Intelligent Spine Interface

Technology
Standing/walking/mobility
Online since 5 November 2021, updated 837 days ago

About this trial

This study is enrolling individuals with chronic spinal cord injuries to study an electrical stimulation device intended to improve voluntary leg function. The device (Intelligent Spine Interface-Commercial; ISI-C) is implanted around the injured spinal cord to transfer recorded nerve signals from above the spinal cord lesion to electrodes below the lesion. Researchers want to see if the ISI device affects voluntary leg movement. This study hopes to understand how nervous system signals travel within the spinal cord, and then to develop a device that can restore volitional control of lower limbs. The study will collect data on safety, leg function (strength, walking) and balance, over 8 months. If selected for the trial, participants will receive imaging studies (e.g. X-rays, etc.), surgery to implant the ISI device, and will receive physical rehabilitation.

Included participants

Gender
All
Age
18 - 65 years
Injury level
C7 - T10
  • Severity (AIS)?
  • AIS-A
    AIS-B
    Time since injury
    1 year - 65 years
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C7-T10
    Additionally, participants must
    NOT have implanted drug pump or pacemaker device

    What’s involved

    Type

    Technology

    Details

    Surgical implantation of a portion of the electrical stimulation device Imaging studies (e.g. X-rays etc.) Physical rehabilitation Various assessments of safety, leg function (strength, walking) and balance

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    Arm/hand function

    General health

    Mental health

    Sensory function

    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 Sep 2021
    • Organisation
    • Rhode Island Hospital
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 1 Sep 2021
    • Organisation
    • Rhode Island Hospital

    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