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Intraoperative Electrical Stimulation to Improve Nerve Grafting Outcome

Intraoperative Electrical Stimulation to Improve Nerve Grafting Outcome

Recruiting
18-80 years
All
Phase N/A

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Overview

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.

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

Inclusion Criteria:

  1. Patients 18-80 years-old with unilateral facial paralysis who are candidates for twostage 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 details
    Facial Paralysis

NCT06335719

The Cleveland Clinic

16 April 2024

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