Intraoperative Brief Electrical Stimulation to Improve Cross-Face Nerve Grafting Outcomes
The Cleveland Clinic
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.
Description
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 intraoperat…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- ProcedureBES
Nerve biopsies during surgery + brief electrical stimulation therapy
- ProcedureStandard of Care surgery
Nerve biopsies during surgery - no brief electrical stimulation therapy
Location
- Cleveland Clinic FoundationCleveland, Ohio