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

Stroke Clinical Trial

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02308852
• Other study ID #: B039201317382
• Status: Suspended
• Phase: N/A
• Start date: October 2014
• Est. completion date: December 2030

Study information

• Verified date: January 2024
• Source: University Hospital of Mont-Godinne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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) .

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 100
• Est. completion date: December 2030
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Deficit in Manual Activities
• Stroke

Intervention

Device:
• tDCS

Locations

Country	Name	City	State
Belgium	University Hospital CHU Dinant Godinne UcL Namur	Yvoir

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Mont-Godinne

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bimanual coordination	The effect of intervention on bimanual motor coordination will be quantified before, during and after executive tasks.	up to 2 hours after intervention. Recall test at 1 week and up to,2,3,4 weeks after the intervention
Secondary	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.	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)