At a glance
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Mixed Methods Investigation of Chronic Facial Paralysis in Individuals With Synkinesis: Study of Outcomes Before and After Treatment
In Brief
A Phase 4 clinical trial evaluating Neuromuscular Retraining Therapy (4 months), Chemodenervation (4 months), and 1 other intervention for Synkinesis. Completed, enrolled 15 participants across 1 site.
Detailed 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 \[Perception of Emotion Expression in Clinical Populations with Facial Paralysis, IRB approval 2015-0366\].
Study Details
Timeline
Interventions
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.