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NCT04148872 · ClinicalTrials.gov registry record · Phase 4
Mixed Methods Investigation of Chronic Facial Paralysis in Individuals With Synkinesis
A Phase 4 study, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Phase 4
- Development phase
- 15
- Enrollment target
NCT04148872 is a Phase 4 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 15 participants.
The verdict
NCT04148872, a Phase 4 study, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 15 participants
- Enrollment target
Study 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 \[Perception of Emotion Expression in Clinical Populations with Facial Paralysis, IRB approval 2015-0366\].
Interventions
- OTHER Neuromuscular Retraining Therapy (4 months)
- DRUG Chemodenervation (4 months)
- OTHER Neuromuscular Retraining + Chemodenervation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2019-10-24 |
| Est. Completion | 2021-08-24 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04148872
The ClinicalTrials.gov registry entry for NCT04148872 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Neuromuscular Retraining Therapy (4 months) is the first listed.
NCT04148872 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04148872 about?
NCT04148872 is a clinical study titled "Mixed Methods Investigation of Chronic Facial Paralysis in Individuals With Synkinesis". 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...
What is the current status of trial NCT04148872?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2019-10-24. Estimated completion is 2021-08-24.
What interventions are being tested in trial NCT04148872?
The interventions under investigation include: Neuromuscular Retraining Therapy (4 months) (OTHER), Chemodenervation (4 months) (DRUG), Neuromuscular Retraining + Chemodenervation (OTHER).
Who is sponsoring clinical trial NCT04148872?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
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