A Neuroprosthesis for Prolonged Standing After SCI Using Multi-Contact Peripheral Nerve Electrodes

Technology
Standing/walking/mobility
Online since 1 November 2021, updated 929 days ago

About this trial

This trial is recruiting individuals with chronic spinal cord injuries to receive an implanted device (IRS-8 or IST-16) and implanted electrodes to activate muscles that move paralyzed muscles. The study hopes to optimize an existing neuroprosthesis device by reducing muscle fatigue. Stimulation parameters will allow one or more muscles (or parts of the same muscle) to rest while the others continue to contract to keep the knee extended and the user upright. Researchers want to see if this will allow users to remain upright for longer periods of time, reduce the risk of falls due to fatigue, and increase the potential of receiving the health benefits of standing. Participants will undergo surgery to place the device and electrodes into the body. The trial will include exercise and physical therapy with the stimulation device turned on.

Included participants

Gender
All
Age
≥ 21 years
Injury level
C6 - T12
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≥ 6 months
  • Injury type
  • Traumatic

    Non-traumatic

    Ischemia

    Healthy volunteers
    No
    C6-T12
    Additionally, participants must
    be capable of moving hip, knee and ankle joints through normal range of motion

    What’s involved

    Type

    Technology

    Details

    Surgery to implant the device and nerve electrodes in the participant’s body. Exercise and do physical therapy to practice standing. Last visit 12 months after surgery. Investigators have not provided information on the number or duration of therapy sessions. Note: A detailed explanation of the full extent of what is required can only be obtained directly from the Investigator.

    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
    • Ended
    • Trial start date
    • 11 Apr 2013
    • Organisation
    • VA Office of Research and Development
    • Trial recruitment status
    • Ended
    • Trial start date
    • 11 Apr 2013
    • 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