Robots Paired With tDCS in Stroke Recovery

Recruiting

Phase 2 Results N/A

Trial Description

The purpose of this study is to evaluate if multiple therapy sessions of Transcranial Direct Current Stimulation (tDCS non-invasive brain stimulation) combined with robotic arm therapy lead to a greater functional recovery in upper limb mobility after stroke than that provided by robotic arm therapy alone.

Conditions

Interventions

  • Transcranial direct current stimulation (tDCS) Device
    Other Names: tDCS; Brain Stimulation
    ARM 1: Kind: Experimental
    Label: tDCS + robotic arm therapy
    Description: Transcranial Direct Current Stimulation (tDCS) 2mA for 20 minutes over the primary motor cortex (M1) in the affected hemisphere followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks
  • Placebo sham Device
    ARM 1: Kind: Experimental
    Label: tDCS sham + robotic arm therapy
    Description: Transcranial Direct Current Stimulation sham condition (0 mA) for 20 minutes over the primary motor cortex (M1) in the affected hemisphere followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks
    ARM 2: Kind: Experimental
    Label: tDCS sham + robotic arm therapy
    Description: Transcranial Direct Current Stimulation sham condition (0 mA) for 20 minutes over the primary motor cortex (M1) in the affected hemisphere followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from baseline in Upper Extremity Fugl Meyer Assessment 12 weeks (immediately following the intervention) and 36 weeks (6 months after the intervention) No
Secondary Change from baseline in Kinematic Data 12 weeks (immediately following the intervention) and 36 weeks (6 months after the intervention) No
Secondary Change from baseline in WOLF motor function test 12 weeks (immediately following the intervention) and 36 weeks (6 months after the intervention) No
Secondary Change from baseline in Motor Power Manual Muscle Test 12 weeks (immediately following the intervention) and 36 weeks (6 months after the intervention) No
Secondary Change from baseline in NIH stroke scale 12 weeks (immediately following the intervention) and 36 weeks (6 months after the intervention) No
Secondary Change from baseline in Stroke Impact Scale (SIS) 12 weeks (immediately following the intervention) and 36 weeks (6 months after the intervention) No

Sponsors