Actively Recruiting
Restoration of Hand Function in Cervical SCI
Led by MetroHealth Medical Center · Updated on 2026-02-24
20
Participants Needed
1
Research Sites
304 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Restoration of Hand Function in Cervical SCI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female adults 18 years of age or older
- Cervical spinal cord injury with motor level from C1 through C7
- American Spinal Injury Association Impairment Scale (AIS) grade A, B, or C
- At least six months post-injury with neurological stability
- Neurologically stable following any nerve transfers affecting the upper extremity (usually one year post-surgery)
- Musculoskeletally and neurologically stable following any tendon transfers affecting the upper extremity (usually six months post-surgery)
- Peripheral nerve innervation to upper extremity muscles with grade 3/5 or higher muscle strength in at least two muscles in one arm
- Good proximal voluntary upper extremity strength defined as biceps/brachialis/brachioradialis strength of 2/5 or higher on Manual Muscle Testing on the side intended for implantation
- Medically stable
- Able to understand and provide informed consent
You will not qualify if you...
- Other neurological conditions such as Multiple Sclerosis or diabetes with peripheral nerve involvement
- Associated peripheral nerve or brachial plexus injury
- Progressive spinal cord injury
- Active implantable medical device like a pacemaker or defibrillator
- Active untreated infections 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 prevent safe participation
- Unhealed fractures preventing functional use of the arm
- Extensive upper extremity denervation with fewer than two excitable hand muscles
- Participation in other ongoing clinical studies that exclude concurrent involvement
- Currently pregnant (implantation delayed until no longer pregnant)
- Presence of disease interfering with safety, compliance, or evaluation
- Other significant medical findings that preclude safe participation as determined by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Actively Recruiting
Research Team
K
Kim Walsh, OTR/L
CONTACT
K
Krissy Hansen, PT
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here