Intraoperative Electrical Stimulation to Improve Nerve Grafting Outcome

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06335719
Study type	Interventional
Source	The Cleveland Clinic
Contact	Hana Rosen, MD
Phone	216-444-7018
Email	rosenh@ccf.org
Status	Recruiting
Phase	N/A
Start date	March 1, 2023
Completion date	June 2025

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