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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DE028565 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
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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.
This, prospective, observational study has two goals which are to determine outcomes of (1) facial impairment and disfigurement, and (2) self-perceptions of facial appearance and well-being in patients who undergo facial reanimation surgery to address unilateral, mid-facial paralysis: one of the most frequent forms of paralysis. These goals are represented by the three Specific Aims as previously stated. The study participants will be patients unilateral with facial paralysis who are slated for facial muscle reconstruction surgery using a free gracilis muscle transfer with one of four innervations: (1) Trigeminal nerve (nV), (2) cross-face nerve graft (nVII), (3) dual using both the trigeminal nerve and a cross-face nerve graft, and (4) midfacial modification. All patients will be recruited from a single treatment Center, the Facial Nerve Center (FNC) at MEEI. Dr. Tessa Hadlock will be the attending for all the patients and will perform the surgeries. The age range for the patients will be 18 to 68 years. The patients will attend TUSDM, where Dr. Trotman maintains her Facial Animation laboratory, for all testing and data collection. All patients will be followed longitudinally and tested at three separate visits: At baseline immediately before surgery, then at five and 18 months after surgery. The 18 month post-surgery testing time is important to track changes related to the regenerative process.13 The specific data to be obtained from each subject will include 3D static facial photographs, video data of different facial animations, 3D objective facial movements/animations, and patient-centered questionnaires to assess condition-specific and general QOL. Dr. Hadlock, the operating surgeon, will be masked to the patients' pre-surgery and outcome data-this study does not involve an Intervention. Patients who are potentially eligible for participation in the study will be identified and recruited based on the selection criteria. Enrolled patients with facial paralysis will continue to receive all other services routinely provided during treatment.
The total number of subjects needed to complete study goal is 96 (n=24 per group). Up to 125 subjects will be screened in order to enroll and complete 96 subjects. All patients will be recruited from the Facial Nerve Center at Massachusetts Eye and Ear Infirmary.
All patients will be followed longitudinally and tested at three separate visits: prior to surgery at MEEI (baseline visit), then at 5 and 18 months after surgery. The longitudinal testing times concur with their recall visits during treatment and are important to track changes.
There will be 3 study visits, each include the following procedures:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Group 1 will have had a muscle transfer driven by the trigeminal nerve (nV). |
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| Group 2 | Group 2 will have had a muscle transfer driven by a cross-face nerve graft (nVII). |
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| Group 3 | Group 3 will have had a muscle transfer driven by dual innervation using both the trigeminal and cross-face nerve graft. |
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| Group 4 | Group 4 will have had manipulations 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychosocial scales/questionnaires | Other | We 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Facial impairment and disfigurement | 3D static facial photographs | 18 months |
| Facial impairment and disfigurement | Video data of different facial animations | 18 months |
| Facial impairment and disfigurement | 3D objective facial movements/animations | 18 months |
| 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". | 18 months |
| 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 SF 36 is a generic health status measure, designed to assess functional status and well-being. This survey is broken into 11 domains. You will also be asked to respond to questions around how you feel and how well you are able to do your usual activities using various scales. | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carroll Ann Trotman, BDS, MA, MS | Contact | 614-292-9755 | trotman.13@osu.edu | |
| Tina Adathakkar | Contact | 614-366-5571 | adathakkar.1@osu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Carroll Ann Trotman, BDS, MA, MS | Ohio State University College of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University College of Dentistry | Recruiting | Columbus | Ohio | 43210 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Dec 22, 2023 | Dec 17, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D005158 | Facial Paralysis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| 3D Facial Measurements | Other | 3D 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). |
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| 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 Recovery Perception survey (PSP) assess a subject's perception of recovery. PSP is assessed by four domains: symptom issues, social/self issues, general health issues, and dentofacial issues. The PSP is comprised of 25 items. You will respond to a series of questions regarding your facial paralysis along a 7-point scale of "No problem" to "Serious problem". |
| 18 months |
| D009422 |
| Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |