Key Grip for Spinal Cord Injury
(KeyGrip Trial)
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.12345Why 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.16789
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-Implantation Evaluation
Evaluation of current hand grasp strength and ability to manipulate objects using surface electrical stimulation
Implantation and Initial Recovery
Surgical implantation of the KeyGrip system and immobilization of hand and forearm in a cast for 3 weeks
Post-Implantation Training and Use
Programming of the implant, training in system use, and home use for exercise and functional activities
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
MetroHealth Medical Center
Lead Sponsor
Citations
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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