A Neuroprosthesis for Seated Posture and Balance

Technology
Standing/walking/mobility
Online since 29 October 2021, updated 843 days ago

About this trial

This trial is recruiting individuals with spinal cord injuries to evaluate the effect of a small functional electrical stimulation (FES) device on trunk stability. The surgically implanted 8-channel neuroprosthesis device applies small currents through wire electrodes connected to the nerves of trunk and hip muscles; this causes those muscles to contract and strengthen. Participants will have the device implanted in the abdomen, with connecting wires placed in the trunk and hips. After a few weeks of recovery, participants will receive training and exercises on how to use the device. Assessments of FES on sitting, posture, stability, breathing, rolling over in bed, and pushing a wheelchair will occur over 36 months.

Included participants

Gender
All
Age
≥ 21 years
Injury level
C4 - T12
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    Time since injury
    ≥ 6 months
  • Injury type
  • Traumatic

    Non-traumatic

    Healthy volunteers
    No
    C4-T12

    What’s involved

    Type

    Technology

    Details

    The participant will receive surgery to implant the stimulator in his abdomen and electrodes in his back and hip muscles. After the surgery, the participant will be monitored in the hospital for 2-5 days. For 2-6 weeks after the surgery, the participant will return home and be encouraged to rest and do minimal activity so that he may heal. The participant will then receive exercise and training to use the stimulation device. The investigators have not yet provided information on the number or duration of therapy sessions.

    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
    • Recruiting
    • Trial start date
    • 30 Nov 2011
    • Organisation
    • VA Office of Research and Development
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 30 Nov 2011
    • 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