Investigation on the Bidirectional Cortical Neuroprosthetic System

Surgery
General health
Online since 19 December 2022, updated 427 days ago

About this trial

This trial is enrolling 5 individuals with chronic cervical spinal cord injuries to test the feasibility and safety of a Brain-Machine-Interface (BMI) system (Bidirectional Cortical Neuroprosthetic System). BMI is a technique using a computer connected to electrodes on the brain to record brain activity and to control an external device. This system is called bidirectional because it records brain activity but also sends sensory feedback to the brain in the form of electrical pulses. If included, participants will undergo a surgical procedure to implant three pairs of electrodes in the brain. Testing will assess the ability to control an assistive device and to detect electrical signals delivered to the brain. The BMI system will be implanted for approximately 52 weeks.

Included participants

Gender
All
Age
22 - 65 years
Injury level
C4 - C6
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    Time since injury
    ≥ 1 year
  • Injury type
  • Traumatic

    Vertebrae fracture

    Traumatic brain injury

    Non-traumatic

    Ischemia

    Brainstem stroke

    Spinal cord stroke

    Stenosis

    Spondylosis

    Healthy volunteers
    No
    C4-C6

    What’s involved

    Type

    Surgery

    Details

    - Participants will undergo a surgical procedure during which 6 electrode arrays will be implanted in the brain. - The device will be implanted for approximately 52 weeks.

    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
    • Recruiting
    • Trial start date
    • 1 Aug 2017
    • Organisation
    • Johns Hopkins University
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 1 Aug 2017
    • Organisation
    • Johns Hopkins University

    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