Efficacy and Safety Study of rTMS for Upper Extremity Motor Function Recovery in Ischemic Stroke Patients

Study Overview
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Brief Summary
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The purpose of this study is to Evaluate Efficacy and Safety of rTMS 『TMS』 for Upper Extremity Motor Function Recovery in Patients with Ischemic Stroke

Detailed Description
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Repetitive transcranial magnetic stimulation (rTMS) can modulate the excitability of cortex but exact efficacy and safety of rTMS is not well established. Eighty four patients will be recruited and will be divided into two groups. Each group will receive the real rTMS or sham rTMS, respectively, over the primary motor cortex of the dominant hand. Individual subject will receive ten sessions of rTMS. Each rTMS session is low frequency (1Hz), total 1800 stimulations. The purpose of this study is to evaluate efficacy and safety of rTMS 『TMS』 for upper extremity motor function recovery in patients with ischemic stroke.

Official Title
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A Randomized, Double-Blind, Sham-Controlled, Multi-center Clinical Trial to Evaluate Efficacy and Safety of rTMS 『TMS』 for Upper Extremity Motor Function Recovery in Patients With Ischemic Stroke

Conditions
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Stroke, Hemiplegia

Intervention / Treatment
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* Device: Low frequency rTMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20-80 yrs old Radiologically confirmed ischemic stroke within 90 days Brunnström stage 3-5 in the affected hand (ischemic stroke-induced hemiplegic side) Patients received stroke treatment and on secondary prevention medication Written informed consent Exclusion Criteria: Previous medical histories of stroke, cerebral vascular operation, seizure Pregnancy, Breastfeeding Patients with hemorrhagic stroke, traumatic brain injury Skin lesion in the stimulation site of scalp Metal implants in the body (cardiac pacemaker or aneurysm clip) Unable to have regular physical and occupational therapies on the affected hand

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: true coil<br>Use the true coil / Low frequency rTMS / Intensity: 100% of resting motor threshold; Location: Motor hotspot in primary motor cortex for the dominant hand; Frequency: 1Hz; Number of total stimuli: 1800; Coil orientation: tangential to scalp | Device: Low frequency rTMS<br>* Intensity: 100% of resting motor threshold; Location: Motor hotspot in primary motor cortex for the dominant hand; Frequency: 1Hz; Number of total stimuli: 1800; Coil orientation: tangential to scalp<br>* Other names: TMS;|
| Sham Comparator: sham coil<br>Use the sham coil / Low frequency rTMS / Intensity: 100% of resting motor threshold; Location: Motor hotspot in primary motor cortex for the dominant hand; Frequency: 1Hz; Number of total stimuli: 1800; Coil orientation: vertical to scalp | Device: Low frequency rTMS<br>* Intensity: 100% of resting motor threshold; Location: Motor hotspot in primary motor cortex for the dominant hand; Frequency: 1Hz; Number of total stimuli: 1800; Coil orientation: tangential to scalp<br>* Other names: TMS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Box and Block Test (affected hand) | Before rTMS (baseline) and 10 days after the completion of 10 sessions of rTMS | up to 17 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Box and Block Test (Affected and unaffected hand) | Before rTMS (baseline), 10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start | up to 40 days | 
| Barthel Index | 10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start | up to 40 days | 
| National Institutes of Health Stroke Scale | 10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start | up to 40 days | 
| Fugl-Meyer Assessment Scale | 10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start | up to 40 days | 
| Grip strength (hand grip, pinch grip, lateral prehension, three jaw chuck) | 10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start | up to 40 days | 
| Finger tapping | 10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start | up to 40 days | 
| B-stage (hand and arm) | 10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start | up to 40 days | 
| Modified Ashworth scale (wrist flexor and extensor, Elbow flexor and extensor, Long finger flexor spasticity) | 10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start | up to 40 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuronal plasticity, Transcranial magnetic stimulation, Stroke, Upper extremity, Function, Recovery