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Only two subjects have been recruited from start of the study. We decided to start the study in this topic, after revising the study protocol.
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| Name | Class |
|---|---|
| Asan Medical Center | OTHER |
| Gyeongsang National University Hospital | OTHER |
| Hanyang University | OTHER |
| Seoul National University Boramae Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham rTMS-Sham rTMS | Sham Comparator | Sham rTMS for 2 weeks |
|
| Sham rTMS-Real rTMS | Experimental | Sham rTMS in the first week and real rTMS in the second week |
|
| Real rTMS-Real rTMS | Experimental | Real rTMS for 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| repetitive transcranial magnetic stimulation (rTMS) | Device | 1 Hz frequency, 15 minutes, intensity of 90% resting motor threshold, with one session a day,
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nam-Jong Paik, MD, PhD | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D006429 | Hemiplegia |
| D002561 | Cerebrovascular Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| OTHER |
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|
| D002318 | Cardiovascular Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |