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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: sham transcranial Direct Current Stimulation; Device: active anodal transcranial Direct Current Stimulation (tDCS); Behavioral: Constraint Induced Movement Therapy (CIMT)

• Registration Number: NCT01983319
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-31
• Study First Submitted QC: 2013-11-06
• Study First Posted: 2013-11-13
• Study Start: 2014-01
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-04
• Last Update Posted: 2017-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CIMT + sham tDCS	Constraint Induced Movement Therapy (CIMT)	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
CIMT + sham tDCS	sham transcranial Direct Current Stimulation	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
CIMT + active anodal tDCS	active anodal transcranial Direct Current Stimulation (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.
CIMT + active anodal tDCS	Constraint Induced Movement Therapy (CIMT)	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.

Primary Outcome Measures

Name	Time	Method
Change in Upper Limb function	Baseline and posttest (an average of 2 weeks from baseline)	The motor function assessment will be done with: Wolf Motor Function Test

Secondary Outcome Measures

Name	Time	Method
GABA (gamma-aminobutyric acid) activity	Baseline	Assessment of GABA activity using MRI spectroscopy. Measurements will be compared between patients undergoing CIMT and healthy subjects.

Trial Locations

Locations (1)

Regionhospital Hammel Neurocenter, Research Unit; 🇩🇰 Hammel, Denmark