Improving Bi-manual Activities in Stroke Patients With Application of Neuro-stimulation
Primary Purpose
Stroke, Deficit in Manual Activities
Status
Suspended
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring bi-manual , motor skill learning , stroke , chronic patients,neuro-rehabilitative robot
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
Sites / Locations
- University Hospital CHU Dinant Godinne UcL Namur
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
real tDCS
Sham tDCS
Arm Description
Patients will receive non-invasive and painless brain stimulation over the brain areas involved in cognitive aptitudes. tDCS will be applied during 20 minutes while patients will perform motor bimanual tasks
this will be exactly as for "real tDCS" unless that the tDCS will be rapidly turned off, unbeknown from patients-therapist-examinator (double-blind trial)
Outcomes
Primary Outcome Measures
bimanual coordination
The effect of intervention on bimanual motor coordination will be quantified before, during and after executive tasks.
Secondary Outcome Measures
standard unimanual evaluation
Performance on motor skill learning tasks and on different commonly used tasks (Purdue Pegboard, hand dynamometer, pinch dynamometer, 9-HPT, motor skill learning with a videogame, ...) will be measured to explore the impact of tDCS on these parameters in chronic stroke patients.
Full Information
NCT ID
NCT02308852
First Posted
December 2, 2014
Last Updated
May 8, 2023
Sponsor
University Hospital of Mont-Godinne
1. Study Identification
Unique Protocol Identification Number
NCT02308852
Brief Title
Improving Bi-manual Activities in Stroke Patients With Application of Neuro-stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Suspended
Study Start Date
October 2014 (Actual)
Primary Completion Date
December 2023 (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 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) .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Deficit in Manual Activities
Keywords
bi-manual , motor skill learning , stroke , chronic patients,neuro-rehabilitative robot
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
tDCS real versus sham tDCS (this is what this is)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
real tDCS
Arm Type
Active Comparator
Arm Description
Patients will receive non-invasive and painless brain stimulation over the brain areas involved in cognitive aptitudes.
tDCS will be applied during 20 minutes while patients will perform motor bimanual tasks
Arm Title
Sham tDCS
Arm Type
Placebo Comparator
Arm Description
this will be exactly as for "real tDCS" unless that the tDCS will be rapidly turned off, unbeknown from patients-therapist-examinator (double-blind trial)
Intervention Type
Device
Intervention Name(s)
tDCS
Primary Outcome Measure Information:
Title
bimanual coordination
Description
The effect of intervention on bimanual motor coordination will be quantified before, during and after executive tasks.
Time Frame
up to 2 hours after intervention. Recall test at 1 week and up to,2,3,4 weeks after the intervention
Secondary Outcome Measure Information:
Title
standard unimanual evaluation
Description
Performance on motor skill learning tasks and on different commonly used tasks (Purdue Pegboard, hand dynamometer, pinch dynamometer, 9-HPT, motor skill learning with a videogame, ...) will be measured to explore the impact of tDCS on these parameters in chronic stroke patients.
Time Frame
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)
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
University Hospital CHU Dinant Godinne UcL Namur
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
36061986
Citation
De Laet C, Herman B, Riga A, Bihin B, Regnier M, Leeuwerck M, Raymackers JM, Vandermeeren Y. Bimanual motor skill learning after stroke: Combining robotics and anodal tDCS over the undamaged hemisphere: An exploratory study. Front Neurol. 2022 Aug 18;13:882225. doi: 10.3389/fneur.2022.882225. eCollection 2022.
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
Improving Bi-manual Activities in Stroke Patients With Application of Neuro-stimulation
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