Improving Rehabilitation by Magnetic Brain Stimulation

Completed

Phase 1 Results

Trial Description

We hope to understand the properties of the motor cortex in the brain of people with stroke using non-invasive magnetic stimulation.

Detailed Description

This case series assesses the effects of five consecutive days of low‐frequency (1 Hz) repetitive transcranial magnetic stimulation (rTMS) with and without a 6‐Hz primer. Although this paper studies able‐bodied individuals, similar rTMS protocols are used to facilitate motor recovery in patients with hemiplegia following stroke. However, the cortical mechanisms associated with repeated daily doses of rTMS are not completely understood.

Conditions

Interventions

  • Repetitive Transcranial Magnetic Stimulation Device
    Intervention Desc: We will position a coil over the motor cortex of the head and give a series of stimulations (called magnetic pulses).
    ARM 1: Kind: Experimental
    Label: 1
    Description: Receive rTMS
    ARM 2: Kind: Experimental
    Label: 2
    Description: Receive sham rTMS
    ARM 3: Kind: Experimental
    Label: Arm 1
    Description: Receive rTMS
    ARM 4: Kind: Experimental
    Label: Arm 2
    Description: Receive sham rTMS
    ARM 5: Kind: Experimental
    Label: Primed rTMS
    Description: Receive 10 min. of 6-Hz rTMS Repetitive Transcranial Magnetic Stimulation at 90% RMT (3,600 pulses). Followed by 30 min. of 1-Hz rTMS at 95% RMT (1,880 pulses)
    ARM 6: Kind: Experimental
    Label: Unprimed rTMS)
    Description: Receive 10 min. of sham rTMS Repetitive Transcranial Magnetic Stimulation. Followed by 30 min. of 1-Hz rTMS at 95% RMT (1,880 pulses)

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary WMFT 2 weeks No
Primary Percentage BOLD (Blood-oxygen-level Dependent Contrast Imaging) Signal From Baseline at 2 Weeks Baseline (day 0) and 2 weeks No

Sponsors