Using electrical stimulation during surgery to improve facial nerve graft outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates whether brief intraoperative electrical stimulation therapy can enhance nerve regeneration and improve smile outcomes for patients undergoing two-stage cross-face nerve graft surgery for facial paralysis. Participants will be randomly assigned to either a treatment group, which receives electrical stimulation during surgery, or a control group, which will receive standard care. Both groups will undergo nerve biopsies, but the treatment group will additionally receive approximately 10 minutes of electrical stimulation. The study aims to evaluate the efficacy of this approach through nerve histology and clinical outcomes measured by clinician assessments and patient-reported metrics.

Why it matters

Who can join: the full rules

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

Where it's running

• Cleveland Clinic Foundation
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Patrick Byrne, MD — The Cleveland Clinic
• Study coordinator: Hana Rosen, MD
• Email: rosenh@ccf.org
• Phone: 216-444-7018

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combined neural mobilization with proprioceptive therapy for Bell’s palsy facial symmetry

  A randomized trial tests whether adding neural mobilization to proprioceptive neuromuscular facilitation helps improve facial symmetry in people with Bell’s palsy.

  Recruiting Foundation University Islamabad · Islamabad · NCT07758543

• Evaluating outcomes of facial reanimation surgery for facial paralysis

  This study is testing how well facial reanimation surgery helps people with one-sided facial paralysis feel and look better over time.

  Recruiting Tufts University · Columbus, Ohio · NCT04934176

• 3 Tesla MRI measurements of facial skin muscles in people with facial paralysis

  This will use a 3 Tesla MRI to see if measuring facial muscle thickness and volume helps understand muscle loss and guide care for adults with facial paralysis.

  Recruiting Centre Hospitalier Universitaire, Amiens · Amiens, Picardie · NCT03115203

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.