In this study, patients who have undergone facial paralysis surgery will be asked to participate. The goal of this study is to compare the facial disability and perception outcomes of facial reanimation surgeries in patients with extensive and permanent, unilateral paralysis using 3D analysis, and compare patient-centered outcomes of facial appearance, well-being, and satisfaction using validated questionnaires. The focus point of this study will be on outcomes of mid-facial reanimation surgeries in patients with more extensive and permanent, unilateral, paralysis of varied etiology and presentation.
The specific aims of the study are as follows. Specific Aim 1. To quantitatively determine the surgical effects/impact on facial disability (facial impairment and disfigurement) among four surgically treated groups of patients with unilateral facial paralysis who undergo free gracilis muscle transfer driven by (1) a trigeminal nerve (nV) graft, (2) a crossface nerve graft (nVII), (3) dual innervation comprising both nerves, and (4) midfacial modification.
1. We will compare the changes in facial disability among the groups before and after surgery, and the differences in facial disability between each surgery group and the controls before and after surgery. 2. Specific Aim 2. To compare among the surgery groups the changes in self-perceptions of facial appearance and well-being that occur due to facial reanimation surgery, and to compare the surgery groups before and at 18 months to historical controls recruited during the tenure of the R21 grant. 3. Specific Aim 3. In patients with facial paralysis, to compare surgeons' current qualitative assessment and 2D, quantitative assessment of facial impairment and disfigurement with the objective, 3D, quantitative assessments in order to determine the clinical utility of the 3D assessment approach as an outcome measure and relevance for dissemination to the surgical community.
Patients with unilateral facial paralysis scheduled for smile reconstruction using free gracilis muscle transfer driven by one of four neuronal inputs, specifically, the trigeminal nerve (nV), a cross-face nerve graft (nVII), dual innervation combining the trigeminal nerve, a cross face nerve graft, and patients who have midfacial modifications that involve performing direct coaptation between the trigeminal nerve and a branch to the native zygomaticus major muscle (5-7 transfer) and selective neurolysis in which several facial nerve branches that innervate muscles antagonistic to the smile animation are transected.
Patient/parent interest/willingness to participate in the study
An ability to comprehend verbal instructions
An age range of 18 to 75 years
Presence of a major facial deformity/condition either congenital or acquired e.g. hemifacial microsomia, cancer
Facial movement disorders due to primary muscular dysfunction or hemifacial spasm in the absence of synkinesis
Mental or hearing impairment to the extent that comprehension or ability to perform the tests is hampered
Subjects who have undergone facial paralysis surgery - four surgically treated groups of patients with unilateral facial paralysis who undergo free gracilis muscle transfer or selective neurolysis via midfacial modification driven by (1) a trigeminal nerve (nV) graft, (2) a cross-face nerve graft (nVII), (3) dual innervation comprising both nerves, and (4) midfacial modification.
Case-only
Prospective
Psychosocial scales/questionnaires
Other interventionWe will use three psychosocial scales/questionnaires for this patient population to gauge patients' perceptions of the impact of their paralysis and their recovery. The questionnaires will be completed by the patients at baseline, and 18 months after surgery. Moreover, we also will compare patient perceptions to the patient-related responses with clinical scoring made by the surgeons using the eFACE,6 Face-Gram/Emotrics12 software, and the 3D dynamic measures.
3D Facial Measurements
Other intervention3D dynamic (objective) facial movement data will be collected first (estimated time 1 hour), followed by static 3D photographic data (estimated time 15 minutes), and then video data of the different facial animations (estimated time 15 minutes).
Facial impairment and disfigurement
3D static facial photographs
Facial impairment and disfigurement
Video data of different facial animations
Facial impairment and disfigurement
3D objective facial movements/animations
Self-perceptions of facial appearance and well-being in patients who undergo facial reanimation surgery to address unilateral, mid-facial paralysis
Patient-centered questionnaires to assess condition-specific and general QOL. • The Facial Clinimetric Evaluation Scale (FaCE) covers six independent domains (facial movement, facial comfort, oral function, eye comfort, lacrimal control, and social function) over the course of 15 asked items. You will be asked to respond to questions around facial functionality on scales of 0 "No difficulty" to 2 "Both sides" and 1 "Not at all" to 5 "Normally"; how often facial paralysis impacts your quality of life on a scale of 1 "All of the time" to 5 "None of the time"; how you agree with certain statements on a scale of 1 "Strongly agree" to 5 "Strongly disagree".
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Tufts University
Lead sponsor
Ohio State University
Sponsor institution
National Institutes of Health (NIH)
Collaborator
National Institute of Dental and Craniofacial Research (NIDCR)
Collaborator
