Cortical Recording and Stimulating Array Brain-Machine Interface

Technology
Arm/hand function
Online since 1 November 2021, updated 841 days ago

About this trial

This trial is recruiting individuals with spinal cord injuries who have limited or no hand activity to test the safety and effect of a brain-machine interface (BMI) device. The device includes two microelectrode arrays that are implanted in the brain to record the specific nerve signals that control movement and sensation in the arms, hands and legs. The electrodes can also send electrical pulses can back to the brain’s sensory areas to allow a feeling of sensation in the extremities. Motor and sensory areas in the brain remain active after spinal cord injury even though the signals do not reach their targets below the injury. The neural signals are interpreted by a computer and translated to movement, which can then be used to control a variety of devices or computer displays. The investigators will study the electrodes for long term recording and movement control. Participants will receive surgery to implant the electrodes. Training and evaluations will last up to 12 months. Surgery will be required to remove the sensors when the trial is completed.

Included participants

Gender
All
Age
22 - 70 years
Injury level
C1 - C5
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    1 year - 70 years
  • Injury type
  • Traumatic

    Non-traumatic

    Healthy volunteers
    No
    C1-C5
    Additionally, participants must
    have limited or no ability to use both hands.
    have no other implanted electrical device (e.g. pacemaker, cochlear implants).

    What’s involved

    Type

    Technology

    Details

    Surgery to implant the sensors. Training (multiple days each week) and evaluations for up to 12 months. A safety evaluation 1-year after your surgery up to 25 months. Surgery to take out the sensors.

    Potential benefits

    Main benefits

    Arm/hand function

    Additional benefits

    General health

    Standing/walking/mobility

    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 Dec 2013
    • Organisation
    • University of Pittsburgh
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 1 Dec 2013
    • Organisation
    • University of Pittsburgh

    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