NCT06611748

Restoration of Hand Function in Cervical SCI

Evaluation of a Simple Neuroprosthesis for Restoration of Hand Function in Cervical Spinal Cord Injury

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: MetroHealth Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 transfers. This study will evaluate the grasp strength that can be achieved with a small, implantable stimulator. KeyGrip is an investigational device that works by activating paralyzed muscles with low levels of electrical current. The word "investigational" means the study device is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA) for the use being studied. Hypothesis. The study is designed to explore the feasibility of this approach; no hypothesis is planned at this stage

Detailed description

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.

Conditions

• Spinal Cord Injury Cervical

Interventions

Type	Name	Description
DEVICE	Key Grip	KeyGrip is an implantable peripheral nerve stimulator that is being studied for its ability to provide coordinated activation of innervated paralyzed muscles. KeyGrip will be configured to activate nerves of the upper extremity (arm and hand) in order to facilitate movements such as hand opening and/or closing
DEVICE	Implanted Key Grip Electrodes	The KeyGrip System uses modified implanted wires (called "electrodes") that deliver stimulation to the muscles. These electrodes are also investigational.

Timeline

• Start date: 2025-01-01
• Primary completion: 2028-11-01
• Completion: 2030-11-01
• First posted: 2024-09-25
• Last updated: 2026-02-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study