NCT06335719

Intraoperative Electrical Stimulation to Improve Nerve Grafting Outcome

Intraoperative Brief Electrical Stimulation to Improve Cross-Face Nerve Grafting Outcomes

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Facial Paralysis

Interventions

Type	Name	Description
PROCEDURE	BES	Nerve biopsies during surgery + brief electrical stimulation therapy
PROCEDURE	Standard of Care surgery	Nerve biopsies during surgery - no brief electrical stimulation therapy

Timeline

• Start date: 2023-03-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-03-28
• Last updated: 2025-07-30

Locations

1 site across 1 country: United States