Transcranial Magnetic Stimulation in Children With Stroke "TMSCS"

Completed

Phase 1 Results N/A

Trial Description

This is a pilot study of repetitive transcranial magnetic stimulation (rTMS) to test tolerance and efficacy in children who have hemiparesis from acquired or presumed perinatal stroke.

Detailed Description

The investigators will begin to test the hypothesis that rTMS will be tolerated and will result in improved hand strength and mobility when compared with sham stimulation.
Aim 1: To determine whether 1 Hz rTMS applied to the hemisphere opposite the infarct (contralesional or healthy hemisphere) is tolerated by children ages 6-18 years who have chronic motor sequelae from a stroke.
Aim 2: To determine whether 8 sessions of inhibitory 1 Hz rTMS to the contralesional healthy hemisphere improves grip strength and hand mobility when compared with sham stimulation in controls.

Conditions

Interventions

  • Transcranial Magnetic Stimulation Device
    Intervention Desc: Transcranial Magnetic Stimulation, repetitive at 1Hz
    ARM 1: Kind: Experimental
    Label: Magnetic Stimulation
    Description: Active Magnetic Stimulation
  • Sham Magnetic Stimulation Device
    Other Names: MagStim
    Intervention Desc: Sham Magnetic Stimulation
    ARM 1: Kind: Experimental
    Label: No Intervention
    Description: Sham Magnetic Stimulation

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Tolerance to repetitive stimulation Up to 2 days Yes
Secondary Upper extremity strength and mobility Up to 2 Months No

Sponsors