Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02)

Technology
Mental health
Online since 19 March 2024, updated 20 days ago

About this trial

This feasibility trial is enrolling two individuals with chronic cervical spinal cord injury (or other motor neuron disorders) to test the potential of a brain-computer interface (BCI) system for reproducing speech. BCI is a technique using a computer and connected electrodes on the brain to record brain activity as the participant tries to talk; in this case the device decodes and outputs the intended speech. If included, participants will have BrainGate2 Neural Interface System sensors implanted into the speech-related area of the cortex. Final evaluation of safety and speech output accuracy will be performed after 1–5 years. ,

Included participants

Gender
All
Age
18 - 80 years
Injury level
C1 - T1
  • Severity (AIS)?
  • Time since injury
    ≥ 12 months
    Healthy volunteers
    No
    C1-T1

    What’s involved

    Type

    Technology

    Details

    - Participants will have the BrainGate2 Neural Interface System, a brain-computer interface (BCI), implanted into the speech-related cortex. - A BCI is a technique using a computer and connected electrodes on the brain to record brain activity as the participant tries to talk and outputs the intended speech. - Final evaluation of safety and speech output accuracy will be performed after 1–5 years.

    Potential benefits

    Main benefits

    Mental health

    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
    • 1 Oct 2024
    • Organisation
    • Massachusetts General Hospital
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 1 Oct 2024
    • Organisation
    • Massachusetts General Hospital

    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