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NCT Number: NCT03974763

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.

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Key information

Conditions

Facial Paralysis Bell Palsy Cranial Nerve Diseases DNA Virus Infections Facial Nerve Diseases Herpesviridae Infections Infections Mouth Diseases Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 5, 2019
Registry last updated
Jun 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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