Brain Controlled Spinal Cord Stimulation in Participants With Cervical Spinal Cord Injury for Upper Limb Rehabilitation

Technology
General health
Online since 20 March 2024, updated 92 days ago

About this trial

This trial is enrolling three individuals with chronic cervical spinal cord injury to test the safety and effect of an implantable electrocorticography (ECoG) neuroprosthetic device combined with electrical epidural spinal cord stimulation (EES) on voluntary arm movements. EES is a technique for stimulating the spinal cord with an implanted electrode array placed next to the spinal cord to modify spinal cord function. ECoG is a technique connecting a computer to implanted electrodes on the brain to record brain activity; brain signals thus control an external device to drive muscle-specific EES. This device has been implanted in four individuals in other studies. If included, participants will undergo surgery for: 1) implantation of the ECoG device on the brain and; 2) implantation of the EES device on the cervical spinal cord. Preliminary efficacy (arm and hand function) will be assessed over 7 months and safety will be monitored for 12 months.

Included participants

Gender
All
Age
18 - 75 years
Injury level
C1 - C8
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≥ 6 months
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C1-C8
    Additionally, participants must
    not have brain damage.
    not have history of epilepsy.
    not have previously been injected with stem cells in the spinal cord.

    What’s involved

    Type

    Technology

    Details

    - Surgery for implantation of the ECoG device on the brain. - Surgery for implantation of the EES device on the cervical spinal cord. - Safety assessments over 12months. - Testing of arm/hand function over 7 months.

    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
    • 22 May 2023
    • Organisation
    • Ecole Polytechnique Fédérale de Lausanne
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 22 May 2023
    • Organisation
    • Ecole Polytechnique Fédérale de Lausanne

    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