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| Name | Class |
|---|---|
| the Ministry of Trade, Industry & Energy(MOTIE, Korea), Ybrain (Korea) | UNKNOWN |
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Upper limb recovery is not predicted by the initial severity of paralysis and the parameters reflecting the integrity of the corticospinal tract (e.g. motor evoked potential, fractional anisotropy in diffusion tensor imaging). Although the inhibition of the contralesional hemisphere is known to be beneficial for the upper limb recovery after stroke in previous studies, this is not proven in the severely paralyzed upper limb. And the studies using the noninvasive stimulation in subacute stroke is lack. In addition, the role of contralesional (unaffected) hemisphere is known to be playing the important role in severe stroke.
In this randomized, double-blind, sham-controlled studies, the patients with subacute stroke (<3 months after stroke onset), severe paralysis of the upper limb with poor prognosis (poor motor score and no response of motor evoked potential recorded in the extensor carpi radialis muscle) will be recruited. Interventional group will receive the 25 mins of anodal transcranial direct current stimulation (tDCS) over the contralesional premotor area plus 25 mins of robotic arm training per session for 10 sessions in 2 weeks. Control group will receive the same treatment except for sham tDCS instead of anodal tDCS over the contralesional premotor area. Functional outcome will be measured before and after the intervention (baseline, immediately after the intervention and 1 month after the intervention). Cortical activation pattern will be measured by the electroencephalography (EEG) at baseline and immediately after the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anodal tDCS | Experimental | This group will receive the 25 mins of the tDCS (Yrain, Korea) over the contralesional premotor area simultaneously with 25 mins of the robotic arm training using Armeo Power (Hocoma, Switzerland), per day. Additional 30 mins of occupational therapy focusing on the arm motor recovery will be provided per day. These interventions will be provided for 10 weekdays. Other conventional rehabilitation (e.g. gait training, speech therapy) will be permitted. Regard to the anodal tDCS, the anode will be placed over the contralesional premotor area (2.5 cm anterior to the C3 or C4 in 10-20 EEG system) and cathode will be placed over the contralateral supraorbital area. The stimulation intensity will be 2mA. |
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| sham tDCS | Placebo Comparator | This group will receive the 25 mins of the tDCS (Yrain, Korea) over the contralesional premotor area simultaneously with 25 mins of the robotic arm training using Armeo Power (Hocoma, Switzerland), per day. Additional 30 mins of occupational therapy focusing on the arm motor recovery will be provided per day. These interventions will be provided for 10 weekdays. Other conventional rehabilitation (e.g. gait training, speech therapy) will be permitted. Regard to the sham tDCS, the anode will be placed over the contralesional premotor area (2.5 cm anterior to the C3 or C4 in 10-20 EEG system) and cathode will be placed over the contralateral supraorbital area. The stimulation intensity will be started but the intensity will decrease and stop in 30 seconds. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tDCS | Device | Regard to the anodal tDCS, the anode will be placed over the contralesional premotor area (2.5 cm anterior to the C3 or C4 in 10-20 EEG system) and cathode will be placed over the contralateral supraorbital area. The stimulation intensity will be 2mA. For the sham tDCS the stimulation will be applied for just first 30 seconds. |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Assessment (FMA) scores of the upper extremity | range: 0 (worst) -66 (best) | Change from Baseline FMA at 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Korean version of modified Barthel Index (K-MBI) | range: 0 (worst) -100 (best) | Change from baseline K-MBI at 2 weeks |
| Korean version of modified Barthel Index (K-MBI) | range: 0 (worst) -100 (best) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Won-Seok Kim, MD, PhD | Contact | +82317877735 | wondol77@gmail.com | |
| Jihong Park, MD | Contact | wpeo00@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Won-Seok Kim, MD, PhD | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | Please Select | 13620 | South Korea |
We are not planning to share the individual data publicly. However, if other researchers interested in our project, they can contact PI by email and we can discuss further for the sharing. If data sharing is decided after the discussion with other researchers, we will consider sharing after the review of the appropriateness by our institutional review board.
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Randomized, double-blind, sham-controlled, parallel group design
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An investigator who applies the tDCS to the participants will not be masked. However, other investigators including outcome assessors and participants will be masked. The other care providers in our department (e.g. other physio- or occupational therapists) will be masked.
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| Change from baseline K-MBI at 6 weeks |
| Brunnstrom stage (B-stage) of arm | range: 1(worst) -6 (best) | Change from baseline B-stage at 2 weeks |
| Brunnstrom stage (B-stage) of arm | range: 1(worst) -6 (best) | Change from baseline B-stage at 6 weeks |
| Box and Block Test (BBT) | maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds, more numbers mean better function | Change from baseline BBT at 2 weeks |
| Box and Block Test (BBT) | maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds, more numbers mean better function | Change from baseline BBT at 6 weeks |
| Modified Ashworth Scale | to measure the spasticity: 6 grades: 0 (no spasticity), 1, 1+, 2, 3, 4 (severe spasticity) | 2 weeks after baseline |
| Modified Ashworth Scale | to measure the spasticity: 6 grades: 0 (no spasticity), 1, 1+, 2, 3, 4 (severe spasticity) | 6 weeks after baseline |
| Manual muscle power test | 3 proximal (shoulder abduction, elbow flexion, and extension) and 5 distal (flexion and extension of the hand and fingers, and thumb flexion) muscle groups, 6 grades ranges from 0 (flaccid) to 5 (strongest). | 2 weeks after baseline |
| Manual muscle power test | 3 proximal (shoulder abduction, elbow flexion, and extension) and 5 distal (flexion and extension of the hand and fingers, and thumb flexion) muscle groups, 6 grades ranges from 0 (flaccid) to 5 (strongest). | 6 weeks after baseline |
| Laterality Index | Ratio of the cortical activation between the contra- and ipsilesional motor area recorded by the electroencephalography | 2 weeks after baseline |
| Laterality Index | Ratio of the cortical activation between the contra- and ipsilesional motor area recorded by the electroencephalography | 6 weeks after baseline |
| Fugl-Meyer Assessment (FMA) scores of the upper extremity | range: 0 (worst) -66 (best) | Change from Baseline FMA at 6 weeks |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
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