Grasp-Release Assessment of a Networked Neuroprosthesis Device for Spinal Cord Injury

This study is testing a new device called the Networked Neuroprosthesis Device (NP-UE) for people with spinal cord injuries at the C5-C7 level. This device is implanted and helps activate nerves in your arm and hand to restore grasp and release functions. Researchers want to see how safe and effective the NP-UE is. You might be able to join if you are over 16, have a cervical (neck area) spinal cord injury (AIS grade A, B, or C) that happened at least six months ago, and are neurologically stable. The study will measure improvements in your hand function using a Grasp-Release Test over 12 months.

Study design: This is an interventional study planning to enroll 13 participants.
What's involved: You would have assessments at pre-implant, and then three, six, and twelve months after the device is implanted.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for 12 months after the device is implanted.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Grasp-Release Assessment of a Networked Neuroprosthesis Device

Recruiting

NAAges 16+InterventionalTreatment

MetroHealth Medical Center

~13 participants

Updated 2025-12-19 on ClinicalTrials.gov

What's tested:Networked Neuroprosthesis Device

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Change in Grasp-Release Test

Measured over Pre-implant and three months post-implant, 6 months post implant, 12 months post implant

Conditions

Spinal Cord Injury at C5-C7 Level

Spinal Cord Injuries

Spinal Cord Injury Cervical

Where it's being run

1 sites across 1 states

Ohio1

Study leadership

Anne Bryden, PhD, OTR/L · PRINCIPAL_INVESTIGATOR · MetroHealth Medical Center

Who to contact

KIm Walsh, OTR/L

[email protected]

216-957-3512

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male or female, age \> 16 years.

Cervical level spinal cord injury, as defined by:

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).

Peripheral nerve innervation to upper extremity muscles, including a grade 3/5 or higher Stimulated Manual Muscle Test (SMMT) strength in at least two of the following muscles in one arm:

Good proximal upper extremity strength as defined by biceps/brachialis/brachioradialis strength of 2/5 or higher on Manual Muscle Test on the side intended for implantation;

Medically stable;

Able to understand and provide informed consent.

Exclusion

Other neurological conditions (MS(multiple Sclerosis), diabetes with peripheral nerve involvement); Associated peripheral nerve / brachial plexus injury

Progressive SCI;

Co-existing cervical spine pathology (syrinx, unstable segment)

Active implantable medical device (AIMD) such as a pacemaker or defibrillator;

Active untreated infection such as pressure injury, urinary tract infection, pneumonia;

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;

Extensive upper extremity denervation (fewer than two excitable hand muscles);

Involvement in other ongoing clinical studies that exclude concurrent involvement in this study;

Disorder or condition that requires MRI monitoring;

Mechanical ventilator dependency;

Currently pregnant (neuroprosthesis implantation delayed until no longer pregnant);

Presence of disease that might interfere with participant safety, compliance, or evaluation of the condition under study;

Other significant medical findings that, in the opinion of the investigator, preclude safe participation in the trial.

What this trial measures

Change in Grasp-Release TestPre-implant and three months post-implant, 6 months post implant, 12 months post implant
Ability to pick up, move, and release six standard objects

Trialytics