to the Army Board for Correction of Military Records
(ABCMR).
(2) Personnel from Army Review Board Agency are available to answer questions
during normal business hours.
VIII. The Way Ahead

Chapter 5-13s will contInue to be monitored both at the installation level and centrally at
the Office of The Surgeon General to ensure that the recommendations listed above are
being followed.

11

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10, 6 March 2012
BAMCIWHMC

PROTOCOL FOR CLINICAL INVESTIGATION - EXPEDITED

1.0 Title: A Comparative Study: ImPACT MIL versus ANAM4TM TBI MIL for Acute
Concussion

2.0 Principal Investigator (PI):

r(b)(6)

f(b)(6)

iPh.D., (Clini cal Neuropswhol agist

8
9

10
II
12

2.1 Associate Investigators (AI):

13
14

~~~;_ _ _ _--"!PLhl!..A.1D~AB~PuPLll{C..L!lcUinil.Cic"",au...I.....,N,-"e""ur.....o""o"'-'svu.cCl.!h""'oJ"""o:-.Q;i""st""-,)

15

16
17
18

19

20
21

~)m

22

~ Ph.D. (Clinical Neurop.~ychologistlMedical Psychologist)

23

24

25
26

27
28
29
30

[--------'
l(b)(6)

I Ph.D., MAl

l(b)(6)

31

32
33
34

35
36

Template Revised 13 April 09

(Clinical Neuropsychologist)Chief, Neuropsychology Service

I

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10, 6 March 2012
2
37
38
39

(b)(6f~~~

(b)(6) - - -

40
41

42
43

44
45

(b)(6)

46
47
48

49
50

51
52

(b)(6)

IPh.D. (Clinical Neuropsychologist)

[u>x6)

53
54

55
56
57

58

,-~._ _ _ ~ . .~_--,MD,

59

Colonel, Medical Corps, US Arm---'y'--_ _ _ _ _ _-.

60

61

62
63

MSM, FACEP

64
65

66
67
68
69

~~(6)__ _

70
71

MS

!(Clinical Psychologist)

72

73

74
75
76

77

(b)(6)
l' - - - - - - - - ' (Rehabilitation Psychologist)
Template Revised 13 April 09

Protocol Title: A Comparative Study: ImP ACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10, 6 March 2012

78

79

80

81

82

83

3.0 Locations:

84

Brooke Army Medical Center

3851 Roger Brooke Drive

Fort Sam Houston, TX 78234

85

86

87

88

89
90

Carl R. Darnall Army Medical Center

36000 Darnall Loop

Fort Hood, TX 76544-4752

91

92
93
94

LandstuhI Army Medical Center

Bldg 3703

LandstuhllKirchberg 66849

95

96
97

98
99

100
101
102

TripIer Army Medical Center

1 Jarrett White Road

Honolulu, HI 96859

Martin Army Community Hospital

7950 Martin Loop
Fort Benning, GA 31905-5637

103

104
105

4.0 Research :Plan

106

4.1 Purpose:

107

The study's purpose is to evaluate the differences in clinical utility and effectiveness
between the Automated Neuropsychological Assessment Metrics 4th edition Military Version
(ANAM 4 TBI MIL) and the Immediate Post-Concussion Assessment and Cognitive Testing
Military Version (ImP ACT MIL), which are both designed to determine the effect of mild
traumatic brain injury (mTBI) on neurocognitive functioning. Since a decreased ability to
maintain balance is also a characteristic ofmTBl, the Unipedal Stance Test (UPST) will be given
as a measure of potential neurological impairment, and compared to the traditional
neurocognitive tests. Another proposed indicator of the presence of brain injury after mild head

108
109
110

III
112
113
114

Template Revised 13 April 09

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version # 10, 6 March 2012
4
ll5
116

trauma is a quantitative electroencephalogy (QEEG), which will be also given as an additional

measure using a portable EEG monitoring device, the AHEAD M-I00.

117
118

119
120
121
122
123
124
125
126
127
128
129
130
131
132

4.2 Hypotheses/Research Questions:

A. To what extent do individuals diagnosed with mTBI differ from otherwise healthy, non
injured individuals on the ANAM4 TBI MIL and ImPACT MIL?
B. Does either neurocognitive assessment battery demonstrate significantly greater

sensitivity and specificity for an acute concussion in a military sample?

C. To what extent do individuals diagnosed with mTBI differ from otherwise healthy, non
injured individuals on the Ahead M-lOO device using the manufacturer's proprietary
interpretive algorithms?

D. Does the use of the Ahead M-IOO demonstrate significantly greater sensitivity and
specificity for an acute concussion in a military sample when compared to traditional
neurocognitive measures?

133

4.3 Significance:

134

143

Mild TBI can be found in both the civilian and military environments. Common causes of
TBI, both civilian and military, include falls, motor vehicle accidents, striking or being thrown
against an object, and assault. According to existing data, more than l.5 million people
experience a traumatic brain injury (TBI) each year in the United States. These injuries have
been identified as possibly causing long-term or permanent impairments. In addition to the
growing population of the injured, mTBI costs the nation nearly $17 billion each year in funding
(Binder, 2003). Accurate neurocognitive assessment calculated by a valid, sensitive, specific,
computerized instrument would greatly assist in the medical care of concussed patients. A rapid
test that shows strong validity and utility will provide the capacity for assessment in remote
locations that lack neuropsychological services.

144

4.4 Military Relevance:

145

The army is currently using two different computerized neurocognitive batteries for
measuring concussion: ANAM4 and INIPACT. Both tests have their advocates and detractors,
but there is no data as to which is superior for this purpose. This study will allow the Army to
best serve its service members by selecting the superior instrument for wider fielding and use.

135
136
137
138
139
140
141
142

146

147
148

Template Revised 13 April 09

Protocol Title: A Comparative Study: ImP ACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10, 6 March 2012
149
150
151
152
153
154
155
156

157
158

Management of acute concussion is a significant problem for the military today. As an

alternative to traditional neuropsychological testing, which can only be conducted by a licensed
clinical neuropsychologist, automated (computerized) neurocognitive testing has been proposed
for the assessment of cognitive impairment in individuals who are suspected to have
mTBI/concussion. It is known that mTBI often does not present with apparent visible symptoms,
and the symptoms may also overlap with other diagnoses; therefore, the most effective test needs
to be chosen to aid in the detection and treatment of mTBI. Additional benefits would include the
means to monitor the injured soldier's status, treatment progress, and return-to-duty potential.
The study seeks to establish which of the tests currently in use by the military has the strongest
validity and utility for soldiers suffering from mild traumatic brain injury (TBI) is considered the
Table 1.

Common Symptoms of Traumatic Brain Injury

Gcner:ll Sym toms of TBI

Head.u:hes
DiHintiry organizing daily tasks
fvletltal ,~onfusion (easilv confused,
e;lSily feeling ovenvh':lmed)
iJgluheldnt"ss or
dizzy
fI.lore sensicivt:' to auditon srjm\lll,
lighr5 1 or other diHr;Ktions
Beh.ayior or mood change5 {feeling
sad. anxious, Of listless)

bLun'od vision. or

Rid. !::.lSre in The mouth

Enigue or krharb"Y (fedillg tired all

Sym toms of l\1oderare ( 0 Severe TB[

L;.ss of o:msciousne...;;s 00 minutes or more)
Lo.~s

of Cl.1<..'l\.1iuarion

Weakness or lHU11bness in rhe e:(tl-enliries

Slurred speech

Dilation of one or both pupil>

Inability to awaken

or nausea
A sevet"C, pC'l'isrenc, 01' worsening headache

ofthe time)
A change in slee , patterns
Trouble WITh men1.011~,
c.oncenrrarion, 01' I..:"kulations
Ea.sily in:iH1.r("1..1 or .illlge red -;-_ _ _-/-_ _ _ _ _ _ _ _ _ _ _ _ _ _ __
ImpllhillhT (bek of lnhibidoll,l
Slowed movement, mJkillg, l'e.ldIng.
or rhinking
Sexual dyshll1<;:tion

159
160
161

162
163

164
165

signature wound of the current conflicts (Okie, 2005; Keltner, 2007). As of September 30,2007
the Pentagon listed 4471 TBI diagnoses from OEF and OIF. However, the founder of the
Congressional Brain Injury Task Force, estimates more than 150,000 instances ofTBI have
occurred among approximately 1.5 million OEF/OIF participants (Zoroya, 2007). The
discrepancy may be due to the idea that an estimated 80% ofTBls are mild (mTBI); a condition
that is not readily apparent (Heegaard, 2007). Most mTBI patients make a rapid recovery, suffer
few post-injury complications, and, for these reasons, often bypass acute medical attention or
Template Revised 13 April 09

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version # 10,6 March 2012
6
166
167

hospitalization. Nevertheless, between three to five percent of mTBI patients develop chronic
symptoms, and delayed symptom onset is not uncommon (McCrea, 2008).

168
169
170
171

In OEF and OIF, the most common sources ofTBI are explosives and blasts (Keltner 2007;
DePalma, 2005; Finkel, 2006; and Warden 2006). Traumatic brain injury accounts for
approximately 60% of war injuries caused by blasts (Keltner, 2005). The severity of the TBI
depends on the magnitude of symptoms that result from the injury, and outcomes can range from
a complete recovery to permanent disability or death (Rao, 2000; Heegaard, 2007; Moppett,
2007). When blasts and other mechanisms of injury that result in loss of consciousness produce
a TBI, the injury may be defined as mild (:s 30 minutes) (American Congress of Rehabilitation
Medicine definition). Also accompanying TBI may be anterograde memory loss or post
traumatic amnesia, as well as difficulty encoding new information following the injury. Not all
TBI victims suffer from loss of consciousness or amnesia. Those with more mild exposure to
trauma may become dazed and confused, characterized by difficulties with orientation,
perception, concentration, memory encoding and retrieval, and judgment.

172
173
174
175
176
177
178
179
180
181
182
183
184
185
186
187
188
189
190
191
192
193
194
195
196
197
198
199
200
201
202
203

Further complicating recovery from mTBI is an assemblage of cognitive, physical, and

emotional symptoms that can occur following mTBI, termed post-concussive syndrome
(Bazarian, 2001; Lishmann, 1988; Vanderploeg 2007). Patients with post-concussive syndrome
may complain of headaches, postural imbalance, insomnia, memory problems, fatigue, irritable
or depressed mood, or interpersonal conflict (Lew, 2006; Vanderploeg, 2005). This syndrome is
challenging to diagnose using a detailed physical exam or neuroimaging alone. It is often the
case, unfortunately, that misattributions of underlying psychopathology prevent post-concussive
syndrome patients from receiving appropriate care.
To date, studies which have attempted to detect the effects of mTBI in a population have
produced only modest results. The natural course of concussion is to heal with few if any
residual symptoms, (Wyman, 2008). Further, as also pointed out by Wyman, the current
classification system for concussion is based upon the criteria of Kay and Associates (1993)
which allows the diagnosis of mTBI with only a transient alteration of consciousness-easily
non-neurologic in etiology-and thus the vast maj ority of mTBI subjects have suffered no
unconsciousness nor loss of memory. Ifthere is a common group neuropsychological correlate
in such a popUlation, it is likely transient and needs to be acutely measured in recent concussion.
Despite the prevalence of wartime mTBI, the chronological stages in improvement of
related sequelae are poorly understood. Due to the complexity of injury, there has been a recent
surge of research to improve techniques for early detection and assessment.
Clinicians and researchers have begun to recognize the utility of computerized testing for
assessing neurological insult (i.e., mTBI; Register-Mihalik, Guskiewicz, Mann & Shields, 2007).
There remains a paucity of evidence that computerized testing immediately following possible
brain injury from blast exposure or alternative sources is beneficial. A study conducted by
McCrea et al. 2005, reported increased sensitivity to acute concussion when comparing
Template Revised 13 April 09

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10, 6 March 2012
7
204
205
206
207
208
209
210
211

212

213
214
215
216
217
218
219
220
221

222
223
224
225
226
227
228
229
230
231
232
233
234
235
236
237

238
239
240
241

242
243

neuropsychological testing to a brief battery consisting ofa graded symptoms checklist (GSC),
standardized assessment of concussion (SAC), and Balance Error Scoring System (BESS). The
BESS has been studied for over 10 years (Broglio 2009) and has become a standard test for
assessing concussion in high school and college athletes. They demonstrated the relative
sensitivity of neurocognitive testing increased by five percent two days following concussion and
by fourteen to thirty percent seven days following a concussion. They noted, however, that the
increased sensitivity at seven days post-mTBI rate must be balanced against the false-positive
rate of nine percent identified in the normal control group. A small but clinically significant
percentage of injured athletes who reported being symptom free by day two continued to be
classified as impaired on the basis of objective balance (the Balance Error Scoring System
(BESS and computerized neurocognitive testing. These data suggest that neuropsychological
testing may be of incremental utility to subjective symptom checklists in identifying the residual
effects of sport-related concussion. The implementation of neuropsychological testing to detect
subtle cognitive impairment is most useful once post concussive symptoms have resolved. This
management model is also supported by practical and other methodological considerations
(McCrea, 2008),
In the past, self reported symptom checklists were a significant tool used to evaluate sports
related concussions, but the lack of objective data made it difficult to properly assess those with
concussions in the sports arena (Oliaro, 2001). The 2005 study by McCrea et al. indicated that
objective balance was clinically significant even when there were no self-reported symptoms in a
post-concussion group. The BESS is a modified version of the Romberg test and can be
administered in less than 10 minutes. It is conducted under six stance conditions: a double-leg
stance, single-leg stance, and heel-to-toe tandem stance - each on a firm surface, then on a
flexible foam surface (Broglio, 2009). The subject is tested with their eyes open as well as eyes
closed. During the trial, the number of errors an athlete makes is counted, with the higher
number of errors representing suppressed balance, If there is an increase of three or more errors
above the baseline this may represent a significant change indicative of a balance impairment
(Valovish-McLeod, 2006) with a sensitivity to concussion reported at 34% and specificity at
91% (McCrea, 2005).
The BESS has been demonstrated to be both reliable and valid for sports-related
concussions (Guskiewicz et aI., 200]; Riemann et at, 1999; Riemann & Guskiewicz, 2000). The
BESS is recommended for use with military personnel (Iverson, 2008). However, the BESS has
often been noted as having poor inter-rater reliability. While the stances of the BESS are simple,
often there is an issue with administrators' subjective evaluation of the test. One rater will count
a fault while another rater watching the same subject would not. Thus this difference can result
in a decrease in test reliability. Per Springer, Marin, Cyhan, Roberts, and Norman (2007), being
able to remove the subjective portions of the test and reduce the number of stances conducted
should result in a test with great reliability and validity, If the necessary clinical information can
be gathered in a shorter period of time using two stances completed twice rather than three
stances completed twice (on two different surfaces), that test may have greater clinical
Template Revised 13 April 09

Protocol Title: A Comparative Study: ImP ACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
8
Version if 10,6 March 2012
244
245
246
247
248
249
250
251
252
253
254
255
256
257
258
259
260
261
262
263
264
265
266
267
268

269
270
271
272
273
274
275
276
277
278
279
280
281
282

283

application than the BESS when assessing for mTBI. The Unipedal Stance Test (UPST) is
described as a method of quantifying static balance ability (Newton, 1989). In this test the
subj ect stands barefoot, both on a hard surface and again of a foam surface, on the leg of their
choice, with the other leg raised near, but not touching, the ankle of their supporting limb. The
subject is asked to focus on a spot on the wall at eye level in front of them and to cross their arms
over their chest. They are to hold this stance as long as possible or up to 45 seconds (Springer et
al., 2007). The measure is then repeated with the patient's eyes closed. Each session is completed
three times and is timed. The timing of the session is stopped if any of the following occur: the
non-stance foot touches the floor, the arms are uncrossed, the stance foot shifts, participants open
their eyes during the eyes closed test, or they reach the maximum time of 4S seconds.
Two computerized, neuropsychological tests, the Immediate Post-concussion Assessment
and Cognitive Testing (ImP ACT) and the Automated Neuropsychiatric Assessment Metric
(ANAM) are currently being administered to active duty military personnel to assess for mTBI.
However, there has been little research supporting the efficacy or accuracy of either test.
Therefore, the best method for assessing mTBI has yet to be established. The most efficacious
approach to addressing uncertainty surrounding the validity and clinical utility of the ImP ACT
and the ANAM is to systematically conduct research comparing the two tests, which will
indicate the assessment that can offer the most accurate measurements of mTBI.
Currently there is a dearth of data in the scientific literature on the computer-based
neurocognitive/neuropsychological test batteries and their use with active duty military
personnel. According to Lovell (2001), the ImPACT 2.0 was designed to objectively measure
visual and verbal memory, working memory, processing speed, visual motor skills, and reaction
time to assist in the diagnosis and tracking recovery of the concussed individual. The test was
developed at the University of Pittsburgh Medical School and has been widely used with high
school and college athletes following sports related concussions. Lovell (2001) noted that the
short administration time of20 minutes as it relates to sports injuries relies on two
administrations; one pre-season (baseline) and one post-injury, in order to measure cognitive
deficits post-concussion. Research indicated one of the key attributes of the ImPACT was its
ability to accurately identify cognitive data and post- concussive symptoms following an injury,
as well as playa key role in determining whether the concussed individual is fit for play return to
work, or requires additional evaluation or services. The military is currently using ImP ACT MIL,
which consists often cognitive tasks (subjective profile and health history questionnaire, current
symptoms, injury description and conditions, and six neuropsychological tests (word
discrimination, design memory, Xs and Os, symbol matching, color match, and three letters).
The ImP ACT MIL is currently being used to aid in the detection, diagnosis, and treatment of
Special Forces soldiers with mTBI. It can be administered individual1y or in a group setting, thus
making its administration to large groups easier than traditional paper and pencil
neuropsychological tests.
In terms of sensitivity of specificity, Schatz et al. (2005) found that among high school
athletes suffering from a concussion; the ImP ACT was successful at identifying 85.5 % of the
Template Revised 13 April 09

Protocol Title: A Comparative Study: ImP ACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version # 10, 6 March 2012
9
284
285
286
287
288
289
290
291
292
293
294
295
296
297
298
299
300
301
302
303
304
305
306
307
308
309
310

311
312
313
J 14

315
316

317
318
319
320

321

cases as either concussed or non-concussed. Visual memory, reaction time, and processing speed
subtest composite scores were found to be very sensitive to detecting mild concussion in high
school athletes. Sensitivity was reported at 81.9% and specificity at 89.4 %. A study by Van
Kampen et al. (2006) supported the idea that objective neuropsychological tests may be more
consistent than that of a measure of self-reported symptoms. According to Aubry et aL (2001),
the risk of false negatives is higher when only paper and pencil neurocognitive measures are
used due to the test's susceptibility to practice and learning effects.
ANAM is the culmination of a long line of computer-based test systems developed by the
Department of Defense and evolved principally from the Unified Tri-Service Cognitive
Performance Assessment Battery (UTC-PAB; Englund, Reeves, et aI., 1987). According to
Reeves et al. (2007), the AN AM was specifically designed to meet the needs of researchers and
clinicians assessing neuropsychological function in long-term (6-12 months), short-term (daily to
weekly), and within session repeated measures assessment. After the Center for the Study of
Human Operator Performance (C-SHOP) based at the University of Oklahoma received the
exclusive license for ANAM, researchers and staff at the center surveyed ANAM users, initiated
a quality assurance assessment of the existing ANAM software, and then set about making
improvements and innovations in order to produce an enhanced suite of ANAM software
products that would provide greater uniformity, capability, and usability, C-SHOP released an
improved version of the ANAM test modules (version 4.0 or ANAM4TM) in the Fall of2006. The
ANAM4TM TBI MIL Battery is the current version being used by the military today. C-SHOP
says the ANAM4TM TBI MIL Battery provides "precise, objective, automated measures of
fundamental neurocognitive functions including response speed, attention/concentration,
immediate and delayed memory, spatial processing, and decision processing speed and
efficiency" (Helmick, et a1., 2006). These qualities of the ANAM4TM TBI MIL Battery are
consistent with past applications of computer-based testing of TBI, with normative work
conducted by DVBIC, and with the Clinical Practice Guidelines and Recommendations
published by the Defense and Veterans Brain Injury Center Working Group on the Acute
Management of Mild Traumatic Brain Injury in Military Operational Settings (Helmick, et aI,
2006).
Levinson and Reeves (1997) conducted a study in which a battery of ANAM tests was able
to correctly classify brain-injured patients with 91 % accuracy, a better level of accuracy than
alternative neuropsychological tests or staff ratings. A review of recent studies involving ANAM
by Cernich, et al. (2007) focused on the sensitivity and specificity of the ANAM. Bleiberg and
Warden (2002) showed that none of the control subjects they tested showed a reliable decline on
more than one ANAM test in comparison to all the injured subjects. Additionally, the
Mathematical Processing test showed the greatest specificity for concussive injury. It was also
noted by Bleiberg and Warden (2002) that the percentage of concussed subjects who failed to
demonstrate practice effects was much greater in comparison to that of the control subjects.

Template Revised 13 April 09

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version 10,6 March 2012
10

324
325
326
327
328
329

Recently, portable, user-friendly EEG devices have been used in the detection and tracking
ofmTBI following sports-related concussions. The McCrea et al. 2010 study-using QEEG to
track mTBI recovery in a cohort of28 athletes-found QEEG results showed a typical course of
recovery following concussion. However, the study also said QEEG findings "suggest that the
duration of physiological recovery after concussion may take longer than observed clinical
recovery." Naunheim et al. 2010 found the use ofQEEG in a TBI-positive population to have
92.45% sensitivity and 90% specificity when compared to a CT for TBI, thus adding to the
validity ofQEEG as a sensitive index of brain function.

330

4.4.1 BrainScope QEEG Background Information

331
332

The BrainScope Ahead M-l 00 is a QEEG device indicated for use to aid in the triage of patients
who are suspected of a traumatically induced structural brain injury and/or clinical maniffestions
of functional brain injury, as a result of an insult to the head from an external force. BrainScope
has spent many years and millions of dollars developing a medical device to address the unmet
need for detecting the level of structural injury and functional impairment from TBI in an acute
setting. The Ahead M-I 00 uses a sophisticated mathematical algorithms to collect and obtain an
output that has clinical utility for the Military, Emergency Medicine and Sports Medicine. It has
been specifically designed to accommodate current military environmental needs including
digital signal processing and immunity to external noise interference.

322
323

333
334
335
336
337
338
339
340
341
342
343
344
345
346
347
348
349
350
351
352
353
354
355
356
357
358
359
360

The Ahead M-I 00 device is a single-use, proprietary headset containing pre-gelled electrodes
will be placed on the subject's forehead and earlobes according to the standard locations of the
modified International 10/20 system, including: FPI, FP2, AFZ, F7, F8, left and right earlobes
and a ground at FPZ. The forehead will be cleaned with a mild abrasive sponge used as standard
practice to improve contact of the headset with the skin. All electrode impedances will be below
lOll prior to the start of the recording.
Subjects will undergo approximately 5 minutes of eyes closed EEG recording. At the end of 5
minutes, if the device has acquired 48 epochs (each 2.5 seconds) of artifact-free data, the
embedded algorithms will process the stored data to obtain the classification result. If 48 epochs
were not recorded in 5 minutes, the device will continue recording for an additional 5 minutes.
In no instance will the algorithm use fewer than 24 epochs of artifact-free data to calculate the
BrainScope Classification Output.
The Ahead M-lOO utilizes a combination of three classification algorithms that enable
discrimination among 4 patient groups. These classification algorithms are combined in a
sequential fashion that maximizes accuracy (sensitivity and specificity) of classification.
The sequence of the classifiers to determine the Ahead M-I 00 Classification in which a patient
belongs is as follows: [1] The first classifier discriminates between patients in Group 4 and all
other Groups combined (all "non-4"). For a patient identified as a "4", the classification process
is over and the results are displayed; if not classified as a 4, then [2] a second classifier is used to
discriminate patients in Group 1 from the balance of the patients (2, 3, or 4). For a patient
Template Revised 13 April 09

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10,6 March 2012
11
361
362
363
364
365

identified as a "1", the classification process is complete; ifnot classified as a "1", then [3] a
third classifier is used to discriminate patients in Groups "2" and "3". This sequence separates
the patients into the 4 classifications uniquely.
Potential Physician Interpretation ofDevice Output
Device
Output

Potential Output
Interpretation
Structural brain
injury (positive CT
finding)

Potential Physician Interpretation

Obtain a head CT rapidly
Transfer to higher level of care if CT is
unavailable.
Do not release the patient

Non-structural brain '

injury and more
severe clinical
manifestations of
functional injury

May require further evaluation

Hold for close, medical observation
Clinician may decide to obtain CT based on
other assessment factors (History of event,
LOC, PTA, symptoms, etc.)

Non-structural brain
injury and less
severe clinical
manifestations of
functional injury

Normal or patients
without head
InJunes

Patient may be released if consistent with

other assessments (neurological exam,
symptoms, etc). Re-evaluation should be
scheduled.

Normal patient, may be released if other

assessments are normal.

Re-evaluation only for new or exacerbated

symptoms.

366
367

4.5 Bibliography:

368
369

Aubry M., Cantu R., Dvorak 1, Graf-Bauman T., Johnston KM., Kelly 1., Lovell M.R.,
McCrory P., Meeuwisse W.H., & Schamasch P. (2002). Summary and Agreement
Template Revised 13 April 09

Protocol Title: A Comparative Study: ImP ACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version # 10,6 March 2012
370
371

12

st

statement of the 1 International Symposium on Concussion in Sport, Vienna 2001.

Clinical Journal ofSports Medicine, J2, 6-11.

373
374

Barr, W.B. & McCrea, M. (2001). Sensitivity and Specificity of Standardized Neurocognitive
Testing Immediately Following Sports Concussion. Journal ofthe International
Neuropsychological Society, 7, 693-702.

375
376

Bazarian J.J., & Atabaki S. (2001). Predicting post-concussion syndrome after minor traumatic
brain injury. Academy ofEmergency Medicine, 8, 788-795.

377
378
379

Binder M. L., (2007). Comment on Cogniform Disorder and Cogniform Condition: Proposed

diagnoses for excessive cognitive symptoms. Archives of Clinical Neuropsychology, 22,

681-682

380
38l
382

Bleiberg J, Kane RL., Garmoe W.S., & Halpern E. (2000). Factor Analysis ofIntervention and

Cost for Mild Traumatic Brain Injury Research. The Clinical Neuropsychologist, 14, 287

- 294.

383
384
385
386

Bleiberg, J, & Warden, D. L, (2002). Computerized Neuropsychological Concussion

Surveillance Instruments: Using the Reliable Change Index (RCI) as a Basis for Clinical

Decision-Making. Poster session presented at American Academy ofNeurology, Denver,

CO.

387
388

Broglio S.P., & Guskiewicz KM. (2009). Concussion in Sports: The Sideline Assessment.

Sports Health, 1(5),361 - 369.

389
390
391

Cernich A, Reeves D., Sun W., & Bleiberg J (2007). Automated Neuropsychological

Assessment Metrics Sports Medicine Battery. Archives ofClinical Neuropsychology 22s,

s101 - s114.

392
393

DePalama RG., Burris D.G., Champion HR, & Hodgson MJ. (2005) Blast Injuries. New
England Journal ofMedicine, 352, 1335 1342.

394
395

Finkel M.F., (2006). The Neurological Consequences of Explosives. Journal ofthe Neurological

Sciences, 1, 63 - 67.

396
397

Guskiewicz KM., Perrin D.H., & Gansneder B.M. (1996). Effects of Mild Head Injury on

Postural Stability in Athletes. Journal ofAthletic Training, 31(4), 300 - 306.

398
399

Heegaard W. & Biros M. (2007). Traumatic Brain Injury. Emergency Medicine Clinics ofNorth

America, 25, 655 - 678.

400
401
402
403
404

Helmick K, et al. (2006) Defense and Veterans Brain Injury Center Working Group on the

Acute Management of Mild Traumatic Brain Injury in Military Operational Settings:

Clinical Practice Guidelines and Recommendations [monograph on the internet.]

Washington (DC): Defense and Veterans Brain Injury Center

http://www.dvbic.orglpdfs/clinical practice guideline recommendations. pdf

405
406

Iverson G.L., Lovell M.R, & Collins M.W. (2003). Interpreting Change on ImPACT Following

Sport Concussion. The Clinical Neuropsychologist, 17(4),460 -467.

372

Template Revised 13 April 09

Protocol Title: A Comparative Study: ImP ACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version it 10,6 March 2012
13
407
408
409

Iverson G.L., Kaarto M.L., & Koehle M.S. (2008). Normative Data for the Balance Error
Scoring System: Implications for Brain Injury Evaluations. Brain Injury, 22(2), 147
152.

413
414

Iverson GL, et al. Post-concussion disorder (Chapter 23). In. Zasler N.D., Katz D.L, Zafonte
R.D. (Editors). Brain Injury Medicine: Principles and Practice. Demos Medical
Publishing LLC, New York, NY, 2007.
Kelther N.L., (2007). Biological Perspectives: Traumatic Brain Injury-War Related. Perspectives
in Psychiatric Care, 43, 223 - 226.

415
416
417

Levinson D.M., & Reeves D.L., (1997). Monitoring Recovery from Traumatic Brain Injury
Using Automated Neuropsychological Assessment Metrics. Archives ofClinical
Neuropsychology, 12, 155 166.

418
419
420

Lew H.L., (2005). Rehabilitation Needs of an Increasing Population of Patients: Traumatic Brain
Injury, Polytrauma and Blast-related Injured. Journal ofRehabilitation Research and
Development, 42, 13 - 16.

421

422

Lishman W.A, (1988). Physiogenesis and Psychogenesis in the 'Post-Concussional Syndrome.'

British Journal ofPsychiatry, 153, 460 469.

423
424

Lovell M. (2009). The Neurophysiology and Assessment of Sports-Related Head Injuries.

Physical Medicine and Rehabilitation Clinics ofNorth America, 1, 45 - 62.

425
426

Lovell M. (2009). The Management of Sports-Related Concussion: Current Status and Future
Trends. Clinics in Sports Medicine, 28, 96 111.

427
428
429
430
431

McCrea M., Barr W.B., Guskiewicz K., et al. (2005) Standard Regression-Based Methods for
Measuring Recovery After Sport-Related Concussion. Journal ofNeuropsychological
Society, 11, 58 69.
McCrea, M. (2008). Mild traumatic Brain Injury and Postconcussion Syndrome. New York, NY:
Oxford University Press.

432
433
434

McCrea, M., Prichep, L. et al. (2010). Acute Effects and Recovery After Sport-Related
Concussion: A Neurocognitive and Quantitative Brain Electrical Activity Study. Journal
ofHead Trauma Rehbilitation,25(4), 283-292

435
436

Moppett, LK., (2007), Traumatic Brain Injury: Assessment, Resuscitation and Early
Management. British Journal ofAnesthesia, 99 (1), 18-31.

437
438
439
440

Naunheim, R. et al. (2010). Use ofBrain Electrical Activity to Quantify Traumatic Brain Injury
in the Emergency Department. Brain Injury (Early Online), Online publication date, July
5,2010.
Newton R. (1989). Review of Tests of Standing Balance Abilities. Brain Injury, 3,335 - 343.

441
442

Okie S. (2005). Traumatic Brain Injury in the War Zone. The New England Journal ofMedicine,
6, 633- 634.

443
444

Oliaro, S., Anderson S., & Hooker D. (2001). Management of Cerebral Concussion in Sports: the
Athletic Trainer's Perspective. Journal qfAthletic Training, 36(3), 257 - 262.

410
411

412

Template Revised 13 April 09

Protocol Title: A Comparative Study: ImP ACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10, 6 March 2012

14

445
446
447

Randolph e., McCrea M., & Barr WE. (2005). Is Neuropsychological Testing Useful in the
Management of Sport-Related Concussion? Journal ofAthletic Training, 41(2), 13 7
152.

448
449

Riemann B.L., & Guskiewicz KM. (2000). Effects of Mild Head Injury on Postural Stability as
Measured Through Clinical Balance Testing. Journal ofAthletic Training, 35(1), 19 -25.

450
451
452

Schatz P., Pardini lE., Lovell M.R, Collins M.W., & Podell K (2006) Sensitivity and
Specificity of the ImPACT Test Battery for Concussion in Athletes. Archives Clinical
Neuropsychology, 21(1), 91 - 99.

453
454
455

Springer B.A., Marin E., Cyhan T., Roberts R,& Grill N. W., (2007) Normative Values for the
Unipedal Stance Test with Eyes Open and Closed. Journal ofGeriatric Physical
Therapy, 30(1), 8 15.

456
457
458

Valovich-McLeod T.e., Barr W.B., McCrea M., & Guskiewicz KM.(2006) Psychometric and
Measurement Properties of Concussion Assessment Tools in Youth Sports. Journal of
Athletic Trainers, 41(4),399 408.

459
460
461
462

Vanderplorg RD., Belanger H.G., Duchnick lD., & Curtiss G. (2007). Awareness Problems
Following Moderate to Sever Traumatic Brain Injury: Prevalence, Assessment Methods
and Injury Correlates. Journal ofRehabilitation Research and Development, 44, 937
950.

463
464
465

Vanderplorg RD., Curtiss G., & Belanger H.G. (2005). Long-Term Neuropsychological
Outcomes Following Mild Traumatic Brain Injury. Journal ofthe International
Neuropsychological SOCiety, 11(3),228 - 236.

466
467
468

Van Kampen D.A, Lovell M.R, Pardini lE., Collins M.W., & Fu F.R (2006) The "Value
Added" ofNeurocognitive Testing After Sports-Related Concussion. The American
Journal of5/Jorts Medicine, 34 (10), 1630 - 1635.

469
470

Warden D. (2006). Military TBI During the Iraq and Afghanistan Wars. Journal ofHead
Trauma Rehabilitation, 21, 398 - 402.

471
472
473

Wilken J.A, Sullivan C.L., LeSwandowski A, & Kane R.L., (2007). The Use of Automated
Neuropsychological Assessment Metrics to Assess the Side-Effect Profiles and Efficacy
of Medication. Archives ofNeuropsychology 22, 127 - 133.

474
475

Wymer, lH., (2008). Psychological and Neuropsychological Correlates of Post-ConcussionaI

Disorder. Neuropsychological Trends, 3,45- 84.

476

477

Zoroya G. Thousands ofTBI Cases Off the Record. USA Today. Publication date: Nov. 29,
2007.

478

4.6 Research Design and Methods:

479

SUMMARY:

480
481

The study consists oftwo arms. Each arm will be given the same set of automated
neurocognitive test batteries. The participants will be as follows: 100 cases of acute concussion,
which will be tested using the ANAl\14 TBI MIL, ImPACT MIL, AHEAD M-IOO and the

482

Template Revised 13 April 09

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version # 10, 6 March 2012
15

505

UPST. A sample of200 normal healthy soldiers will be given the ANAM4TM TBI MIL,
ImPACT MIL, AHEAD M - 100 and UPST. Controls are necessary to establish the use of the
ANAM4TM TBI MIL and the ImPACT MIL on normal healthy active duty military controls. The
order in which the tests are administered will be changed so that half of the concussed and
control group participants take the ANAM4TM TBI MIL first and then the ImP ACT MIL while
the other half will take the ImPACT MIL first and then the ANAM4TM TBI MIL, thus allowing
for a counterbalance of any possible order effect, carryover, or fatigue. The effects of carryover
or fatigue is unknown at this time. The test manufactures believe it would be minimal, however,
this is an important variable to determine. Between the two test administrations participants will
be given a brief break before beginning their second test battery. At some point during test
administration a short
known as AHEAD M - 100, will be given. The AHEAD M-I 00
device is a handheld portable EEG (brain electrical signals) monitor. The monitor involves the
use of a non-invasive adhesive headset to collect the data in a very similar way to the ECG
monitor for the heart. The device performs some initial processing of the EEG signal giving each
patient a score from one to four which reflects their clinical risk. Study personnel will be blinded
to the clinical data. The results of testing will not be shared with the clinicians involved in
treatment decisions to be assured that treatment plans are not influenced. For purposes of the
study, the BrainScope Classification result will not display at the conclusion of the test. The
result will be stored on the device and electronically transferred to the study monitor for data
analysis. This data will be used for study analysis, but not for clinical decision-making. During
the break period the UPST will be administered and scored. All tests will be administered by
staff trained in the administration of the ANAM4 TBI MIL, ImP ACT MIL, UPST, and AHEAD
M - 100.

506

SAMPLE SIZE:

507
508
509

This study will use a target sample size of 100 acutely concussed cases and 200 active duty
military controls, for a total study size of 300 participants with full data sets. The large sample
size will provide sufficient power of .90 to detect between and with in-group effects.

510

RECRUITMENTIELIGIBILITY:

51 I

517

Participants in the concussion group will be recruited from the Emergency Department
(ED) at each of the research locations: (SAMMC), (CRDAMC), (LRMC), , (MACH) and
(TAMC), each site will define testing locations as necessary. All participants will be age 18 - 55.
All research investigators will work at the hospitals in question and will have appropriate staff
identification and access. Participants with a diagnosis ofmTBI will be contacted and tested
within 72 hours of the concussion event. Participants may be recruited from the ED and tested on
site or may have an appointment scheduled for testing within 72 hours post-concussion.

518
519
520

Recruitment from the ED will include participation from the ED staff to aid in identifying
those with possible concussion. The ED staffwill be informed about the study and referral
information will be given to the staff Also a member of the study team will be placed in the ED

483
484
485
486
487
488
489
490
491
492
493
494
495
496
497
498
499
500
501
502
503
504

512
513

514
515
516

Template Revised 13 April 09

Protocol Title: A Comparative Study: ImP ACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
16
Version #10, 6 March 2012

522
523
524
525
526
527

and will recruit from there when appropriate for them to do so without interrupting the ongoing
functions of the ED. If a member of the study team is not at the ED at time of discharge the
concussed person will be given the research assistances contact information and asked to contact
them as soon as possible pertaining to the study. No patient HIP AA information will provided to
the research staff by the ED staff. The ED staffwill act to identify possible participants and
initial study contact will be made either using a study recruitment flyer or by study staff located
in the ED at the time.

528
529
530
531
532
533
534
535

Study recruitment for controls will be conducted at the SRP site in a group setting prior to
the administration of the ANAM. Service members are tested in groups of25 - 50 depending on
the size of the testing location. Prior to testing, testing instructions are given to group members in
a class like setting. Recruitment of potential control group members will be conducted at that
time. Recruitment efforts will be brief consisting of a non-military civilian research assistant
giving a brief (less than 5 minutes) speech to the group asking for participants (see appendix).
Participants who choose to participate in the study will be asked to move into a separate
designated testing area to continue with the consent, screening questionnaire and testing.

536

INCLUSION CRITERIA:

521

537
538
539
540
541
542

1) TBI-positive group [mTBI). Individuals age 18 - 55 who have access to care at the
medical treatment facilities used in the gathering of research, who report to a level II
point of care for suspected concussionlmTBI, and who subsequently meet the DoD
criteria for acute concussion as determined by gathered information set forth on page 1 of
the MACE which has been incorporated into the screening questionnaire used for this
study. Participants must be fluent in English.

543
544
545
546
547
548

2) Healthy military control group [HMC; no-TBI]. Military controls will consist of
otherwise healthy soldiers, 18 55 years of age, and recruited from the Soldier Readiness
Processing (SRP) site at Ft. Hood, Texas, and Schofield Barracks, Hawaii. These soldiers
will be asked to participate in the study since they are already scheduled to take the
ANAM4 TBI MIL as part of the SRP requirements. Participants must be fluent in
English.

549
550
551
552
553
554
555
556
557
558

EXCLUSION CRITERIA:
1) TBI-positive group [mTBI]. Individuals taking any mind-altering medication or reporting
a level of pain >7 (10 point scale). 1fthe Principal Investigator determines that
individuals with lower pain levels are unable to focus attention adequately on the
neurocognitive assessment task, the exclusion criteria will be expanded with approval of
the IRB. Individuals with disorders requiring any of the following medications will be
excluded from the study, any anti-psychotic medications or Phenothiazane (e.g. Seroquel,
Thorazine, Haldol, or Olanzapine). Anyone taking any kind of Benzodiazepines (e.g.
Valium or Klonopin) will be excluded. Other exclusionary medication will include
Benadryl or similar sedating antihistamines, stimulants such as Ritalin or other
Template Revised 13 April 09

Protocol Title: A Comparative Study; ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10,6 March 2012
17
559
560
561
562

Amphetamines and mood stabilizers (e.g. Tegretol, Lithium, Topamax, Depakote, or

Lamictal). Individuals who report the use of any mind altering substances within eight
hours prior to testing will be excluded from participating. Female participants who are
pregnant will also be excluded from the study.

563
564
565
566
567
568
569
570
571
572
573
574
575

2) Healthy military control group [HMC; no-TBI]. Individuals will be excluded from
participation if they have a history of mild traumatic brain injury within 90 days,
moderate brain injury within the past three years, or any lifetime history of severe brain
injury. Individuals who are on any mind altering medication or report a level of pain >7
(10 point scale). If the Principal Investigator determines that individuals with lower pain
levels are unable to focus attention adequately on the neurocognitive assessment task, the
exclusion criteria will be expanded with approval of the IRB. Individuals who report the
use of any mind altering substances within eight hours prior to testing will be excluded as
will pregnant females. Use of certain medications will also result in exclusion from the
study, including; any anti-psychotic medications or Phenothiazane (e.g. Seroquel,
Thorazine, Haldol, or Olanzapine), Benzodiazepines (e.g. Valium or Klonopin), Benadryl
or similar sedating antihistamines, stimulants such as Ritalin or other Amphetamines, and
mood stabilizers (e.g. Tegretol, Lithium, Topamax, Depakote, or Lamictal).

576

PROCEDURE:

578
579
580
581
582
583
584
585
586
587
588
589
590
591
592
593
594

1) TBI-positive group. Participants in the concussed group will be tested individually. They
will either be tested at the Emergency Department (ED) or at an office near the ED
following their discharge from the ED. Or if admitted for observation or other health
issues, testing may be conducted in the participant's room at the hospital. If, for any
reason, the participant is either unable to test at that time or does not feel comfortable
testing in the ED, an appointment for testing within the 72 hour window after the
concussion can be made. If testing cannot be completed within the 72 hour post
concussion window, the participant will be excluded from the study. Because the
concussed subjects will be recruited from four different research sites, the order in which
the tests are administered will be alternated for each participant at each location.
Informed consent will be obtained prior to testing and participants will be given the
opportunity to ask questions both before and after testing. Before any testing begins the
completion of a screening questionnaire will be required and completed by the research
staff in order to ensure the participant meets study criteria. Contact information for
follow-up research and delivery of testing results is included within the informed consent.
Participants will be contacted by phone one week (7 days) post-concussion and will be
asked about their current post-concussion symptoms. This will include questions from
page one of the screening questionnaire and should be less than 5 minutes in duration.

595
596
597
598

2) Both the ANAM4 TBI MIL and ImPACT MIL will be administered in accordance with
the current guidelines used for administration by the military. The estimated testing time
is approximately 60 minutes. The test battery will include the screening questionnaire
(see appendix), which incorporates the same information as the first page of the Military

577

Template Revised 13 April 09

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version # 10, 6 March 2012
18
599
600
601
602
603
604
605
606
607
608
609
610
611
612
613
614
615
616
617
618

Acute Concussion Evaluation (MACE), currently used to identify mTBI per DoD
standards; the ANAM4 TBI MIL instructions and testing (25 minutes); the UPST
instructions and testing (5 minutes); the ImPACT MIL instructions and testing (20
minutes) ; and the AHEAD M - 100 (10 minutes) will comprise the test battery for this
study.
3) Healthy military control group. Participants in the control group will be active duty
soldiers recruited from the Soldier Readiness Process (SRP) sites at Ft. Hood and
Schofield Barracks. As part of their SRP soldiers are required to take the ANAM4TM TBI
MIL. As per military standards the ANAM4TM TBI MIL will be administered in a group
setting. Given that the soldiers are already taking one of the two tests being compared,
they will be asked to volunteer to take the ImPACT MIL, AHEAD M 100 and UPST,
which will add roughly 40 minutes to their overall testing time. For those who choose to
participate they will complete the screening questionnaire in order to ensure those being
tested meet the study criteria for inclusion and then the first 100 participants will take the
tests in the following order: ANAM4 TBI MIL + ImP ACT MIL and the next 100 vice
versa. Between each test administration a short break will be given. Before starting the
second test the UPST will be administered and scored. The administration of AHEAD M
- 100 will occur either before testing begins or following test completion. The order of
test administration will be tracked by the test administrator on the questionnaire form
provided in appendix A.

619
620
621
622

Time frame:

Data collection is expected to last 330 days from the start of the study once it is approved

by the IRB.

623
624
625
626
627

Test results reporting:

Testing results will be reviewed by the PI with disposition to follow. Reports will be

mailed out to participants if testing indicates any abnormalities. Participants may choose to

include these reports as part of their medical records. The reports may also be used by medical

care providers and may help in determining diagnosis and course of treatment for participants.

628

4.7 Number of Subjects:

629

TOTAL NUMBER OF SUBJECTS (nation-wide/study-wide)

630
631
632
633
634
635

Subjects will be recruited until the number of concussed (mTBI) participants reaches 100
and the number of military control subjects reaches 200. The following power analysis was
based on Aim #1 for the ANOVA model. Given the desire to maintain a 2: 1 ratio of control to
mTBI participants, a power analysis was performed given the following parameters: level of
significance of .05, power of .8, a conservative 2-sided test, and a medium effect size: Cohen's d
= .5 (standardized effect size). Using the harmonic mean for deriving sample size (based on the
desired 2: I ratio) as found in Cohen (1988): n' 2nA nB/(nA + nB) a power of .81 for a medium

636

Template Revised l3 April 09

300

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version if I 0, 6 March 2012

19

639
640
641
642

effect size is achieved when 100 controls and 50 experimental subjects (n' = 66.67) are sampled;
thus, a total sample size ofN = 150 will suffice if a medium effect size is attained. Initially it
was proposed that 200 controls and 100 experimental subjects would be sampled (N 300); if
this was to be the case, a power of .98 (n' = 133.33) would be obtained. Note that an
approximate power of.8 for 200 control and 100 experimental subjects will be obtained if the
effect size is .35 (which is a more conservative, albeit safer, effect size estimate).

643

5.0 Human Subject Protection

644

5.1 Source of Data:

637
638

645

No additional data sources will be used at this time for this protocol.

646

5.2 Benefits:

647
648
649
650
651

This is an important study. The study will help to ensure the clinical instruments that are
currently being used to detect mTBI in the active duty army population are actually measuring
what needs to be measured. This will make it possible to diagnose mTBI faster and more
accurately, increasing the Army's ability to monitor the Soldier's status, recovery, and return-to
duty potential.

652
653
654

Benefits to concussed subjects participating in the study will include optional

documentation of their neurocognitive functioning within 72 hours of their concussion. Subjects
can retain the documentation for their medical records.

655

There is no direct benefit to those in the control group for their participation.

Template Revised 13 April 09

Protocol Title: A Comparative Study: ImP ACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10, 6 March 2012

20

656

5.3 Risks:

657
658

The PI of this protocol will use a continuous monitoring process to insure the data at
participating sites is of high quality and the study is properly conducted.

659
660
661

Pre-Training: Each site will be visited by a training team comprised of PI verified

experts on the tools and techniques of the study and train study personnel to criteria on
proper data collection for the study prior to any data being collected.

662
663
664

The local PI will, in all cases, be a licensed and credentialed independent health care
provider known to be of good character and in good standing with their health care
facility.

665
666

The PI will visit each site early in the data collection process to insure proper procedures
are being followed.

667
668

All subject data will be returned to the primary coordinating center as collected, where
they will be audited to insure that:

669

Informed consent is properly signed

670

Informed consent is properly witnessed

671

All demographic information is properly completed

672

All study information is properly collected and coded.

673
674
675

If any record appears to have any irregularities, the subject will be contacted by
the PI to insure they were properly consented, and the data was properly
collected.

676
677
678
679
680
681
682
683
684
685
686
687

Foreseeable Risks. Neuropsychological testing by its nature is non-invasive and involves no

risk of physical harm for any participant. Since these are cognitively taxing exercises, however,
individuals may become frustrated or unhappy if they are performing poorly. Examiners are
trained in reassurance and encouragement to obtain the patient's best performance.
The BrainScope AHEAD M-l 00 is a non-invasive, "non-significant risk" (NSR) device
per FDA guidance entitled, "Significant Risk and Non-significant Risk Medical Device studies".
A letter from BrainScope Company, Inc. is attached as appendix E to this protocol. In order to
fully comply with the abbreviated IDE requirements for the AHEAD M-I00, the following
requirements have been met:
The device is labled in accordance with the labeling provisions of the IDE regulation 812.5
"CAUTION - Investigational Device. Limited by Federal law to investigational use."
Template Revised 13 Apri1 09

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10, 6 March 2012
21
688

689
690

691

692

693

694

695
696
697
698
699
700
701
702
703
704
705
706
707
708

Study PI will obtain and maintain IRB approval throughout the investigation as non
significant risk device study.
Informed consent will be obtained from each participant in accordance to 21 CFR 50.
Proper monitoring ofthe application and data collection of this device and compliance under
the approved protocol will be maintained by AI's and research staff.
Records and reports will be maintained as indicated in section 5.4 of this protocol
At no time during this study will the AHEAD M-l 00 be commercialized, promoted, test
marketed, misrepresented as anything other than an investigational device by the study AI,
PIs or research staff

It is recognized that the QEEG evaluation is noninvasive and uses passive sensors, so that
no electrical current is put into the brain. In order to obtain good sensor connections, it is not
unusual for the skin to require cleaning to remove oilss and dead skin cells. A cleansing sponge
provided by the manufacturer will be used for this purpose. This may result in the risk of mild
skin irritation (temporty reddening of the skin lasting only a few minutes) for some participants
in tiny areas under the sensors creating the only foreseeable risk. The most significant
foreseeable adverse outcome to the patient would result from triggering the Reporting Criteria
mandated by UCMJ. The informed consent process makes clear, and this will be verbally
instructed as well, that "there are limits to confidentiality in health care information, and we will
be mandated to report serious crimes, such as war crimes, danger to self or others, or domestic
abuse."

712
713
714

Risk Management and Emergency Response. If the research participant becomes

frustrated, they will be allowed to rest until they regain composure and feel they are able to give
their best performance. If the research participant is deemed a danger to him or herself or others,
appropriate emergency medical systems will be employed. All research will take place in a
Health Care Facility of at least level II, and any medical crisis or emergency will engage this
health care systems' response.

715
716
717

Measurements taken to Minimize Risk. Testing will be paced with a programmed break
period each hour. All testing will be done in a climate-controlled area, and participants will be
allowed to get water between testing sets. Subjects can terminate testing at any time.

709
710
711

718
719
720
721
722
723
724
725

Adverse Events
Consideration of Adverse Events will hereafter consi st of Adverse Events and Adverse
Device Effects, including anticipated adverse device effects and unanticipated adverse device
effects.
Adverse Event:
Any untoward/undesirable clinical occurrence in a clinical investigation of a Subject using a
device and/or product and which does not necessarily have a causal relationship with this
Template Revised 13 April 09

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10,6 March 2012
22
726
727
728
729

treatment. An Adverse Event can therefore be any unfavorable and/or unintended sign,
symptom, or disease temporarily associated with the use of a device or product, whether or
not it is considered related to the device product.

730
731
732
733
734
735
736
737
738
739
740
741
742
743
744
745
746
747
748
749
750
751
752
753

Anticipated Adverse Procedure Effect:

Any adverse effect related to the procedure (QEEG), which is identified in the protocol prior
to study commencement.
Unanticipated Adverse Procedure Effects:
Any adverse effects on health or safety or any life threatening problem or death caused by, or
associated with, a procedure, if that effect, problem, or death was not previously identified in
nature, severity or degree of incidence in the protocol or application (including a
supplementary plan or application) or any other unanticipated problem associated with a
procedure that relates to the rights, safety or welfare of Subjects (see Appendix F
Reportable Event Submission Form - IRBO). All Adverse Events occurring during the study
procedure (venipuncture) and immediately after (within 30 minutes), whether or not
attributed to the venipuncture, observed by the PI/AI or reported by the Subject, will be
recorded on the Adverse Event CRF.
Safety Monitoring
The PI/Als will monitor all Adverse Event reports to identify and trend all events that would
require temporary discontinuation of study enrollment, to fully characterize device safety, to
modify the study protocol, or to terminate the study.
Reporting Procedures for All Adverse Events
After review with the Subject by the study PI/AIs, all Adverse Events will be documented in
the Subject's source document and on the appropriate Reportable Event Submission Form.
The following attributes must be assigned:

754

description of event

755

date of onset

756

date of resolution

757

duration

758

severity

759

relationship to the study procedures

762

763

760
761

764
765

actions taken
outcomes
attending physician treating event
determination as to whether event is anticipated or unanticipated

If the Adverse Event is of such severity in the Investigator's judgment that it warrants
withdrawal from the study, the Subject should be withdrawn and a termination assessment
Template Revised 13 April 09

Protocol Title: A Comparative Study: ImP ACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10, 6 March 2012

23

766
767
768

performed (EOS CRFs completed). The Subject should be given appropriate care under
medical supervision until symptoms resolve.

769
770

Adverse Events are described as mild, moderate or severe. The severity of Adverse Events
will be assessed on the following severity index scale:

771

Mild - The Adverse Event is transient, requires no treatment, and does not interfere with
the study Subject's daily activity.

Moderate - The Adverse Event introduces a low level of inconvenience or concern to the

Subject and may interfere with daily activities, but is usually ameliorated by simple

therapeutic measures.

Severe - The Adverse Event interrupts the Subject's usual daily activity and requires

systematic therapy or other treatment. Severe is defined as a measure of the intensity of a

reaction, effect, or experience.

The relationship of an Adverse Event to the study will be graded as follows:

772

773
774
775
776
777
778
779
780
781
782
783
784

785
786
787

788
789
790
791
792

793
794

795
796
797
798
799
800

801
802
803
804

None - The Adverse Event is not associated with the study device use.
Remote - The temporal association is such that the study device is not likely to have had

an association with the observed Adverse Event.

Possible - This causal relationship is assigned when the Adverse Event:

o Follows a reasonable temporal sequence from device use, but

o Could have been produced by the study Subject's clinical state or other modes of

therapy administered to the study Subject.

Probable - This causal relationship is assigned when the Adverse Event:

o Follows a reasonable temporal sequence from device use,

o Abates upon discontinuation of the treatment.

o Cannot be reasonably explained by known characteristics of the Subject's clinical

state.
Highly Probable - This causal relationship is assigned when the Adverse Event:

o Follows a reasonable temporal sequence from device use,

o Abates upon discontinuation ofthe treatment, and

0
Is confirmed by the reappearance of the Adverse Event on repeat exposure.

All unanticipated problems involving risk to subjects or others, serious adverse events related

to participating in the study, i and subject deat~s related to artici ation in the study should be

promptly reported bv phone ( b ) ( 6 ) b y email (b)(6)

or by
facsimilei(b){6)
to the USAMRMC Office of Research Protections, Human
Research Protection Office (HRPO). A complete written report will follow the initial
notification. In addition to the methods above, the complete report will be sent to the U.S.
Army Medical Research and Materiel Command, ATTN: MCMR-ZB-PH, 504 Scott Street,
Fort Detrick, Maryland 21702-5012.
!

Template Revised 13 April 09

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version it 10, 6 March 2012
24
805
806
807

808
809
810
811
812
813
814
815
816
817
818
819
820
821
822
823
824
825
826
827
828
829
830
831
832
833
834
835
836
837

838
839
840
841
842
843

Reports will be submitted to the BAMC IRB as well as the local IRB if occurring at different

study collection point if the Adverse Events are related to the study design or procedures.

Serious and Expected Adverse Events. Reportable Event Submission Forms (Appendix G)

will be submitted to the HRPO with the Continuing Review.

Deaths
Deaths which must be reported to the Human Research Protection Office/Institutional
Review Boards include:

All deaths while participating in the study.

For all deaths, copies of available autopsy reports and relevant medical reports should be sent
to the sponsor or its designee with Subject's name masked (except for the first initials of the
first and last name).
Withdrawals for Adverse Events
All Adverse Events which result in the Subject's withdrawal from the study must be reported
immediately by telephone or e-mail to USAMRMC.The Investigator may be asked to
provide detailed follow-up information. The PIIAI will report to the appropriate regulatory
authorities. The PliAIs must notify their own IRB of all Unanticipated Adverse Device
Effects occurring at the site, and Unanticipated Adverse Events reports.
Protocol Deviations
Protocol deviations or violations that have occurred, have not been pre-approved by the
HRPO, and which may adversely affect the rights, safety, or welfare of subjects, or the
integrity of the research data will be recorded immediately on discovery by the PI!AIs.
Unanticipated protocol problems will also be reported in this way, and include problems that
pose a risk to subjects, affect others in the research study, or which significantly impact the
integrity of the research data, such as breaches in confidentiality and losses or destruction of
research or study samples.
Any deviation from the protocol that may have an effect on the safety or rights of the Subject
or the integrity of the study must be reported to the USAMRMC ORP HRPS as soon as the
deviation is indentified.
Reporting Unanticipated Problems Involving Risks To Subjects Or Others, Serious
Adverse Events And Deaths To The HQ, USAMRMC IRS.

All unanticipated problems involving risk to Subjects or others. serious adverse events, and
all Subject deaths will be promptly reportedbbv ohone!(b)(6)
Ibye-mail
~b)(6)J by facsimilel( )(6)
I to the HQ, USAMRMC IRB, or
sent to the U.S. Army Medical Research and Materiel Command, ATTN: MCMR-RP, 504

Template Revised 13 April 09

Protocol Title: A Comparative Study: ImP ACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10,6 March 2012
844
845

25

Scott Street, Fort Detrick, Maryland 21702-5012. A complete written report will follow the
initial notification.

846
847

5.4 Safeguards for Protecting Information:

848
849
850
851
852
853
854
855
856
857
858
859
860
861
862
863
864
865
866
867

All of the data will be identified with a study participant number rather than the
participant's name to maintain confidentiality. The master list will be maintained by the PI
during the course of the study. All electronic data will be stored on a secure, password-protected
computer. No computer used for storing data will be connected to the server at any time. All
paper research records will be kept in a locked file prior to being transferred to a locked file and
office at the Warrior Resiliency Program (WRP) BAMC. All electronic research records will be
kept in a password-protected computer in the investigator's designated locked office at WRP. As
the primary center for this study the staff at BAMC will be the collection point for all
participating data collection sites. The electronic information will be sent to the staff located at
the WRP, Lincoln Center location weekly for data processing and storage. Each site will save
encrypted (Credent To Go) testing data to a CD and then upload that data to a limited access
Army Knowledge Online folder for retrieval. After the information has been uploaded from the
CD the CD will be destroyed. This information will be retained at WRP during the life of the
protocol. Data confidentiality will be strictly protected. Only individuals immediately involved
in the study will have access to files that include subject identifying information. The only
exceptions to Confidentiality would be for legally mandated disclosures as verified by BAMC's
Judge Advocate General, or modification to this protocol approved by the BAMC IRB. Group
data will be summarized in final report documents, and aspects of individual volunteer's
performance may be reported as well; however, participants' names will never be published as a
contributor of specific data points or as a participant in the investigation.

868
869
870

The data will be archived and may be used or included in subsequent studies for purposes
which cannot be anticipated at the present time. All guarantees of anonymity and confidentiality
will still apply.

871
872
873
874
875
876
877
878
879

When the results of the study are printed or talked about in conferences, no information
will be given out that would tell anyone whom the participants are. Records of participants
taking part in this study may only be made public in accordance with federal law, including the
Federal Privacy Act, 5 US.C. 552a, and its implementing regulations. DD Form 2005, Privacy
Act Statement-Health Care Records, contains the Privacy Act Statement for the records. If
participants sign this consent form, they give their permission for information that we get from
their participation in this study to be printed in medical literature, discussed for teaching
purposes, and used to further medical science. All information about participants will be given
without identifying them.

Template Revised 13 April 09

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10, 6 March 2012
26
880

5.5 Informed Consent:

881

Informed consent will be collected prior to collection of data or testing. Each testing site
will have either an Associate Investigator or research assistant on the protocol with appropriate
CV and CITI training available to answer any questions regarding the study and who will be
responsible for ensuring informed consent is appropriately obtained and properly recorded. The
Informed Consent forms are different for the Concussion and Control groups they are attached in
the appendices.

882
883
884
885
886

892
893

Because this study is limited to individuals with mTBI only, it is not anticipated that the
mental capacity of any volunteer will be severely compromised. If, however, an individual does
not appear capable of giving informed consent for whatever reason they will not be included in
the study. Mind-altering substances such as tranquilizers, conscious sedation, or anesthesia are
exclusion criteria, and service members using those will not be allowed to participate. All
subjects will be 18 - 55 years of age. Individuals will not be rushed into making the decision to
participate and will be allowed to discuss any concerns in private.

894

6.0 Data Analysis:

895
896
897
898
899
900
901
902
903

Study AimslEndpoints:

887
888
889
890
891

904
905
906
907
908
909
910
911
912
913
914
915
916
917
918

This exploratory study will examine the sensitivity and specificity of three novel devices which
are hypothesized to be useful in the diagnosis of concussion (mTBI). Patients with a known
concussion (mTBI) meeting the DoD definition of concussion will be compared to matched
soldiers with no recent concussion history. Each instrument provides a graded output:
Normal/mild/severely abnormaL A multivariate approach will initially be pursued, incorporating
all of the instruments simultaneously in the predictive model. This global approach will aid in
ascertaining accuracy of classification between groups for each instrument, and as well take into
account the extent of collinearity between the instruments.

To test the given the dichotomous outcome (i.e., mTBI vs. control) a multiple binary logistic
regression will be conducted. A logistic regression and may also incorporate the key predictors
(e.g., QEEG) to determine not only the predictive power of each predictor (e.g., logit, odds ratio,
etc.) but to also extract classification information on sensitivity (true positives) and specificity
(true negative). The results of this analysis can also be used to conduct a receiver operating
characteristic (ROC) analysis and a significance test for area under the curve (AUC). There are
various ways by which to assess model fit in logistic regression (Hosmer & Lemeshow, 1989),
those being as follows:
1) A chi-square test is conducted to see if the model is improved when the predictor are
entered. If significance is obtained (a .OS) then the addition of the covariates indicates
Template Revised 13 April 09

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion

Version HIO, 6 March 2012

919
920

27

model improvement over and beyond the origin only model (the difference in -2LL are
used for the test statistic).

921
922

2) The Hosmer-Lemeshow goodness-of-fit test is used to ascertain how well the model fits
the data. For this test, a non-significant result is desired.

923
924
925
926

3) The individuallogits (log ofthe odds) will be examined and tested for each predictor.
Again, a level of significance of .05 will be the nominal level of significance for each
covariate. Moreover, the odds ratio (OR) and the accompanying 95% confidence interval
(CI) will be furnished for each variable. If the CI around the OR does not include 1.0,
then significance is obtained.

927
928
929
930
931
932
933
934

4) Additionally, sensitivity (hit rate for true positives) and specificity (hit rate for true
negatives) will also be computed for each of the logistic models; hence affording the
opportunity to draw comparisons between the instruments (i.e., ANAM, IMP ACT).
Any other variables germane to the test ofthe model, such as UPST and/or EEG will also be
incorporated if deemed warranted. Moreover, in a reversal of the model, it may be of interest to
conduct a multivariate analysis of variance (MANOVA) to see if the two treatment arms differ
on the linear combination of the instruments.

935
936
937
938
939
940
941
942
943
944
945
946
947
948
949
950
951
952
953
954
955
956
957
958

The role of post hoc analysis: it may be reasonably argued that membership in the category
"normal control" does not guarantee lack of pathology in this group. All control members will
fill out a TBI history questionnaire and symptom checklist. this data may be reanalyzed to factor
in past history ofTBI and whether abnormal controls are truly a 'miss'.
Further, it is possible members of the concussed group may have recovered from their
concussion prior to testing. Participants will be evaluated based on the number of current
symptoms for evidence of recovery.
As a further extension for analyzing sensitivity and specificity (I - specificity will be on the x
axis), a Receiver Operating Characteristic (ROC) graphic will be furnished for each of the
instruments shedding insight into the relationship of true and false positives. Moreover, another
function of the ROC analysis is the possibility oflocating area under the curve (AUC) so as to
detect optimal cut points.
Additionally, though not a specific aim, so as to assess the extent of convergent validity (i.e.,
instruments measuring similar constructs should exhibit substantive correlations) a bivariate
correlation will be computed for each of the instruments. Though there is no rigid cut-point as to
what constitutes convergent validity (AERA, 1999), it is anticipated that correlations will be at
least> .3 (i.e., 9% shared variance) which approximates a medium effect size per Cohen (1988)
and will then provide preliminary evidence of convergent validity. Another exploratory approach
that can be used to shed insight into classification, is finite mixture modeling. Akin to cluster
analysis, in this case the group is an unknown quantity, but based on the model covariates (e.g.,
Template Revised 13 April 09

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version if 10, 6 March 2012
28
959
960
961
962
963

ANAM, IMPACT, QEEG, certain demographics or ancillary test scores) and their inter
correlation, classification based on maximizing homogeneity within groups and heterogeneity
between groups can be exploited (McLachlan & Peel, 2000) and thus engender a closer
examination of characteristics unique to these unknown classes.

964

References

965
966
967

968

AERA, APA, NCtvlE (1999). Standards for Educational and Psychological Testing. DC:

AERA. (Standards)

969
970

971
972

973

Cohen (1988). Statistical power analysis/or the behavioral sciences. (2 nd Ed.). Hillsdale, NJ:

Lawrence Erlbaum.

Hosmer, D. W., & Lemeshow, S. (1989). Applied logistiC regression. NY: John Wiley.

McLachlan, G., & Peel, D. (2000). Finite mixture models. NY: John Wiley.

974
975
976

7.0 Duration of Study:

Estimated start date and approximate duration of the study:

978
979

The study is expected to start in May 2011 data collection is expected to take no longer
than four months (120 days) and analysis of data to take an additional six months (180 days)
after data collection is complete for a total research time of 10 months (300 days).

980

8.0 Funding:

981
982
983

Support for materials and supplies will be provided by Medical Research and Materiel
Command through a congressionally mandated research grant. Additional manpower for data
collection will be obtained through the Grant Administrator at The Geneva Foundation.

984
985
986
987
988

9.0 Signature Section:

977

989
990
991
992

9.1 Principal Investigator:

I am aware that I am not authorized to accept any funds or other form of compensation for
conducting research. All subjects will be treated in compliance with all applicable
organizational, service, DoD and Federal regulations, and all applicable FDA and HHS
guidelines.
Date - - - - - Template Revised 13 April 09

if

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10,6 March 2012
29
993
994
995
996
997
998
999
1000
1001
1002

9.2 Associate Investigator Signature Page

1003

I have read the above protocol and agree with its content. All subjects will be treated in
compliance with all applicable organizational, service, DoD and Federal regulations, and all
applicable FDA and HHS guidelines.

1004
1005
1006
1007
1008
1009
10 10

Date ---------
,(b)(6)

...

~=---------~==~

(b)(6)

~~~====~~~~~~~

1011
1012
1013
1014
1015
1016
1017
1018
1019
1020
1021
1022
1023
1024

I have read the above protocol and agree with its content. All subjects will be treated in
compliance with all applicable organizational, service, DoD and Federal regulations, and all
applicable FDA and HHS guidelines.
Date ---------

1025
1026
1027
1028

(b)(6)

I Ph.D.{Clinical

NeuropsychologistlMedical Psychologist)

~=---------~~~~~~~~~~~~~~~~~~~~~

(b)(6)

1029
1030
1031

Template Revised 13 April 09

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 IBI MIL for an Acute
Concussion
Version fl10, 6 March 2012
30
1032
1033
1034
1035

I have read the above protocol and agree with its content. All subjects will be treated in
compliance with all applicable organizational, service, DoD and Federal regulations, and all
applicable FDA and HHS guidelines.
Date - - - - - -

1036
1037
1038
1039

I-cc---c-c=-_ _ _---'~P-T'-'D~P-"-'T.

mOCS,(Physical Therapist)

1040
1041
lO42
1043
1044
1045
1046
1047
1048
1049
1050

I have read the above protocol and agree with its content. All subjects will be treated in
compliance with all applicable organizational, service, DoD and Federal regulations, and all
applicable FDA and HHS guidelines.
Date - - - - - -

1051
1052
1053
1054
1055
1056
1057
1058
1059
1060
1061
1062
1063
1064
1065
1066
1067

I have read the above protocol and agree with its content. All subjects will be treated in
compliance with all applicable organizational, service, DoD and Federal regulations, and all
applicable FDA and HHS guidelines.
Date - - - - -

1068
1069
1070
1071
1072
1073
Template Revised 13 April 09

Protocol Title: A Comparative Study: ImP ACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10, 6 March 2012
1074
1075
1076
1077

31

I have read the above protocol and agree with its content. All subjects will be treated in
compliance with all applicable organizational, service, DoD and Federal regulations, and all
applicable FDA and HHS guidelines,

1078
1079
1080
1081
1082
1083
1084

l(b~)(=6)_ _ _-lI,~ (Clinical NeuroosvchologisO

Date - - - - - -

(b){6)

1085
1086
1087
1088
1089

I have read the above protocol and agree with its content. All subjects will be treated in
compliance with all applicable organizational, service, DoD and Federal regulations, and all
applicable FDA and HHS guidelines,

1090
1091
1092
1093
1094
1095
1096
1097
1098
1099

j(b)(6)----l
~~-" .. ---~-------:

ID

MSM FACEP

Date - - - - -

Colonel, Medical Corps, lIS Army

j(b)(6)

llOO

1101
1102
1103

I have read the above protocol and agree with its content. All subjects will be treated in

1104

Date
-----

1105
1106
1107
1108
1109
1110
1111
1112

compliance with all applicable organizational, service, DoD and Federal regulations, and all
applicable FDA and HHS guidelines.
,_"_.. _ . _ __~- (Clinical Psychologist)

MS

Template Revised 13 April 09

Protocol Title: A Comparative Study: ImP ACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10, 6 March 2012
1113
1114
1115

32

I have read the above protocol and agree with its content All subjects will be treated in
compliance with all applicable organizational, service, DoD and Federal regulations, and all
applicable FDA and HHS guidelines.

1116

Date - - - - -

1117
1118
1119
ll20
ll21
1122
ll23
ll24
1125
1126

9.3 PI Service Chief (BAMC)

1127
1128

I have considered this protocol and am able to approve personnel and resource support. I
understand that I will be the point of contact for correction of deficiencies should the principal
investigator fail to meet the requirements agreed to in the Letter of Compliance.

1129

Il30

Date

1131
1132

------

1133
1134
1135
ll36

_ _ _ _ . . . -'Psy.D.

1137

9.4 Statistical Review

1138
1139
1140

I have reviewed the data analysis plan for this protocol and approve of the plan as written. I
understand that I will be the point of contact for this project's data analysis.
Date- - - - -

ll41
1142
1143
1144
ll45
1146

Template Revised 13 April 09

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute

Concussion
Version #10,6 March 2012

33

1147

9.5 Scientific Merit Review:

1148
1149
1150

1151
1152

1153

1154

1155

1156

This protocol has been reviewed and found to have sufficient scientific merit for consideration

by the Institutional Review Board.

Date_ _ _ _ __

1157

1158

Template Revised 13 April 09

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute

Concussion
Version it 10, 6 March 201 2

34

Appendix A - Questionnaire
Demographic Information
Gender:
Male

D Female

Date of Birth: _ _ _ _ _ _(month/day/year)

Age:

Ethnicity:
Marital Status: D Single
Education:

D Married

D Separated D Divorced

Widowed

D No HS Diploma

D HS Diploma

D College Courses

D College Degree

D Graduate Degree

D Professional Degree

Total Education in Years:

Military:

Civilian:

Branch of Service

Occupation

Rank/Grade

Prior Military Service

DYes DNo

Time in Service

Military Dependent

DYes DNo

MOS
Deployed OEF/OIF
Number of Deployments
Rate your current level of pain TODAY-From 1 (nothing) to 10 (The worst pain you can
imagine):
None

10

How would you rate your OVERALL physical health?

Poor

Excellent

How would you rate your OVERALL mentaVemotional health?

Poor

History of Health Problems and Treatment:

Are you on any current prescribed medication?

Template Revised 13 April 09

Excellent

DYes

DNo

Severe

Protocol Title: A Comparative Study: ImP ACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version lO,6March2012

35

TypelDosage:
a.

b.
c.

d.
List any non-prescription medication, supplemental vitamins or alternative medications (ex. St
John's Wort, Kava, Melatonin, Glucosamine)
a.

b.
c.
d.
Have you been diagnosed with a concussion in the past?

OYes

ONo

If yes, when? _ _ _ _ _ _ _ _ _ __
How many concussions have you had?

02 o 3

6 or more

Weight: _ _ _ _ _ _ _.lbs.

Height:
Have you

0 lost 0 gained weight in the past 3 months? _ _ __ lbs.

How many hours of sleep do you get per night? _ _ _ _ _ _ _ __

Any

0 increased 0 decreased sleep in the past 3 months? _ _ _ _.hours

Do you have problems falling asleep, restless sleep, early awakening?

Yes

How much sleep did you get in the last 24 hours?

hours

Do you drink alcohol?

Have you had any alcohol in the last 8 hours?
Have you taken any mind altering substances in the last 8 hours?

o Yes
o Yes
o Yes

ONo

ONo
ONo
DNo

If yes, what did you take?

Have you ever been diagnosed with a learning disorder?
Have you ever had brain surgery of any kind?
Do you have a seizure disorder?

Template Revised 13 April 09

o Yes
o Yes

ONo

Yes

ONo

ONo

Protocol Title: A Comparative Study: ImP ACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10, 6 March 2012

36

The following is to be completed by study staff: Post Concussion Group ONLY

Description of Incident:
What happened?

Tell me what you remember?

Were you dazed, confused, "saw stars"

Did you hit your head?

o Yes
o Yes

ONo

o Yes

ONo

ONo

Cause of Injury? (Circle all that apply):

0
0
0
0

Motor vehicle accident

Fall
Sports related
Other

Was a helmet worn?

Amnesia before: Are there any events just BEFORE the injury that are not remembered?
(Assess for continuous memory prior to injury)

Yes

No

If yes, how long _ _ __

Amnesia after: Are there any events just AFTER the injuries that are not remembered?
(Assess time until continuous memory after the injury)
Yes

No

If yes, how long _ _ __

Does the individual report "blacking out" or loss of consciousness?

Yes

No

If yes, how long _ _ __

Did anyone observe a period of loss of consciousness or unresponsiveness?

No

Yes

If yes, how long _ _ __

Have you had any concussions in the last 12 months?

Yes

No

Template Revised 13 April 09

If yes, howlong _ _ _ __

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion

Version #10, 6 March 2012

37

Symptoms: (check all that apply)

o
o

o Headaches
o Dizziness

Irritability

0 Visual disturbances

0 Ringing in the ears

Memory problems

o Balance problems
o Nausea/vomiting
Symptom Score

Difficulty concentrating

Other _ _ _ _ _ _ __

A (no current symptoms)

B (one or more current symptoms)

Curent DATE/TI'NIE: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __

Concussive Event DATE/TIME:

Time eJapsed since this injury?

-------------------------------------- hours

Time elapsed since this injury and beginning of testing?

hours

Questions for seven day follow up interview (con cussed group ONLY)
Rate your current level of pain TODAY -From 1 (nothing) to 10 (The worst pain you can

imagine):

None

10

Severe

Symptoms: (check all that apply)

Headaches

D
0

Dizziness
Memory problems
Balance problems

Nausea/vomiting

D
D
0
D
0

Difficulty concentrating

Irritability

Visual disturbances

Ringing in the ears

Other

Note the order the tests were administered in 1 - 4:

D AHEAD D

ANAM

ImPACT

UPST

Template Revised 13 April 09

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10, 6 March 2012

38
Appendix B - Unipedal Test Instructions
U nipedal Leg Stance

Subject ID:

0 0

o o

Date:

Read the following to the subject

1) During this test you will stand on your non-dominant foot. This is the opposite foot that
you would kick a ball with.
2) The test will begin on a hard surface and then we will have you stand on a piece offoam.
3) Stand barefoot on your non-dominant foot, with the other leg raised so that the raised
foot is near but not touching the ankle of your stance leg.
4) Prior to raising the limb, cross your arms over your chest, like this (demonstrate)
5) Focus on a spot on the wall at eye level in front ofyou, for the duration of the eyes open
test.
6) I will use a stopwatch to measure the amount oftime you are able to stand on one foot.
7) The time starts when you raise your foot off the floor.
8) The time ends when you either: (1) use your arms (i.e., uncrossed arms), (2) use your
raised foot to touch the floor, (3) move your weight-bearing foot to maintain your balance
(i.e., rotate foot on the ground) 4) open your eyes during the eyes closed test or (5) a
maximum of 45 seconds had elapsed.
9) I will conduct this test 3 times in each position.
Dominate foot: (circle
one)

Time 1

Time 2

Time 3

Average
Time

/ Right
Hard surface eyes open
Left

: Hard surface eyes closed

i
I

. Foam surface eyes open

i

Foam surface eyes

closed

Template Revised 13 April 09

I:

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version # 10, 6 March 2012
39
Appendix C - Recruitment Script Concussed Group

Recruitment Script for concussed group for ImPACT MIL v. ANAM4

To be read prior to persons who meet the prerequisites of having sustained a mTBIIconcussion
within the last 72 hours.
This will be read to those who have had sustained a concussion and were referred from the ED
prior to collecting informed consent. It will be read in private to the concussed by a member of
the research staff. Recruitment efforts will be brief consisting of a non-military civilian research
assistant giving a brief (less than 5 minutes) speech asking forthe concussed participation. The
script for the speech will be read as follows:
Hello my name is
. I am here on behalf of the U.S. Army Medical
Research and Material Command (USAMRMC) and I am recruiting volunteers to
participate in a study on mTBIIconcussion. There are currently two different
neurocognitive tests used by the US Army today. One of them is the ANAM (automated
neuropsychological assessment metric) and the other test is the ImPACT MIL
(Immediate Post-Concussion Assessment and Cognitive Testing Military Version)
currently being used to evaluate Special Forces troops. The study you are being asked to
volunteer to participate in is designed to compare these two tests to see which of the tests
is better suited for detecting the effects of acute concussion. For the purpose of this study
we have asked the emergency department staff to aid in identifying those who have
recently (within the last 72 hours) received a concussion. Everyone who has sustained a
concussion is being asked to participate as part of the study group. If you choose to
participate in the study it would take approximately one hour and will include the
following: review of the Informed Consent sheet; a short screening questionnaire; two
computerized neurocognitive tests, the ANAM and ImPACT; a short balancing test
(UPST); and AHEAD M - 100, which involves the administration of a noninvasive, short
EEG to monitor brain electrical signals.. There will be a break between each test and the
balancing test will be conducted prior to the start of the second test. You will receive no
financial benefit for your participation in this study but your time is greatly appreciated.
Testing results will be reviewed by a neuropsychologist and if there are any abnormal
results a write-up of the testing results will be sent to you for your medical records. At
this time would you be interested in learning more about this study?
Those who elect to learn more about the study will be given the protocol ICD to review and ask
questions about prior to testing if they agree to participate. Each member will be asked to
complete the short screening questionnaire consisting of demographic information and the first
page of the MACE (post-concussion symptom checklist). After each participant has completed
the ICD and the questionnaire the first computerized test will be administered. Participants will
complete the first test and be given a short break (10 mins.). During this time they may get
Template Revised 13 April 09

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10,6 March 2012

40

something to drink, use the restroom, smoke, stretch, etc. prior to starting the next test session
each participant will be given a short balance test and then testing instruction will be given.

Template Revised 13 April 09

l:

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10, 6 March 2012
41
Appendix D - Recruitment Script Control Group

Recruitment Script for control group for ImPACT MIL v. ANAM4

To be read prior to service members already registered to take the ANAM as part of the SRP
process.
Service members are tested in groups of25 - 50 depending on the size of the testing location.
Prior to testing, testing instruction are given to group members in a class like setting.
Recruitment of potential control group members will be conducted at that time. Recruitment
efforts will be brief consisting of a non-military civilian research assistant giving a brief (less
than 5 minutes) speech to the group asking for participants. The script for the speech will be read
as follows:
Hello my name is
. I am here on behalf of the US. Army Medical
Research and Material Command (USAMRMC) and I am recruiting volunteers to
participate in a study. There are currently two different neurocognitive tests used by the
US Army today. One of them is the ANAM (automated neuropsychological assessment
metric) which you will be taking today as part of the SRP process. The other test is the
ImPACT MIL (Immediate Post-Concussion Assessment and Cognitive Testing Military
Version) currently being used to evaluate Special Forces troops. The study you are being
asked to volunteer to participate in is designed to compare these two tests to see which of
the tests is better suited for detecting the effects of acute concussions in an active duty
population. Everyone here is being asked to participate as part ofthe control group. Since
everyone here is taking the ANAM the additional time I am asking for participation is an
additional 40 minutes and will include the following: review of the Informed Consent
sheet, a short screening questionnaire; two computerized neurocognitive tests, the ANAM
and ImPACT; a short balancing test (UPST and AHEAD M - 100, which involves the
administration of a noninvasive, short EEG to monitor brain electrical signals .. There will
be a break between each test and the balancing test will be conducted prior to the start of
the second test. You will receive no financial benefit for your participation in this study
but your time is greatly appreciated. At this time who would be interested in learning
more about this study?
Those who elect to learn more about the study will be asked to step across the hall into another
testing room and will be given the protocol ICD to review and ask questions about prior to
testing if they agree to participate. Each member will be asked to complete the short screening
questionnaire consisting of demographic information and the first page of the MACE (post
concussion symptom checklist). After each participant has completed the ICD and the
questionnaire the first computerized test will be administered. Participants will complete the first
test and be given a short break (10 mins.) during this time they may get something to drink, use
the restroom, smoke, stretch, etc. prior to starting the next test session each participant will be

Template Revised 13 April 09

Protocol Title: A Comparative Study: ImP ACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version 10,6 March 2012
42
given a short balance test and then testing instruction will be given. Participants will be free to
continue with the SRP process once they have completed their second test.

Template Revised 13 April 09

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version # 10, 6 March 2012
43
Appendix - E BrainScope CEO IDE Letter

.::1
.... ift
.....
!Id
.. . ~e_"
"'~"","",
"-10

II

November 19, 2010

Ph.D.
NeurocooniliveAssessmenl Br~

c._ _ _ _---'

I$Wgj

L ..... _ _ __

Dear Dr.
The BrainScope Ahead M-100 device is a non-invasive, 'non-significant risk (NSR) device [see 21 CFR 812.2(b)
arid FDA Guidance entitled, "Significant Risk and Non-significant Risk Medical Device Studies"]. This generic type of
device, designed and marketed for EEG signal acquisition and processing, falls under Class I\" per 21 CFR
882.1400. FDA policy allows that EEG devices are specifically exempt from the need for an Investigational Device
Exemption ODE) [see 21CFR812.2(c) and FDA Guidance for IRBs and Cis - 1998 Update at
http://www.fda.goviociohrthrbsidevices.html].
The BrainScope system consists of a handheld, battery operated device and a disposable non-invasive adhesive
headset which contains electrodes that are similar to standard, off-the-shelf silver-silver chloride EEG electrodes.
The data acquisition time for the BrainScope is 5 to 10 minutes total, depending mostly upon patient compliance.
The device is intended as an assessment tool, not for continuous monitoring, thus the amount of time the electrodes
reside on the patient's skin is minimal. The purpose of the clinical investigation is to collect brain electrical activity
from human subjects. During clinical investigational use, the device will not provide any diagnostic or classification
information and therefore will not impact upon patient care.
In summary, the BrainScope Ahead M-100 device used in this study does not pose a significant risk to the study
subjects. Therefore, the study of the BrainScope device may be considered a non-significant risk study.
Sincerely,

if

! .

j'- '"

Michael E. Singer, Ph.D.

Chief Executive Officer
BrainScope Company, Inc.

Template Revised 13 April 09

Protocol Title: A Comparative Study: ImP ACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10,6 March 2012
44

8120 Woodmont Ave.

Suite 250
Bethesda, MD 20814

(240) 752-7680

(800) 230-7573

www.BrainScop

Template Revised 13 April 09

Protocol Title: A Comparative Study: ImP ACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10,6 March 2012
45
Appendix F - Site Impact Statements

IMPACT STATEMENT
3
~

;)

ProjC2: Title: A Comparative Stul),: ImPACT MIL V~l'StlS A:t'\A.v14 TBI '\-llL:o:: Acute
c."Hcl:.ssion

PrindpuJ Invcslig<tlOr:

SL'nil;ciDl:purlllll.'fll: Brvuk Anny Mctli(;l:d Center Department of Emergency '.1edicil1e

lO

12

As,j:;tance Requested: Requesting ED staff to aid in identifying and referring those

paticllls with mTBlto ANAM research statrt()r parljcil~ation in tie current study. Study

IJ
14

memhcl' ()f the re~ear<:h team will ht: ~yailable to ~e'\'iew the lCD, ans'....e r m.1)' :juestiol1S

I!

15
16

information will be given to the CD stail' pertaining 1:0 i1,clusion:exclnsion criterh and n
pertdning to the
study.

~lLldy

and. schedule appointments as apptc)priate fOI' the purpose of the

1/

21

Total Nlllnber of Patients to be Studied: This study requires the pru1icillatioll of one
hundr:;:d concllssed (mTBl) patients tlom tour Anny Medical Centers. Partic'iplUltli y.-ill
he re:crnitr.d 1111t1' the, rotal n!1l11he:r of C:\Jllcnsse..iimTBI pntlems h~ le.uched Oll~ Lumill:.d.
There is no fie! number of patiellt'l required per location.

22
Tl

Nt] mbl"t

18
19
):1

:'4
25
26

21
21)

29
30
31
32
33

of PatIents per ~,,1onth: The~ is no set r.un:ber of p.\(i~lls r",1.[ u.ired per month.
D(1,,, will be collected fur a total ofi'o'l.U mOlltus (12.0 Ji.1YS).

Length ofSmdy Tl1e swdy is expecl<:J to shut in September 2010 data collection is
expeC1.ed 10 luke Il() l()llg~r thi.l.ll ful.lL lIluJlths (120 :lay:;) u.ml unuly~is of data to take an
additio:l::t[ sL'i. muutl:l.S (I80 day:;) arrer dutu colh:Cctinn is oornpktc fm a total tesearch time
of 1(I months (300 day~).

J:j
35

.B
39
411
41

42

:J

ni~appnwed,

c:nnot support activity.

".'j'Q. Approved, no :;;om:ncllt.

43

44

C Approved with cnrrm::nt.

45

1{i

Template Revised 13

Te111pla:e Version 2.1.

r Feb 20] 0

Protocol Title: A Comparative Study: ImP ACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10, 6 March 2012
46

Dule:

Template Revised 13 April 09

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10,6 March 2012
47

"
~

P.f(}jecl Title: A c.ompamtivc Sludy~ imPACT Mit yersus ANAM4 'I'm MIL for
Concussion

AcI.1!e

87

Pl'jl'l(;:ipalll'1vt'l!ligalor:

Se-rvice/Depanmcnt Carl R. DarnaU ,I\rrny Mi:wcal Center 1)cpm1lncnt ofEm<rs,,"'I1CY

I(}

L_~

____

______

Me<lieil1t>

C!

15
E~

A"",";starl'Ce Req uested: Requesting ED staff waid in identifying wid referring I.htt:lle
patie!llts with mlTSI. too ANAM researllhslaff'tm panici"alj~n in tlxcum::nt-study. Study
inform!;1 ion '.1.'il! be given to t~ ED ~12ff pertaining; to i 1\(:1 ust.oftJe;xcltlsia!l c:rile:ria and a
mt:m bet oflht: tt'.,r;carchtCflm will be av~il~hle to rf"iew thelen, an!i14Jt1tRy q~iom:
prntuning \<;,1 ttl; ~I udy lind !C'hIUi4; appoi ntmrnalisapprQptlate fortb~ pLJr:pos~ afm e

11

SII.Jd)<.

I"
20

T()lalt...:'(;Imbcr (;lfP'aJ!CmSOIO be Studied: Tbis Judy requires tbepanicipatJofl oralie

hundred COncU:5IS.:G {mTill} p:.tlenlS from (our Army Mcd1C4J Cmtcr!l. PW11clpants: will

Jl

be l'el.'ru~l"d tlfitillhe toIalllutnb.el' of oonc ussooim1'01 pllti;:I'l!!> has readwd ~ne tnmdred..

There is 110 set numbt,-r ~)r patientS n:quircd pcrlocation.

.2
H

14

1~

2)

24

Number of fla.ttent:! per Month: lhere .~ nl) ~t nulJtbi:r nfpaticnl.'i fI.:quircd per month.

will be collected for a lotal OCrt1ur mon!hs (120 days).

23

i);ll'lt

11

Length Of:S1U~.b; The study is expected to start ill Se'p(~bet 26] 0 daia col~lion i$

!8

expect~d (0 take nu longl!T Ihanfour mOl'llh~ (120days)nnd III1l1lysis cf dnl.lllo mite :m

adwtiQlLalsix Illonth$ (l SO (l,f1Y$) Ilflcrdata .:oUc:;t.:ligfl j~l:Qrnplel; for IIlmal fs,wc;h time

~9
;1.0
)1

l:!

)3
)4

35
;J(,

fm:~;

__..

--.lrllIJ....D'--'-Lw.T~C...;!J"-'1......
S..Ll{C-"i""'it)w.j{""'iduN.1I.'e..LIU.l.l.lj"rYdK>I.gi~J

)1
III
19
4(}

41
ill
4:/

v"

Di~l!ppN,wed. CMIlO!

.14

'J;;'

Apprcw(!(l, 1!1(1 (XI1ll~l1t

'r;/

Approved will!

sUPJ!On. OCliil)'.

45

46

Template Revised 13 April 09

eom.m~nL

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute

Concussion
Version #10, 6 March 2012

48

Dalt;!' .hltltl tJ6. lO!f}

.17

48
49

jU

~~__ ~________~~.. ~

jl

jJ
:54

Template Revised 13 April 09

_____~

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10,6 March 2012
49
Dale' June 06,

2{) 1()

IMPACT STATEMENT

Project Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for Acute
Concussion

4
5
6

Principal Investigator:

7
g

~-----~--------~

Service/Depa.rtment: Fe Hood Soldier Readiness Process Site

to
II
12

Assistance Requested: Allow study staff ANAM test administrators to brief SRP soldiers
prior to ANAM testing about the current study and recruit study participants. This may
add an additional 40 minutes to the length of the participants testing time.

13

14
15
16
17
18

Total Number of Service Members to be Studied: This study requires the participation of
two hundred control (non-ooncussed) active duty service members from two active duty
SRP sites. Participants will be recruited until the total number of controllnon-concussed
service members has reached two lllUldred. There is no set number of service members
required per location.

19
20

Number of Patients per Month: There is no set number ofpamcipants required per
month. Data will be collected for a total of four months (120 days).

21

22
23
24
25

Length of Study: The study is expected to start in September 201 0 data collection is
expected to take no longer than four months (120 days) and analysis of data to take an
additional six months (180 days) after data collection is complete for a total research time

26

27

28
29
30
3!

32
33
34
35

36
37

Date

:(b)(6)=--_~h,D., LTC, MS (Clinical Neuropsychologist)

L.

38
39

40
41
42
43

44
45
46

Disapproved, cannot support activity.

~~roved, no comment.
C Approved with comment.

Template Revised 13 April 09

J() Jllf'I~

/0

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute

Concussion
Version #10,6 March 2012

50

l(b)(6)

JUt - 12010
~l

(b)(6)
(b)(6)~-

54
~5

5/,

Template Revised 13 April 09

Protocol Title: A Comparative Study: ImP ACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10,6 March 2012

S1

Template Revised 13 April 09

I

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10, 6 March 2012
52

Pr.~:':"l 11th:: A C'nmpllT,lUv,;'

Shu]:',

lmrAC1MIL\'el~U,~ANAM4

'IU' Mlllbt tktlt

(I)l'\\;U$~il1!!

f'rindp;jJ bLY~');llf::lwr: ~b)(6)

.,

\!!h'SI),,:';lh.~ 1fn~~~liuak.r:'~~~~~_ _ _~

Ii)

s.:nkeiLkpm lHient. Maltitl Army (\II,l\n\tll1l:y HospiJ:u ~.i<I.r(men! OrbIlCll!tJl~)'

If

M\:'J~m<:

I:'
i.!

14
IS

A"sh,ilIlICl:'lh~LJt)i;HH."Ll: 1{t.'X1U~"'linl:\ 11 USlllt'i It.111iiiifl ;d~tltifybltl IlIld to1;:mng tl\/J$I!

r~i"',!Jt,with mrBllo ;.\N,\MJCliCllrch st"fHor paniipaHooinibc~nl !itr.lJy,SfOO)'
mJOtmI1I!un wi It Dc9i ,tn to the lill $\;ljf pel1ainillQl1l,)incl!is,iollfcxc1Wlinti~i&l:Jill&1da

1(,

m~lIIbl!rnrfb(1 n..'$I.<fm;I1II.'e!ljl will t~II\4i1nhh: III rc\ii~w'bt ICl1:,~'~1:f .. nyqll~jUlll;

17

f\l.'1'IIl'niOI? Ii) Ih<: Shl1:ly~lI\d 3d~ld.: <lPlX'inltnrnlsas ~ppropOlIt.! f<lt1nc pUrpilSi.l oj'llK-

I~

~Hldy.

':~.l

::;1
::'~

2~

1/,

TN>!1 l\ umi-tl,,'I' IIf P;l!h:nt~ lore Sl\~jjl.l: Thi:;smdy rcquite:ithep:n1icJ[lI1\lQll ot' Ql'le'
hundred ':()ll>:U$!\l.!:i (luml ~ i}:llkm~ irum iiw Arm~ Mc,lic~Jt:et\I~l1i.ll""1j~i""'lUla ,,,ill 111:
(LX'HII!1.....1Ulllillhcl"UllIlIU111"Cf ,,) c"I~~I..~im'IIH(l~lict1f1! hlls R:1~clgdunl:ill1l11dred.
11~:c i~ lkl ~\~~ u-!:unhcr vfp;uj..~nl$,t\~,tuil\\lperloc~Tifln.
Nljml~r<)f Vi'llit'l'l!li [1..(M~ntl}l: TikI\' is IIIl ""JnlH~r uf')~tticnt:i n:qulw.:lpcr UitlJllh,
Dal,!!, wil! b<~, c()I1I,,">.:b..'<i fOT n 101.(11 offoormoolh!t Hlu da)lIi,

:1
=S

lXlll~tll ..rSIm.ly: 'n'C&1 lidy i~ .:tlllt:>:wd III t,"tkcnu J~~r 11l!1Ilftilir n;onw j 12(1d.'1)';'J)und
...':;tb;si~ ~If ,!;jI;1 \\1 (.lke an nddiduO'Ji ~ix momh:,; (ISOdil!,'S) anerdatacolieClioll is
1(.[ II JOlaJ IC,Cilrch Jim&: of II! mjml~ c:mo d.~'$)_

f(ibXlelr"
)1

:N'

"'J

''!

Di:,appn,\vI,,"l1 C'llit)()t

;;'tl))l)(II'1

II
I~

AVPI~I\'~'d, IWi.!lI1lllWl1l,

.1.\
,~-4

'i Al)rtu~~ witht.ltnlllCl1l.

~I:;

1(,

Template Revised 13 April 09

aclh"it)';

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute

Concussion
Version #10, 6 March 2012

Template Revised 13 April 09

53

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10,6 March 2012
54

Template Revised 13 April 09

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10, 6 March 2012
55
Appendix G Reportable Event Submission Form
U S Army Medical Research and Materiel Command

Office of Research Protections

HO, USAMRMC InstiMional Revfew Board

Reportable Event Submi$slon Form

Purpose,' Use this (ann for the initial reporting of any study-related event that requires prompt
reporting e$ per the "Re$pOnsibiJiIies of the Pr'inQpallnvestigatOf in Humlitll
Subjects Res8erch Investigator Agreement."
Directions: Place the cursor where )'00 wish to type. and tab through the form. ThtJcompieted
form and any supporting documentallonshould be sent by emai/to

Date of this report:

Person Reporting Event
Name:
TltlelPosition/Association ~1h Study:

Phone numb&r.
Email address:
-~.
~~--------.------,,-.-,~----------..-------------------~-----~
Protocol Information
Protocol Number:
Study Title:

Name of Prindpallllv$stiaator:
Event Information

SubjedlO#;
Data of Event
Time of Ev&rlt:
f---- Location of Ewnt

---~.

_~~_.

_ _ _ _ _ _ _ _ _ w _ _ _ _--I
.~

Event type(s) Check a/l that apply

D Unanticipated problem Invol\ilng risks to subjects or others
D Sedous adverse event
D Oealh
D Protocol deviatkm hat may affect the safety or rights of subjects and/or th& integrity of the
study
D Ch ange to the prollX:Ol taken without pria' IRB riWiew to eDmlnate an apparoot imm$dlaIB
hazll'd to research $lJbject
D Incarceration of a subject
Significant mdings that might aff$Cl h wW.,gness of subjects to enroll or to continue to take
pa-t
Co!ll)lalnt by subject or other
D NOl'lOOmpliancEl'Mth lhe regulations or reqUlr&rn&nts
D Pending compliance InspectlonMslt by the FDA, OHRP. or other governmentaf agency
D Other event

o
o

Template Revised 13 April 09

Protocol Title: A Comparative Study: ImP ACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10,6 March 2012
56

rief Description of Event (who, what, why)

Initial Actions Taken

Follow-up Actions to be Taken

FOR INTERNAL USE ONL'f.

Reportfec.eiYid by
Date and Urne reporl received
Repod HI01:Jived vra

Phcnecal

Fax

o Email
ROIJliog

Name ___________ Dele.

lI1!tisls

Reromrnerlded Action

Recommended ActiOn:
_ _ _ _ _ _ _ rete,
Name

Reoommended. Acbl.
CcnoHlencs of HQ tJ.RMC lRBApp/owal Authority 0

(signaluffI)

Template Revised 13 April 09

YesD NoD

NA

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10, 6 March 2012
57
Appendix H Individual Investigator Agreement

Department of Defense

Human Research Protection Program

DoD INDIVIDUAL INVESTIGATOR AGREEMENT

Part 1
AGREEMENT INFORMATION

This Department of the Defense (000) Individual Investigator Agreement describes th8
responsibilities of the Individual who is engaged In human subject research and is not
an employee of the assured insti1ution, but is essocia1ed with the assured institution for
the purpose of conducting research, This Agreement also describes the responsibilities
of the (:Issured institution. This Agreement, when signed, becomes part of the
institution's Federal A~urance for the Protection of Human Research Subjects (e.g"
000 Assurance or Department of Health and Human Services (DHHS) Federalwide
Assurence (FWA.
A, Nama of Investigator:

~~_ _ _ _ _

PhD

B. Institution with the Assurance:

Name: US Army Institute of Surgical Research

000 Assurance Number: DOD A20104

OHHS PNA Number [if applicable]: FWA00009672

C. Scope:
This Agreement applies to all research performed by this Investigator and supported by

the Ins1itution with the Assurance, unless sr:ecified below.

Limitation of Scope (if applicable):

This individualln~.c!lli;lU!.llg~ment will apply to approved protocols

conducted by Or~
until this agreement is rescinded.
D. Effective Date:
This Agreement is effective as of the date signed by the DoD Component DeSignated
Official and expires on the date listed in Part 4, paragraph D.

Template Revised 13 April 09

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10, 6 March 2012
58
Part 2

INVESTIGATOR RESPONSIBILITIES

As the Investigator named above, I:

A. Havs reviewed: a) The Belmont Report: EftlicaJ Principles and Guidelines for the
Proiectiofi cf Human Subjects of Researcli; b) the U.S. Department of Defense (000)
regulations for the protccticn of human subjects at 32 Coda of Federal Reguiafions, Part
219 (32 CFR 219) and DoD Directive 3216.02; c) the Assurance of the institution
refe'enced above; d) the DoD Component policies ide!''!l!fied in Part 3 of the 000
Assurance (if applicable); and e) the relevant insti1utional policies and procedures for
the protection of human subjects,
8, Understand and accept the responsibihty to comply with the standards ;ma
requirements stipulated in the above doclIments and to protect the rights and welfare of
human subjects Involved in research conducted under this Agreement.
C. Will comply with all other applicable federal. 000, international, state, and loeallaVls,
regulations, and poiicies that provide protections for human subjects participating in
research conducted under this Agreement
D. Will complete any education and training required by the InstitutiDn and the IRB prior
to initiating research covered under this Agreement (attach documentaiion).
E. 'NlII abide by all determinations of the Institutional RevIew Board(s) (iRB) designated
under the Institution's Assurance and will acoept the final authority and deoisions of the
IR8, including but not limited 10 directives to terminate my participation in designated
research activities.
F, Will not enroll subjects or start research activities under this Agreement prior to its
review and aPP"oval by the IRB and the Institution.
G, Will comply with requirernenis from the IRS when responsible for enrolling subjects,
to illclude ootaining, documenting, and maintaining reoords of informed consent for
each such subjeLi. or each subject's legally authorized representative as required under
DoD regulations at 32 CFR 219.
H. Ackilowledge and agree to cooperate with t!i& IRD for initial and continuing review.
report for the research referenced above, and provide all information requested by the
IRS or institution in a timely fashion,
I. Will seek prior IRS revrew and approval for all proposed Ghanges in the research
except where necessary to eliminate apparent immediate hazards to subjects or others.
J, Will report immediately to the IRS a) unanticipated problems involving risks to
subjects or others and b) serious or continuing non-compliance

Template Revised 13 April 09

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10, 6 March 2012
59
K. Will comply with recordkeeping requirements for research protocols referenced
above.
.
L. Will make all other notifications as specified by the IRS and the Institution.

M. Acknowledge my primary responsibility for safeguarding the rights and vJelfare of

each research subject, and that the subject's rights and welfare wlll take precedence
over the goals alld requirements of the research.

Part 3

ASSURED INSTITUTION'S R!:SPONSI8IUTIES

This Institution will apply the tt3rms of its assurance 10 Ule

as specified in tile scope of tllis Agreement, Part 1.

lJ1v~tigator

aM the researCh

Part 4
AGREEMENT BETWeEN AN INVESTIGATOR AND AN ASSURED INSTITUTION
The Investigator or an official of lhe assured Institution may unilaterally terminate this
agreement upon written noUfication to other signatories.
A. Investigator:

Il,Inders1and my responsibilities as described in 1his Agreement and the policies

referenced in Part 'd.A above, I acknowledge and accept my responsibility for protecting
the rights and welfare of human research subjects and for complying with all appiicable
proviions ~~~~'-"-"-"'=~~=.!..:~~_~

Signature:

'Clinical Neuropsychologist)

3
Template Revised 13 April 09

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10, 6 March 2012
60
B. Acknowledgement by Investigator's Employer (or 000 Supervisor if 000
Employee):
I am aware that my employee is entering into this agreement.

Name:l(b)(6)

OPT. OCS

Fl<lGrade: COl--=
I

C. Institutionsl Official of the Assured Institution:

Acting in an authorized capacity on behalf of this Institution and with an understanding oftlie
Institution's responsibilities urJ.d,erthe Institution's Assurance, I,will provide oversight of the
Investigator and the res~~noon9~nder th!sAgreement.
I(b)(6)
,
Signatur~
Date:
MAR 23 2011 ,
I,

Name:l(b)(6)
RankJGrade: Colonel, MedicarCorps
Title: Commander
Telephone n "
!(b)(6)
FAX number: (b)(6)
Email addres$1(5)(=6)-
Mailing Address:r)(6)

Template Revised 13 April 09

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10, 6 March 2012
61
Appendix I BrainScope Scientific Overview

ScientificUnderpinnings

Confidential

Template Revised 13 April 09

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute

Concussion
Version #10,6 March 2012

62

Confidentiality

1M. J
THIS DOCUMENT CONTAINS CONFIDENTIAL PROPRIETARY AND/OR
j

SECRET INFORMATON
(BRAINSCOPE).

OWNED

BY

BRAINSCOPE

. COMPANY,

ANY PERSON ACCEPTING THIS DOCUMENT AND/OR INFORMATIONAGREE$

TO MAKE NO DISCLOSURE, USE OR DUPLICATION THEREOF. EXCEPT AS

AUTHORIZED IN WRITING BY THE. BRAINSCOPEMANAGEMENT_tJPON
REQUEST OF BSC, TH IS DOCU MENT MUST BE RETURNEDOROESTRPYED.

The BrainScope Ahead M-IOO System isanlnvestigational Devicepnly/for

use only by qualified personnel, and the use of the device remains lirnited by
U.S. Federal law to investlgatfonal uses only.

Brarf1Scope makes no

representations regarding the device/ssafety or efficacy.

Template Revised 13 April 09

Protocol Title: A Comparative Study: ImP ACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10, 6 March 2012
63

Template Revised 13 April 09

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10,6 March 2012
64
(b)(4)

Template Revised 13 April 09

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10, 6 March 2012
65

Template Revised 13 April 09

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version # 10, 6 March 2012
66
(b)(4)

Template Revised 13 April 09

Protocol Title: A Comparative Study: ImPACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version #10, 6 March 2012
67

Template Revised 13 April 09

Protocol Title: A Comparative Study: ImP ACT MIL versus ANAM4 TBI MIL for an Acute
Concussion
Version 10,6 March 2012

Template Revised 13 April 09

68

Alternatives to ANAM

Rehabilitation and Reintegration

g
Division ((R2D))
Health Policy and Services
Office of The Surgeon General

18 DECEMBER 2011

ANAM
ANAM was chosen
h
as a ttemporary solution
l ti tto th
the

requirement for neurocognitive testing, pending the result of

a head to head study of available alternatives.
ANAM limitations:

Antiquated software
poor instructions
practice effects of up to 60%
lack of validity and effort measures
low specificity to TBI
lack of frontal lobe measures
difficult to use clinical report.

NCAT Viewable Report

ImPACT
Most
M t Popular
P
l (NFL and
d NHL,
NHL mostt colleges)
ll
)
Adopted instead of the ANAM by Special Operations

Command
Slightly longer than the ANAM,
Measures things the ANAM doesnt
doesn t
Better instructions
A more user friendly report.
Might be too difficult for some lower GT service members.

ImPACT has greater

demonstrated sensitivity than
ANAM

The ImPACT Report: Much clearer than ANAM

CNS Vital Signs

The
Th mostt popular
l test
t t used
d in
i drug
d
research
h and
db
by
pharmaceutical companies is the CNS Vital Signs (CNSVS)
test.
The most advanced software and database capabilities of
any NCAT.
Excellent Instructions
Excellent Report
Little track record in sports or concussion

CNS Vital Signs Improved Report

Defense Automated
Neuropsychological Assessment (DANA).
Still in development by Navys BUMED
Advanced handheld unit ((Android Operating
p
g System).
y
)
Designed for the military, and specifically for mTBI.
Excellent differential diagnosis between mTBI and PTSD.
Controls for practice effects.
Adresses objections to ANAM
DANA is it has yet to see extensive use, and so advantages
are not yet confirmed.

Slide 10 of 34

Cogstate Sport
Developed
D
l
d iin A
Australia
t li and
d exported
t d tto C
Canada
d
Attempt to make NCAT easier to understand by basing test

on a Deck of Cards
Cards.
Well liked
Not validated with American Military

Slide 12 of 34

Headminders CSI
Headminders
H d i d
was used
db
by th
the Ai
Air F
Force iin Balad,
B l d 20072007

2008 with some success.

Patent claims against the government/ongoing litigation
made it unavailable to be used in the DVBIC Head to Head
study
Due to Above, has not been seriously considered as a
replacement for ANAM.

Slide 14 of 34

Head to Head Studies

Four
F
Head
H d tto Head
H d St
Studies
di are underway
d
or proposed:
d
1. DCoE/DVBIC study comparing four tests. Results not

available until at least 2014

2014.
Army Head to Head study which compares ANAM to
ImPACT,, being
g conducted at five centers across the Army.
y
Done mid-2012.
Army funded (Wisconsin/Michael McCrae ) using college
athletes as an analog to soldiers in an expanded version of
the Army study. Not started
4 Proposed in
4.
in theater
theater head to head study (DVBIC).
(DVBIC) Lacks
personnel.

Conclusion
Hard
H d tto recommend
d a change
h
without
ith t d
data.
t
Objective expert panel would likely recommend ImPACT if a
change was sought today
today.

T t lN b C
TotalNumberConcussedfromCombatives:72
df
C b ti
72
Totalof28tested
beforeQEEGwas
availableandtherehave
been4testsusingQEEG
wheredatawasntable
tobecollected(3for
insufficientdataandone
head set was too big to
headsetwastoobigto
fitSM).Totalof40Full
setsofdataforthe
concussedgroup.

4
28

N QEEG
NoQEEG
Fulldataset
QEEGerror

40

40%ofN100

TotalNumberofControls:64
NoQEEG7

FFullData
ll D t
Set57

NoQEEG
FullDataSet
Stillneeded

Still
needed
143

28%ofN200