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Post Stroke Motor Learning

Primary Purpose

Stroke, Hemiparesis

Status
Suspended
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
transcranial direct current stimulation tDCS
transcranial magnetic stimulation TMS
Sponsored by
University Hospital of Mont-Godinne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Neurology, CHU Mont-Godinne

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Real

sham

Arm Description

Real tDCS

Sham tDCS

Outcomes

Primary Outcome Measures

Motor learning improvement with tDCS
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
Does cerebral mechanisms underlying motor learning differ from healthy subject to stroke patients?
Neurophysiological outcome measure
measure of brain excitability and connectivity with TMS (single and paired pulse)

Full Information

First Posted
January 19, 2012
Last Updated
May 8, 2023
Sponsor
University Hospital of Mont-Godinne
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1. Study Identification

Unique Protocol Identification Number
NCT01519843
Brief Title
Post Stroke Motor Learning
Official Title
Post-stroke Procedural Learning: From Neural Substrates to Therapeutic Modulation by Non-invasive Brain Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Suspended
Study Start Date
September 2010 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Mont-Godinne

4. Oversight

Data Monitoring Committee
No

5. 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.
Detailed Description
transcranial direct current stimulation will be used for NIBS

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiparesis
Keywords
stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Real
Arm Type
Active Comparator
Arm Description
Real tDCS
Arm Title
sham
Arm Type
Placebo Comparator
Arm Description
Sham tDCS
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation tDCS
Intervention Description
tdcs (ELDITH, Neuroconn, Ilmenau, Germany)
Intervention Type
Device
Intervention Name(s)
transcranial magnetic stimulation TMS
Intervention Description
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
Primary Outcome Measure Information:
Title
Motor learning improvement with tDCS
Description
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
Time Frame
Improvement on motor learning were recorded from baseline to 4 weeks after the intervention
Secondary Outcome Measure Information:
Title
Neuroimaging
Description
Does cerebral mechanisms underlying motor learning differ from healthy subject to stroke patients?
Time Frame
before motor learning, during motor learning and after (immediately, 30,60min) motor learning (with or without tDCS)
Title
Neurophysiological outcome measure
Description
measure of brain excitability and connectivity with TMS (single and paired pulse)
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Department of Neurology, CHU Mont-Godinne
City
Yvoir
State/Province
Namur
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
35311345
Citation
Riga A, Gathy E, Ghinet M, De Laet C, Bihin B, Regnier M, Leeuwerck M, De Coene B, Dricot L, Herman B, Edwards MG, Vandermeeren Y. Evidence of Motor Skill Learning in Acute Stroke Patients Without Lesions to the Thalamus and Internal Capsule. Stroke. 2022 Jul;53(7):2361-2368. doi: 10.1161/STROKEAHA.121.035494. Epub 2022 Mar 21.
Results Reference
derived
PubMed Identifier
33175411
Citation
Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
Results Reference
derived

Learn more about this trial

Post Stroke Motor Learning

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