Restoration of Hand Function in Cervical SCI
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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
Sponsor: MetroHealth Medical Center
You may qualify if…
- ✓ 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 months post-surgery).
- ✓ Peripheral nerve innervation to upper extremity muscles, including Grade 3/5 or higher Stimulated Manual Muscle Testin at least two of the muscles in one arm:
- ✓ Good proximal voluntary upper extremity strength as defined by biceps/ brachialis / brachioradialis strength of 2/5 or higher on Manual Muscle Testing the side intended for implantation;
- ✓ Medically stable; and
You may not qualify if…
- ✕ Other neurological conditions (Multiple Sclerosis, diabetes with peripheral nerve involvement);
- ✕ Associated peripheral nerve / brachial plexus injury;
- ✕ Progressive Spinal Cord Injury;
- ✕ Active implantable medical device (AIMD) such as a pacemaker or defibrillator;
- ✕ Active untreated infection such as urinary tract infection or pneumonia;
- ✕ Active pressure injury;
- ✕ History of coagulopathy, HIV, cardiopulmonary disease, bradycardia, poorly controlled autonomic dysreflexia, or chronic obstructive pulmonary disease that would preclude safe participation in the trial as determined by the investigator;
- ✕ Unhealed fractures that prevent functional use of arm;
Where it's recruiting
Cleveland
Source: ClinicalTrials.gov · NCT06611748 · last updated 2026-02-24