Promoting Healing of Injured Nerves With Electrical Stimulation Therapy

Last updated: August 20, 2024
Sponsor: Checkpoint Surgical Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Nerve Injury

Treatment

Checkpoint BEST System

Clinical Study ID

NCT05884125
0153-CSP-002
W81XWH1920065
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Upper extremity mixed or motor nerve injury from the brachial plexus to the wristcrease.

  • 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

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 notlimited to language barriers, mental status barriers, inability to consent, andpregnancy/lactation.

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Checkpoint BEST System
Phase:
Study Start date:
June 12, 2023
Estimated Completion Date:
June 30, 2027

Study 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.

Connect with a study center

  • Northwestern Feinberg School of Medicine - Department of Orthopaedic Surgery

    Chicago, Illinois 60611
    United States

    Site Not Available

  • The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery

    Columbus, Ohio 43212
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.