Using electrical stimulation during surgery to improve facial nerve graft outcomes
Intraoperative Brief Electrical Stimulation to Improve Cross-Face Nerve Grafting Outcomes
This study is testing if using electrical stimulation during surgery can help improve nerve healing and smiles for people getting surgery for facial paralysis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06335719 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with unilateral facial paralysis who are eligible for two-stage cross-face nerve graft surgery.
Not a fit: Patients with bilateral facial paralysis or those with medical conditions that prevent them from undergoing the surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve nerve regeneration and functional outcomes for patients with facial paralysis.
How similar studies have performed: While the use of electrical stimulation in nerve repair is a promising area, this specific application in facial reanimation surgery is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cleveland, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.