Intraoperative Brief Electrical Stimulation to Improve Cross-Face Nerve Grafting Outcomes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- The Cleveland Clinic
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- To evaluate efficacy of an intraoperative dose of brief electrical stimulation (BES) to improve axonal regeneration across a cross-face nerve graft (CFNG) using nerve histology.
Study Overview
Brief 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.
Detailed 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 intraoperative dose of brief electrical stimulation (BES) to improve axonal regeneration across a cross-face nerve graft (CFNG) using nerve histology and to evaluate clinical outcomes of treatment and control groups using clinician graded, patient reported, and objective smile metric.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
This is a randomized, controlled, double-blinded (patient and evaluator) prospective study. Plan is to enroll up to 30 patients, with a minimum of 20 completing full follow-up. Randomization 2:1 treatment to control due to previous peripheral nerve research demonstrating intraoperative stimulation accelerates axonal regeneration
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Bilateral facial paralysis
- •Age less than 18 years-old or older than 80 years-old
- •Comorbid medical condition preventing two-stage CFNG surgery
Arms & Interventions
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.
Intervention: BES (Procedure)
Control Group
Control group undergoes only nerve biopsies during surgery - no brief electrical stimulation.
Intervention: Standard of Care surgery (Procedure)
Outcomes
Primary Outcomes
To evaluate efficacy of an intraoperative dose of brief electrical stimulation (BES) to improve axonal regeneration across a cross-face nerve graft (CFNG) using nerve histology.
Time Frame: 24 months
Efficacy evaluation
Secondary Outcomes
- To evaluate clinical outcomes of treatment and control groups using patient reported, and IRB approved CCF Facial Nerve Survey.(24 months)