Restoration of Hand Function in Cervical SCI

NCT06611748 | Recruiting DMC FDA Device

• 2 other identifiers: STUDY00000625ID573-FY24-25
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Cervical Spinal Cord Injury (SCI)

Outcome Measures

Primary Outcomes (1)

• Grasp-Release Test (GRT)

  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.

  baseline, 3-weeks post treatment, 12-weeks post treatment, 26-week post treatment, 52 weeks post treatment

Secondary Outcomes (3)

• Grasp Strength

  baseline, 3 weeks post treatment, 12 weeks post treatment, 26-week post treatment, 52 weeks post treatment

• Activities of Daily Living Abilities Test

  baseline, 12-weeks post treatment, 26-weeks post treatment, and 52-weeks post treatment

• Canadian Occupational Performance Measure (COPM)

  baseline, 12-weeks post treatment, 26-weeks post treatment, and 52-weeks post treatment

Study Arms (1)

KeyGrip device implantation

EXPERIMENTAL

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.

Device: Key Grip; Device: Implanted Key Grip Electrodes

Interventions

Key Grip DEVICE

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

KeyGrip device implantation

Implanted Key Grip Electrodes DEVICE

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

KeyGrip device implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• MetroHealth Medical Center: lead

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

RECRUITING

Related Links

• KeyGrip website

Study Officials

• Megan Moynahan

  MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kim Walsh, OTR/L

CONTACT

216-957-3512; kwalsh3@metrohealth.org

Krissy Hansen, PT

CONTACT

216-957-3584; khansen1@metrohealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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. The study will evaluate participants; grasp strength and ability to manipulate standard objects with each participant serving as their own control, comparing stimulation ON vs. OFF.

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 25, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2030
• Last Updated: February 24, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)