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DST SATYAM PROPOSAL

ON:

Dr Abhishek Pathak(DM
Neurology)
Assistant Professor, Department
of Neurology, I.M.S, B.H.U,
Varanasi
Origin of Proposal
ALS is a neurodegenerative disease, causing upper
and lower motor neurons to degenerate very rapidly
leading to clinical symptoms from limb weakness to
dysphagia, dysarthria, muscle cramps, etc

Riluzole is the only drug available which delays


death from few months, without any effect on the
natural history .

Yoga has been tried in few cases to benefit the


symptoms of cramps with significant results.
Definition of the problem
The global incidence and prevalence of the disease
is roughly 1.5-2.7/100,000 population and 2.7-
7.4/100,000 population respectively.

Incidence and prevalence of the disease in India is


3.6 and 7.2 per 100, 000 population respectively.

Typically the disease has relentless progression and


survival for 3 years after the disease is roughly 50%
though 20% of the patient survives longer.

The clinical features can be considered in relation to


neurological regions or levels: bulbar, cervical, and
lumbar
Contnd...
Depending on the region of involvement, patients have
their clinical manifestations. Weakness of upper limb,
lower limb, truncal weakness or respiratory muscle
involvement.

In absence of any effective treatment, the quality of life


is poor and the present management is based on
palliative and symptomatic management without any
effect on the natural history of the disease.

Alternative medicine especially Yoga and meditation has


never been adequately studied in the disease which
might hold some benefit, even if symptomatic and in
turn decrease the financial burden on the patient and
the family.
VARANASI
STATUS AT IMS BHU
ALS Registry as a part of DM thesis, to look
at quality of life and neurological function.

37 patients have been been recruited in


the past 6 months.

10 patients were on Yoga which was self


motivated.

Study is under progress.


Objectives:
To study the effect of yoga and meditation in
ALS patients on:

The ALS Specific Quality of Life-Revised


(ALSSQOL-R) at 0, 6 month and 1 year.

The motor strength assessed through MRC scale at


0, 6 month and 1 year.

The serum concentration of neuro filament light


chain 0, 6 month and 1 year.

DTI sequences of MRI Brain at 0, 6 month and 1


year.
Methodology:
INCLUSION CRITERIA:
Age more than 18 years

All consecutive ALS patients (diagnosed as per


Awaji Shima Criteria 2008, definite, probable and
possible) visiting the neurology OPD or admitted
in neurology ward will be included in the study
with Kings College staging < 3

Patient consenting for the study.


EXCLUSION CRITERIA

Patient unable to perform the yoga and meditation


exercises.

ALS with dementia(FTD-ALS)

Previous history of any other chronic illness or


stroke in the past.
All selected patients of ALS would be randomized
by startified block randomization and each of the
ALS patient will have neurological examination
along with ALS quality of life scale at 0, 6months
and at 1 year. At the same time periods patients
would undergo serum assesement of light chain
neurofilament, DTI brain and Qol Scale.

ALS patients randomized to yoga group, would


undergo training sessions of yoga and meditation
at our centre of Yoga by a trained yoga teacher.
Sessions of 2/ week for 48 weeks. Each session
would be for an hour. Patients would also be given
a CD with instruction videos of Yoga .
STATISTICS
Based on a pilot investigations, with 10 participants on
Yoga and 12 patients on conventional therapy, pooled
SD of the change was 3.62 with average difference of
2.5 between ALS patients on Yoga and those on
conventional therapy.

To calculate the sample size, following formula was used


n= {(z + z1- )2 s2 (1+ 1/)} % d2

With the presumption that everyone may not carry on


yoga, as per suggestion, it was decided that the ratio of
Yoga patients and patients on conventional therapy will
be 1:1.5 taking =95% and 1- = 95%, n obtained is
38 and conventional was 57.
YOGA TRAINING
Nadishodhana Pranayama
training
Diaphragmatic Breathing
Tada Asana
Parvatasana
Ekapada Asana
Dwi Pada Asana
Meditation
Neurofilament light chain(NF-
L)
There are three subunits of mammalian
neurofilaments : Light or lowest (NF-L) runs at 68-
70 kDa. Medium or middle (NF-M) runs at about
145-160 kDa

Antibodies are available to these proteins used in


histological sections

Neurofilaments in blood an spinal fluid of people


with ALS may be used to assess disease
progression and neurodegeneration.
Diffuse Tensor Imaging (DTI)
Diffusion tensor imaging (DTI) is recognized as a robust
MRI tool for the in vivo analysis of white matter neuronal
tracts

DTI data derive neural tract directional information on the


basis of the local properties of water diffusion, and
regional re- ductions of DTI metrics may be indicative of
axonal degeneration as well as to myelin degradation.

DTI-based analysis of the neuropathologically-defined


progression pattern in ALS provide a tool for imaging in
vivo the stage of disease in correlation to the clinical
phenotype.
First year :
1.Purchase of major and minor equipment, reagents, consumables and ELISA kit etc.
2.Appointment of project staff (JRF).
3.Base line MRI of ALS patients
4.Base line blood collection for neurofilaments expression in ALS patients
5.Yoga sessions to ALS patients
6.Preparation of first annual report
Second year
1.MRI of ALS patients with yoga intervention and without yoga after one year
2.Blood collection of ALS patients with yoga intervention and without yoga after one year
for neurofilaments expression in ALS patients
3.Yoga sessions carry on for next year to ALS patients
4.Preparation of second annual report
Third year
1.MRI of ALS patients with yoga intervention and without yoga after two year
2.Blood collection of ALS patients with yoga intervention and without yoga after two year
for neurofilaments expression in ALS patients
3.Expression of neurofilament expression will be assessed by ELISA
4.Data collection and interpretation
5.Compilation of result and writing for communication
6. Preparation of final report
Time schedule of activities giving milestones
Work plan
ALS patients

Randomize selection

ALS Control ALS yoga

Yoga session by expert


2 times/week for 48-52 weeks
Follow up for MRI and blood sampling after 6 month, and 1 year

ALSSQOL-R
Muscle strengthening through MRC scale
Baseline DTI brain
Light chain neurofilament in serum
Salaries/wages
Item BUDGET (in Rupees)
1st Year 2nd Year 3rd year Total
1 Junior Research Fellow 360000/- 360000/- .360000/- 10,80000/- Rs.
(Rs25,000/month + 20%
HRA)

2 Data operator (6000 72000/- Rs. 72000/- Rs. 72000/- 216000/- Rs.
Rs. /month)

Total 432000/- 432000/- 432000/- 1296000/- Rs.


Budget for Consumable Materials

Item BUDGET (in Rupees)


1st Year 2nd Year 3rd year Total
ELISA plate, Centrifuge 200000 200000 200000 600000
tubs, Tips, Blood
collecting tubes, globs
glass were and antibodies
etc.

MRI and blood test of 500000 300000 200000 1000000


100 patient
700000 500000 400000 1600000
Budget for Travel
BUDGET (in Rupees)
1st Year 2nd Year 3rd year Total
Travel (Only inland 40,000 40,000 40,000 1,20,000
travel)
Total 40,000 40,000 40,000 1,20,000

Budget for Other Costs/Contingencies


Sl. No. Other BUDGET (in Rupees)
costs/Contingency
1st Year 2nd Year 3rd year Total
Travel expenses (For the 2,00,000 1,00,000 1,00,000 4,00,000
patient), data operator
Total 2,00,000 1,00,000 1,00,000 4,00,000
Budget for Equipment
Sl. No. Generic name of the Imported/Indigenous Estimated Spare time
Equipment along with Costs for other
make & model users (in
%)

1 Remi Cooling Imported 3,00,000 30%


centrifuge

2 Sanyo deep freezer Imported 6,00,000

3 Miner equipment , Indian 1,00,000

Micro Pipette
Total 10,00,000
Budget Estimates: Summary
Item BUDGET (in Rupees)
1st Year 2nd Year 3rd year Total
A Recurring
1.Salaries/wages 360000/- 360000/- 360000/- 10,80,000/-

2. Consumables 700000 500000 400000 16,00,000


3. Travel 40000 40000 40000 1,20,000
4. Other costs 200000 100000 100000 4,00,000
B Equipments:- Remi 1000000 - - 10,00,000
Cooling centrifuge, Sanyo
deep refrigerator and
Miner equipment ,

Grand Total (A+B) 2300000 1000000 900000 50,00,000

Overhead charges 100000 100000 100000 300000


total 2940080 1290080 1290080 50,00,000
THANK YOU