3D Dynamic and Patient-Centered Outcomes of Facial Reanimation Surgery in Patients With Facial Paralysis

NCT04934176 | Recruiting

• 2 other identifiers: 134121R01DE028565
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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. 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.

Conditions

Facial Paralysis

Outcome Measures

Primary Outcomes (6)

• 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

• 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

Study Arms (4)

Group 1

Group 1 will have had a muscle transfer driven by the trigeminal nerve (nV).

Other: Psychosocial scales/questionnaires; Other: 3D Facial Measurements

Group 2

Group 2 will have had a muscle transfer driven by a cross-face nerve graft (nVII).

Other: Psychosocial scales/questionnaires; Other: 3D Facial Measurements

Group 3

Group 3 will have had a muscle transfer driven by dual innervation using both the trigeminal and cross-face nerve graft.

Other: Psychosocial scales/questionnaires; Other: 3D Facial Measurements

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.

Other: Psychosocial scales/questionnaires; Other: 3D Facial Measurements

Interventions

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.

Group 1; Group 2; Group 3; Group 4

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).

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts University: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

The Ohio State University College of Dentistry

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Facial Paralysis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Carroll Ann Trotman, BDS, MA, MS

  Ohio State University College of Dentistry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carroll Ann Trotman, BDS, MA, MS

CONTACT

614-292-9755; trotman.13@osu.edu

Tina Adathakkar

CONTACT

614-366-5571; adathakkar.1@osu.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of the College of Dentistry

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 22, 2021
• Study Start: June 3, 2021
• Primary Completion: January 3, 2026
• Study Completion (Estimated): June 3, 2026
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

US (1)