A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia

Technology
Arm/hand function
Online since 19 March 2024, updated 20 days ago

About this trial

This pilot trial is enrolling 12 individuals with chronic cervical spinal cord injury to test the safety and feasibility of a functional orthotic sleeve on on grasp function. This device, the NeuroLife Sleeve System, is a non-invasive, forearm sleeve with 160 electrodes; it both records muscle activity and electrically stimulates the muscles. Muscle activity is recorded using electromyography (EMG), a technique that records naturally occurring muscle activity through a surface electrode. The muscles are stimulated using functional electrical stimulation (FES), a technique that applies electrical signals through the skin to nerves to cause contraction of weakened or paralyzed muscles. If included, participants will undergo 3 training sessions a week using the sleeve for 12 weeks. Final testing of arm and hand function will be performed after 4 months.

Included participants

Gender
All
Age
≥ 22 years
Injury level
C1 - C8
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≥ 12 months
    Healthy volunteers
    No
    C1-C8
    Additionally, participants must
    NOT have a pacemaker
    NOT have uncontrolled seizure disorder
    NOT be ventilator dependent

    What’s involved

    Type

    Technology

    Details

    - Participants will undergo 3 training sessions a week using the NeuroLife Sleeve System for a total of 12 weeks. - The NeuroLife Sleeve System is a non-invasive, forearm-worn sleeve with 160 electrodes that record muscle activity and electrically stimulate the muscles. - Final testing of upper-limb function will be performed after 4 months.

    Potential benefits

    Main benefits

    Arm/hand function

    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
    • 31 Oct 2023
    • Organisation
    • Ohio State University
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 31 Oct 2023
    • Organisation
    • Ohio State University

    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