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Restoring Hand Function in Cervical Spinal Cord Injury with KeyGrip

This study is looking into a new way to help people with cervical spinal cord injury (SCI) regain hand function. It's testing a device called KeyGrip, which is an implantable peripheral nerve stimulator. KeyGrip works by using small electrical currents to activate paralyzed muscles in the arm and hand, aiming to improve movements like opening and closing your hand. This device is currently investigational, meaning it's still being tested and isn't yet approved by the FDA for this specific use. The study will measure how well KeyGrip helps with grasp strength and the ability to manipulate objects. You might be able to join if you are an adult (18 or older) with a cervical spinal cord injury (C1-C7, AIS A, B, or C) that happened at least six months ago and is stable. The study plans to enroll 20 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 20 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your hand function will be measured at baseline, 3 weeks, 12 weeks, 26 weeks, and 52 weeks after treatment.

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

NCT06611748

Restoration of Hand Function in Cervical SCI

Recruiting
NAAges 18+InterventionalDevice feasibility
MetroHealth Medical Center
~20 participants
Updated 2026-02-24 on ClinicalTrials.gov
What's tested:Key GripImplanted Key Grip Electrodes

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Grasp-Release Test (GRT)
Measured over baseline, 3-weeks post treatment, 12-weeks post treatment, 26-week post treatment, 52 weeks post treatment

Conditions

Spinal Cord Injury Cervical

Explore related trials

Spinal Cord Injury

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Megan Moynahan · 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 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
Able to understand and provide informed consent;

Exclusion

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;
Extensive upper extremity denervation (fewer than two excitable hand muscles);
Involvement in other ongoing clinical studies that exclude concurrent involvement in this study;
Currently pregnant (neuroprosthesis implantation delayed until no longer pregnant based on self-report); Urine or serum testing will happen during the pre-surgery evaluation.
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

  • Grasp-Release Test (GRT)baseline, 3-weeks post treatment, 12-weeks post treatment, 26-week post treatment, 52 weeks post treatment

    The GRT is a standardized pick-and-place test that evaluates two prehensile patterns (palmar and lateral grasp) using standardized objects of different weights and sizes that are designed to mimic objects encountered in daily life.