Efficacy Basics of Bihemispheric Motorcortex Stimulation After Stroke

Completed

Phase N/A Results N/A

Trial Description

The aim of the study is to investigate whether the combination of bihemispheric ("dual") transcranial direct current stimulation (tDCS) and motor training on 5 consecutive days facilitates motor recovery in chronic stroke. Results will be compared to a matched group of patients undergoing anodal tDCS as well as a control group receiving sham tDCS. Functional and structural magnetic resonance imaging (MRI) before/after the intervention and during a 3 month follow-up will help investigating neural correlates of expected changes in motor function of the affected upper extremity.

Conditions

Interventions

  • Motor Training Other
    Intervention Desc: Motor training of the affected upper extremity (5 days, 25 min/day).
    ARM 1: Kind: Experimental
    Label: Dual tDCS + motor training
    Description: Motor training of the affected upper extremity combined with dual transcranial direct current stimulation (tDCS).
    ARM 2: Kind: Experimental
    Label: Anodal tDCS + motor training
    Description: Motor training of the affected upper extremity combined with anodal tDCS.
    ARM 3: Kind: Experimental
    Label: Sham tDCS + motor training
    Description: Motor training of the affected upper extremity combined with sham tDCS.
  • TDCS Device
    Intervention Desc: transcranial direct current stimulation (tDCS)
    ARM 1: Kind: Experimental
    Label: Dual tDCS + motor training
    Description: Motor training of the affected upper extremity combined with dual transcranial direct current stimulation (tDCS).
    ARM 2: Kind: Experimental
    Label: Anodal tDCS + motor training
    Description: Motor training of the affected upper extremity combined with anodal tDCS.
    ARM 3: Kind: Experimental
    Label: Sham tDCS + motor training
    Description: Motor training of the affected upper extremity combined with sham tDCS.

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Motor Function of the Affected Upper Extremity Change from baseline after 5 days (immediately after intervention) No
Secondary Functional Magnetic Resonance Imaging After 5 days (immediately after intervention), after 3 months vs baseline (before intervention) No
Secondary Diffusion Tensor Imaging After 5 days (immediately after intervention), after 3 months vs baseline (before intervention) No
Secondary Transcranial Magnetic Stimulation After 5 days vs baseline (before intervention) No

Sponsors