Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System

Technology
General health
Online since 8 November 2021, updated 834 days ago

About this trial

This is a trial to test the effect of a device called the Bidirectional Neural Bypass System on hand and wrist movement and sensation in individuals with chronic complete tetraplegia after high cervical SCI. If included in this trial, the participant will first receive neurological examinations and brain scans (functional magnetic resonance image (fMRI) and diffusion tensor image (DTI)). If eligible for continued participation, the participant will undergo surgery to implant electrodes into the brain, which can record brain activity and deliver stimulation to specific brain areas. After surgical recovery, the participant will undergo an X-Ray computed tomography (CT) scan and will be discharged from the hospital. After full recovery, the participant will attend 3x4-hour study sessions a week for 12 months to test hand and wrist movement and sensation. This trial does not have a control group.

Included participants

Gender
All
Age
22 - 65 years
Injury level
C1 - C5
  • Severity (AIS)?
  • AIS-A
    Time since injury
    1 year - 65 years
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C1-C5
    Additionally, participants must
    have a spinal cord injury for at least one year.
    have a neurological level of injury between C1-C5.
    have an ASIA impairment scale (AIS) A: complete; no feeling or movement below the injury

    What’s involved

    Type

    Technology

    Details

    First stage: The first visit includes a neurological examination and a brain scan (functional magnetic resonance image (fMRI) and diffusion tensor image (DTI)). Second stage: The participant will undergo surgery to implant the electrodes into the brain. During surgical recovery, the participant will have an X-Ray CT Scan and then discharged from the hospital. Third stage: 3 x 4-hour sessions a week for 12 months to test hand and wrist function.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Arm/hand function

    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
    • 30 Sep 2019
    • Organisation
    • Northwell Health
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 30 Sep 2019
    • Organisation
    • Northwell Health

    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