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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: Completed Phase 4 study, sponsored by University of Wisconsin, Madison.

NCT04148872 is a Phase 4 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 15 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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

Primary Outcome

Participants will be videotaped as part of routine care and undergo a blinded SFGS scoring. Scoring is determined by a voluntary movement score (5-items scored from 1-5 where 1 is unable to move and 5 is complete voluntary movement - total range of 5-25, multiplied by 4, where a higher score is a better outcome) minus a resting symmetry score (total of 0-4 where 0 is normal and 4 indicates some asymmetry, multiplied by 5, where a lower score is a better outcome) minus a synkinesis score (5-items

Interventions

  • OTHER Neuromuscular Retraining Therapy (4 months)
  • DRUG Chemodenervation (4 months)
  • OTHER Neuromuscular Retraining + Chemodenervation

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2019-10-24
Est. Completion 2021-08-24
Phase Phase 4
University of Wisconsin, Madison

1,039 total trials

What the finished NCT04148872 record still lists

NCT04148872 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 3 interventions - of which Neuromuscular Retraining Therapy (4 months) is the first listed.

NCT04148872 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT04148872's enrollment target sits among peer trials

15 1880th of 2000 higher than 100 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04148872, the US trial registry maintained by the National Library of Medicine. NCT04148872 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.