ARC Therapy to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury

Technology
General health
Online since 5 June 2024, updated 16 days ago

About this trial

This trial is enrolling 16 individuals with sub-acute to chronic spinal cord injury (at least one month post injury) to test the safety and effect of a spinal cord stimulation intervention called ARC-IM on blood pressure management and trunk control. ARC-IM is a technique for stimulating the spinal cord with implanted electrodes placed next to the spinal cord in the epidural space. If included, participants will receive surgery to implant the electrodes; electrical stimulation will be applied to the spinal cord. Final testing of safety measures will be performed after 12 months.

Included participants

Gender
All
Age
≥ 18 years
Injury level
C3 - T6
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≥ 1 month
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C3-T6
    Additionally, participants must
    have orthostatic hypotension.
    must NOT have an indwelling baclofen or insulin pump

    What’s involved

    Type

    Technology

    Details

    - participants will receive surgery for implantation of the ARC-IM System - stimulation will be applied to the spinal cord - final testing of safety measures will be performed after 12 months

    Potential benefits

    Main benefits

    General health

    Additional benefits

    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
    • 5 Sep 2023
    • Organisation
    • ONWARD Medical, Inc.
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 5 Sep 2023
    • Organisation
    • ONWARD Medical, Inc.

    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