Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Neural Acquisitor & Stimulator System in Patients With Motor Disability

Technology
General health
Online since 19 March 2024, updated 260 days ago

About this trial

This pilot trial is enrolling 9 individuals with chronic cervical spinal cord injuries, brain stem stroke, amyotrophic lateral sclerosis and other motor disorders to evaluate the safety and efficacy of NEO, a brain-computer interface (BCI) system. BCI is a technique using a computer and connected electrodes on the brain to record brain activity, thus allowing control of an external device. If included, participants will undergo surgery for implantation of the NEO device, which will allow them to control external equipment such as a wheelchair or robotic arm. Final assessment of safety and efficacy will be performed after 12 months.

Included participants

Gender
All
Age
18 - 80 years
Injury level
C1 - C8
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≥ 1 year
    Healthy volunteers
    No
    C1-C8

    What’s involved

    Type

    Technology

    Details

    - Participants will undergo surgery for implantation of the NEO device. - The NEO will allow participants to control external equipment, such as wheelchairs or robotic arms, through a brain-computer interface. - Final assessment of safety and efficacy will be performed 12 months after implantation.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Mental health and psychosocial factors

    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
    • 1 Jul 2023
    • Organisation
    • Neuracle Medical Technology(Shanghai) Co.,Ltd.
    • Trial recruitment status
    • Recruiting soon
    • Trial start date
    • 1 Jul 2023
    • Organisation
    • Neuracle Medical Technology(Shanghai) Co.,Ltd.

    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