Facial Paralysis
Conditions
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.
Interventions
PROCEDUREBES
Nerve biopsies during surgery + brief electrical stimulation therapy
PROCEDUREStandard of Care surgery
Nerve biopsies during surgery - no brief electrical stimulation therapy
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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
Intervention model description
Patients will undergo all the standard steps of the facial reanimation procedures. The difference in care is 2/3 participants may receive the brief electrical stimulation therapy. Other 1/3 of study participants will undergo the surgery as they normally would if they had not chosen to participate.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 24 months | Efficacy evaluation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate clinical outcomes of treatment and control groups using patient reported, and IRB approved CCF Facial Nerve Survey. | 24 months | Evaluation of Clinical Outcomes |
Countries
United States
Contacts
Primary ContactHana Rosen, MD
Backup ContactJohn O'Neill, MD
Outcome results
None listed