An Early Feasibility Study of the ReHAB System

Technology
General health
Online since 16 August 2023, updated 193 days ago

About this trial

This trial is enrolling up to12 individuals with chronic cervical spinal cord injury to test the feasibility of implanting small electrodes in the parts of the brain that control movement and sensation; that procedure will be combined with surface electrodes on the upper arm and shoulder that activate paralyzed muscles of the arm and hand using signals from the brain electrodes. Investigators call this reHAB (Reconnecting the Hand and Arm to the Brain). If included, participants will undergo surgery for implantation of the brain electrodes. Testing will assess participants' ability to control the position of a cursor on a monitor using the recorded neural signals. The study lasts 13 months; participants can then opt to remain in a long-term (5 year) study.

Included participants

Gender
All
Age
22 - 65 years
Injury level
C1 - C8
  • Severity (AIS)?
  • Time since injury
    ≥ 12 months
    Healthy volunteers
    No
    C1-C8
    Additionally, participants must
    Be at least 12 months post onset of tetraplegia.
    Not have an implanted stimulator (e.g. pacemaker or stimulators (of the spinal cord, deep brain, vagus nerve), cochlear implant, or defibrillator.
    Not be ventilator dependent.

    What’s involved

    Type

    Technology

    Details

    - participants will undergo surgery for implantation of the electrodes - participants will be evaluated over 13 months

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Arm/hand 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
    • 9 Apr 2019
    • Organisation
    • University Hospitals Cleveland Medical Center
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 9 Apr 2019
    • Organisation
    • University Hospitals Cleveland 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