Improving Bi-manual Activities in Stroke Patients With Application of Neuro-stimulation

Not Applicable

Suspended

• Conditions: Deficit in Manual Activities; Stroke
• Interventions: Device: tDCS

• Registration Number: NCT02308852
• Lead Sponsor: University Hospital of Mont-Godinne

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) .

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-12-02
• Study First Submitted QC: 2014-12-03
• Study First Posted: 2014-12-04
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-10
• Primary Completion: 2025-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
real tDCS	tDCS	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
Sham tDCS	tDCS	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)

Primary Outcome Measures

Name	Time	Method
bimanual coordination	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 Outcome Measures

Name	Time	Method
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)	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.

Trial Locations

Locations (1)

University Hospital CHU Dinant Godinne UcL Namur; 🇧🇪 Yvoir, Belgium