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Function and Form Outcomes in Patients With Facial Paralysis

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ClinicalTrials.gov Identifier: NCT03974763
Recruitment Status : Completed
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Tufts University

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.


Condition or disease
Facial Paralysis Bell Palsy

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.

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Study Type : Observational
Actual Enrollment : 104 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Function and Form Outcomes in Patients With Facial Paralysis
Actual Study Start Date : June 20, 2016
Actual Primary Completion Date : May 24, 2018
Actual Study Completion Date : May 24, 2018

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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). [ Time Frame: December 2019 ]
    First outcome measure for facial soft tissue disability = Maximum displacement (mm)

  2. 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). [ Time Frame: December 2019 ]
    Second outcome measure for facial soft tissue disability = velocity (mm/s)

  3. 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). [ Time Frame: December 2019 ]
    Third outcome measure for facial soft tissue disability = and asymmetry of facial soft tissue landmarks (this is a ratio measure)

  4. To compare the facial disability in the patients with a group of age- and sex-frequency matched normal subjects. [ Time Frame: December 2019 ]
    First outcome measure for group comparison = difference in maximum displacement (mm) between patients with facial disability and control group subjects

  5. To compare the facial disability in the patients with a group of age- and sex-frequency matched normal subjects. [ Time Frame: December 2019 ]
    Second outcome measure for group comparison = velocity (mm/s)

  6. To compare the facial disability in the patients with a group of age- and sex-frequency matched normal subjects. [ Time Frame: December 2019 ]
    Third outcome measure for group comparison = asymmetry of facial soft tissue landmarks (ratio)

  7. In patients with acute, unilateral, flaccid facial paralysis, to compare the current, qualitative, clinical assessment methods for facial disability. [ Time Frame: December 2019 ]
    First outcome measure = average correlation across surgeons for their ratings on the House-Brackman scale and the patients' mean measures of maximum displacement

  8. In patients with acute, unilateral, flaccid facial paralysis, to compare the current, qualitative, clinical assessment methods for facial disability. [ Time Frame: December 2019 ]
    Second outcome measure = average correlation across surgeons for their ratings on the House-Brackman scale and the patients' mean measures of velocity

  9. In patients with acute, unilateral, flaccid facial paralysis, to compare the current, qualitative, clinical assessment methods for facial disability. [ Time Frame: December 2019 ]
    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

  10. In patients with acute, unilateral, flaccid facial paralysis, to compare the current, qualitative, clinical assessment methods for facial disability. [ Time Frame: December 2019 ]
    Fourth outcome measure = average correlation across surgeons for their ratings on the Sunnybrook Facial Grading System and the patients' mean measures of maximum displacement

  11. In patients with acute, unilateral, flaccid facial paralysis, to compare the current, qualitative, clinical assessment methods for facial disability. [ Time Frame: December 2019 ]
    Fifth outcome measure = average correlation across surgeons for their ratings on the Sunnybrook Facial Grading System and the patients' mean measures of velocity

  12. In patients with acute, unilateral, flaccid facial paralysis, to compare the current, qualitative, clinical assessment methods for facial disability. [ Time Frame: December 2019 ]
    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

  13. 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. [ Time Frame: December 2019 ]
    Measurement Tools: SP36 questionnaire, FaCE questionnaire.

  14. 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. [ Time Frame: December 2019 ]
    Measurement Tools: PSP questionnaire.

  15. To correlate the patients' perceptions over time with the quantitative measures of facial disability. [ Time Frame: December 2019 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974763


Locations
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United States, Massachusetts
Tufts University School of Dental Medicine
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Carroll Ann Trotman Tufts University School of Dental Medicine

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Responsible Party: Tufts University
ClinicalTrials.gov Identifier: NCT03974763     History of Changes
Other Study ID Numbers: 11299
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tufts University:
Facial Paralysis
Bell's Palsy
unilateral
3D
3D imaging
Facial form
Facial function

Additional relevant MeSH terms:
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Bell Palsy
Facial Paralysis
Paralysis
Facies
Disease Attributes
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mouth Diseases
Stomatognathic Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Facial Nerve Diseases
Cranial Nerve Diseases