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To explore the safety of applying repetitive low-frequency transcranial magnetic stimulation using a wearable medical electromagnetic generator in stroke patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stroke patients | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| wearable rTMS | Device | Application of inhibitory low-frequency rTMS on unaffected primary motor cortex by wearable rTMS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | All types of adverse events that occurred during clinical trials | Before and after 2 weeks of intervention / Soon after every intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of Fugl-Meyer assessment | Fugl-Meyer assessment for motor function in score | Before and after 2 weeks of intervention |
| Changes of manual muscle test (MMT) | Manual muscle test for strength in score |
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Inclusion criteria
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ye Ji Jeong, BS | Contact | +82 031 780 6003 | 6003 | a240283@chamc.co.kr |
| Name | Affiliation | Role |
|---|---|---|
| Minyoung Kim, M.D., Ph.D. | Bundang CHA Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Before and after 2 weeks of intervention |
| Changes of box and block test (BBT) | Box and block test for gross manual dexterity in number of blocks from on compartment of a box to another of equal size within 60 seconds | Before and after 2 weeks of intervention |
| Changes of action research arm test (ARAT) | Action research arm test for functional ability of upper extremity in score | Before and after 2 weeks of intervention |
| Changes of Korean mini-mental state examination (K-MMSE) | Korean mini mental state exam for cognitive function in score | Before and after 2 weeks of intervention |
| Changes of Korean version of Modified Barthel Index (K-MBI) | Korean version of modified barthel index for functional status in score | Before and after 2 weeks of intervention |
| Changes of geriatric depression scale (GDS-d) | Geriatric depression scale for depression in scale | Before and after 2 weeks of intervention |
| Changes of electroencephalograpy (EEG) | Electroenchphalography is a test that measures EEG power in alpha band | Before and after 2 weeks of intervention |
| Changes of Evoked-potentials (EP) | Evoked potential is an electrical potential recorded from the nervous system of a human or animal following presentation of a stimulus. In this study, motor- and sensory- evoked potentials are included. | Before and after 2 weeks of intervention |
| Changes of motion analysis | Motion analysis with motion capture setup and data processing or streaming of patients movements. In this study, data of motion capture include kinetic and kinematic data including physiological parameter. | Before and after 2 weeks of intervention |
| Changes of functional near-infrared spectroscopy (fNIRS) | Funtional near-infrared spectroscopy meausures cortical activity in concentration of oxy- and deoxy-hemoglobin | Before and after 2 weeks of intervention |
| Changes of blood biomarker | Blood biomarker include expression of tumor necrosis factor (TNF)-a and interleukin (IL)-1b | Before and after 2 weeks of intervention |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |