Restoration of Hand Function in Cervical SCI

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
MetroHealth Medical Center
Study ID
NCT06611748
Status
Recruiting
Apply to this trial

Conditions

  • Spinal Cord Injury Cervical

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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
  • 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.

Study Details

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

Key Dates

Start date
Jan 1, 2025
Status verified
Nov 2025
Primary completion
Nov 30, 2028
Completion
Nov 30, 2030

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
MetroHealth Medical CenterClevelandOhio44109
Kim Walsh, OT
[email protected]
216-957-3512
Krissy Hansen, PT, ATP
[email protected]
216-957-3584
Megan Moynahan (PRINCIPAL_INVESTIGATOR)

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By research site
MetroHealth Medical Center· Cleveland, OH

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