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

This study has been completed.
Sponsor:
Collaborators:
Regionshospitalet Hammel Neurocenter
Aarhus University Hospital
Information provided by (Responsible Party):
Krystian Figlewski, University of Aarhus
ClinicalTrials.gov Identifier:
NCT01983319
First received: October 31, 2013
Last updated: February 4, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention
Stroke
Device: active anodal transcranial Direct Current Stimulation (tDCS)
Device: sham transcranial Direct Current Stimulation
Behavioral: Constraint Induced Movement Therapy (CIMT)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation Combined With Constraint Induced Movement Therapy and Role of GABA Activity in Stroke Recovery

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 64
Study Start Date: January 2014
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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
Device: sham transcranial Direct Current Stimulation
sham transcranial Direct Current Stimulation 30 min with CIMT
Other Name: placebo stimulation
Behavioral: Constraint Induced Movement Therapy (CIMT)
2 weeks of CIMT
Other Name: CIMT
No Intervention: Healthy control subjects
20 healthy age-matched control subjects will undergo MRI spectroscopy of the brain.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01983319

Locations
Denmark
Regionhospital Hammel Neurocenter, Research Unit
Hammel, Denmark, 8450
Sponsors and Collaborators
University of Aarhus
Regionshospitalet Hammel Neurocenter
Aarhus University Hospital
Investigators
Study Director: Henning Andersen, Professor Aarhus University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Krystian Figlewski, MD, University of Aarhus
ClinicalTrials.gov Identifier: NCT01983319     History of Changes
Other Study ID Numbers: M-2013-268-13
Study First Received: October 31, 2013
Last Updated: February 4, 2017

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 27, 2017