SynkinesisPhase 4NCT04148872
Mixed Methods Investigation of Chronic Facial Paralysis in Individuals With Synkinesis
A Phase 4 study testing Neuromuscular Retraining Therapy (4 months), Chemodenervation (4 months) and Neuromuscular Retraining + Chemodenervation in people with Synkinesis, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Synkinesis
- What is being tested?
- Neuromuscular Retraining Therapy (4 months), Chemodenervation (4 months) and Neuromuscular Retraining + Chemodenervation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2019to 24 Aug 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mixed Methods Investigation of Chronic Facial Paralysis in Individuals With Synkinesis: Study of Outcomes Before and After Treatment
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].
Read the detailed description
Facial nerve paralysis is a devastating event that in up to 30% of cases may result in chronic weakness and/or the disfiguring condition of synkinesis, a long-lasting muscle discoordination of facial movement caused by aberrant facial nerve regeneration after facial nerve paralysis. This is believed to have a detrimental effect on social interactions, mental health, and quality of life.
Neuromuscular retraining therapy and ipsilateral chemodenervation into discoordinated muscles by injection (onabotulinumtoxinA/Botox, Allergan or incobotulinumtoxinA/Xeomin, Merz) are two common treatments for the abnormal muscle movements found in synkinesis. No study has compared the effectiveness of these treatment modalities for synkinesis. Retrospective data including our series at the University of Wisconsin Facial Nerve Clinic show significant benefit of retraining therapy using clinician- and patient-reported outcome measures. However, the manner in which this therapy may be optimized for use in treatment of the sequelae of facial paralysis is unclear. While literature shows beneficial improvement in outcomes with chemodenervation in prospective studies, no study has explored the effectiveness of physical therapy for synkinesis in a controlled, prospective manner. Further, the efficacy of therapy has not been shown to improve recognition and emotional information interpretation, both thought to be impaired in synkinesis.
This study has 3 specific aims:
AIM 1: Determine the effect of neuromuscular retraining or chemodenervation on clinician-reported and patient-reported outcomes. The primary outcome measure after four and eight months of treatment will be the clinician-reported Sunnybrook Facial Grading System (SFGS) scored on participant videos by blinded reviewers. Further, the investigators seek to measure the efficacy of treatment with existing patient-reported instruments. A correlation of clinician-reported outcome measure changes to changes in patient-reported instruments with treatment will be calculated, including the widely utilized disease specific Synkinesis Assessment Questionnaire (SAQ) and Facial Clinimetric Evaluation Scale (FaCE), and with two disease non-specific instruments, the Hospital Anxiety and Depression Scale (HADS), and Brief-Illness Perception Questionnaire (BIPQ). The efficacy of our clinical intervention will be measured with social-perceptual and mental health outcome measurement before and after treatment (AIM 3).
AIM 2: Determine the social, emotional, and functional burden of synkinesis, not captured in current patient-reported outcome measures as well as effect of treatment. Qualitative interviews with individual participants collected before treatment, after four months of treatment, and after eight months of treatment will be analyzed to study the burden of disease, experience with treatment, and potential differences in both treatments. The primary outcome is to identify the domains that may be missing from existing patient-reported measures collected in AIM 1. To do this, findings to assessment domains (i.e. decreased engagement, negative mood, etc.) in the FaCE, SAQ, and the two disease non-specific instruments, HADS and BIPQ will be compared. The investigators will then evaluate their findings based on domains in Patient-Reported Outcomes Measurement Information System (PROMIS) measures, an NIH-supported collection of validated and standardized scales.
AIM 3: Quantify the disruption in social functioning caused by synkinesis using innovative social-perceptual outcomes and emotion recognition tasks. Prior to treatment, participants will enroll in IRB Protocol 2015-0366 and complete a series of social functioning and mental health instruments and emotion expression recognition tasks. Results will be compared to control participants without facial disability to reveal the social-perceptual impairment attributable to synkinesis. Repetition of these tasks after four months of either treatment may show improvement in recognition and emotional information interpretation when compared to initial measurements.
- Conditions
- Synkinesis
- Being tested
- Neuromuscular Retraining Therapy (4 months), Chemodenervation (4 months), Neuromuscular Retraining + Chemodenervation
- Medical subject headings
- Synkinesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Chemodenervation (4 months)Drug
Also called onabotulinumtoxin A, Botox, incobotulinumtoxin A, Xeomin
A neurotoxin that temporarily reduces muscle activity and minimizes the effects of uncoordinated muscle.
Neuromuscular Retraining + ChemodenervationOther
Participants will receive both interventions for the last 4 months of their time on study.
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular Retraining Therapy | Active comparator | Neuromuscular retraining therapy alone for four months, with botulinum toxin injection added during an additional four month period. Receives: 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. Receives: Drug: Chemodenervation (4 months); Other: Neuromuscular Retraining + Chemodenervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 months
Secondary outcomes (14)
Synkinesis Assessment Questionnaire (SAQ) at Baseline
The SAQ is a 9-item questionnaire where each item is scored on a scale from 1-5, 1 is seldom or not at all, and 5 is all of the time, or severely. A higher score indicates a worse outcome. The total range in possible scores is 9-100 (summate scores for questions 1-9/45x100 = SAQ total score) with higher scores indicating more severe facial paralysis symptoms. SAQ scores will be collected as part of routine care throughout the study. Scores will be reported for baseline, 4 months (mid-study), and 8 months (end of study).
Measured: Baseline
Synkinesis Assessment Questionnaire (SAQ) at 4 Months
The SAQ is a 9-item questionnaire where each item is scored on a scale from 1-5, 1 is seldom or not at all, and 5 is all of the time, or severely. A higher score indicates a worse outcome. The total range in possible scores is 9-100 (summate scores for questions 1-9/45x100 = SAQ total score) with higher scores indicating more severe facial paralysis symptoms. SAQ scores will be collected as part of routine care throughout the study. Scores will be reported for baseline, 4 months (mid-study), and 8 months (end of study).
Measured: 4 months
Synkinesis Assessment Questionnaire (SAQ) at 8 Months
The SAQ is a 9-item questionnaire where each item is scored on a scale from 1-5, 1 is seldom or not at all, and 5 is all of the time, or severely. A higher score indicates a worse outcome. The total range in possible scores is 9-100 (summate scores for questions 1-9/45x100 = SAQ total score) with higher scores indicating more severe facial paralysis symptoms. SAQ scores will be collected as part of routine care throughout the study. Scores will be reported for baseline, 4 months (mid-study), and 8 months (end of study).
Measured: 8 months
Facial Clinimetric Evaluation Scale (FaCE) at Baseline
The FaCE scale is 15-item self-report survey to assess the symptoms of facial paralysis in the past week. The total possible range of scores is 15-100 where the higher the score, the lesser the symptoms. Scores will be reported for baseline, 4 months (mid-study), and 8 months (end of study).
Measured: Baseline
Facial Clinimetric Evaluation Scale (FaCE) at 4 Months
The FaCE scale is 15-item self-report survey to assess the symptoms of facial paralysis in the past week. The total possible range of scores is 15-100 where the higher the score, the lesser the symptoms. Scores will be reported for baseline, 4 months (mid-study), and 8 months (end of study).
Measured: 4 months
Facial Clinimetric Evaluation Scale (FaCE) at 8 Months
The FaCE scale is 15-item self-report survey to assess the symptoms of facial paralysis in the past week. The total possible range of scores is 15-100 where the higher the score, the lesser the symptoms. Scores will be reported for baseline, 4 months (mid-study), and 8 months (end of study).
Measured: up to 8 months
Hospital Anxiety and Depression Scale (HADS) at Baseline
The HADS instrument measures anxiety and depressive tendency. 7-items are scored for depression with a total score of 0-21 where the higher the score, the more symptoms of depression. 7-items are scored for anxiety with a total score of 0-21 where the higher the score, the more symptoms of anxiety. Scores will be reported for baseline, 4 months (mid-study), and 8 months (end of study).
Measured: Baseline
Hospital Anxiety and Depression Scale (HADS) at 4 Months
The HADS instrument measures anxiety and depressive tendency. 7-items are scored for depression with a total score of 0-21 where the higher the score, the more symptoms of depression. 7-items are scored for anxiety with a total score of 0-21 where the higher the score, the more symptoms of anxiety. Scores will be reported for baseline, 4 months (mid-study), and 8 months (end of study).
Measured: 4 months
Hospital Anxiety and Depression Scale (HADS) at 8 Months
The HADS instrument measures anxiety and depressive tendency. 7-items are scored for depression with a total score of 0-21 where the higher the score, the more symptoms of depression. 7-items are scored for anxiety with a total score of 0-21 where the higher the score, the more symptoms of anxiety. Scores will be reported for baseline, 4 months (mid-study), and 8 months (end of study).
Measured: 8 months
Brief-Illness Perception Questionnaire (BIPQ) at Baseline
The BIPQ is a 9-item questionnaire, where the first 8-items are scored from 0-10. To determine a composite score, items 3, 4, and 7 should be reversed scored and added to 1, 2, 5, 6, and 8 (total range of possible scores from 0-80). The higher the score the more threatening the illness is perceived to be. Scores will be reported for baseline, 4 months (mid-study), and 8 months (end of study).
Measured: Baseline
Brief-Illness Perception Questionnaire (BIPQ) at 4 Months
The BIPQ is a 9-item questionnaire, where the first 8-items are scored from 0-10. To determine a composite score, items 3, 4, and 7 should be reversed scored and added to 1, 2, 5, 6, and 8 (total range of possible scores from 0-80). The higher the score the more threatening the illness is perceived to be. Scores will be reported for baseline, 4 months (mid-study), and 8 months (end of study).
Measured: 4 months
Brief-Illness Perception Questionnaire (BIPQ) at 8 Months
The BIPQ is a 9-item questionnaire, where the first 8-items are scored from 0-10. To determine a composite score, items 3, 4, and 7 should be reversed scored and added to 1, 2, 5, 6, and 8 (total range of possible scores from 0-80). The higher the score the more threatening the illness is perceived to be. Scores will be reported for baseline, 4 months (mid-study), and 8 months (end of study).
Measured: up to 8 months
Pre-Treatment Qualitative Interviews
Qualitative analysis will proceed concurrently with data collection to allow identified themes to be explored in subsequent interviews. In qualitative research this involves both coding the written transcripts and then modeling the coded data. All team members will analyze the data and look for themes and trends that are emergent from the data. For the pre-treatment interviews, Conventional Content Analysis will be employed to obtain direct information from study participants without imposing preconceived categories or theoretical perspectives.
Measured: up to 8 months
Post-Treatment Qualitative Interviews
Qualitative analysis will proceed concurrently with data collection to allow identified themes to be explored in subsequent interviews. In qualitative research this involves both coding the written transcripts and then modeling the coded data. All team members will analyze the data and look for themes and trends that are emergent from the data. For post-treatment interviews, directed content analysis will be employed as findings from pre-treatment interviews will guide analysis of post-treatment interviews while capturing emergent themes that come up in the data.
Measured: up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start24 Oct 2019
- Primary completion24 Aug 2021
- Study completion24 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SynkinesisStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott R Chaiet, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148872
- Sponsor's protocol ID
- 2019-0406
- Other IDs
- A539770, SMPH/SURGERY/SURGERY*OT, Protocol Version 4/15/2020
- Status last verified
- Aug 2022
- First submitted
- 30 Oct 2019
- Last updated
- 29 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mixed Methods Investigation of Chronic Facial Paralysis in Individuals With Synkinesis: Study of Outcomes Before and After Treatment
- ClinicalTrials.gov ID
- NCT04148872
- Acronym / sponsor ID
- 2019-0406
- Conditions
- Synkinesis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- 24 Aug 2021 (actual)
- Study completion
- 24 Aug 2021 (actual)
- First posted
- 4 Nov 2019 (actual)
- Results
- Posted 29 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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].
Detailed description
Facial nerve paralysis is a devastating event that in up to 30% of cases may result in chronic weakness and/or the disfiguring condition of synkinesis, a long-lasting muscle discoordination of facial movement caused by aberrant facial nerve regeneration after facial nerve paralysis. This is believed to have a detrimental effect on social interactions, mental health, and quality of life.
Neuromuscular retraining therapy and ipsilateral chemodenervation into discoordinated muscles by injection (onabotulinumtoxinA/Botox, Allergan or incobotulinumtoxinA/Xeomin, Merz) are two common treatments for the abnormal muscle movements found in synkinesis. No study has compared the effectiveness of these treatment modalities for synkinesis. Retrospective data including our series at the University of Wisconsin Facial Nerve Clinic show significant benefit of retraining therapy using clinician- and patient-reported outcome measures. However, the manner in which this therapy may be optimized for use in treatment of the sequelae of facial paralysis is unclear. While literature shows beneficial improvement in outcomes with chemodenervation in prospective studies, no study has explored the effectiveness of physical therapy for synkinesis in a controlled, prospective manner. Further, the efficacy of therapy has not been shown to improve recognition and emotional information interpretation, both thought to be impaired in synkinesis.
This study has 3 specific aims:
AIM 1: Determine the effect of neuromuscular retraining or chemodenervation on clinician-reported and patient-reported outcomes. The primary outcome measure after four and eight months of treatment will be the clinician-reported Sunnybrook Facial Grading System (SFGS) scored on participant videos by blinded reviewers. Further, the investigators seek to measure the efficacy of treatment with existing patient-reported instruments. A correlation of clinician-reported outcome measure changes to changes in patient-reported instruments with treatment will be calculated, including the widely utilized disease specific Synkinesis Assessment Questionnaire (SAQ) and Facial Clinimetric Evaluation Scale (FaCE), and with two disease non-specific instruments, the Hospital Anxiety and Depression Scale (HADS), and Brief-Illness Perception Questionnaire (BIPQ). The efficacy of our clinical intervention will be measured with social-perceptual and mental health outcome measurement before and after treatment (AIM 3).
AIM 2: Determine the social, emotional, and functional burden of synkinesis, not captured in current patient-reported outcome measures as well as effect of treatment. Qualitative interviews with individual participants collected before treatment, after four months of treatment, and after eight months of treatment will be analyzed to study the burden of disease, experience with treatment, and potential differences in both treatments. The primary outcome is to identify the domains that may be missing from existing patient-reported measures collected in AIM 1. To do this, findings to assessment domains (i.e. decreased engagement, negative mood, etc.) in the FaCE, SAQ, and the two disease non-specific instruments, HADS and BIPQ will be compared. The investigators will then evaluate their findings based on domains in Patient-Reported Outcomes Measurement Information System (PROMIS) measures, an NIH-supported collection of validated and standardized scales.
AIM 3: Quantify the disruption in social functioning caused by synkinesis using innovative social-perceptual outcomes and emotion recognition tasks. Prior to treatment, participants will enroll in IRB Protocol 2015-0366 and complete a series of social functioning and mental health instruments and emotion expression recognition tasks. Results will be compared to control participants without facial disability to reveal the social-perceptual impairment attributable to synkinesis. Repetition of these tasks after four months of either treatment may show improvement in recognition and emotional information interpretation when compared to initial measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular Retraining Therapy | Active comparator | Other: Neuromuscular Retraining Therapy (4 months), Other: Neuromuscular Retraining + ChemodenervationNeuromuscular retraining therapy alone for four months, with botulinum toxin injection added during an additional four month period. |
| Chemodenervation | Active comparator | Drug: Chemodenervation (4 months), Other: Neuromuscular Retraining + ChemodenervationIpsilateral 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular Retraining Therapy (4 months)Neuromuscular retraining is an intervention where facial therapists utilize voluntary input to access improved movement patterns in patients with synkinesis. | Other | Neuromuscular Retraining Therapy |
| Chemodenervation (4 months)Also: onabotulinumtoxin A, Botox, incobotulinumtoxin A, XeominA neurotoxin that temporarily reduces muscle activity and minimizes the effects of uncoordinated muscle. | Drug | Chemodenervation |
| Neuromuscular Retraining + ChemodenervationParticipants will receive both interventions for the last 4 months of their time on study. | Other | Chemodenervation, Neuromuscular Retraining Therapy |
Primary outcome
Change in Sunnybrook Facial Grading System (SFGS) Between Baseline and 4 Month Scoring
Time frame: up to 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. Scores from baseline will be compared to those at 4 months and the change between the two will be reported.
Sunnybrook Facial Grading System (SFGS) at Baseline
Time frame: 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.
Sunnybrook Facial Grading System (SFGS) at 4 Months
Time frame: 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.
Sunnybrook Facial Grading System (SFGS) at 8 Months
Time frame: 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.
14 secondary outcomes
Synkinesis Assessment Questionnaire (SAQ) at Baseline
Time frame: Baseline
Synkinesis Assessment Questionnaire (SAQ) at 4 Months
Time frame: 4 months
Synkinesis Assessment Questionnaire (SAQ) at 8 Months
Time frame: 8 months
Facial Clinimetric Evaluation Scale (FaCE) at Baseline
Time frame: Baseline
Facial Clinimetric Evaluation Scale (FaCE) at 4 Months
Time frame: 4 months
Facial Clinimetric Evaluation Scale (FaCE) at 8 Months
Time frame: up to 8 months
Hospital Anxiety and Depression Scale (HADS) at Baseline
Time frame: Baseline
Hospital Anxiety and Depression Scale (HADS) at 4 Months
Time frame: 4 months
Hospital Anxiety and Depression Scale (HADS) at 8 Months
Time frame: 8 months
Brief-Illness Perception Questionnaire (BIPQ) at Baseline
Time frame: Baseline
Brief-Illness Perception Questionnaire (BIPQ) at 4 Months
Time frame: 4 months
Brief-Illness Perception Questionnaire (BIPQ) at 8 Months
Time frame: up to 8 months
Pre-Treatment Qualitative Interviews
Time frame: up to 8 months
Post-Treatment Qualitative Interviews
Time frame: up to 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Peripheral Facial Palsy, Rehabilitation
RecruitingObservational study
Genetic Studies of Strabismus, Congenital Cranial Dysinnervation Disorders (CCDDs), and Their Associated Anomalies
Congenital Fibrosis of Extraocular Muscles, Duane Retraction Syndrome
Enrolling by invitation
Motor Imagery and Mirror Therapy on Synkinesis, Facial Asymmetry, Facial Function and QoF in Bell's Palsy Patients.
Bell Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott R Chaiet, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Neuromuscular Retraining Therapy (4 months), Chemodenervation (4 months) and Neuromuscular Retraining + Chemodenervation in people with Synkinesis, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sunnybrook Facial Grading System (SFGS) Between Baseline and 4 Month Scoring (time frame: up to 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2022.