Intraoperative Electrical Stimulation to Improve Nerve Grafting Outcome

Last updated: August 12, 2024
Sponsor: The Cleveland Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cataplexy

Treatment

BES

Standard of Care surgery

Clinical Study ID

NCT06335719
IRB #22-926
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients 18-80 years-old with unilateral facial paralysis who are candidates fortwo- stage CFNG smile reanimation surgery (i.e. CFNG-driven free gracilis muscletransfer (FGMT) or dual innervation FGMT).

  2. Agree to participate in the study.

Exclusion

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

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: BES
Phase:
Study Start date:
March 01, 2023
Estimated Completion Date:
June 01, 2025

Study 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.

Connect with a study center

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

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