tDCS Combined With Constraint Induced Movement Therapy and Role of GABA Activity in Stroke Recovery

Study Overview
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Brief Summary
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The aim of this study is to determine whether noninvasive brain stimulation in form of active transcranial direct current stimulation (tDCS) combined with constraint induced movement therapy (CIMT) offers an additional benefit as compared with sham tDCS combined with CIMT in patients with stroke. Furthermore the purpose is to highlight changes in GABA activity more than 3 months after stroke and its importance for effect of tDCS and CIMT combined with tDCS.

Official Title
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Transcranial Direct Current Stimulation Combined With Constraint Induced Movement Therapy and Role of GABA Activity in Stroke Recovery

Conditions
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Stroke

Intervention / Treatment
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* Device: active anodal transcranial Direct Current Stimulation (tDCS)
* Device: sham transcranial Direct Current Stimulation
* Behavioral: Constraint Induced Movement Therapy (CIMT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: stroke onset >3 months prior to study enrollment subject has at least 10 degrees mobility over wrist, thumb and fingers on the affected side subject can move, stand up and stand firmly with constrained healthy hand subject can perform training 6 hours daily in 2 weeks subject is able to understand instructions and be able to cooperate Exclusion Criteria: pregnancy contraindications to MRI of brain epilepsy, major psychiatric disease excessive pain that prevents training history of other diseases resulting decreased mobility of affected upper limb

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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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CIMT + active anodal tDCS<br>Subjects in this group will be trained with constraint-induced movement therapy for the hand (10 consecutive sessions Monday- Friday) while concurrently receiving active anodal transcranial Direct Current Stimulation 1,5 mA for 30 min. | Device: active anodal transcranial Direct Current Stimulation (tDCS)<br>* Anodal transcranial Direct Current Stimulation 1.5 mA in 30 minutes with CIMT<br>* Other names: transcranial stimulation;Behavioral: Constraint Induced Movement Therapy (CIMT)<br>* 2 weeks of CIMT<br>* Other names: CIMT;|
| Sham Comparator: CIMT + sham tDCS<br>Subjects in this group will be trained with constraint-induced movement therapy for the hand (10 consecutive sessions Monday- Friday) while concurrently receiving sham transcranial Direct Current Stimulation | Device: sham transcranial Direct Current Stimulation<br>* sham transcranial Direct Current Stimulation 30 min with CIMT<br>* Other names: placebo stimulation;Behavioral: Constraint Induced Movement Therapy (CIMT)<br>* 2 weeks of CIMT<br>* Other names: CIMT;|
| No Intervention: Healthy control subjects<br>20 healthy age-matched control subjects will undergo MRI spectroscopy of the brain. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Upper Limb function | The motor function assessment will be done with: Wolf Motor Function Test | Baseline and posttest (an average of 2 weeks from baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GABA (gamma-aminobutyric acid) activity | Assessment of GABA activity using MRI spectroscopy. Measurements will be compared between patients undergoing CIMT and healthy subjects. | Baseline |