Brain Machine Interface (BMI) in Subjects Living With Quadriplegia

Technology
Arm/hand function
Online since 2 November 2021, updated 889 days ago

About this trial

This trial is recruiting individuals with chronic cervical (neck area) spinal cord injuries to assess the safety and feasibility of a brain stimulation device to activate muscles related to grasping. The implant (Activa PC+S) delivers electrical stimulation but also records brain activity. It is an improved version of a device already in use for deep brain stimulation. If selected, participants will undergo surgery to implant the brain stimulation device over the motor cortex of the brain. Electrodes in the device will record brain signals and send them to be processed by computer. Training in grasping will be provided over a 3-6 month period (24 sessions). After final assessments at 24 months, participants can continue to use the device as long as it continues working.

Included participants

Gender
All
Age
22 - 50 years
Injury level
C5 - C6
  • Severity (AIS)?
  • AIS-A
    AIS-B
    Time since injury
    1 month - 50 years
  • Injury type
  • Traumatic

    Non-traumatic

    Healthy volunteers
    No
    C5-C6

    What’s involved

    Type

    Technology

    Details

    The participant will undergo surgery to implant the device over the motor areas of the brain. 24 distinct sessions or visits of testing over a 3-6 month period.

    Potential benefits

    Main benefits

    Arm/hand function

    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
    • Ended
    • Trial start date
    • 1 Nov 2015
    • Organisation
    • University of Miami
    • Trial recruitment status
    • Ended
    • Trial start date
    • 1 Nov 2015
    • Organisation
    • University of Miami

    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