Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Location status: Recruiting
NCT Number: NCT06335719
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Cleveland, Ohio, 44195, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Nerve biopsies during surgery + brief electrical stimulation therapy
Nerve biopsies during surgery - no brief electrical stimulation therapy
Time frame: 24 months
Efficacy evaluation
Time frame: 24 months
Evaluation of Clinical Outcomes
Interested in participating?
Request InfoThe Cleveland Clinic
Other
Intraoperative Brief Electrical Stimulation to Improve Cross-Face Nerve Grafting Outcomes
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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