CTRI Number |
CTRI/2020/02/023487 [Registered on: 20/02/2020] Trial Registered Prospectively |
Last Modified On: |
05/07/2020 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Medical Device |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
Study of TMS for enhancing recovery of function after acute stroke. (TRYST) |
Scientific Title of Study
|
Transcranial magnetic
stimulation for enhancing recovery of function after acute stroke.(TRYST) |
Trial Acronym |
TRYST |
Secondary IDs if Any
|
Secondary ID |
Identifier |
nil |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Pawan Ojha |
Designation |
Associate Professor |
Affiliation |
Grant Medical College, JJ Group of Hospitals |
Address |
ward 23, fourth floor, Dept of neurology, Grant Medical College, JJ Group of Hospitals, Byculla , Mumbai 400008
Mumbai MAHARASHTRA 400008 India |
Phone |
9820523745 |
Fax |
|
Email |
ptojha@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
Name |
Dr Pawan Ojha |
Designation |
Associate Professor |
Affiliation |
Grant Medical College, JJ Group of Hospitals |
Address |
ward no 23, fourth floor, department of neurology, Grant Medical College, JJ Group of Hospitals, Byculla , Mumbai 400008
Mumbai MAHARASHTRA 400008 India |
Phone |
9820523745 |
Fax |
|
Email |
ptojha@yahoo.co.in |
|
Details of Contact Person Public Query
|
Name |
Dr Pawan Ojha |
Designation |
Associate Professor |
Affiliation |
Grant Medical College, JJ Group of Hospitals |
Address |
ward 23, fourth floor, department of neurology, Grant Medical College, JJ Group of Hospitals, Byculla , Mumbai 400008
Mumbai MAHARASHTRA 400008 India |
Phone |
9820523745 |
Fax |
|
Email |
ptojha@yahoo.co.in |
|
Source of Monetary or Material Support
|
Investigator will bear the overall expenses which are likely to be small |
|
Primary Sponsor
|
Name |
Investigator initiated |
Address |
GGMC and Sir JJ group of Hospitals, Byculla, Mumbai, Maharashtra 400008 |
Type of Sponsor |
Government medical college |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Pawan Ojha |
GGMC and Sir JJ Hospital |
department of neurology, ward 23 and 24, fourth floor, GGMC and Sir JJ Hospital, Byculla, Mumbai Mumbai MAHARASHTRA |
9820523745
ptojha@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 2 |
Name of Committee |
Approval Status |
Institutional Academic Ethics Committee Mulund Fortis Hospital |
Approved |
Institutional Ethics Committee GGMC and sir JJ hospital mumbai |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
repetitive Transcranial Magnetic Stimulation |
Machine: The rTMS machine used will be NeuroSoft MS-D.
Coil: Flat or Curved Circular Coil with a diameter of 15cm will be used.
Physical Therapy: Standardized physical therapy will be given for a duration of about 40 minutes, which will be focused on the affected side and will be based on the principles of neuroplasticity. This will be given to patients of both the groups uniformly.
Experimental: rTMS will be applied with a circular coil angled at 45 degrees from the sagittal axis and positioned at the C3,C4,F3 in accordance with the international 10-20 marking system, which co responds to the right or left primary motor cortex (M1) injured.
Stimulation will be given at ipsilesional M1 and DLPFC at 5Hz. TMS burst duration: 10 seconds, Inter-burst interval: 20 seconds.
Train of 8 minutes at each site, totalling 800 stimuli at each site with 100% Resting Motor Threshold (RMT).
Inhibition will be done at contralesional M1 at 1 Hz. TMS burst duration: 50 seconds, Inter-burst interval: 10seconds
Train of 16 minutes, totalling 800 stimuli at each site with 100% Resting Motor Threshold (RMT).
Duration of each session is 32 minutes. The subjects will receive 10 sessions (over two weeks) every month for two consecutive months.
After TMS, patients will be submitted to 30 minutes of physical therapy protocol.
|
Comparator Agent |
Sham stimulation |
Sham stimulation will be done with the stimulator in the sham mode at 1 Hz (generates pulses at 90% lower intensity of RMT), with the coil rotated vertically above the
non lesional motor cortex.
Duration of each session is 32 minutes and 10 sessions over two weeks for two consecutive months of enrolment will be given.
After TMS, patients will be submitted to 30 minutes of physical therapy protocol.
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
1. First episode of acute hemispheric stroke (infarct or bleed) as established on neuroimaging
2. Age 18 - 80 years
3. Day 3 – 15 from onset of stroke symptoms,
4. NIH arm motor score >1
5. Stable GCS greater than or equal to 8 and off ventilator for 48 hours
|
|
ExclusionCriteria |
Details |
1 Patients with major cognitive deficits/spasticity / contracture/limb deformities interfering with study participation.
2. Epilepsy, psychosis, delirium.
3. Patients who received Intravenous or Intra-arterial tissue plasminogen activator or thrombectomy
4. Concomitant acute Myocardial Infarction, pulmonary embolism or Deep Venous Thrombosis
5. Hemodynamic instability
6. Major cardiac, renal, hepatic or pulmonary dysfunction
7. Uncontrolled sepsis
8. Trauma-orthopedic injury that limits the range of motion of the upper limb
9. Contraindications to TMS like intracranial metallic implants, cardiac implants, pacemakers
10. Pregnancy or likely to become pregnant during the study period.
11. Patients with stroke associated with CNS infections, HIV, malignancy, haemopoetic disorders
12. Premorbid MRS score- greater than 2
13. Not willing to consent
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Improvement in FMA-UE(Fugl Meyer Assessment-Upper extremity) score |
3 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
MAS (modified ashworth score), ARAT (action research arm test) and MRS (modified rankin scores) |
3 months |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
|
25/02/2020 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Background: Patients with acute
stroke have limb weakness and spasticity,
affecting normal functioning. Limited recovery from stroke may be partly caused by imbalanced interaction between the
cerebral hemispheres, with reduced
excitability of the ipsilesional motor cortex while
excitability of the contralesional motor cortex is increased. Non- invasive brain stimulation with repetitive transcranial
magnetic stimulation (rTMS) may aid in
relieving a post- stroke interhemispheric excitability
imbalance, which could improve functional recovery. While there are encouraging studies in patients with chronic
stroke, the evidence of rTMS efficacy in motor recovery and alleviation of
spasticity is lacking in the setting of acute stroke.
Methods and Objectives: An Interventional
Double Blinded Randomized Study of 60
subjects presenting with acute stroke (3-15
days from onset) will be studied. The effects of ipsilesional primary motor cortex(M1) and DLPFC at 5Hz, with
contralesional M1 at 1Hz will be studied.
Subjects will receive 10 sessions of rTMS over two weeks for two consecutive months, apart from routine
physical therapy.
The primary outcome
will be explored on a superiority analysis basis, by comparison of mean increase in FMA -UE (Fugl Meyer
Assessment– upper extremity) scores from baseline to 3 months between the
intervention and sham group stroke patients,
Secondary outcome parameters including ARAT, MRS, SSQoL,
BDI etc. will be assessed at predefined
intervals.
|