Actively Recruiting
Intraoperative Brief Electrical Stimulation to Improve Cross-Face Nerve Grafting Outcomes
Led by The Cleveland Clinic · Updated on 2025-07-30
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to find out if brief electrical stimulation applied during surgery can improve nerve healing and smile outcomes in patients with unilateral facial paralysis undergoing two-stage cross-face nerve graft facial reanimation surgery. The study compares the effects of this stimulation to standard care without stimulation. It focuses on nerve regeneration and clinical outcomes related to smile function. Participants will be randomly assigned in a 2:1 ratio to either a treatment group or a control group. Both groups will have nerve biopsies during surgery, which do not affect surgery length or results. The treatment group additionally receives about 10 minutes of brief electrical stimulation during the first stage of the nerve graft surgery, while the control group does not. During the study, researchers will evaluate nerve regeneration using nerve tissue analysis and assess clinical outcomes through patient surveys and objective smile measurements over 24 months. Participants will be monitored for nerve healing and smile function, with follow-up assessments to measure the effects of the electrical stimulation compared to standard care.
CONDITIONS
Brief Title
Intraoperative Electrical Stimulation to Improve Nerve Grafting Outcome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 to 80 years old with paralysis on one side of the face
- Candidates for two-stage cross-face nerve graft smile reanimation surgery
- Agree to participate in the study
You will not qualify if you...
- Bilateral facial paralysis
- Younger than 18 years old or older than 80 years old
- Medical condition preventing two-stage cross-face nerve graft surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery plus immediate recovery period
Participants undergo cross-face nerve graft surgery with nerve biopsies. The treatment group receives brief electrical stimulation therapy during surgery, while the control group receives only the nerve biopsies.
1 surgical visit plus immediate post-operative care
Duration - Up to 24 months
Participants are followed for clinical outcomes and nerve regeneration assessments after surgery.
Periodic follow-up visits over 24 months
Trial Site Locations
Total: 1 location
1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
H
Hana Rosen, MD
J
John O'Neill, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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