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NCT06335719NARecruiting

Intraoperative Electrical Stimulation to Improve Nerve Grafting Outcome

The Cleveland Clinic

Start Date

3/1/2023

Completion Date

12/31/2026

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.

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.

Eligibility Criteria

Age Range: 18 years to 80 years

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

Interventions

PROCEDURE

BES

PROCEDURE

Standard of Care surgery

Interested in This Trial?

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Conditions

Facial Paralysis

Locations

Cleveland Clinic Foundation

Cleveland, Ohio 44195

United States