Intraoperative Electrical Stimulation to Improve Nerve Grafting Outcome
ConditionFacial Paralysis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe Cleveland Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Bilateral facial paralysis
Age less than 18 years-old or older than 80 years-old
Comorbid medical condition preventing two-stage CFNG surgery
Trial design
Design model
Parallel
Treatments tested in this trial
BES
Procedure/SurgeryNerve biopsies during surgery + brief electrical stimulation therapy
Standard of Care surgery
Procedure/SurgeryNerve biopsies during surgery - no brief electrical stimulation therapy
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Treatment GroupExperimental treatment 1 intervention
Group B: Control GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Efficacy evaluation
Time frame
24 monthsSecondary outcomes
1
To evaluate clinical outcomes of treatment and control groups using patient reported, and IRB approved CCF Facial Nerve Survey.
Evaluation of Clinical Outcomes
Time frame
24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov