Transcranial Direct Current Stimulation (tDCS)-Enhanced Stroke Recovery

Completed

Phase 2 Results N/A

Trial Description

The purpose is to determine whether application of a non-invasive battery powered device called transcranial direct current stimulation (tDCS) can improve recovery of hand weakness after stroke beyond what is achievable with rehabilitative treatment alone.

Conditions

Interventions

  • Transcranial direct current stimulation Device
    Intervention Desc: Transcranial direct current stimulation (tDCS) is the application of weak electrical currents (1-2 mA) to modulate the activity of neurons in the brain.
  • Sham tDCS Behavioral
    Intervention Desc: Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.
  • TDCS Device
    Intervention Desc: 1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.
    ARM 1: Kind: Experimental
    Label: tDCS and occupational therapy
    Description: 1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.
  • Sham tDCS Device
    Intervention Desc: Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.
    ARM 1: Kind: Experimental
    Label: Sham and occupational therapy
    Description: Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.

Trial Design

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

Patient Involvement

Eligible patients with weakness in their arm and or hand, within 15 days of their stroke will be randomized either in rehabilitative training (RT) transcranial Direct Current Stimulation (tDCS) or in RT placebo stimulation for 1 hour daily, Monday through Friday for 10 weekdays. tDCS will be applied for first 20 minutes of simultaneous rehabilitative therapy. A subgroup of patients will undergo functional MRI (fMRI) and transcranial magnetic stimulation (TMS) testing. Jebsen Taylor Test; Wolf Motor Function Test; Medical Research Council grading scale; Barthel Index; Abilhand questionnaire; Ashworth Spasticity Scale; Beck Depression Inventory; Visual Analog Pain Scale; Mini Mental Status Scale; NIHSS; Motor Activity Log; fMRI overactivation in motor cortex: voxel count and intensity at 2 weeks, 3 months and 1 year after stroke.

Outcomes

Type Measure Time Frame Safety Issue
Primary Upper Extremity Fugl-Meyer
Secondary Jebsen Taylor Test; Wolf Motor Function Test; Medical Research Council grading scale; Barthel Index; Abilhand questionnaire; Ashworth Spasticity Scale; Beck Depression Inventory; Visual Analog Pain Scale; Mini Mental Status Scale; NIHSS; Motor Activity Log; fMRI overactivation in motor cortex: voxel count and intensity.
Secondary Jebsen Taylor Test 2 weeks, 3 months, 1 year after stroke No
Secondary Wolf Motor Function Test 2 weeks 3 months 1 year after stroke No
Secondary Medical Research Council grading scale 2 weeks, 3 months and 1 year after stroke No
Secondary Barthel Index 2 weeks, 3 months and 1 year after stroke No
Secondary Abilhand questionnaire 2 weeks, 3 months and 1 year after stroke No
Secondary Ashworth Spasticity Scale 2 weeks, 3 months and 1 year after stroke No
Secondary Beck Depression Inventory 2 weeks, 3 months and 1 year after stroke No
Secondary Visual Analog Pain Scale Daily during therapy, 2 weeks, 3 months and 1 year after stroke Yes
Secondary Mini Mental Status Scale 2 weeks, 3 months and 1 year after stroke Yes
Secondary NIHSS 2 weeks, 3 months and 1 year after stroke Yes
Secondary Motor Activity Log 2 weeks, 3 months and 1 year after stroke No
Secondary fMRI overactivation in motor cortex: voxel count and intensity 2 weeks, 3 months and 1 year after stroke No

Sponsors