Recruiting

Intraoperative Stimulation

Sponsor:

The Cleveland Clinic

Code:

NCT06335719

Conditions

Facial Paralysis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

BES

Standard of Care surgery

Study Details

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

Study ID

NCT06335719

Start date

Mar 1, 2023

Status verified date

Jul, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

experimental: Control Group

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

Interventions

BES

Nerve biopsies during surgery + brief electrical stimulation therapy

Standard of Care surgery

Nerve biopsies during surgery - no brief electrical stimulation therapy

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Hana Rosen, MD

216-444-7018rosenh@ccf.org

John O'Neill, MD

440-445-8175oneillj2@ccf.org

Locations

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Hana Rosen, MD

2164447018rosenh@ccf.org

John O'Neill, BS

4405062611oneillj2@ccf.org

Principal Investigator:

Patrick Byrne, MD

More Information

Sponsor

The Cleveland Clinic

Last update posted

Jul 30, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2025-07-30.