Key Grip for Spinal Cord Injury

(KeyGrip Trial)

Overseen By Krissy Hansen, PT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MetroHealth Medical Center

Disqualifiers: Neurological conditions, Peripheral nerve injury, AIMD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Megan Moynahan

Principal Investigator

MetroHealth Medical Center

Eligibility Criteria

This trial is for adults over 18 with a cervical spinal cord injury, stable for at least six months post-injury. They should have some upper arm strength and be medically stable. The study excludes those who are not neurologically or musculoskeletally stable after certain surgeries.

Inclusion Criteria

My spinal cord injury is in my neck (C1-C7) and is classified as severe to moderate.

It has been over 6 months since my injury.

I have been stable for a year after surgery on nerves in my arm.

Exclusion Criteria

I have a nerve injury in my arm.

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Pre-Implantation Evaluation

Evaluation of current hand grasp strength and ability to manipulate objects using surface electrical stimulation

1 week

1 visit (in-person)

Implantation and Initial Recovery

Surgical implantation of the KeyGrip system and immobilization of hand and forearm in a cast for 3 weeks

3 weeks

1 visit (in-person for surgery)

Post-Implantation Training and Use

Programming of the implant, training in system use, and home use for exercise and functional activities

12 months

3 visits (in-person at 3, 6, and 12 months)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

3 visits (in-person at 3, 6, and 12 months)

Treatment Details

Interventions

• Key Grip

Trial Overview The trial tests KeyGrip, an investigational device designed to restore hand function in people with spinal cord injuries by using electrical currents to activate paralyzed muscles. It's still being researched and isn't FDA-approved yet.

Participant Groups

Group I: KeyGrip device implantation Experimental Treatment 1 Intervention

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. Two to four stimulating electrodes 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.

Who Is Running the Clinical Trial?

MetroHealth Medical Center

Lead Sponsor

Trials

125

Recruited

22,600+