Epidural Stimulation After 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 with an implanted electrode placed next to the spinal cord (epidural stimulation: ES) in combination with walking in an externally worn powered robotic device to assist movement (exoskeleton: EKSO®) on motor control in veterans with spinal cord injury. If included, the participant will first receive surgery to implant the ES device. After implantation, the participant will practice walking for 30-60 minutes with the EKSO® device and ES between parallel bars, or with a walker or crutches. The training sessions will be performed twice daily, in the morning and evening, 5 days per week. Before and after training (at 6 months), the participant will undergo a low-energy x-ray scan (dual energy x-ray absorptiometry: DXA) to test changes in bone composition, in addition to tests to measure walking and standing parameters, and cardiovascular fitness.

Included participants

Gender
All
Age
18 - 70 years
Injury level
C6 - S5
  • Severity (AIS)?
  • AIS-A
    AIS-B
    Time since injury
    ≥ 2 years
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C6-S5
    Additionally, participants must
    have a spinal cord injury for at least 2 years.
    have a neurological level of injury below C5.
    have one of the following ASIA impairment scale (AIS) classifications:

    What’s involved

    Type

    Technology

    Details

    Surgery for implantation of the ES device. After implantation, the participant will practice walking for 30-60 minutes with the EKSO® device and ES between parallel bars, or with a walker or crutches. The training sessions will be performed twice daily, in the morning and evening, 5 days per week. Before and after training (at 6 months), the participant will undergo a low-energy x-ray scan (dual energy x-ray absorptiometry: DXA) to test changes in bone composition.

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    Bone health

    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
    • Unknown
    • Trial start date
    • 1 Jan 2020
    • Organisation
    • McGuire Research Institute
    • Trial recruitment status
    • Unknown
    • Trial start date
    • 1 Jan 2020
    • Organisation
    • McGuire Research Institute

    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