NeuroCognitive Communicator: Safety Study

Technology
Mental health and psychosocial factors
Online since 3 November 2021, updated 896 days ago

About this trial

This trial is enrolling individuals with chronic cervical (neck area) spinal cord injuries to test the safety of an implanted device (NeuroPort) that uses thoughts and intentions to control external applications. The implant, called a brain-computer interface (BCI), connects a computer to two small electrode arrays placed on the brain, one in the region controlling motor (movement) function, and the other in the region involved in cognitive (thought) function. The recording of movement intention can be translated into commands for the computer to activate an external device, which might be used for steering assistive applications, robotic arms, or for guiding through a virtual reality environment. Participants will undergo surgery for implanting the electrodes. Various assessments will be done throughout the study, evaluating the safety, feasibility, and usability of the BCI. Final testing will be performed after 6 months.

Included participants

Gender
All
Age
18 - 70 years
Injury level
C1 - C8
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    1 year - 70 years
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C1-C8
    Additionally, participants must
    live within one hour travel of the site.
    NOT have other implanted device, e.g. pacemaker

    What’s involved

    Type

    Technology

    Details

    Surgery for the implantation of the electrodes Assessments of the BDI technology throughout the 6 months study duration

    Potential benefits

    Main benefits

    Mental health and psychosocial factors

    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
    • 13 May 2019
    • Organisation
    • Ottawa Hospital Research Institute
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 13 May 2019
    • Organisation
    • Ottawa Hospital Research Institute

    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