Standing, Stepping and Voluntary Movement Spinal Cord Epidural Stimulation

Technology
Standing/walking/mobility
Online since 2 January 2024, updated 195 days ago

About this trial

This is a trial to test the effect of a technique for stimulating the spinal cord with an implanted electrode placed next to the spinal cord (spinal cord epidural stimulation: scES) on standing and stepping function after spinal cord injury. If included, the participant will have an invasive procedure to place the scES stimulating electrode into the spinal canal. The participant will undergo 80 sessions stand and step training without scES. Then they will undergo 80 sessions with specific scES settings while practicing standing (stand-scES), stepping (step-scES), and voluntary movements of the legs and trunk (vol-scES). All training will also be performed with assistance of a trainer overground or in a harness on a body weight support treadmill. Stepping, standing, voluntary movement, cardiovascular, respiratory, bladder, bowel, and sexual function will be tested after 1 year.

Included participants

Gender
All
Age
≥ 18 years
Injury level
C1 - S5
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≥ 2 years
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C1-S5
    Additionally, participants must
    have a spinal cord injury for at least 2 years.
    have a non-progressive spinal cord injury.
    be unable to walk independently overground.

    What’s involved

    Type

    Technology

    Details

    Surgical implantation of scES stimulation device with epidural electrodes 80 sessions of stand and step training without scES. 80 sessions of scES while practicing standing (stand-scES), stepping (step-scES), and voluntary movements of the legs and trunk (vol-scES). All training will also be performed with assistance of a trainer overground or in a harness on a body weight support treadmill. Stepping, standing, voluntary movement, cardiovascular, respiratory, bladder, bowel, and sexual function will be tested after 1 year.

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    Bladder health/function

    Bowel health

    General health

    Sexual health

    Mechanism of action

    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
    • Active
    • Trial start date
    • 2 Nov 2020
    • Organisation
    • University of Louisville
    • Trial recruitment status
    • Active
    • Trial start date
    • 2 Nov 2020
    • 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