NCT05884125NARecruiting

Promoting Healing of Injured Nerves With Electrical Stimulation Therapy

Checkpoint Surgical Inc.

Start Date

6/12/2023

Completion Date

6/1/2027

Summary

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.

Detailed Description

Preliminary research has shown that delivering a brief period of electrical stimulation following nerve repair promotes nerve healing and functional recovery. This pilot study is investigating the use of a single dose of therapeutic electrical stimulation to promote nerve healing. The therapy is delivered as part of the surgical intervention to address peripheral nerve injury in the arm.

Eligibility Criteria

Age Range: 18 years to 80 years

Inclusion Criteria: * Upper extremity mixed or motor nerve injury from the brachial plexus to the wrist crease. * Candidate for surgical intervention. * Indicated for surgical repair by nerve transfer, primary repair, or nerve grafting. * Are age 18-80 years. * Signed and dated informed consent form. Exclusion Criteria: * Severe comorbid condition, such as arrhythmia or congestive heart failure, preventing surgery. * Primary repair requiring graft \>6cm. * Nerve reconstruction occurring \>12 months post injury. * Age less than 18 or greater than 80 years. * All contraindications to included/required surgical procedure, including but not limited to language barriers, mental status barriers, inability to consent, and pregnancy/lactation.

Interventions

DEVICE

Checkpoint BEST System

Interested in This Trial?

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Conditions

Nerve InjuryPeripheral Nerve InjuriesPeripheral Nerve Injury Upper LimbNerve Palsy

Locations

The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery

Columbus, Ohio 43212

United States