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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01983319
• Other study ID #: M-2013-268-13
• Status: Completed
• Phase: N/A
• First received: October 31, 2013
• Last updated: February 4, 2017
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: February 2017
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• active anodal transcranial Direct Current Stimulation (tDCS)
Anodal transcranial Direct Current Stimulation 1.5 mA in 30 minutes with CIMT
• sham transcranial Direct Current Stimulation
sham transcranial Direct Current Stimulation 30 min with CIMT

Behavioral:
• Constraint Induced Movement Therapy (CIMT)
2 weeks of CIMT

Locations

Country	Name	City	State
Denmark	Regionhospital Hammel Neurocenter, Research Unit	Hammel

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, Regionshospitalet Hammel Neurocenter

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	GABA (gamma-aminobutyric acid) activity	Assessment of GABA activity using MRI spectroscopy. Measurements will be compared between patients undergoing CIMT and healthy subjects.	Baseline