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A Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Wireless Brain-Computer Interface（BCI）System NEO in Patients With Tetraplegia

Technology
Arm/hand function
Online since 4 September 2025, updated 62 days ago
Curated trial

About this trial

This trial is enrolling up to 32 participants with chronic cervical spinal cord injury to test the effect on arm and hand function of a wireless, implantable brain-computer interface (BCI) system named "NEO" ("Neuro Electronics Opportunity"). BCI is a technique that interfaces a computer with electrodes on the surface of the brain to record electrical brain activity; these electrical signals can then be used to help control an external device. If included, participants will receive the NEO BCI implant and participate in training sessions to learn how to use the system to control an undefined "external assistive device." Final testing of safety and efficacy will be performed after 6 months.

Included participants

Gender
All
Age
18 - 65 years
Injury level
C1 - T1
  • Severity (AIS)?
    • Time since injury
    ≥ 1 year
    Healthy volunteers
    No
    C1-T1
    Additionally, participants must
    NOT have already been implanted with medical devices that deliver electrical energy to the central nervous system

    What’s involved

    Type

    Technology

    Details

    - Participants will receive the NEO brain-computer interface (BCI) implant and participate in training sessions to control external equipment. - A BCI is a technique using a computer and connected electrodes on the brain to record brain activity and also to control an external device. - Final testing of safety and efficacy will be performed after 6 months.

    Potential benefits

    Main benefits

    Arm/hand function

    Additional benefits

    General health

    Mental health and psychosocial factors

    Sensory function

    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 soon
    • Trial start date
    • 20 May 2025
    • Organisation
    • Neuracle Medical Technology(Shanghai) Co.,Ltd.
    View on clinicaltrials.gov
    for more details
    • Trial recruitment status
    • Recruiting soon
    • Trial start date
    • 20 May 2025
    • Organisation
    • Neuracle Medical Technology(Shanghai) Co.,Ltd.
    View on clinicaltrials.gov
    for more details

    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

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