Transcutaneous Spinal Cord Stimulation in Children With Incomplete Spinal Cord Injury

Technology
Standing/walking/mobility
Online since 25 June 2024, updated 136 days ago

About this trial

This trial is enrolling 20 children (3-16 years) with chronic, incomplete spinal cord injury above T10 to test the safety and effect of skin-surface (transcutaneous) spinal cord stimulation (TSCS) on muscle activity, strength, and walking function. If included, participants will undergo 24 two-hour sessions over 8 weeks of individualized gait training, including 60 minutes of treadmill training. Then the participants will receive 60 minutes of either: 1) TSCS; or 2) sham stimulation. Sessions will occur at least three times per week for a total of 24 sessions. Final testing of walking ability will be performed after 8 weeks.

Included participants

Gender
All
Age
3 - 16 years
Injury level
C1 - T9
  • Severity (AIS)?
  • AIS-C
    AIS-D
    Time since injury
    ≥ 6 months
    Healthy volunteers
    No
    C1-T9
    Additionally, participants must
    NOT have a cardiac pacemaker or defibrillator

    What’s involved

    Type

    Technology

    Details

    - Participants will undergo 60 minutes of treadmill training, strength training, segmental task practice, and walking interventions. - Then the participants will receive 60 minutes of either 1) TSCS or 2) sham stimulation. - Sessions will occur at least three times per week, for a total of 24 sessions. - Final testing of walking ability will be performed after 8 weeks.

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    General health

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more

    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 3 Mar 2022
    • Organisation
    • Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 3 Mar 2022
    • Organisation
    • Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more