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Restoration of Hand Function in Cervical SCI

Study acronym: KeyGrip
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv6
  2. Secondary endpoints: details revised at 1 of 3 entriesv5
  3. Primary endpoint revised
    • Interventions: Key Grip (Device) to Implanted Key Grip Electrodes (Device), Key Grip (Device)
    • Secondary endpoints: 2 to 3
    • Site contact updated
    v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v3
  5. Start date: Nov 1, 2024 to Jan 1, 2025v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06611748
Lead Sponsor MetroHealth Medical Center
Conditions
(from sponsor)		 Spinal Cord Injury Cervical
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov