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

University Hospital of Mont-Godinne

Status: Suspended

Conditions: Deficit in Manual Activities; Stroke

Treatments: Device: tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT02308852

B039201317382

Details and patient eligibility

About

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.

Full 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) .

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

real tDCS

Active Comparator group

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

Treatment:

Device: tDCS

Sham tDCS

Placebo Comparator group

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)

Treatment:

Device: tDCS