Actively Recruiting
Grasp-Release Assessment of a Networked Neuroprosthesis Device
Led by MetroHealth Medical Center · Updated on 2025-12-19
13
Participants Needed
1
Research Sites
357 weeks
Total Duration
On this page
Sponsors
M
MetroHealth Medical Center
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The overall objective of this trial is to characterize the safety and effectiveness of the Networked Neuroprosthesis Device - Upper Extremity (NP-UE) in individuals living with cervical SCI.
CONDITIONS
Official Title
Grasp-Release Assessment of a Networked Neuroprosthesis Device
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, age > 16 years
- Cervical spinal cord injury with motor level from C1 to C7
- ASIA Impairment Scale grade A, B, or C
- At least six months post-injury and neurologically stable
- 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)
- Peripheral nerve innervation with at least two arm muscles having stimulated muscle strength of grade 3/5 or higher
- At least two of these muscles must have voluntary strength of grade 2/5 or lower
- Good proximal upper extremity strength with biceps/brachialis/brachioradialis strength of 2/5 or higher on the side 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
- Peripheral nerve or brachial plexus injury
- Progressive spinal cord injury
- Co-existing cervical spine problems like syrinx or unstable segments
- Active implantable medical devices such as pacemakers or defibrillators
- Untreated active infections like pressure injuries, urinary tract infections, or pneumonia
- History of coagulopathy, HIV, cardiopulmonary disease, bradycardia, uncontrolled autonomic dysreflexia, or chronic obstructive pulmonary disease preventing safe participation
- Unhealed fractures that limit arm function
- Extensive upper extremity denervation with fewer than two excitable hand muscles
- Participation in other clinical studies that exclude concurrent involvement
- Conditions requiring MRI monitoring
- Mechanical ventilator dependency
- Currently pregnant (implantation delayed until pregnancy ends)
- Diseases interfering with safety, compliance, or study evaluation
- Other significant medical findings that preclude safe participation as judged by the investigator
AI-Screening
AI-Powered Screening
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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
A
Anne Bryden, Ph.D, OTR/L
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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