Promoting Healing of Injured Nerves With Electrical Stimulation Therapy

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Checkpoint Surgical Inc.
Study ID
NCT05884125
Status
Recruiting
Apply to this trial

Conditions

  • Nerve Injury
  • Nerve Palsy
  • Peripheral Nerve Injuries
  • Peripheral Nerve Injury Upper Limb

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Checkpoint BEST System — DEVICE
    Single use medical device, consisting of electric stimulator and intraoperative lead. Therapy consists of single, 10 minute dose delivered proximal to site of decompression/repair

Study Details

This study is evaluating a new therapeutic use of electrical stimulation to promote nerve healing and improve functional recovery following surgical intervention for peripheral nerve injury in arm. Participants will be randomized into one of two groups, treatment or control, with all participants receiving standard of care treatment for the nerve injury. The treatment group will also receive a single dose of the therapeutic stimulation during the surgical intervention for their nerve injury.

Key Dates

Start date
Jun 12, 2023
Status verified
Aug 2024
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Brief Electrical Stimulation Therapy
    Single, 10 minute dose of electrical stimulation delivered to the injured nerve during surgical intervention.
  • No Intervention: Standard of Care
    Surgical intervention for repair of peripheral nerve injury.

Primary Outcome Measure

Change in Motor Recovery assessed using the Medical Research Council (MRC) motor grading [ Time Frame: Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State Univeristy - Department of Plastic and Reconstructive SurgeryColumbusOhio43212
Research Coordinator
[email protected]
614-293-8566
Amy M Moore, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Columbus, OH

By research site
The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery· Columbus, OH

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