Function and Form Outcomes in Patients With Facial Paralysis

NCT ID: NCT03974763

Last Updated: 2019-06-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 104 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-20
• Study Completion Date: 2018-05-24

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.

Conditions

Facial Paralysis; Bell Palsy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Test Group

Patients with acute, unilateral, facial paralysis (Bell's Palsy)

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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

• 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 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Tufts University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carroll Ann Trotman

Role: PRINCIPAL_INVESTIGATOR

Tufts University School of Dental Medicine

Locations

Tufts University School of Dental Medicine

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

11299

Identifier Type: -

Identifier Source: org_study_id