Repetitive Bihemispheric Transcranial Direct Current Stimulation After Stroke

Recruiting

Phase 1/2 Results N/A

Trial Description

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.

Detailed Description

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.

Conditions

Interventions

  • Bihemispheric transcranial direct current stimulation Device
    Intervention Desc: 5x5 cm tDCS electrode over C3 or C4 (10-20 system) with concurrent rehabilitation
    ARM 1: Kind: Experimental
    Label: True stimulation
    Description: True repetitive bihemispheric transcranial direct current stimulation, anodal at ipsilesional M1 while cathodal at contralesional M1, daily 20 minutes for 10 sessions
    ARM 2: Kind: Experimental
    Label: Sham stimulation
    Description: Repetitive bihemispheric transcranial direct current stimulation, as the experimental stimulation condition but only for 30 seconds

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Fugl-Meyer test baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke No
Primary Action Research Arm test baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke No
Secondary Motor evoked potential baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke No
Secondary Active motor threshold baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke No
Secondary Ipsilateral silent period baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke No
Secondary Short interval intracortical inhibition baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke No
Secondary Motor task ERD peak amplitude baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke No
Secondary Motor task ERS peak amplitude baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke No
Secondary Resting state functional connectivity baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke No

Sponsors