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NCT Number: NCT06335719

Intraoperative Electrical Stimulation to Improve Nerve Grafting Outcome

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location status: Recruiting

Location contact

Brandon Hopkins, MD

SUB_INVESTIGATOR

Dane Genther, MD

SUB_INVESTIGATOR

Derek Vos, BS

SUB_INVESTIGATOR

Hana Rosen, MD

CONTACT

[email protected]

2164447018

John O'Neill, BS

CONTACT

[email protected]

4405062611

Michael Fritz, MD

SUB_INVESTIGATOR

Patrick Byrne, MD

PRINCIPAL_INVESTIGATOR

Peng Ding, MD

SUB_INVESTIGATOR

Peter Ciolek, MD

SUB_INVESTIGATOR

Stephen Hadford, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).
  • Agree to participate in the study.

Exclusion criteria

  • Bilateral facial paralysis
  • Age less than 18 years-old or older than 80 years-old
  • Comorbid medical condition preventing two-stage CFNG surgery

Treatment and study plan

BES

Procedure

Nerve biopsies during surgery + brief electrical stimulation therapy

Standard of Care surgery

Procedure

Nerve biopsies during surgery - no brief electrical stimulation therapy

Primary outcomes

  1. 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.

    Time frame: 24 months

    Efficacy evaluation

Secondary outcomes

  1. To evaluate clinical outcomes of treatment and control groups using patient reported, and IRB approved CCF Facial Nerve Survey.

    Time frame: 24 months

    Evaluation of Clinical Outcomes

Study contacts

Contact information is provided by the study sponsor or research team.

Hana Rosen, MD

CONTACT

[email protected]

216-444-7018

John O'Neill, MD

CONTACT

[email protected]

440-445-8175

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 28, 2024
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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