A Brain Centered Neuroengineering Approach for Motor Recovery After Stroke: Combined rTMS and BCI Training

Completed

Phase N/A Results N/A

Trial Description

The purpose of this study is to determine whether the combination of low frequency repetitive transcranial magnetic stimulation (rTMS) and motor-imagery-based brain computer interface (BCI) training is effective for enhancing motor recovery after stroke.
The PI's hypothesis is that, in comparison with traditional physical therapy alone, subjects receiving supplementary rTMS and BCI training will show greater functional improvements in hand motor ability over time as well as recovery of normal motor connectivity patterns.

Detailed Description

The goal of the present study is to develop and evaluate a brain based approach to improve motor recovery after stroke, by combining rTMS and BCI training. Treatments will consist of low frequency rTMS applied to the contralesional hemisphere, followed by BCI training to encourage activity within the lesioned hemisphere. The primary objective of this study is to test the main hypothesis above in a stroke patient population. Subjects will also undergo a period of BCI only treatments after completion of the combined rTMS and BCI portion.

Conditions

Interventions

  • RTMS Device
    Intervention Desc: Low frequency rTMS (either real or sham) will be applied to the contralesional hemisphere at a rate of 1Hz for 10 minutes.
    ARM 1: Kind: Experimental
    Label: Sham rTMS + Real BCI Training
    Description: Subjects will receive sham rTMS followed by real BCI training.
    ARM 2: Kind: Experimental
    Label: Real rTMS + Real BCI Training
    Description: Subjects will receive real rTMS followed by real BCI training.
  • BCI Training Behavioral
    Intervention Desc: BCI training will consist of a series of EEG-based motor-imagery tasks with virtual feedback presented on a computer screen.
    ARM 1: Kind: Experimental
    Label: Sham rTMS + Real BCI Training
    Description: Subjects will receive sham rTMS followed by real BCI training.
    ARM 2: Kind: Experimental
    Label: Real rTMS + Real BCI Training
    Description: Subjects will receive real rTMS followed by real BCI training.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Subject)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in Hand Motor Function over 12 weeks as measured by the Jebsen Taylor Hand Test Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks), Follow-Up (12 weeks) No
Secondary Changes in Hand Motor Function over 12 weeks as measured by the Box and Block Test Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks), Follow-up (12 weeks) No
Secondary Changes in Hand Motor Function over 12 weeks as measured by the Finger Tracking Test Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks), Follow-up (12 weeks) No
Secondary Changes in the Resting Motor Threshold over 12 weeks Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks), Follow-up (12 weeks) No
Secondary Changes in Inter-hemispheric Inhibition over 12 weeks Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks), Follow-up (12 weeks) No
Secondary Changes in the NIH Stroke Scale over 12 weeks Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks), Follow-up (12 weeks) Yes
Secondary Subject Report of Symptoms within 12 weeks of participation Yes
Primary Changes in cortical excitability and cortical activation patterns as measured by MRI and functional MRI Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks) No
Secondary Changes in Hand Motor Function as measured by the Box and Block Test Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks), Follow-up (12 weeks) No
Secondary Changes in Hand Motor Function as measured by the Finger Tracking Test Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks), Follow-up (12 weeks) No
Secondary Changes in the Resting Motor Threshold Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks), Follow-up (12 weeks) No
Secondary Changes in Inter-hemispheric Inhibition Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks), Follow-up (12 weeks) No

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