Neuroregeneration Enhanced by Transcranial Direct Current Stimulation (TDCS) in Stroke "NETS"

Recruiting

Phase N/A Results N/A

Trial Description

Testing the hypothesis that non-invasive brain stimulation by transcranial direct current stimulation (tDCS) combined with functional training in the subacute phase of first-ever stroke will enhance functional regeneration compared with a Placebo intervention.

Detailed Description

Stroke is the leading cause of long-term disability, which significantly impairs the economic and social life of patients and society. Every year 200 000 to 250 000 patients suffer a stroke in Germany. Only a small number of the stroke survivors recover to a degree that allows them to return into their professional and private life. Despite significant efforts to develop novel and efficient treatment strategies the level of functional regeneration is still not satisfying. Thus, the development of innovative and effective treatment strategies will have a major impact for the patients' life, the society and the public health system.
Within the proposed project an innovative, non-invasive and cost effective interventional strategy, based on the combination of a specific rehabilitative training and brain stimulation by transcranial direct current stimulation (tDCS), will be used to enhance functional regeneration in stroke patients. The intervention will be applied in an early stage in which plasticity, cortical reorganization and functional improvement is most pronounced. We hypothesize that the combination of anodal tDCS delivered to the motor cortex of the affected hemisphere combined with training over a period of two weeks in the subacute stage after stroke will significantly enhance cortical plasticity, functional regeneration and long-term outcome determined by clinical and functional outcome measures compared with Placebo stimulation.

Conditions

Interventions

  • DC-Stimulator to apply tDCS or Sham tDCS Device
    Intervention Desc: Anodal tDCS (20 minutes) or Sham stimulation will be applied once a day in combination with standardized upper extremity rehabilitative training
    ARM 1: Kind: Experimental
    Label: tDCS
    Description: tDCS + Training
    ARM 2: Kind: Experimental
    Label: Sham tDCS
    Description: Placebo + Training
  • DC-Stimulator to apply tDCS Device
    Intervention Desc: Anodal tDCS (20 minutes) stimulation will be applied once a day in combination with standardized upper extremity rehabilitative training
    ARM 1: Kind: Experimental
    Label: tDCS
    Description: DC-Stimulator to apply tDCS + Training
  • DC-Stimulator to apply Sham tDCS Device
    Intervention Desc: Sham stimulation will be applied once a day in combination with standardized upper extremity rehabilitative training
    ARM 1: Kind: Experimental
    Label: Sham tDCS
    Description: DC-Stimulator to apply Sham tDCS (Placebo) + Training

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 Upper Extremity Fugl-Meyer-Assessment (UEFMA) 12 months after the intervention No
Secondary Jebsen-Taylor Test (JTT), Action Research Arm Test (ARAT), Nine Hole Peg Test (NHPT), Stroke Impact Scale (SIS), UEFMA 12 months after the intervention (day11, 40, 100, 190 after intervention) No
Secondary Action Research Arm Test (ARAT) 1 day, 30 days, 90 days, and 12 months after the intervention
Secondary Nine Hole Peg Test (NHPT) 1 day, 30 days, 90 days, and 12 months after the intervention
Secondary Stroke Impact Scale (SIS) 1 day, 30 days, 90 days, and 12 months after the intervention

Sponsors