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

Recruiting

Phase 1/2 Results N/A

Trial Description

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.

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.

Conditions

Interventions

  • TDCS Device
    ARM 1: Kind: Experimental
    Label: real tDCS
    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 2: Kind: Experimental
    Label: Sham tDCS
    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)

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Crossover Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary bimanual coordination up to 2 hours after intervention. Recall test at 1 week and up to,2,3,4 weeks after the intervention No
Secondary 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) No

Sponsors