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

February 4, 2017 updated by: Krystian Figlewski, University of Aarhus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hammel, Denmark, 8450
        • Regionhospital Hammel Neurocenter, Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: active anodal transcranial Direct Current Stimulation (tDCS)
Anodal transcranial Direct Current Stimulation 1.5 mA in 30 minutes with CIMT
Other Names:
  • tDCS
  • Non invasive brain stimulation
  • transcranial stimulation
Behavioral: Constraint Induced Movement Therapy (CIMT)
2 weeks of CIMT
Other Names:
  • CIMT
Sham Comparator: 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
Behavioral: Constraint Induced Movement Therapy (CIMT)
2 weeks of CIMT
Other Names:
  • CIMT
Device: sham transcranial Direct Current Stimulation
sham transcranial Direct Current Stimulation 30 min with CIMT
Other Names:
  • placebo stimulation
No Intervention: Healthy control subjects
20 healthy age-matched control subjects will undergo MRI spectroscopy of the brain.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GABA (gamma-aminobutyric acid) activity
Time Frame: Baseline
Assessment of GABA activity using MRI spectroscopy. Measurements will be compared between patients undergoing CIMT and healthy subjects.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital
Regionshospitalet Hammel Neurocenter

Investigators

  • Study Director: Henning Andersen, Professor, Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

October 31, 2013

First Submitted That Met QC Criteria

November 6, 2013

First Posted (Estimate)

November 13, 2013

Study Record Updates

Last Update Posted (Estimate)

February 7, 2017

Last Update Submitted That Met QC Criteria

February 4, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-2013-268-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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