Intraoperative Electrical Stimulation to Improve Nerve Grafting Outcome

NCT06335719 | Recruiting

• 1 other identifier: IRB #22-926
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Facial Paralysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To evaluate clinical outcomes of treatment and control groups using patient reported, and IRB approved CCF Facial Nerve Survey.

  24 months

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Control Group

EXPERIMENTAL

Control group undergoes only nerve biopsies during surgery - no brief electrical stimulation.

Procedure: Standard of Care surgery

Interventions

BES PROCEDURE

Nerve biopsies during surgery + brief electrical stimulation therapy

Treatment Group

Standard of Care surgery PROCEDURE

Nerve biopsies during surgery - no brief electrical stimulation therapy

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Agree to participate in the study.

You may not qualify if:

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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Facial Paralysis

Interventions

BES

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick Byrne, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hana Rosen, MD

CONTACT

216-444-7018; rosenh@ccf.org

John O'Neill, MD

CONTACT

440-445-8175; oneillj2@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This is a randomized, controlled, double-blinded (patient and evaluator) prospective study. Plan is to enroll up to 30 patients, with a minimum of 20 completing full follow-up. Randomization 2:1 treatment to control due to previous peripheral nerve research demonstrating intraoperative stimulation accelerates axonal regeneration
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will undergo all the standard steps of the facial reanimation procedures. The difference in care is 2/3 participants may receive the brief electrical stimulation therapy. Other 1/3 of study participants will undergo the surgery as they normally would if they had not chosen to participate.

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 28, 2024
• Study Start: March 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)