Effects of the Quantity of Repetitive Transcranial Magnetic Stimulation(rTMS) on the Recovery After Stroke

Study Overview
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Brief Summary
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The aim of this multicentric double blind study (randomized study) is to demonstrate the relationship between the amount of rTMS and the efficacy in the treatment of upper extremity motor deficits of stroke patients.

Detailed Description
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Repetitive transcranial magnetic stimulation (rTMS) can modulate excitability of the brain via non-invasive methods. In that sense, rTMS has been used to treat a variety of symptoms of stroke during last two decades. Especially, improvement of upper extremity function has been proved by many studies. However, it remains uncertain about the optimum amount of rTMS. The aim of this multicentric double blind study (randomized study) is to demonstrate the relationship between the amount of rTMS and the efficacy in the treatment of upper extremity motor deficits of stroke patients. Fifty-seven patients will be included with written consent. After randomization, the subject will receive 3 different amount of treatment rTMS-rTMS, Sham-rTMS, Sham-Sham) in double blind methods.

Official Title
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Effects of the Quantity of Repetitive Transcranial Magnetic Stimulation on the Recovery of Upper Motor Function After Stroke: a Randomized Controlled Trial

Conditions
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Stroke, Hemiplegia

Intervention / Treatment
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* Device: repetitive transcranial magnetic stimulation (rTMS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: single mono-hemispheric ischemic or hemorrhagic stroke 1st onset stroke patient Upper extremity functional deficit attributable to acute stroke A stage of at least 3 on brunnström pre-treatment Written signed consent Exclusion Criteria: Multiple lesion Bilateral cortical lesion and motor problems Cerebellar, or brainstem lesions History of more than one stroke Uncontrolled medical problems, such as: cardiopulmonary disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer, or renal disease; Increased intracranial pressure History of seizure confirmed by interview and medical chart review Any individual who is on medication which is known to lower seizure threshold Other conditions that increase the risk of side effects due to rTMS procedures: a metal plate or metal object in the skull or eye, intracardiac line, increased intracranial pressure, cardiac pacemaker, implanted medication pump, tricyclic antidepressants, neuroleptics, history of seizure in the immediate family An age of less than 20 years old Any current actively treated medical or surgical condition or neurological or psychiatric illness other than stroke Complications that would prevent participation in the intervention, such as severe pain and severe spasticity Inability to cooperate outcome measure-related task Severe language disturbances Serious cognitive deficits Non-vascular cause for the neurological symptoms other central nervous system Disorder or peripheral neuropathy of the upper extremity Taking medication which interrupt brain activity Women who are pregnant

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham rTMS-Sham rTMS<br>Sham rTMS for 2 weeks | Device: repetitive transcranial magnetic stimulation (rTMS)<br>* 1 Hz frequency, 15 minutes, intensity of 90% resting motor threshold, with one session a day, Real: unaffected M1 hotspot Sham: coil perpendicular to scalp<br>* Other names: TAMAS;|
| Experimental: Sham rTMS-Real rTMS<br>Sham rTMS in the first week and real rTMS in the second week | Device: repetitive transcranial magnetic stimulation (rTMS)<br>* 1 Hz frequency, 15 minutes, intensity of 90% resting motor threshold, with one session a day, Real: unaffected M1 hotspot Sham: coil perpendicular to scalp<br>* Other names: TAMAS;|
| Experimental: Real rTMS-Real rTMS<br>Real rTMS for 2 weeks | Device: repetitive transcranial magnetic stimulation (rTMS)<br>* 1 Hz frequency, 15 minutes, intensity of 90% resting motor threshold, with one session a day, Real: unaffected M1 hotspot Sham: coil perpendicular to scalp<br>* Other names: TAMAS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Fugl-Meyer Assessment scale (upper extremity) |  | Baseline, weekly during treatment, at 4-week follow-up,and at 12-week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in grip strength, lateral pinch force, tip pinch force, Purdue pegboard test, K-MBI, mRS,and brunnström stage |  | Baseline, weekly during treatment, at 4-week follow-up,and at 12-week follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Upper Extremity, Stroke, rTMS, Cerebrovascular disease, hemiplegia, Transcranial magnetic stimulation, repetitive transcranial magnetic stimulation, rehabilitation