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

Phase 3
Conditions
Health Condition 1: G819- Hemiplegia, unspecified
Registration Number
CTRI/2020/02/023487
Lead Sponsor
Investigator initiated
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
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.

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Improvement in FMA-UE(Fugl Meyer Assessment-Upper extremity) scoreTimepoint: 3 months
Secondary Outcome Measures
NameTimeMethod
MAS (modified ashworth score), ARAT (action research arm test) and MRS (modified rankin scores)Timepoint: 3 months
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