Evaluation of a Simple Neuroprosthesis for Restoration of Hand Function in Cervical Spinal Cord Injury
MetroHealth Medical Center
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
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male or female adults 18 years of age or older; * Cervical spinal cord injury as defined by: a) International Standard for Neurological Classification of Spinal Cord Injury motor level of C1 through C7; and b) American Spinal Injury Association Impairment Scale (AIS) grade A, B, or C; * Six months or more post-injury (neurostability); * Neurologically stable following any nerve transfers affecting the upper extremity (typically, one-year post-surgery); * Musculoskeletally and neurologically stable following any tendon transfers affecting the upper extremity (typically 6…
Interventions
- DeviceKey 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
- DeviceImplanted Key Grip Electrodes
The KeyGrip System uses modified implanted wires (called "electrodes") that deliver stimulation to the muscles. These electrodes are also investigational.
Location
- MetroHealth Medical CenterCleveland, Ohio