An interventional study of Bihemispheric transcranial direct current stimulation in Stroke, sponsored by Taipei Veterans General Hospital, Taiwan. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-11-30.
Sponsored by Taipei Veterans General Hospital, Taiwan · Not applicable, Interventional, and Treatment
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 32 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Taipei Veterans General Hospital, Taiwan is the lead sponsor of 325 studies on the registry; 72 are open to participants now.
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Exclusion Criteria:
True repetitive bihemispheric transcranial direct current stimulation, anodal at ipsilesional M1 while cathodal at contralesional M1, daily 20 minutes for 20 sessions
Device: Bihemispheric transcranial direct current stimulation
Repetitive bihemispheric transcranial direct current stimulation, as the experimental stimulation condition but only for 120 seconds
Device: Bihemispheric transcranial direct current stimulation
5x5 cm tDCS electrode over C3 or C4 (10-20 system) with concurrent rehabilitation
Fugl-Meyer test
stroke motor function scale
Time frame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Action Research Arm test
stroke motor function scale
Time frame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Modified Rankin Scale
Global disability poststroke
Time frame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Resting state functional connectivity
Functional MRI
Time frame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Motor evoked potential
Transcranial magnetic stimulation test
Time frame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Active motor threshold
Transcranial magnetic stimulation test
Time frame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Ipsilateral silent period
Transcranial magnetic stimulation test
Time frame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Short interval intracortical inhibition
Transcranial magnetic stimulation test
Time frame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Motor task ERD peak amplitude
magnetoencephalography
Time frame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Motor task ERS peak amplitude
magnetoencephalography
Time frame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Plan to share: No
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This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Taipei Veterans General Hospital, Taiwan