Repetitive Bihemispheric Transcranial Direct Current Stimulation After Stroke

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Bihemispheric Modulation of the Motor Cortex by Repetitive Transcranial Direct Current Stimulation After Stroke

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Device: Bihemispheric transcranial direct current stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 20-80 years old Patients with first-time, unilateral, ischemic stroke with contralateral mild to moderate hand weakness Brain MRI confirmed subcortical stroke in the middle cerebral artery territory Post-stroke 2-6 weeks with stable clinical condition Exclusion Criteria: Stroke with cortical lesions Containing metal implants (such as implanted electrodes, pacemakers) Sensitive or fear of electromagnetic waves Pregnant women History of alcohol or drug abuse History of seizures or epilepsy Claustrophobia Other significant disease or neuropsychiatric disorders

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: True stimulation<br>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<br>* 5x5 cm tDCS electrode over C3 or C4 (10-20 system) with concurrent rehabilitation<br>|
| Sham Comparator: Sham stimulation<br>Repetitive bihemispheric transcranial direct current stimulation, as the experimental stimulation condition but only for 120 seconds | Device: Bihemispheric transcranial direct current stimulation<br>* 5x5 cm tDCS electrode over C3 or C4 (10-20 system) with concurrent rehabilitation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transcranial Direct Current Stimulation, Neuroplasticity