Precise Robotically IMplanted Brain-Computer InterfacE

Surgery
General health
Online since 5 October 2024, updated 165 days ago

About this trial

This trial is enrolling 3 individuals with chronic cervical spinal cord injury (or tetraparesis due to ALS) to evaluate the safety and functionality of a robot implanted brain-computer-interface device, the Neuralink N1. The N1 uses electrode threads in the brain to record brain activity. These signals are then processed by a computer allowing the user to control external digital devices. If included, participants will receive the skull-mounted, wireless, rechargeable N1, implanted in the brain by a robotic electrode thread inserter. Final testing of device functionality and safety will be performed after 6 years.

Included participants

Gender
All
Age
22 - 75 years
Injury level
C1 - T1
  • Severity (AIS)?
  • Time since injury
    ≥ 1 year
    Healthy volunteers
    No
    C1-T1
    Additionally, participants must
    NOT have an active implanted device

    What’s involved

    Type

    Surgery

    Details

    - Participants will receive the skull-mounted, wireless, rechargeable N1 Implant, implanted in the brain by the R1 Robot, a robotic electrode thread inserter. - The N1 Implant is brain-computer interface that uses connected electrodes in the brain to record brain activity. This is then processed by a computer to control external digital devices. - Final testing of the device functionality and safety will be performed after 6 years.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Mental health and psychosocial factors

    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 Jan 2024
    • Organisation
    • Neuralink Corp
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 9 Jan 2024
    • Organisation
    • Neuralink Corp

    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