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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help individuals with spinal cord injuries regain hand function. It tests a small device called KeyGrip, which sends gentle electrical signals to activate paralyzed hand muscles. Suitable candidates have had a cervical spinal cord injury for at least six months, are medically stable, and retain some muscle function in their arms. Participants will have the KeyGrip device implanted and can control it through a phone app. The goal is to assess the effectiveness of this method in improving hand strength and function. As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research that could transform spinal cord injury rehabilitation.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor to get a clear answer.

What prior data suggests that this method is safe for restoring hand function in people with spinal cord injury?

Research has shown that spinal cord stimulation (SCS) techniques, such as those used in the Key Grip device, carry a low risk of causing additional spinal cord injury. One study found such injuries occurred in only 2.13% of cases, indicating the procedure is generally safe and unlikely to harm the spinal cord further.

In studies on similar devices, direct stimulation might cause discomfort, but this is rare and usually manageable. Although the Key Grip device is still under testing, current evidence suggests it should be well-tolerated. Participants in similar studies have reported few serious side effects.

Each person's experience may vary. Regular check-ups and monitoring are part of the study to ensure participant safety and address any issues that might arise. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for spinal cord injury focus on rehabilitation therapies or medications to manage symptoms and complications. However, the Key Grip treatment is unique because it involves a device implantation to directly stimulate muscles in the hand and arm. Unlike traditional methods, Key Grip uses a small receiver and stimulating electrodes placed under the skin, allowing individuals to control muscle stimulation via a phone app. Researchers are excited about this because it offers a new way to potentially restore hand function and independence for those with spinal cord injuries, providing a more personalized and tech-driven approach compared to existing treatments.

What evidence suggests that the KeyGrip device is effective for restoring hand function in spinal cord injury?

Studies have shown promising results for the KeyGrip device, tested in this trial, in helping people with spinal cord injuries regain hand function. Research indicates that participants can move their paralyzed limbs using a simple interface, allowing more effective control of hand movements. Other studies have found significant improvements in hand strength and the ability to grasp objects. Users have also reported better control when holding things. These findings suggest that KeyGrip could be a helpful tool for improving hand function in those with spinal cord injuries. ^{1 6 7 8 9}

Who Is on the Research Team?

Megan Moynahan

Principal Investigator

MetroHealth Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: KeyGrip device implantation Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

MetroHealth Medical Center

Lead Sponsor

Trials

125

Recruited

22,600+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06611748

Restoration of Hand Function in Cervical SCI (KeyGrip) KeyGrip is an investigational device that works by activating paralyzed muscles with low levels of electrical current. The word "investigational" means the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9537317/

Activating effective functional hand movements in individuals ... We also showed that participants were able to trigger the activation of movements of their paralyzed limb using an intuitive interface ...

3. nature.com nature.com/articles/s41591-024-02940-9

Non-invasive spinal cord electrical stimulation for arm and ... Secondary endpoint analysis revealed significant improvements in fingertip pinch force, hand prehension and strength, upper extremity motor and ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2590109525001119

Therapeutic Effects of Noninvasive Technology Modalities ... Outcomes were evaluated in four studies for motor score, seven for muscle performance, and seven for walking ability. Most interventions ...

5. withpower.com withpower.com/trial/phase-wounds-and-injuries-8-2022-775c7

Hand Orthosis for Spinal Cord Injury An initial study demonstrated that the device helped users increase hand strength and the ability to hold objects without losing control, suggesting good user ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4724311/

The Incidence of Spinal Cord Injury in Implantation ... Our study shows the overall incidence of SCI in SCS is low (2.13%) supporting that SCS is a safe procedure. No significant difference was found in the rates of ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1094715925000078

Safety and Effectiveness of Multisite Transcutaneous ... Evaluate the preliminary safety and efficacy of multi-site transcutaneous spinal cord stimulation (tSCS) combined with activity-based therapy (ABT) in ...

8. nature.com nature.com/articles/s41591-025-03614-w

An implantable system to restore hemodynamic stability ... These findings in 14 participants establish the path to designing a pivotal device trial that will evaluate the safety and efficacy of EES to ...

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P010032b.pdf

1. Summary Of Safety And Effectiveness Data Contact between an active electrode and an implanted IPG, lead or extension can cause direct stimulation of the spinal cord and cause severe ...