Mixed Methods Investigation of Chronic Facial Paralysis in Individuals With Synkinesis

NCT ID: NCT04148872

Last Updated: 2022-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-24
• Study Completion Date: 2021-08-24

Brief Summary

This proposal will prospectively assess the social, physical, and emotional recognition function in participants with synkinesis. It will measure the effectiveness of neuromuscular retraining therapy to improve muscle coordination compared to chemodenervation, the more established treatment modality, in a single-blinded, randomized control trial using clinician- and patient-reported outcomes measures. The hypothesis tested is that participants undergoing neuromuscular retraining therapy will achieve greater improvement on clinical outcome measures as compared to participants receiving chemodenervation.

In this clinical trial, 36 participants undergoing treatment for synkinesis will be enrolled into one of two treatment arms: chemodenervation or neuromuscular retraining therapy. Participants can expect to be on study for approximately 8 months.

Participants who enroll in this mixed methods investigation will be recruited from patients of the University of Wisconsin Facial Nerve Clinic and also be enrolled in a another study for assessment [Perception of Emotion Expression in Clinical Populations with Facial Paralysis, IRB approval 2015-0366].

Detailed Description

Facial nerve paralysis is a devastating event that in up to 30% of cases may result in chronic weakness and/or the disfiguring condition of synkinesis, a long-lasting muscle discoordination of facial movement caused by aberrant facial nerve regeneration after facial nerve paralysis. This is believed to have a detrimental effect on social interactions, mental health, and quality of life.

Neuromuscular retraining therapy and ipsilateral chemodenervation into discoordinated muscles by injection (onabotulinumtoxinA/Botox, Allergan or incobotulinumtoxinA/Xeomin, Merz) are two common treatments for the abnormal muscle movements found in synkinesis. No study has compared the effectiveness of these treatment modalities for synkinesis. Retrospective data including our series at the University of Wisconsin Facial Nerve Clinic show significant benefit of retraining therapy using clinician- and patient-reported outcome measures. However, the manner in which this therapy may be optimized for use in treatment of the sequelae of facial paralysis is unclear. While literature shows beneficial improvement in outcomes with chemodenervation in prospective studies, no study has explored the effectiveness of physical therapy for synkinesis in a controlled, prospective manner. Further, the efficacy of therapy has not been shown to improve recognition and emotional information interpretation, both thought to be impaired in synkinesis.

This study has 3 specific aims:

AIM 1: Determine the effect of neuromuscular retraining or chemodenervation on clinician-reported and patient-reported outcomes. The primary outcome measure after four and eight months of treatment will be the clinician-reported Sunnybrook Facial Grading System (SFGS) scored on participant videos by blinded reviewers. Further, the investigators seek to measure the efficacy of treatment with existing patient-reported instruments. A correlation of clinician-reported outcome measure changes to changes in patient-reported instruments with treatment will be calculated, including the widely utilized disease specific Synkinesis Assessment Questionnaire (SAQ) and Facial Clinimetric Evaluation Scale (FaCE), and with two disease non-specific instruments, the Hospital Anxiety and Depression Scale (HADS), and Brief-Illness Perception Questionnaire (BIPQ). The efficacy of our clinical intervention will be measured with social-perceptual and mental health outcome measurement before and after treatment (AIM 3).

AIM 2: Determine the social, emotional, and functional burden of synkinesis, not captured in current patient-reported outcome measures as well as effect of treatment. Qualitative interviews with individual participants collected before treatment, after four months of treatment, and after eight months of treatment will be analyzed to study the burden of disease, experience with treatment, and potential differences in both treatments. The primary outcome is to identify the domains that may be missing from existing patient-reported measures collected in AIM 1. To do this, findings to assessment domains (i.e. decreased engagement, negative mood, etc.) in the FaCE, SAQ, and the two disease non-specific instruments, HADS and BIPQ will be compared. The investigators will then evaluate their findings based on domains in Patient-Reported Outcomes Measurement Information System (PROMIS) measures, an NIH-supported collection of validated and standardized scales.

AIM 3: Quantify the disruption in social functioning caused by synkinesis using innovative social-perceptual outcomes and emotion recognition tasks. Prior to treatment, participants will enroll in IRB Protocol 2015-0366 and complete a series of social functioning and mental health instruments and emotion expression recognition tasks. Results will be compared to control participants without facial disability to reveal the social-perceptual impairment attributable to synkinesis. Repetition of these tasks after four months of either treatment may show improvement in recognition and emotional information interpretation when compared to initial measurements.

Conditions

Synkinesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Neuromuscular Retraining Therapy

Neuromuscular retraining therapy alone for four months, with botulinum toxin injection added during an additional four month period.

Group Type: ACTIVE_COMPARATOR

Neuromuscular Retraining Therapy (4 months)

Intervention Type: OTHER

Neuromuscular retraining is an intervention where facial therapists utilize voluntary input to access improved movement patterns in patients with synkinesis.

Neuromuscular Retraining + Chemodenervation

Intervention Type: OTHER

Participants will receive both interventions for the last 4 months of their time on study.

Chemodenervation

Ipsilateral chemodenervation with botulinum toxin injections alone for four months (onabotulinumtoxinA/Botox, Allergan or incobotulinumtoxinA/Xeomin, Merz), with neuromuscular retraining therapy added for an additional four months.

Group Type: ACTIVE_COMPARATOR

Chemodenervation (4 months)

Intervention Type: DRUG

A neurotoxin that temporarily reduces muscle activity and minimizes the effects of uncoordinated muscle.

Neuromuscular Retraining + Chemodenervation

Intervention Type: OTHER

Participants will receive both interventions for the last 4 months of their time on study.

Interventions

Neuromuscular Retraining Therapy (4 months)

Neuromuscular retraining is an intervention where facial therapists utilize voluntary input to access improved movement patterns in patients with synkinesis.

Intervention Type: OTHER

Chemodenervation (4 months)

A neurotoxin that temporarily reduces muscle activity and minimizes the effects of uncoordinated muscle.

Intervention Type: DRUG

Neuromuscular Retraining + Chemodenervation

Participants will receive both interventions for the last 4 months of their time on study.

Intervention Type: OTHER

Other Intervention Names

onabotulinumtoxin A; Botox; incobotulinumtoxin A; Xeomin

Eligibility Criteria

Inclusion Criteria

• Has ipsilateral synkinesis of facial muscles
• It has been at least four months since their onset of peripheral facial paralysis from any cause
• Ability to read and write in English

Exclusion Criteria

• previous treatment with reanimation surgery (except for upper eyelid weight placement)
• intolerance or contraindication to botulinum toxin injection
• previous treatment for synkinesis with chemodenervation or neuromuscular retraining therapy
• pregnant and/or breastfeeding women
• participants with impaired decision-making capacity, including those with severe psychiatric illnesses

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott R Chaiet, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin

Madison, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

A539770

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/SURGERY/SURGERY*OT

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 4/15/2020

Identifier Type: OTHER

Identifier Source: secondary_id

2019-0406

Identifier Type: -

Identifier Source: org_study_id