Neuromodulation Techniques After SCI

Technology
Standing/walking/mobility
Online since 4 November 2021, updated 895 days ago

About this trial

This trial is enrolling individuals with spinal cord injuries to test the effect of a powered robotic device (exoskeleton) to assist walking, combined with one of two techniques for electrically stimulating the spinal cord. The stimulation involves either a surgically implanted electrode array placed next to the spinal cord (epidural stimulation), or skin surface (transcutaneous) stimulation. Researchers want to see if exoskeleton-based rehab offers benefits for independent standing and stepping, and also whether it may reverse other health-related consequences of SCI. Participants will undergo 3 months of exoskeleton training followed by 6 months of either 1) training along with epidural stimulation or training with skin surface stimulation (3 sessions/week).

Included participants

Gender
Male
Age
18 - 70 years
Injury level
C1 - T10
  • Severity (AIS)?
  • AIS-A
    AIS-B
    Time since injury
    1 month - 70 years
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C1-T10
    Additionally, participants must
    NOT have an implanted device, e.g. pacemaker

    What’s involved

    Type

    Technology

    Details

    If included, the participant will train 3 times per week for 2 months with either 1) the exoskeleton and TS or 2) the exoskeleton and sham-TS. Final assessments will be performed 6 months after the training sessions.

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    Bladder health/function

    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
    • 1 Jun 2020
    • Organisation
    • VA Office of Research and Development
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 1 Jun 2020
    • Organisation
    • VA Office of Research and Development

    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