Post Stroke Motor Learning

Sponsor

University Hospital of Mont-Godinne (Other)

Overall Status

Recruiting

CT.gov ID

NCT01519843

Collaborator

(none)

100

Enrollment

Location

Arms

243

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Stroke Hemiparesis	Device: transcranial direct current stimulation tDCS Device: transcranial magnetic stimulation TMS	N/A

Detailed Description

transcranial direct current stimulation will be used for NIBS

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2010

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2030

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Motor learning improvement with tDCS [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

Secondary Outcome Measures

Neuroimaging [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?
Neurophysiological outcome measure [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Department of Neurology, CHU Mont-Godinne	Yvoir	Namur	Belgium

Sponsors and Collaborators

University Hospital of Mont-Godinne

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pr Yves Vandermeeren, MD, PhD, Professor, University Hospital of Mont-Godinne

ClinicalTrials.gov Identifier:

NCT01519843

Other Study ID Numbers:

B039201212957

First Posted:

Jan 27, 2012

Last Update Posted:

Apr 29, 2021

Last Verified:

Apr 1, 2021

Keywords provided by Pr Yves Vandermeeren, MD, PhD, Professor, University Hospital of Mont-Godinne

stroke

Additional relevant MeSH terms:

Stroke

Paresis

Study Results

No Results Posted as of Apr 29, 2021