Promoting Healing of Injured Nerves With Electrical Stimulation Therapy

Purpose

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.

Conditions

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

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Brief Electrical Stimulation Therapy 		Single, 10 minute dose of electrical stimulation delivered to the injured nerve during surgical intervention.
  • Device: Checkpoint BEST System
    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
    Other names:
    • Brief Electrical Stimulation (BES) Therapy
No Intervention
Standard of Care 		Surgical intervention for repair of peripheral nerve injury.

Recruiting Locations

The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery
Columbus, Ohio 43212
Contact:
Research Coordinator
614-293-8566
nervenerds@osumc.edu

More Details

Status
Recruiting
Sponsor
Checkpoint Surgical Inc.

Study Contact

Eric Walker, PhD
216-370-9107
ewalker@checkpointsurgical.com

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.