Non-invasive Brain Stimulation and Occupational Therapy To Enhance Stroke Recovery "TDCS+OT"

Active, not recruiting

Phase 2/3 Results N/A

Trial Description

The purpose of this study is to determine whether a non-painful, non-invasive, brain-stimulation technique called transcranial direct current stimulation (tDCS) combined with occupational therapy (OT) will improve motor function in patients with chronic stroke. The aim is to determine the effect of applying real (anodal and/or cathodal) vs sham (pretend) tDCS to the motor brain region to improve motor function in chronic stroke patients. Our research in normal subjects has shown that motor skills can be enhanced if tDCS is applied to the brain's motor region during motor learning. The effects after a single session of tDCS can last for up to 30 minutes, effects of multiple sessions (one session per day) can last for weeks. Furthermore, single sessions of tDCS applied to the motor regions in stroke patients have shown that improvements in motor functions can be seen and that effects may last for at least 30 minutes. Patients enrolled in this trial will be randomized to receive either real tDCS or sham tDCS in combination with OT once a day for up to 10 days. Assessments will be done by investigators who are blinded to the intervention. Patients are also blinded as to whether they are receiving real or sham tDCS. We hypothesize that real tDCS applied to the motor regions in combination with OT results in a subsequent improvement in motor function of the recovering hand over sham tDCS in combination with OT.

Conditions

Interventions

  • Occupational therapy Other
  • Transcranial direct current stimulation Device
    Other Names: tDCS
    Intervention Desc: A sham current runs between two electrode positions and might affect the underlying brain tissue.
    ARM 1: Kind: Experimental
    Label: Sham-tDCS + Occupational Therapy
    Description: Each subject will receive up to 10 days of traditional occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with sham (pretend) tDCS for up to 45 min. over the primary motor region.
    ARM 2: Kind: Experimental
    Label: Real-tDCS + Occupational Therapy
    Description: Each subject will receive up to 10 days of traditional occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with real transcranial direct current stimulation (tDCS) over the primary motor region for up to 45 min.
  • Transcranial Direct Current Stimulation Device
    Other Names: Non-invasive brain stimulation; Brain stimulation; Enhancing stroke recovery
    Intervention Desc: A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue
    ARM 1: Kind: Experimental
    Label: Real-tDCS + Occupational Therapy
    Description: Each subject will receive up to 10 days of traditional occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with real transcranial direct current stimulation (tDCS) over the primary motor region for up to 45 min.

Trial Design

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

Patient Involvement

Patients will be assigned to one of two arms: Arm 1: Real-tDCS + Occupational Therapy: Active Comparator Each subject will receive up to 10 days of traditional occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with real transcranial direct current stimulation (tDCS) over the primary motor region for up to 45 min. or Arm 2: Sham-tDCS + Occupational Therapy: Sham Comparator Each subject will receive up to 10 days of traditional occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with sham (pretend) tDCS for up to 45 min. over the primary motor region.

Outcomes

Type Measure Time Frame Safety Issue
Primary 3-Joint Range of Motion (3J-ROM); Fugl-Meyer Assessment of Upper Extremity Motor Impairment.
Secondary Wolf-Motor-Function-Test; Functional MRI Activation Pattern; Diffusion Tensor Imaging; Transcranial Magnetic Stimulation (TMS); Motor Activity Log Rating Scales; Modified Ashworth Scale.
Primary 3-Joint Range of Motion (3J-ROM) Two Baseline Assessments; Treatment days 5, 10; Follow Up No
Primary Fugl-Meyer Assessment of Upper Extremity Motor Impairment Two Baseline Assessments; Treatment days 5, 10; Follow-Up No
Secondary Wolf-Motor-Function-Test Two Baseline Assessments; Treatment days 5, 10; Follow-up No
Secondary Functional MRI Activation Pattern Baseline; Follow-up No
Secondary Diffusion Tensor Imaging Baseline; Follow-up No
Secondary Transcranial Magnetic Stimulation (TMS) Baseline; Follow-up No
Secondary Motor Activity Log Rating Scales 2 Baseline Assessments; Treatment Days 5, 10; Follow-up No
Secondary Modified Ashworth Scale Baseline; Treatment days 5, 10 No
Primary 3-Joint Range of Motion (3J-ROM) Two Baseline Assessments; Treatment days 5, 10; Follow Up No

Sponsors