NCT04934176 · Tufts University
3D Dynamic and Patient-Centered Outcomes of Facial Reanimation Surgery in Patients With Facial Paralysis
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Columbus, Ohio
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 27, 2024 · Source of record for eligibility and locations