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| Name | Class |
|---|---|
| DongGuk University | OTHER |
| Seoul National University Hospital | OTHER |
| REMED | UNKNOWN |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| true coil | Experimental | 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 |
|
| sham coil | Sham Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low frequency rTMS | Device | 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Vital Sign | Before rTMS (baseline), 10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start | up to 40 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nam-Jong Paik, MD, PhD | Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DongGuk University Ilsan Hospital | Goyang-si | Gyeonggi-do | 410-773 | South Korea | ||
| Seoul National University Bundang Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32807013 | Derived | Kim WS, Kwon BS, Seo HG, Park J, Paik NJ. Low-Frequency Repetitive Transcranial Magnetic Stimulation Over Contralesional Motor Cortex for Motor Recovery in Subacute Ischemic Stroke: A Randomized Sham-Controlled Trial. Neurorehabil Neural Repair. 2020 Sep;34(9):856-867. doi: 10.1177/1545968320948610. Epub 2020 Aug 18. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D006429 | Hemiplegia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| 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 |
| Seongnam-si |
| Gyeonggi-do |
| 463-707 |
| South Korea |
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |