Post Stroke Motor Learning

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:
NCT01519843
First received: January 19, 2012
Last updated: December 27, 2012
Last verified: December 2012
  Purpose

Noninvasive brain stimulations (NIBS) will be used in chronic stroke patients to improve motor learning.

Functional magnetic resonance imaging will be used to evaluate the mechanisms underlying motor learning in healthy volunteers and in chronic stroke patients.


Condition Intervention
Stroke
Hemiparesis
Device: transcranial direct current stimulation tDCS
Device: transcranial magnetic stimulation TMS

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: Post-stroke Procedural Learning: From Neural Substrates to Therapeutic Modulation by Non-invasive Brain Stimulation

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

Primary Outcome Measures:
  • Motor learning improvement with tDCS [ Time Frame: Improvement on motor learning were recorded from baseline to 4 weeks after the intervention ] [ Designated as safety issue: No ]
    performance on a motor skill learning task and on different commonly used task (Purdue Pegboard, hand dynamometer, pinch dynamometer, 9-HPT ,...) were measured to explore the impact of tDCS on these parameters


Secondary Outcome Measures:
  • Neuroimaging [ Time Frame: before motor learning, during motor learning and after (immediately, 30,60min) motor learning (with or without tDCS) ] [ Designated as safety issue: No ]
    Does cerebral mechanisms underlying motor learning differ from healthy subject to stroke patients?

  • Neurophysiological outcome measure [ Time Frame: start of session 5min before motor learning, just at the end of the motor learning, after 30 min of motor learning, after 60 min of motor learning, Recall test at 1,2,3,4 weeks after the day of intervention (with or without tDCS) ] [ Designated as safety issue: No ]
    measure of brain excitability and connectivity with TMS (single and paired pulse)


Estimated Enrollment: 100
Study Start Date: September 2010
Estimated Study Completion Date: December 2030
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Real
Real tDCS
Device: transcranial direct current stimulation tDCS
tdcs (ELDITH, Neuroconn, Ilmenau, Germany)
Device: transcranial magnetic stimulation TMS
TMS (The Magstim Company Ltd, UK) Magstim 200² with a figure-of-eight coil was used to determine the hot spot eliciting consistent movements in the contralateral hand
Placebo Comparator: sham
Sham tDCS
Device: transcranial direct current stimulation tDCS
tdcs (ELDITH, Neuroconn, Ilmenau, Germany)
Device: transcranial magnetic stimulation TMS
TMS (The Magstim Company Ltd, UK) Magstim 200² with a figure-of-eight coil was used to determine the hot spot eliciting consistent movements in the contralateral hand

Detailed Description:

transcranial direct current stimulation will be used for NIBS

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • stroke with at least slight deficit

Exclusion Criteria:

  • epilepsy
  • contraindication to tDCS and/or to fMRI
  • presence of metal in the head
  • inability to understand / complete behavioral tasks
  • chronic intake of alcohol or recreational drugs
  • major health condition
  • presence of pacemaker (for the fMRI part only)
  • 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: NCT01519843

Locations
Belgium
Department of Neurology, CHU Mont-Godinne Recruiting
Yvoir, Namur, Belgium
Contact: Yves Vandermeeren, MD,PhD    081 42 3321 ext +32    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: NCT01519843     History of Changes
Other Study ID Numbers: B039201212957
Study First Received: January 19, 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:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014