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| Name | Class |
|---|---|
| Chungnam National University Hospital | OTHER |
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The purpose of this study is to evaluate the efficacy and safety of repetitive transcranial magnetic stimulation applied with an electromagnetic therapy stimulator 'ALTMS-A' for upper-limb motor function recovery with the sham control group for those who need upper-limb rehabilitation treatment for subcortical and brainstem stroke
After low-frequency repetitive transcranial magnetic stimulation (rTMS) over the contralesional motor cortex (M1), the score of the Box and Block test increased immediately, especially in patients without cortical involvement.
Eighty-eight patients will be recruited and divided into two groups. Each group will receive 10 sessions of the real rTMS or sham rTMS over the contralesional primary motor cortex. Each rTMS session consists of low-frequency (1Hz) 1800 stimulations.
The objective of this study is to evaluate the efficacy and safety of rTMS for upper-limb motor function in patients with subcortical and brainstem stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| real rTMS | Experimental | Use the real rTMS coil |
|
| sham rTMS | Sham Comparator | Use the sham rTMS coil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-frequency rTMS (experimental) | Device | Frequency: Low-frequency (1Hz) rTMS / Intensity: 100% of resting motor threshold / Location: motor hotspot of the contralesional primary motor cortex (the first dorsal interosseous muscle) / Number of total stimuli : 1800 ; Coil orientation: tangential to scalp |
| Measure | Description | Time Frame |
|---|---|---|
| Box and Block test | Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS | upto 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Box and Block test | Before rTMS (baseline) and immediately after the completion of 10 sessions of rTMS | upto 14 days |
| Fugl-Meyer Assessment Scale | Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS |
| Measure | Description | Time Frame |
|---|---|---|
| Vital sign | Before rTMS (baseline), immediately after the completion of 10 sessions of rTMS, and 4 weeks after the completion of 10 sessions of rTMS | upto 42 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 |
|---|---|---|---|---|---|---|
| Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital | Seongnam-si | Korea, Gyeonggi-do | 463-707 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37693768 | Derived | Cho HM, Cha S, Sohn MK, Jee S, Chang WK, Kim WS, Paik NJ. Investigation of the efficacy of low-frequency repetitive transcranial magnetic stimulation on upper-limb motor recovery in subacute ischemic stroke without cortical involvement: a protocol paper for a multi-center, double-blind randomized controlled trial. Front Neurol. 2023 Aug 25;14:1216510. doi: 10.3389/fneur.2023.1216510. eCollection 2023. |
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ALTMS-A
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|
| Low-frequency rTMS (sham comparator) | Device | Frequency: Low-frequency (1Hz) rTMS / Intensity: 100% of resting motor threshold / motor hotspot of the contralesional primary motor cortex (the first dorsal interosseous muscle) / Number of total stimuli : 1800 ; Coil orientation: vertical to scalp |
|
| upto 42 days |
| modified Barthel Index (the Korean version) | Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS | upto 42 days |
| National Institutes of Health Stroke Scale | Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS | upto 42 days |
| Finger tapping | Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS | upto 42 days |
| Brunnstrom stage (hand and arm) | Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS | upto 42 days |
| Modified Ashworth scale (wrist flexor, wrist extensor, elbow flexor, elbow extensor, and finger flexor) | Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS | upto 42 days |
| Grip strength (hand grip, pinch grip, lateral prehension, three jaw chuck) | Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS | upto 42 days |
| Department of Rehabilitation Medicine, Chungnam National University Hospital, Korea | Daejeon | 35015 | South Korea |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D006429 | Hemiplegia |
| D002544 | Cerebral Infarction |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D009336 | Necrosis |
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