CompletedPhase 4

Mixed Methods Investigation of Chronic Facial Paralysis in Individuals With Synkinesis

United States15 participantsStarted 2019-10-24

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

Who can participate

Age range

18 Years – 89 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Sunnybrook Facial Grading System (SFGS) Between Baseline and 4 Month Scoring

Timeframe: up to 4 months

Sunnybrook Facial Grading System (SFGS) at Baseline

Timeframe: Baseline

Sunnybrook Facial Grading System (SFGS) at 4 Months

Timeframe: 4 months

Sunnybrook Facial Grading System (SFGS) at 8 Months

Timeframe: 8 months

Trial details

NCT IDNCT04148872

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-08-24

Results submitted2022-08-10

View on ClinicalTrials.gov More Synkinesis trials