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

University of Aarhus

Status: Completed

Conditions: Stroke

Treatments: Behavioral: Constraint Induced Movement Therapy (CIMT); Device: sham transcranial Direct Current Stimulation; Device: active anodal transcranial Direct Current Stimulation (tDCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT01983319

M-2013-268-13

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 3 patient groups

CIMT + active anodal tDCS

Experimental group

Description:

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.

Treatment:

Device: active anodal transcranial Direct Current Stimulation (tDCS)

Behavioral: Constraint Induced Movement Therapy (CIMT)

CIMT + sham tDCS

Sham Comparator group

Description:

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

Treatment:

Device: sham transcranial Direct Current Stimulation

Behavioral: Constraint Induced Movement Therapy (CIMT)

Healthy control subjects

No Intervention group

Description:

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