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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-12-31

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.

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Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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CIMT + active anodal tDCS

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.

Group Type EXPERIMENTAL

active anodal transcranial Direct Current Stimulation (tDCS)

Intervention Type DEVICE

Anodal transcranial Direct Current Stimulation 1.5 mA in 30 minutes with CIMT

Constraint Induced Movement Therapy (CIMT)

Intervention Type BEHAVIORAL

2 weeks of CIMT

CIMT + sham tDCS

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

Group Type SHAM_COMPARATOR

sham transcranial Direct Current Stimulation

Intervention Type DEVICE

sham transcranial Direct Current Stimulation 30 min with CIMT

Constraint Induced Movement Therapy (CIMT)

Intervention Type BEHAVIORAL

2 weeks of CIMT

Healthy control subjects

20 healthy age-matched control subjects will undergo MRI spectroscopy of the brain.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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active anodal transcranial Direct Current Stimulation (tDCS)

Anodal transcranial Direct Current Stimulation 1.5 mA in 30 minutes with CIMT

Intervention Type DEVICE

sham transcranial Direct Current Stimulation

sham transcranial Direct Current Stimulation 30 min with CIMT

Intervention Type DEVICE

Constraint Induced Movement Therapy (CIMT)

2 weeks of CIMT

Intervention Type BEHAVIORAL

Other Intervention Names

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tDCS Non invasive brain stimulation transcranial stimulation placebo stimulation CIMT

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes