Multifocal Brain Magnetic Stimulation in Chronic Ischemic Stroke

Enrolling by invitation

Phase N/A Results N/A

Trial Description

Transcranial magnetic stimulation for post-stroke upper-body motor deficits.

Detailed Description

This study uses transcranial magnetic stimulation of brain motor areas to test whether upper-body motor function can be improved. This is a double-blind study where half of patients will receive real stimulation and half will receive sham (placebo) stimulation.

Conditions

Interventions

  • Transcranial Magnetic Stimulation Other
    Intervention Desc: Transcranial magnetic stimulation delivered through scalp
    ARM 1: Kind: Experimental
    Label: Active treatment
    Description: Active treatment with transcranial magnetic stimulation device.
    ARM 2: Kind: Experimental
    Label: Sham treatment
    Description: Sham treatment with transcranial magnetic stimulation device.
  • Repetitive Transcranial Magnetic Stimulation (TMS) Device
    Other Names: TMS; transcranial magnetic stimulation; Transcranial Rotating Permanment Magnet Stimulation (TRPMS); rTMS
    Intervention Desc: Repetitive transcranial magnetic stimulation delivered through a cap to the scalp whereby the rTMS activity is on (active treatment) or off (sham treatment).
    ARM 1: Kind: Experimental
    Label: Active treatment w/rTMS
    Description: Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap and are provided ACTIVE treatment delivering transcranial magnetic stimulation; the cap's rTMS capability is on.
    ARM 2: Kind: Experimental
    Label: Sham treatment w/rTMS
    Description: Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap and are provided SHAM treatment not delivering any transcranial magnetic stimulation; the cap's rTMS capability is not turned on.

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Percent increase in number and mean intensity (mean T value) of activated voxels in the cortical areas surrounding the lesion on functional MRI One business day before treatment begins, one business day after treatment ends No
Secondary Fugl-Meyer motor arm score One business day before treatment begins, one business day after treatment ends No
Secondary ARAT (Action Research Arm Test) One business day before treatment begins, one business day after treatment ends No
Secondary Hand dynamometer One business day before treatment begins, one business day after treatment ends No
Secondary Pinchmeter score One business day before treatment begins, one business day after treatment ends No
Secondary Timed Up and Go Test One business day before treatment begins, one business day after treatment ends No
Secondary Modified Rankin Scale (mRS) One business day before treatment begins, one business day after treatment ends No
Secondary Pinch dynamometer score One business day before treatment begins, one business day after treatment ends

Sponsors