Clinical trial NCT03974763: Function and Form Outcomes in Patients With Facial Paralysis
Official title: Function and Form Outcomes in Patients With Facial Paralysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Facial Paralysis
Bell Palsy
Keywords: Facial Paralysis
Bell's Palsy
unilateral
3D
3D imaging
Facial form
Facial function
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2019-06-05
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects for this study will be adults 18 to 75 years. The subjects who are potentially eligible for participation will be identified through the participating Centers: For the patients with facial paralysis through the Facial Nerve Center (FNC) at Massachusetts Eye and Ear Infirmary (MEEI); and for the control subjects through Tufts University School of Dental Medicine (TUSDM). Subjects recruited from MEEI will attend TUSDM for testing where Dr. Trotman maintains her Facial Animation laboratory. The participating surgeon is Dr. Tessa Hadlock and she will be responsible for the clinical care of all patients.

Brief summary: This study will be unique for the rehabilitation of patients with facial paralysis in that the focus is to generate novel 3D facial soft tissue measures to characterize the condition and temporal changes, and on the generation of future testable hypotheses to optimize surgical interventions and outcomes. In addition, the investigators will extend our previous work, beyond the facial circumoral and lip areas/zones, to characterize additional facial zones specific for facial paralysis.

The approach for facial mapping of soft tissue movement, when validated through this proposed study, can be used for both surgical planning and to support the development and training of implantable facial pacing devices. Mapping both normal facial movements and movements of patients with unilateral facial paralysis are vital to describe the temporal and spatial course of the recovery process. Ultimately, this information can be used to inform clinicians on the precise placement of these devices and the signal strength needed to facilitate movements in the required 'paralyzed' facial zones until the recovery process has been completed.

Detailed description: Patients with facial paralysis have an obvious facial disability. The resultant facial disability includes facial disfigurement and impairment in soft tissue movements, particularly in facial expressive behaviors. These negative physical sequelae not only impact facial esthetics and function, but also patients' social and emotional quality of life. Treatments range from non-surgical interventions and facial reanimation surgery to new implantable facial pacing devices that would potentially initiate artificial movement on the paralyzed side of the face. Traditionally, surgeons' plan treatment based on isolated measurements made from 2D photographs and subjective grading of the patient's face, both of which are limited in scope and dimension. Our research group has demonstrated the utility of a novel 3D dynamic and static quantitative (objective) measures for the evaluation of facial soft tissue function. The measures are objective and quantitative, and they provide a more precise diagnosis of facial soft tissue disability and evaluation of surgical outcomes. The main goal of this prospective, observational study is to determine the applicability of these novel 3D dynamic and static measures for quantification and measurement of impairment and disfigurement, as well as change over time, in patients with facial paralysis. The global hypothesis is that the use of the measures will provide a more comprehensive analysis of the severity of facial paralysis and the changes over time (recovery) when compared with current assessment methods.

Eligibility criteria: Patients with Facial Paralysis Inclusion criteria

* A diagnosis of virally triggered, acute, unilateral facial paralysis (Bell's Palsy)
* Able to attend baseline visit at Tufts within 6 weeks of onset of the condition and with an estimated potential for recovery between 6-12 weeks
* Patient interest/willingness to participate in the study
* An ability to comprehend verbal instructions; and an age range of 18 to 75 years

Exclusion criteria

* Facial movement disorders due to primary muscular dysfunction or hemifacial spasm in the absence of synkinesis
* Complaints of facial paralysis but no evidence of weakness on physical examination
* Previous facial soft tissue surgery and/or Orthognathic surgery
* Mental or hearing impairment to the extent that comprehension or ability to perform the tests is hampered

Control Participants Inclusion criteria

* Subject interest/willingness to participate in the study
* An ability to comprehend verbal instructions
* An age range of 18 to 75 years

Exclusion criteria

* Facial soft tissue surgery, orthognathic surgery, and/or facial soft tissue disorder
* Mental or hearing impairment to the extent that comprehension or ability to perform the tests is hampered

Primary outcomes:
measure: To quantitatively evaluate the range of facial soft tissue disability in patients with acute, unilateral, flaccid facial paralysis and track the changes over time (3-month recovery period).
timeFrame: December 2019
measure: To quantitatively evaluate the range of facial soft tissue disability in patients with acute, unilateral, flaccid facial paralysis and track the changes over time (3-month recovery period).
timeFrame: December 2019
measure: To quantitatively evaluate the range of facial soft tissue disability in patients with acute, unilateral, flaccid facial paralysis and track the changes over time (3-month recovery period).
timeFrame: December 2019
measure: To compare the facial disability in the patients with a group of age- and sex-frequency matched normal subjects.
timeFrame: December 2019
measure: To compare the facial disability in the patients with a group of age- and sex-frequency matched normal subjects.
timeFrame: December 2019
measure: To compare the facial disability in the patients with a group of age- and sex-frequency matched normal subjects.
timeFrame: December 2019
measure: In patients with acute, unilateral, flaccid facial paralysis, to compare the current, qualitative, clinical assessment methods for facial disability.
timeFrame: December 2019
measure: In patients with acute, unilateral, flaccid facial paralysis, to compare the current, qualitative, clinical assessment methods for facial disability.
timeFrame: December 2019
measure: In patients with acute, unilateral, flaccid facial paralysis, to compare the current, qualitative, clinical assessment methods for facial disability.
timeFrame: December 2019
measure: In patients with acute, unilateral, flaccid facial paralysis, to compare the current, qualitative, clinical assessment methods for facial disability.
timeFrame: December 2019
measure: In patients with acute, unilateral, flaccid facial paralysis, to compare the current, qualitative, clinical assessment methods for facial disability.
timeFrame: December 2019
measure: In patients with acute, unilateral, flaccid facial paralysis, to compare the current, qualitative, clinical assessment methods for facial disability.
timeFrame: December 2019
measure: To assess perceptions of facial appearance over time in patients with acute, unilateral, flaccid facial paralysis and to compare these perceptions with those of control subjects.
timeFrame: December 2019
measure: To assess perceptions of quality of life over time in patients with acute, unilateral, flaccid facial paralysis and to compare these perceptions with those of control subjects.
timeFrame: December 2019
measure: To correlate the patients' perceptions over time with the quantitative measures of facial disability.
timeFrame: December 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts University School of Dental Medicine
state: Massachusetts
Study officials:
affiliation: Tufts University School of Dental Medicine
name: Carroll Ann Trotman
role: PRINCIPAL_INVESTIGATOR
References: