Neuromodulation of Spinal Locomotor Circuitry to Elicit Stepping After Pediatric Spinal Cord Injury

Technology
Standing/walking/mobility
Online since 8 November 2021, updated 840 days ago

About this trial

This is a trial to test the effect of a technique for stimulating the spinal cord via surface stimulation (i.e., transcutaneous spinal stimulation: TcStim) on stepping in children with spinal cord injury. The study consists of 3 independent parts. If included, the participant will receive one of: 1) TcStim at single or multiple spinal levels while lying down to produce muscle activity in lower limbs; 2) TcStim while stepping on a moving treadmill with a supportive harness that holds the participant upright i.e. Body-weight support (BWS) + TcStim; 3) 60 x 1-hour BWS training sessions, 5 times per week, followed by combination training of BWS + TcStim for another 60 x 1-hour sessions, 5 times per week. Combination training activities include standing, stepping, and sitting on and off the treadmill.

Included participants

Gender
All
Age
4 - 12 years
Injury level
C1 - T12
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    1 month - 12 years
  • Injury type
  • Traumatic

    Non-traumatic

    Ischemia

    Healthy volunteers
    No
    C1-T12
    Additionally, participants must
    be between the ages of 4-12 years.
    have a spinal cord injury for at least 1 year.
    have a neurological level of injury at or above T12.

    What’s involved

    Type

    Technology

    Details

    TcStim at a single or multiple spinal levels; TcStim while stepping on a moving treadmill with a body-weight support (BWS) harness that holds the participant upright 60 x 1-hour training sessions, 5 times per week, followed by a combination training + TcStim for another 60 x 1-hour sessions, 5 times per week. Combination training activities include standing, stepping, and sitting on and off the treadmill.

    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
    • By invitation
    • Trial start date
    • 12 Apr 2021
    • Organisation
    • University of Louisville
    • Trial recruitment status
    • By invitation
    • Trial start date
    • 12 Apr 2021
    • Organisation
    • University of Louisville

    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