Rehabilitation Combined With Bihemispherictranscranial Direct Current Stimulation in Subacute Ischemic Stroke "RECOMBINE"

Recruiting

Phase N/A Results N/A

Trial Description

Rehabilitation after stroke improves motor functions by promoting plastic changes however, after completing standard rehabilitation, 50-60% of patients still exhibit some degree of motor impairment and require at least partial assistance in activities of day living. Therefore, the exploration of other approaches to promote recovery is compulsory. Non invasive brain stimulation and motor rehabilitation are thought to share similar mechanisms in inducing neuroplastic changes in the human cortex and an emerging field of research is focusing on the possibility of coupling both therapies in order to achieve an additive effect and improve outcome.
We hypothesize that coupling bihemispheric transcranial direct current stimulation (tDCS) with simultaneous physical/occupational therapy in the subacute phase of ischemic stroke patients may improve upper limb motor recovery in humans.
This is a randomized, controlled, double blind, cross-over, multicentre, clinical trial. Thirty-six ischemic stroke patients in the subacute phase will be recruited in three centers of neurorehabilitation in Switzerland. After stratification based on the Fugl-Meyer Assessment Upper Extremity according to the severity of the deficit, the patient will be randomized to receive besides standardized physical/occupational treatment according to the Impairment-Oriented Training, tDCS of themotor cortex (1.5 mA, 30 minutes) (group 1: 12 patients) or sham stimulation (without current) (group 2: 12 patients). After three weeks of treatment group 1 and 2 will cross-over and will be treated for other three weeks. Group 3 (12 patients) will receive routine physical/occupational treatment and sham tDCS for six weeks. Assessment will be performed before starting tDCS, at week 3, 6 and at 6 months. Outcome measures are the Fugl-Meyer Assessment Upper Extremity, the extended Barthel Index, the Ashworth scale, the Test of Upper Limb Apraxia (only baseline, week 6, month6), the grip strength evaluated by the Jamar Hydraulic Hand dynamometer. At baseline at week 6 and at month 6 depression will be assessed by the Hamilton depression Rating Scale.

Conditions

Interventions

  • Sham stimulation Device
    Intervention Desc: Sham stimulation for 30 seconds on 15 days during 6 weeks
    ARM 1: Kind: Experimental
    Label: 3 Sham-Sham
    Description: Treatment for 6 weeks daily with sham stimulation
  • Transcranial direct current stimulation (tDCS) Device
    Other Names: tDCS; Low intensity transcranial DC stimulator; Soterix 1x1
    Intervention Desc: Anodal tDCS of the ipsilesional motor cortex and cathodal tDCS of contralesional motor cortex (1.5 mA, 30 minutes) for 15 days during three weeks, then sham stimulation for 30 seconds on 15 days during 3 weeks
    ARM 1: Kind: Experimental
    Label: 1 tDCS-Sham
    Description: tDC stimulation for 3 weeks, then cross-over to sham stimulation
  • Sham stimulation, then tDCS Procedure
    Intervention Desc: Sham stimulation for 30 seconds on 15 days during 3 weeks, then anodal tDCS of the ipsilesional motor cortex and cathodal tDCS of contralesional motor cortex (1.5 mA, 30 minutes) for 15 days during three weeks
    ARM 1: Kind: Experimental
    Label: 2 Sham-tDCS
    Description: Sham stimulation for 3 weeks, then cross over to tDCS stimulation

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Endpoint: Efficacy Study
  • Intervention: Crossover Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Fugl-Meyer Assessment Upper Extremity 6 months No
Secondary Barthel Index 3 weeks No
Secondary Ashworth scale 3 weeks No
Secondary Test of Upper Limb Apraxia (TULIA) 6 weeks No
Secondary Grip strength 3 weeks No
Secondary Hamilton depression Rating scale 6 weeks No

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