STENTRODE First in Human Early Feasibility Study

Technology
General health
Online since 16 April 2024, updated 290 days ago

About this trial

This is a first in human trial in five individuals, to evaluate the safety of a device to record brain activity without open brain surgery. Additionally, the trial will evaluate the ability of the device to transmit brain signals for one year after implantation. Although not the purpose of this trial, devices such as these may be used to control assistive technology that can perform activities for individuals who are unable to use their arms. If included in this trial, the Stentrode™ device, a small metallic mesh tube with electrode contacts, will be placed into a blood vessel of the brain. Participants will be monitored for adverse events over 12 months. There is no control group in this study.

Included participants

Gender
All
Age
18 - 75 years
Injury level
C1 - S5
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    12 months - 75 years
  • Injury type
  • Traumatic

    Non-traumatic

    Ischemia

    Healthy volunteers
    No
    C1-S5
    Additionally, participants must
    have a spinal cord injury for at least 12 months or be diagnosed with amyotrophic lateral sclerosis (ALS), stroke, muscular dystrophy or loss of limbs.
    be between the ages of 18 and 75 years.
    be an English speaker.

    What’s involved

    Type

    Technology

    Details

    Placement of the device will occur via a short surgical procedure, involving a small skin incision in the neck, where the Stentrode™ device will be placed in a blood vessels in the brain. Participants will be monitored for adverse events, brain activity signal quality, and Stentrode™ performance over 12 months.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Mechanism of action

    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
    • Ended
    • Trial start date
    • 27 May 2019
    • Organisation
    • Synchron, Inc.
    • Trial recruitment status
    • Ended
    • Trial start date
    • 27 May 2019
    • Organisation
    • Synchron, Inc.

    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