Recruiting

Observational Study

Sponsor:

Tufts University

Code:

NCT04934176

Conditions

Facial Paralysis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Psychosocial scales/questionnaires

3D Facial Measurements

Study Details

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. 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.

Conditions

Facial Paralysis

Study ID

NCT04934176

Start date

Jun 3, 2021

Status verified date

Dec, 2024

Completion date

Jun 3, 2026

Anticipated

Primary completion date

Jan 3, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

125 participants

Anticipated

Interventions and Outcome Measures

Arms

Group 1

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

Group 2

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

Group 3

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

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.

Interventions

Psychosocial scales/questionnaires

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.

3D Facial Measurements

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).

Primary outcome measure

  • Facial impairment and disfigurement [ Time Frame: 18 months ]
  • Facial impairment and disfigurement [ Time Frame: 18 months ]
  • Facial impairment and disfigurement [ Time Frame: 18 months ]
  • Self-perceptions of facial appearance and well-being in patients who undergo facial reanimation surgery to address unilateral, mid-facial paralysis [ Time Frame: 18 months ]
  • Self-perceptions of facial appearance and well-being in patients who undergo facial reanimation surgery to address unilateral, mid-facial paralysis [ Time Frame: 18 months ]
  • Self-perceptions of facial appearance and well-being in patients who undergo facial reanimation surgery to address unilateral, mid-facial paralysis [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Carroll Ann Trotman, BDS, MA, MS

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

Tina Adathakkar

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

Locations

The Ohio State University College of Dentistry

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Carroll Ann Trotman, BDS, MA, MS

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

Tina Adathakkar

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

More Information

Sponsor

Tufts University

Last update posted

Dec 27, 2024

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tufts University on 2024-12-27.