Study of TMS for enhancing recovery of function after acute stroke. (TRYST)

Phase 3

Not yet recruiting

Conditions: Hemiplegia, unspecified,

Registration Number: CTRI/2020/02/023487

Lead Sponsor: Investigator initiated

Brief Summary: **Background**: Patients with acutestroke have limb weakness and spasticity,affecting normal functioning. Limited recovery from stroke may be partly caused by imbalanced interaction between thecerebral hemispheres, with reducedexcitability of the ipsilesional motor cortex whileexcitability of the contralesional motor cortex is increased. Non- invasive brain stimulation with repetitive transcranialmagnetic stimulation (rTMS) may aid inrelieving a post- stroke interhemispheric excitabilityimbalance, which could improve functional recovery. While there are encouraging studies in patients with chronicstroke, the evidence of rTMS efficacy in motor recovery and alleviation ofspasticity is lacking in the setting of acute stroke.

**Methods and Objectives**: An InterventionalDouble Blinded Randomized Study of 60subjects presenting with acute stroke (3-15days from onset) will be studied. The effects of ipsilesional primary motor cortex(M1) and DLPFC at 5Hz, withcontralesional M1 at 1Hz will be studied.Subjects will receive 10 sessions of rTMS over two weeks for two consecutive months, apart from routinephysical therapy.

The primary outcomewill be explored on a superiority analysis basis, by comparison of mean increase in FMA -UE (Fugl MeyerAssessmentâ€“ upper extremity) scores from baseline to 3 months between theintervention and sham group stroke patients,Secondary outcome parameters including ARAT, MRS, SSQoL,BDI etc. will be assessed at predefinedintervals.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

1. First episode of acute hemispheric stroke (infarct or bleed) as established on neuroimaging 2. Age 18.
80 years 3. Day 3 â€“ 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.

Exclusion Criteria

1 Patients with major cognitive deficits/spasticity / contracture/limb deformities interfering with study participation.
Epilepsy, psychosis, delirium.
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.
Premorbid MRS score- greater than 2 13.
Not willing to consent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in FMA-UE(Fugl Meyer Assessment-Upper extremity) score	3 months

Secondary Outcome Measures

Name	Time	Method
MAS (modified ashworth score), ARAT (action research arm test) and MRS (modified rankin scores)	3 months

Trial Locations

Locations (1): GGMC and Sir JJ Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
GGMC and Sir JJ Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Dr Pawan Ojha
Principal investigator
9820523745
ptojha@yahoo.co.in