Mixed Methods Investigation of Chronic Facial Paralysis in Individuals With Synkinesis

• Status: Completed
• Trial end date: 2021-08-24
• Target enrollment: 0
• Participant gender: All

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].

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Treatments: Botulinum Toxins, Type A; incobotulinumtoxinA

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