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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 

 
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