Intraoperative Brief Electrical Stimulation to Improve Cross-Face Nerve Grafting Outcomes
Intraoperative Brief Electrical Stimulation to Improve Cross-Face Nerve Grafting Outcomes
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.
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.
Inclusion Criteria:
Exclusion Criteria:
rosenh@ccf.org216-444-7018
oneillj2@ccf.org440-445-8175
Cleveland, Ohio 44195, United States
rosenh@ccf.org2164447018
oneillj2@ccf.org4405062611