[BrainConnexion] - Neurodevice Phase I Trial

Technology
Arm/hand function
Online since 4 November 2021, updated 838 days ago

About this trial

This trial is enrolling individuals with cervical (neck area) spinal cord injuries to test the usage of an implantable brain-computer electrode array (BrainConnexion) placed on the cortical surface of the brain. While SCI disrupts the nerve pathways involved in voluntary movement, brain activity to elicit movements is still generated. An implanted electrode array can record the neuronal activity of the motor cortex. This information can then be transferred to a computer program (brain-computer-interface) that directs a powered assistive device that can be guided by the user’s thoughts. This study will evaluate the safety of the device, as well as the efficacy of the electrodes for long-term recording of neural activities and thus control of the external assistive device. If included in the study, participants will have surgery to implant the electrode array. Brain activity will be wirelessly recorded and integrated with the prosthetic device at least once a week for 12 months.

Included participants

Gender
All
Age
21 - 70 years
Injury level
C1 - C8
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≤ 70 years
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C1-C8
    Additionally, participants must
    NOT have history of epilepsy or seizures
    be able to perform pre-operation Brain Computer Interface training

    What’s involved

    Type

    Technology

    Details

    Surgical implantation to place the wireless brain-computer interface system on the brain surface over the motor cortex Outcome assessments to check the signal recording quality and to test the use of the external assistive prosthetic device

    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
    • Active
    • Trial start date
    • 21 Nov 2017
    • Organisation
    • National Neuroscience Institute
    • Trial recruitment status
    • Active
    • Trial start date
    • 21 Nov 2017
    • Organisation
    • National Neuroscience 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