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Impact of Non-invasive Brain Stimulation on Motor Recuperation

This study is currently recruiting participants.
Verified December 2012 by University Hospital of Mont-Godinne
Sponsor:
Information provided by (Responsible Party):
Yves Vandermeeren, University Hospital of Mont-Godinne
ClinicalTrials.gov Identifier:
NCT01544699
First received: February 10, 2012
Last updated: December 27, 2012
Last verified: December 2012
History of Changes
  Purpose

tDCS (transcranial direct current stimulation) will be used in chronic stroke patients to improve a variety of functions with superior or inferior limb.


Condition Intervention
Stroke
 Device: tDCS (ELDITH)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Non-invasive Brain Stimulation on Motor Recuperation

Further study details as provided by University Hospital of Mont-Godinne:

Primary Outcome Measures:
  • change in motor function before/after tDCS [ Time Frame: Baseline (>6 months after stroke), immediately after intervention (30min of tDCS), 10-20-30-40-50-60 min after intervention; long-term after intervention : 1-2-3-4 weeks ] [ Designated as safety issue: No ]
    Motor performance improvement with inferior or superior limb


Estimated Enrollment: 200
Study Start Date: January 2012
Estimated Study Completion Date: January 2030
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Real stimulation
real tDCS
 Device: tDCS (ELDITH)
tdcs (ELDITH, Neuroconn, Ilmenau, Germany) transcranial direct current stimulation
Sham Comparator: Sham
sham tDCS
 Device: tDCS (ELDITH)
tdcs (ELDITH, Neuroconn, Ilmenau, Germany) transcranial direct current stimulation

Detailed Description:

tDCS will be used in chronic stroke patients to improve a variety of functions such as motor functions with superior or inferior limb.

tDCS will be applied in a placebo-controlled, double-blind, randomised fashion. Behavioural data will be collected before and after tDCS, as well as brain functional imaging data.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • stroke with at least slight deficit in superior or inferior limb

Exclusion Criteria:

  • epilepsy
  • contraindication to tDCS and/or to fMRI
  • presence of metal in the head
  • inability to understand/complete behavioural tasks
  • chronic intake of alcohol or recreative drugs
  • major health condition
  • presence of pacemaker
  • pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01544699

Locations
Belgium
Department of Neurology, CHU Mont-Godinne Recruiting
Yvoir,, Namur,, Belgium
Contact: Yves Vandermeeren, MD, PhD     +32 81 42 3321     yves.vandermeeren@uclouvain.be    
Sponsors and Collaborators
University Hospital of Mont-Godinne
  More Information

No publications provided

Responsible Party: Yves Vandermeeren, Professor, University Hospital of Mont-Godinne
ClinicalTrials.gov Identifier: NCT01544699     History of Changes
Other Study ID Numbers: B039201212957(2)
Study First Received: February 10, 2012
Last Updated: December 27, 2012
Health Authority: Belgium: Ethics Committee
Belgium: Institutional Review Board

Keywords provided by University Hospital of Mont-Godinne:
stroke

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 May 23, 2013