Post Stroke Motor Learning

May 8, 2023 updated by: Pr Yves Vandermeeren, MD, PhD, University Hospital of Mont-Godinne

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

transcranial direct current stimulation will be used for NIBS

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Namur
      • Yvoir, Namur, Belgium
        • Department of Neurology, CHU Mont-Godinne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor learning improvement with tDCS
Time Frame: Improvement on motor learning were recorded from baseline to 4 weeks after the intervention
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
Improvement on motor learning were recorded from baseline to 4 weeks after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuroimaging
Time Frame: before motor learning, during motor learning and after (immediately, 30,60min) motor learning (with or without tDCS)
Does cerebral mechanisms underlying motor learning differ from healthy subject to stroke patients?
before motor learning, during motor learning and after (immediately, 30,60min) motor learning (with or without tDCS)
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)
measure of brain excitability and connectivity with TMS (single and paired pulse)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Mont-Godinne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2010

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2030

Study Registration Dates

First Submitted

January 19, 2012

First Submitted That Met QC Criteria

January 24, 2012

First Posted (Estimate)

January 27, 2012

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B039201212957

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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