Post Stroke Motor Learning
This study is currently recruiting participants.
Verified December 2012 by University Hospital of Mont-Godinne
Sponsor:
University Hospital of Mont-Godinne
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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:
|
Paresis Stroke Cerebral Infarction Neurologic Manifestations Nervous System Diseases Signs and Symptoms Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on May 16, 2013