Intraoperative Electrical Stimulation to Improve Nerve Grafting Outcome

July 28, 2025 updated by: The Cleveland Clinic

Intraoperative Brief Electrical Stimulation to Improve Cross-Face Nerve Grafting Outcomes

A research study to find out if brief intraoperative electrical stimulation therapy improves nerve regeneration and smile outcomes following two-stage cross face nerve graft facial reanimation surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants that choose to enroll in this study will be randomly assigned in a 2:1 ratio to a "treatment" or "control" group. In either group, patients will receive the same care as they normally would except for two minor differences. First, patients in both groups undergo nerve biopsies during surgery; these biopsies do not affect the length or outcome of surgery. Second, the treatment group will receive brief electrical stimulation therapy for approximately 10 minutes during the first stage cross-face nerve graft surgery.

The purpose of this study is to evaluate efficacy of an intraoperative dose of brief electrical stimulation (BES) to improve axonal regeneration across a cross-face nerve graft (CFNG) using nerve histology and to evaluate clinical outcomes of treatment and control groups using clinician graded, patient reported, and objective smile metric.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hana Rosen, MD
  • Phone Number: 216-444-7018
  • Email: rosenh@ccf.org

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Contact:
        • Principal Investigator:
          • Patrick Byrne, MD
        • Sub-Investigator:
          • Michael Fritz, MD
        • Sub-Investigator:
          • Brandon Hopkins, MD
        • Sub-Investigator:
          • Peter Ciolek, MD
        • Sub-Investigator:
          • Dane Genther, MD
        • Sub-Investigator:
          • Stephen Hadford, MD
        • Sub-Investigator:
          • Peng Ding, MD
        • Sub-Investigator:
          • Derek Vos, BS
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients 18-80 years-old with unilateral facial paralysis who are candidates for two- stage CFNG smile reanimation surgery (i.e. CFNG-driven free gracilis muscle transfer (FGMT) or dual innervation FGMT).
  2. Agree to participate in the study.

Exclusion Criteria:

  1. Bilateral facial paralysis
  2. Age less than 18 years-old or older than 80 years-old
  3. Comorbid medical condition preventing two-stage CFNG surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
Treatment group undergoes nerve biopsies during surgery. In addition, patients in the treatment group receive brief electrical stimulation therapy for approximately 10 minutes during the first stage cross-face nerve graft surgery.
Procedure: BES
Nerve biopsies during surgery + brief electrical stimulation therapy
Experimental: Control Group
Control group undergoes only nerve biopsies during surgery - no brief electrical stimulation.
Procedure: Standard of Care surgery
Nerve biopsies during surgery - no brief electrical stimulation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate efficacy of an intraoperative dose of brief electrical stimulation (BES) to improve axonal regeneration across a cross-face nerve graft (CFNG) using nerve histology.
Time Frame: 24 months
Efficacy evaluation
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate clinical outcomes of treatment and control groups using patient reported, and IRB approved CCF Facial Nerve Survey.
Time Frame: 24 months
Evaluation of Clinical Outcomes
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Patrick Byrne, MD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 15, 2024

First Submitted That Met QC Criteria

March 21, 2024

First Posted (Actual)

March 28, 2024

Study Record Updates

Last Update Posted (Actual)

July 30, 2025

Last Update Submitted That Met QC Criteria

July 28, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB #22-926

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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