Mixed Methods Investigation of Chronic Facial Paralysis in Individuals With Synkinesis
Condition: Synkinesis
MeSH terms: Bell Palsy; Facial Paralysis; Paralysis; Synkinesis
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Neuromuscular Retraining Therapy (4 months); Chemodenervation (4 months); Neuromuscular Retraining + Chemodenervation
Intervention type(s): Other; Drug; Other
Intervention description(s): Neuromuscular retraining is an intervention where facial therapists utilize voluntary input to access improved movement patterns in patients with synkinesis.; A neurotoxin that temporarily reduces muscle activity and minimizes the effects of uncoordinated muscle.; Participants will receive both interventions for the last 4 months of their time on study.
Other intervention name(s): onabotulinumtoxin A; Botox; incobotulinumtoxin A; Xeomin
Intervention MeSH terms: Botulinum Toxins, Type A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment