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

Not Applicable

Completed

• Conditions: Stroke

• 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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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