Intraoperative Brief Electrical Stimulation to Improve Cross-Face Nerve Grafting Outcomes
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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.
Locations
United States
Ohio
Cleveland Clinic Foundation
RECRUITING
Cleveland
Contact Information
Primary
Hana Rosen, MD
rosenh@ccf.org
216-444-7018
Backup
John O'Neill, MD
oneillj2@ccf.org
440-445-8175
Time Frame
Start Date: 2023-03-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 20
Treatments
Experimental: 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.
Experimental: Control Group
Control group undergoes only nerve biopsies during surgery - no brief electrical stimulation.
Related Therapeutic Areas
Sponsors
Leads: The Cleveland Clinic