Efficacy Basics of Bihemispheric Motorcortex Stimulation After Stroke

Study Overview
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Brief Summary
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The aim of the study is to investigate whether the combination of bihemispheric (dual) transcranial direct current stimulation (tDCS) and motor training on 5 consecutive days facilitates motor recovery in chronic stroke. Results will be compared to a matched group of patients undergoing anodal tDCS as well as a control group receiving sham tDCS. Functional and structural magnetic resonance imaging (MRI) before/after the intervention and during a 3 month follow-up will help investigating neural correlates of expected changes in motor function of the affected upper extremity.

Official Title
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Efficacy Basics of Bihemispheric Motorcortex Stimulation After Stroke

Conditions
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Stroke, Hemiparesis

Intervention / Treatment
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* Device: tDCS
* Behavioral: Motor training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic stroke (>6 months after stroke) age: 18 to 80 years non-hemorrhagic or hemorrhagic stroke Exclusion Criteria: more than 1 stroke severe alcohol disease or drug abuse, severe psychiatric disease like depression or psychosis severe cognitive deficits severe untreated medical conditions other neurologic diseases severe microangiopathy pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dual tDCS + motor training<br>Motor training of the affected upper extremity combined with dual transcranial direct current stimulation (tDCS). | Device: tDCS<br>* transcranial direct current stimulation (tDCS)<br>Behavioral: Motor training<br>* Motor training of the affected upper extremity (5 days, 25 min/day).<br>|
| Active Comparator: Anodal tDCS + motor training<br>Motor training of the affected upper extremity combined with anodal tDCS. | Device: tDCS<br>* transcranial direct current stimulation (tDCS)<br>Behavioral: Motor training<br>* Motor training of the affected upper extremity (5 days, 25 min/day).<br>|
| Sham Comparator: Sham tDCS + motor training<br>Motor training of the affected upper extremity combined with sham tDCS. | Device: tDCS<br>* transcranial direct current stimulation (tDCS)<br>Behavioral: Motor training<br>* Motor training of the affected upper extremity (5 days, 25 min/day).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor Function of the Affected Upper Extremity | Effects of dual tDCS + training vs sham-tDCS + training on the motor function of the affected upper extremity (measured by standardized behavioral tests). | Change from baseline after 5 days (immediately after intervention) | 
| Motor Function of the Affected Upper Extremity | Effects of dual tDCS + training vs sham-tDCS + training on the motor function of the affected upper extremity (measured by standardized behavioral tests). | change from baseline after 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor Function of the Affected Upper Extremity | Effects of dual tDCS + training vs anodal tDCS + training on the motor function of the affected upper extremity (measured by standardized behavioral tests). | After 5 days (immediately after intervention), after 3 months vs baseline (before intervention) | 
| Functional Magnetic Resonance Imaging | Effects of dual tDCS + training vs anodal tDCS + training vs sham-tDCS + training on task-specific activations and functional connectivity (measured by functional Magnetic Resonance Imaging, fMRI). | After 5 days (immediately after intervention), after 3 months vs baseline (before intervention) | 
| Diffusion Tensor Imaging | Effects of dual tDCS + training vs anodal tDCS + training vs sham-tDCS + training on cerebral microstructure (measured by Diffusion Tensor Imaging, DTI). | After 5 days (immediately after intervention), after 3 months vs baseline (before intervention) | 
| Transcranial Magnetic Stimulation | Effects of dual tDCS + training vs anodal tDCS + training vs sham tDCS + training on excitability of the primary motor cortex (measured by Motor Evoked Potentials, MEP, using Transcranial Magnetic Stimulation, TMS). | After 5 days vs baseline (before intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Hemiparesis, tDCS, Motor cortex