COMMAND Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis

Technology
General health
Online since 12 March 2024, updated 66 days ago

About this trial

This trial is enrolling 5 individuals with severe motor impairment (including spinal cord injuries) to test the safety and feasibility of an implantable brain-computer-interface (BCI) device, the Synchron motor neuroprosthesis. BCI is a technique using a computer and connected electrodes on the brain to record brain activity that could be used to control an external digital device. The Synchron device is inserted in the cerebral cortex by way of the jugular vein (endovascular). Once in place, the device detects and wirelessly transmits brain signals, such as those for motor intent. If included, participants will undergo a minimally invasive surgical procedure to implant the BCI device. Final safety testing will be done after 12 months.

Included participants

Gender
All
Age
21 - 75 years
Injury level
C1 - C8
  • Severity (AIS)?
  • Time since injury
    All
    Healthy volunteers
    No
    C1-C8
    Additionally, participants must
    NO history of pulmonady embolism
    NO history of deep vein thrombosis
    NO history or current psychiatric or psychological disorder

    What’s involved

    Type

    Technology

    Details

    Participants will undergo a surgical procedure to implant the BCI device in the brain. - Final safety testing will be done 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
    • Active
    • Trial start date
    • 27 Apr 2022
    • Organisation
    • Synchron, Inc.
    • Trial recruitment status
    • Active
    • Trial start date
    • 27 Apr 2022
    • Organisation
    • Synchron, 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