Intraoperative Electrical Stimulation to Improve Nerve Grafting Outcome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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

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Facial Paralysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will undergo all the standard steps of the facial reanimation procedures. The difference in care is 2/3 participants may receive the brief electrical stimulation therapy.

Other 1/3 of study participants will undergo the surgery as they normally would if they had not chosen to participate.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

This is a randomized, controlled, double-blinded (patient and evaluator) prospective study. Plan is to enroll up to 30 patients, with a minimum of 20 completing full follow-up. Randomization 2:1 treatment to control due to previous peripheral nerve research demonstrating intraoperative stimulation accelerates axonal regeneration

Study Groups

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Treatment Group

Treatment group undergoes nerve biopsies during surgery. In addition, patients in the treatment group receive brief electrical stimulation therapy for approximately 10 minutes during the first stage cross-face nerve graft surgery.

Group Type EXPERIMENTAL

BES

Intervention Type PROCEDURE

Nerve biopsies during surgery + brief electrical stimulation therapy

Control Group

Control group undergoes only nerve biopsies during surgery - no brief electrical stimulation.

Group Type EXPERIMENTAL

Standard of Care surgery

Intervention Type PROCEDURE

Nerve biopsies during surgery - no brief electrical stimulation therapy

Interventions

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BES

Nerve biopsies during surgery + brief electrical stimulation therapy

Intervention Type PROCEDURE

Standard of Care surgery

Nerve biopsies during surgery - no brief electrical stimulation therapy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No