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Non-invasive repetitive bi-hemispheric transcranial direct current stimulation (tDCS) may restore post-stroke bi-hemispheric balance by increase peri-lesional cortex activity and suppress abnormal inhibition from non-lesional hemisphere, and therefore enhance after-effects of rehabilitation. In this double-blind, randomized controlled trial, investigators aim to investigate whether multi-session, bihemispheric tDCS to the primary motor cortex (M1) in combination with upper extremity rehabilitation therapy affected motor functional outcome, ipsilesional motor circuit excitability using transcranial magnetic stimulation (TMS) and magnetoencephalography (MEG) measures.
Investigators will consecutively enroll subacute (2-6 weeks after stroke onset) patients with first-time, unilateral, ischemic subcortical stroke in the middle cerebral artery territory with mild to moderate hand weakness. All subjects will be randomly allocated to receive daily bihemispheric tDCS (anodal tDCS to ipsilesional M1 and cathodal tDCS to contralesional M1 with 2 mA stimulation for 20 min) or daily sham tDCS (same but stimulation for only 30 seconds) with simultaneous physical/occupational therapy, for total 10 sessions. Changes in upper extremity motor function score (Fugl-Meyer test and Action Research Arm test), corticospinal excitability from the transcranial magnetic stimulation(TMS), and sensorimotor oscillations from the magnetoencephalography (MEG) will be assessed before and after intervention, as well as 3 months after stroke. All stroke patients will receive tDCS and standard medical, rehabilitation treatments in rehabilitation ward.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| True stimulation | Experimental | True repetitive bihemispheric transcranial direct current stimulation, anodal at ipsilesional M1 while cathodal at contralesional M1, daily 20 minutes for 20 sessions |
|
| Sham stimulation | Sham Comparator | Repetitive bihemispheric transcranial direct current stimulation, as the experimental stimulation condition but only for 120 seconds |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bihemispheric transcranial direct current stimulation | Device | 5x5 cm tDCS electrode over C3 or C4 (10-20 system) with concurrent rehabilitation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer test | stroke motor function scale | baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke |
| Measure | Description | Time Frame |
|---|---|---|
| Action Research Arm test | stroke motor function scale | baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke |
| Modified Rankin Scale | Global disability poststroke |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| I-Hui Lee, M.D., Ph.D. | Contact | + 886-2-28712121 | 8109 | ihlee@vghtpe.gov.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital | Recruiting | Taipei | 112 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36849990 | Derived | Hsu SP, Lu CF, Lin BF, Tang CW, Kuo IJ, Tsai YA, Guo CY, Lee PL, Shyu KK, Niddam DM, Lee IH. Effects of bihemispheric transcranial direct current stimulation on motor recovery in subacute stroke patients: a double-blind, randomized sham-controlled trial. J Neuroeng Rehabil. 2023 Feb 27;20(1):27. doi: 10.1186/s12984-023-01153-4. |
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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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| baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke |
| Resting state functional connectivity | Functional MRI | baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke |
| Motor evoked potential | Transcranial magnetic stimulation test | baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke |
| Active motor threshold | Transcranial magnetic stimulation test | baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke |
| Ipsilateral silent period | Transcranial magnetic stimulation test | baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke |
| Short interval intracortical inhibition | Transcranial magnetic stimulation test | baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke |
| Motor task ERD peak amplitude | magnetoencephalography | baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke |
| Motor task ERS peak amplitude | magnetoencephalography | baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |