Skip to main content
OpenTrials
Completed

NCT Number: NCT01983319

tDCS 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Regionhospital Hammel Neurocenter, Research Unit

Hammel, 8450, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

active anodal transcranial Direct Current Stimulation (tDCS)

Device

Anodal transcranial Direct Current Stimulation 1.5 mA in 30 minutes with CIMT

Other names: tDCS, Non invasive brain stimulation, transcranial stimulation

Sham Transcranial Direct Current Stimulation

Device

sham transcranial Direct Current Stimulation 30 min with CIMT

Other names: placebo stimulation

Constraint induced movement therapy (CIMT)

Behavioral

2 weeks of CIMT

Other names: CIMT

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital
  • Regionshospitalet Hammel Neurocenter

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 13, 2013
Registry last updated
Feb 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.