Impact of Non-invasive Brain Stimulation on Motor Recuperation

This study is currently recruiting participants. (see Contacts and Locations)
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
  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

Resource links provided by NLM:


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
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: 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 July 24, 2014