Improving Bi-manual Activities in Stroke Patients With Application of Neuro-stimulation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- University Hospital of Mont-Godinne
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- bimanual coordination
- Status
- Suspended
- Last Updated
- 2 years ago
Overview
Brief Summary
Noninvasive brain stimulations (NIBS) will be used in healthy volunteers and in chronic stroke patients to improve bimanual activities and motor learning.
Functional magnetic resonance imaging will be used to evaluate the mechanisms underlying bimanual activities and motor learning in healthy volunteers and in chronic stroke patients.
A neuro-rehabilitation robot (REA2PLAN, AXINESIS, Louvain-la-Neuve, Belgium) will be used for motor learning.
Detailed Description
tDCS will be used in a sham-controlled, double-blind, randomized, cross-over control trial in chronic stroke patients with motor deficits. After informed consent and recruitment, patients will be randomly (computer method) allocated to real or sham tDCS, that will be applied during performance of bimanual activities and/or motor learning. A few minutes/hours/days/weeks after completing one trial's arm, the patients will enter the other trial's arm (double-blind cross-over design). Baseline and follow-up outcomes about bimanual and unimanual motor tasks will be collected. For a subset of subjects, motor learning and data acquisition will be performed with a neuro-rehabilitation robot (REA2PLAN, AXINESIS, Louvain-la-Neuve, Belgium) .
Investigators
Pr Yves Vandermeeren, MD, PhD
Professer Yves Vandermeeren
University Hospital of Mont-Godinne
Eligibility Criteria
Inclusion Criteria
- •stroke with at least slight deficit
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
bimanual coordination
Time Frame: up to 2 hours after intervention. Recall test at 1 week and up to,2,3,4 weeks after the intervention
The effect of intervention on bimanual motor coordination will be quantified before, during and after executive tasks.
Secondary Outcomes
- standard unimanual evaluation(immediately, 30, 60 min; and up to 2 hours after intervention. Recall test at 1 week and up to,2,3,4 weeks after the intervention))