drugset / Trial / NCT04148872

Mixed Methods Investigation of Chronic Facial Paralysis in Individuals With Synkinesis

NCT04148872

Phase 4 Completed 15 enrolled University of Wisconsin, Madison
RandomizedParallel-groupSingle-blindTreatment

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 \[Perception of Emotion Expression in Clinical Populations with Facial Paralysis, IRB approval 2015-0366\].

Timeline

Start
2019-10-24
Primary completion
2021-08-24
Completion
2021-08-24

Drugs

EvaluationDrugModalityDoseRoute
Comparator Botulinum toxin type A Protein / enzyme biologic