Intraoperative Electrical Stimulation to Improve Nerve Grafting Outcome

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: Facial Paralysis
• Intervention / Treatment: Procedure: BES; Procedure: Standard of Care surgery

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

• Study Contact: Name: Hana Rosen, MD; Phone Number: 216-444-7018; Email: rosenh@ccf.org
• Study Contact Backup: Name: John O'Neill, MD; Phone Number: 440-445-8175; Email: oneillj2@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic Foundation
      • Contact: John O'Neill, BS; Phone Number: 4405062611; Email: oneillj2@ccf.org
      • 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: Hana Rosen, MD; Phone Number: 2164447018; Email: rosenh@ccf.org

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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.	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.	Evaluation of Clinical Outcomes	24 months

Collaborators and Investigators

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

Study record dates

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: Neurologic Manifestations; Mouth Diseases; Stomatognathic Diseases; Nervous System Diseases; Infections; Virus Diseases; DNA Virus Infections; Herpesviridae Infections; Cranial Nerve Diseases; Facial Nerve Diseases; Paralysis; Bell Palsy; Facial Paralysis
• 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