Mixed Methods Investigation of Chronic Facial Paralysis in Individuals With Synkinesis

NCT04148872 | Completed Phase 4 Results DMC FDA Drug

• 4 other identifiers: 2019-0406A539770SMPH/SURGERY/SURGERY*OTProtocol Version 4/15/2020
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Synkinesis

Outcome Measures

Primary Outcomes (4)

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

  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 scored from 0-3 where 0 is none and 3 is severe, a lower score is a better outcome). Total possible range of scores is 20-100, with a higher score being a better outcome. Scores from baseline will be compared to those at 4 months and the change between the two will be reported.

  up to 4 months

• Sunnybrook Facial Grading System (SFGS) at Baseline

  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 scored from 0-3 where 0 is none and 3 is severe, a lower score is a better outcome). Total possible range of scores is 20-100, with a higher score being a better outcome.

  Baseline

• Sunnybrook Facial Grading System (SFGS) at 4 Months

  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 scored from 0-3 where 0 is none and 3 is severe, a lower score is a better outcome). Total possible range of scores is 20-100, with a higher score being a better outcome.

  4 months

• Sunnybrook Facial Grading System (SFGS) at 8 Months

  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 scored from 0-3 where 0 is none and 3 is severe, a lower score is a better outcome). Total possible range of scores is 20-100, with a higher score being a better outcome.

  8 months

Secondary Outcomes (14)

• Synkinesis Assessment Questionnaire (SAQ) at Baseline

  Baseline

• Synkinesis Assessment Questionnaire (SAQ) at 4 Months

  4 months

• Synkinesis Assessment Questionnaire (SAQ) at 8 Months

  8 months

• Facial Clinimetric Evaluation Scale (FaCE) at Baseline

  Baseline

• Facial Clinimetric Evaluation Scale (FaCE) at 4 Months

  4 months

Study Arms (2)

Neuromuscular Retraining Therapy

ACTIVE COMPARATOR

Neuromuscular retraining therapy alone for four months, with botulinum toxin injection added during an additional four month period.

Other: Neuromuscular Retraining Therapy (4 months); Other: Neuromuscular Retraining + Chemodenervation

Chemodenervation

ACTIVE COMPARATOR

Ipsilateral chemodenervation with botulinum toxin injections alone for four months (onabotulinumtoxinA/Botox, Allergan or incobotulinumtoxinA/Xeomin, Merz), with neuromuscular retraining therapy added for an additional four months.

Drug: Chemodenervation (4 months); Other: Neuromuscular Retraining + Chemodenervation

Interventions

Neuromuscular Retraining Therapy (4 months) OTHER

Neuromuscular retraining is an intervention where facial therapists utilize voluntary input to access improved movement patterns in patients with synkinesis.

Neuromuscular Retraining Therapy

Chemodenervation (4 months) DRUG

A neurotoxin that temporarily reduces muscle activity and minimizes the effects of uncoordinated muscle.

Also known as: onabotulinumtoxin A, Botox, incobotulinumtoxin A, Xeomin

Chemodenervation

Neuromuscular Retraining + Chemodenervation OTHER

Participants will receive both interventions for the last 4 months of their time on study.

Chemodenervation; Neuromuscular Retraining Therapy

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Synkinesis

Interventions

Nerve Block; Botulinum Toxins, Type A; incobotulinumtoxinA

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Scott Chaiet, MD
• Organization: University of Wisconsin - Madison

chaiet@surgery.wisc.edu

608-263-0192

Study Officials

• Scott R Chaiet, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 4, 2019
• Study Start: October 24, 2019
• Primary Completion: August 24, 2021
• Study Completion: August 24, 2021
• Last Updated: September 29, 2022
• Results First Posted: September 29, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)