Function and Form Outcomes in Patients With Facial Paralysis

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.

Study Overview

• Status: Completed
• Conditions: Bell Palsy; Facial Paralysis

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.

• Study Type: Observational
• Enrollment (Actual): 104

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts University School of Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Test Group; Patients with acute, unilateral, facial paralysis (Bell's Palsy)
Control Group; A group of age- and sex-frequency matched 'normal' controls. Based on past research, gender and age are possible confounders of facial movement/function. Thus, the control group will be frequency-matched to the patient group on gender and age.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	First outcome measure for facial soft tissue disability = Maximum displacement (mm)	December 2019
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).	Second outcome measure for facial soft tissue disability = velocity (mm/s)	December 2019
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).	Third outcome measure for facial soft tissue disability = and asymmetry of facial soft tissue landmarks (this is a ratio measure)	December 2019
To compare the facial disability in the patients with a group of age- and sex-frequency matched normal subjects.	First outcome measure for group comparison = difference in maximum displacement (mm) between patients with facial disability and control group subjects	December 2019
To compare the facial disability in the patients with a group of age- and sex-frequency matched normal subjects.	Second outcome measure for group comparison = velocity (mm/s)	December 2019
To compare the facial disability in the patients with a group of age- and sex-frequency matched normal subjects.	Third outcome measure for group comparison = asymmetry of facial soft tissue landmarks (ratio)	December 2019
In patients with acute, unilateral, flaccid facial paralysis, to compare the current, qualitative, clinical assessment methods for facial disability.	First outcome measure = average correlation across surgeons for their ratings on the House-Brackman scale and the patients' mean measures of maximum displacement	December 2019
In patients with acute, unilateral, flaccid facial paralysis, to compare the current, qualitative, clinical assessment methods for facial disability.	Second outcome measure = average correlation across surgeons for their ratings on the House-Brackman scale and the patients' mean measures of velocity	December 2019
In patients with acute, unilateral, flaccid facial paralysis, to compare the current, qualitative, clinical assessment methods for facial disability.	Third outcome measure = average correlation across surgeons for their ratings on the House-Brackman scale and the patients' mean measures of asymmetry of facial soft tissue landmarks	December 2019
In patients with acute, unilateral, flaccid facial paralysis, to compare the current, qualitative, clinical assessment methods for facial disability.	Fourth outcome measure = average correlation across surgeons for their ratings on the Sunnybrook Facial Grading System and the patients' mean measures of maximum displacement	December 2019
In patients with acute, unilateral, flaccid facial paralysis, to compare the current, qualitative, clinical assessment methods for facial disability.	Fifth outcome measure = average correlation across surgeons for their ratings on the Sunnybrook Facial Grading System and the patients' mean measures of velocity	December 2019
In patients with acute, unilateral, flaccid facial paralysis, to compare the current, qualitative, clinical assessment methods for facial disability.	Sixth outcome measure = average correlation across surgeons for their ratings on the Sunnybrook Facial Grading System and the patients' mean measures of asymmetry of facial soft tissue landmarks	December 2019
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.	Measurement Tools: SP36 questionnaire, FaCE questionnaire.	December 2019
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.	Measurement Tools: PSP questionnaire.	December 2019
To correlate the patients' perceptions over time with the quantitative measures of facial disability.	Relationship between the quantitative measurements of facial movement with the quality of life and patient perception measures. This relationship will be measured using the linear mixed effects model or generalized estimating equations as appropriate.	December 2019

Collaborators and Investigators

• Sponsor: Tufts University
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Carroll Ann Trotman, Tufts University School of Dental Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2016
• Primary Completion (Actual): May 24, 2018
• Study Completion (Actual): May 24, 2018

Study Registration Dates

• First Submitted: September 24, 2018
• First Submitted That Met QC Criteria: May 31, 2019
• First Posted (Actual): June 5, 2019

Study Record Updates

• Last Update Posted (Actual): June 5, 2019
• Last Update Submitted That Met QC Criteria: May 31, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: unilateral; 3D; Facial Paralysis; Bell's Palsy; 3D imaging; Facial form; Facial function
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Virus Diseases; Infections; Neurologic Manifestations; Disease Attributes; Stomatognathic Diseases; Mouth Diseases; DNA Virus Infections; Cranial Nerve Diseases; Herpesviridae Infections; Facial Nerve Diseases; Paralysis; Bell Palsy; Facial Paralysis; Facies
• Other Study ID Numbers: 11299 (DAIDS ES Registry Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No