Restoration of Standing and Walking With ISMS in Humans

Technology
Standing/walking/mobility
Online since 10 July 2024, updated 120 days ago

About this trial

This trial is recruiting individuals with chronic complete paraplegia to test the usage of electrical stimulation in the spinal cord to potentially restore control of standing or walking. The study aims to extend by two hours a routine spinal surgery (used to correct a deformity or stabilize the lower thoracic spine) in order to evaluate an IntraSpinal Micro-Stimulation (ISMS) device to map and stimulate part of the spinal cord (T9-12). The device will also measure the effect on the leg muscles used for standing or walking, across the hips, knees and ankles. If selected, participants will receive standard surgery with an extension of 2 hours to conduct the ISMS study. Movement assessment and MRI will be done before and after the intervention.

Included participants

Gender
All
Age
18 - 50 years
Injury level
T2 - T8
  • Severity (AIS)?
  • AIS-A
    Time since injury
    ≥ 1 year
  • Injury type
  • Traumatic

    Non-traumatic

    Healthy volunteers
    No
    T2-T8
    Additionally, participants must
    already be scheduled for routine spinal surgery in the region of T9-12.
    have the ability to travel to Nashville (Tennessee).
    NOT have other implanted device, e.g. pacemaker or stimulator

    What’s involved

    Type

    Technology

    Details

    The participant will undergo the planned thoracic surgery with an extension to conduct the study using the ISMS device. Before and after the surgery, the participant will do a gait assessment and an MRI scan. The follow-up assessment will be done 1, 3 and 6 month post-surgery.

    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
    • 1 Jan 2015
    • Organisation
    • Vanderbilt University Medical Center
    • Trial recruitment status
    • Ended
    • Trial start date
    • 1 Jan 2015
    • Organisation
    • Vanderbilt University Medical Center

    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