Recruiting

Hand Function

Sponsor:

MetroHealth Medical Center

Code:

NCT06611748

Conditions

Spinal Cord Injury Cervical

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Key Grip

Implanted Key Grip Electrodes

Study Details

Brief summary:

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

Spinal Cord Injury Cervical

Study ID

NCT06611748

Start date

Jan 1, 2025

Status verified date

Nov, 2025

Completion date

Nov, 2030

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: KeyGrip device implantation

The KeyGrip system components will be implanted in a single surgical procedure, lasting up to 90 minutes.

For this study, a small receiver will be placed under the skin in the forearm. Up to four stimulating electrodes(investigational) will be surgically placed in muscles of the hand or arm. Wires from these electrodes will be tunneled beneath the skin and connected to the receiver device located in the forearm.

The study participant will control the electrical stimulation by using a phone app that communicates to a power unit that is placed on the skin over the receiver. Following implantation of the device, periodic evaluations will be performed to assess their condition, and the operation and usefulness of the device.

Depending on the study participant's usage level, they may need to recharge the batteries every night.

Interventions

Key Grip

KeyGrip is an implantable peripheral nerve stimulator that is being studied for its ability to provide coordinated activation of innervated paralyzed muscles. KeyGrip will be configured to activate nerves of the upper extremity (arm and hand) in order to facilitate movements such as hand opening and/or closing

Implanted Key Grip Electrodes

The KeyGrip System uses modified implanted wires (called "electrodes") that deliver stimulation to the muscles. These electrodes are also investigational.

Primary outcome measure

  • Grasp-Release Test (GRT) [ Time Frame: baseline, 3-weeks post treatment, 12-weeks post treatment, 26-week post treatment, 52 weeks post treatment ]

Central Contacts and Locations

Central contacts

Kim Walsh, OTR/L

216-957-3512kwalsh3@metrohealth.org

Krissy Hansen, PT

216-957-3584khansen1@metrohealth.org

Locations

MetroHealth Medical Center

Recruiting

Cleveland, Ohio, United States, 44109

Contacts

Kim Walsh, OT

216-957-3512kwalsh3@metrohealth.org

Krissy Hansen, PT, ATP

216-957-3584khansen1@metrohealth.org

Principal Investigator:

Megan Moynahan

More Information

Sponsor

MetroHealth Medical Center

Last update posted

Feb 24, 2026

Last verified

Nov, 2025

Keywords

  • Cervical Spinal Cord Injury (SCI)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MetroHealth Medical Center on 2026-02-24.