Restoration of Hand Function in Cervical SCI

Surgery
Arm/hand function
Online since 21 October 2024, updated 60 days ago

About this trial

The purpose of this study is to evaluate a new method of restoring hand function to people with spinal cord injury. Current methods to restore hand function include tendon transfers and nerve transfer...

Included participants

Gender
All
Age
≥ 18 years
Injury level
C1 - C7
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    Time since injury
    ≥ 6 months
    Healthy volunteers
    No
    C1-C7
    Additionally, participants must
    NOT have an active implantable medical device (AIMD) such as a pacemaker or defibrillator;

    What’s involved

    Type

    Surgery

    Details

    The purpose of this study is to evaluate an alternative method of restoring hand function to people with spinal cord injury. Current methods to restore hand function include tendon transfers (surgery that moves working muscles and tendon to replace a nonworking muscle and tendon) and nerve transfers (surgery that reroutes a healthy nerve to connect to a damaged nerve and restore function or sensation). This study will evaluate the grasp strength and ability to manipulate objects that can be achieved with a small (2 inches long) implantable stimulator. The device we are using to achieve this is the Nalu Medical Peripheral Nerve Stimulator. Nalu Medical Peripheral Nerve Stimulator is a stimulator currently used to treat chronic pain. The Nalu Medical Peripheral Nerve Stimulator is currently cleared for marketing by the U.S. Food and Drug Administration (FDA) for the use of spinal cord stimulation and peripheral nerve stimulation to block pain signals. The Nalu Medical Peripheral Nerve Stimulator has not been approved by the FDA for the use being tested in this study. We intend to use this device to activate paralyzed muscles. When being used for the purpose of this study, we will refer to the device as the KeyGrip System. The KeyGrip System is an investigational use of an FDA approved device (The Nalu Medical Peripheral Nerve Stimulator) that works by activating paralyzed muscles with low levels of electrical current. The word "investigational" means the way we are using the device is still being tested in research studies and is not approved by the (FDA) for the use being studied. This study will use the KeyGrip System to try to restore hand function to people with spinal cord injury. What is involved in this study? If the participant chooses to be in this study, the participant will undergo the following procedures: * a screening procedure that involves using surface electrical stimulation (that is, stimulation using pads placed on the skin) to evaluate whether the participants muscles can be activated with electrical stimulation. * Following this, the participant will undergo an evaluation of their current hand grasp strength, and the ability to perform a test of hand grasp that involves manipulating standard objects. * If the participants are a candidate for the study, participants will undergo surgery to implant the KeyGrip system, after which the hand and forearm will be immobilized in a cast for 3 weeks to protect the electrodes from movement. * Participants will then have the implant programmed to provide grasp and will be trained in how to use the system to perform activities. * Participants will then be able to use the system at home for exercise and for functional activities. * Over the course of the first year, participants will return at 3-, 6-, and 12-months to evaluate grasp strength, and ability to manipulate standard objects. * It is important to note that investigators do not plan to remove the study device after participation in the study ends. If participants wish to remove the study device after finishing participating or if participants withdraw from the study, a surgery to remove the device can be scheduled. Participants will be in this research study for one year, after which participants may continue to use the device. Participants will continue to be contacted by the research team to monitor any adverse events participants may experience.

    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
    • Recruiting soon
    • Trial start date
    • 1 Jan 2025
    • Organisation
    • MetroHealth Medical Center
    • Trial recruitment status
    • Recruiting soon
    • Trial start date
    • 1 Jan 2025
    • Organisation
    • MetroHealth Medical Center

    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