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| ID | Type | Description | Link |
|---|---|---|---|
| A539770 | Other Identifier | UW Madison | |
| SMPH/SURGERY/SURGERY*OT | Other Identifier | UW Madison | |
| Protocol Version 4/15/2020 | Other Identifier | UW Madison |
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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].
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neuromuscular Retraining Therapy | Active Comparator | Neuromuscular retraining therapy alone for four months, with botulinum toxin injection added during an additional four month period. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott R Chaiet, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Neuromuscular Retraining Therapy | Neuromuscular retraining therapy alone for four months, with botulinum toxin injection added during an additional four month period. 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. Neuromuscular Retraining + Chemodenervation: Participants will receive both interventions for the last 4 months of their time on study. |
| FG001 | Chemodenervation | 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. Chemodenervation (4 months): A neurotoxin that temporarily reduces muscle activity and minimizes the effects of uncoordinated muscle. Neuromuscular Retraining + Chemodenervation: Participants will receive both interventions for the last 4 months of their time on study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Neuromuscular Retraining Therapy | Neuromuscular retraining therapy alone for four months, with botulinum toxin injection added during an additional four month period. 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. Neuromuscular Retraining + Chemodenervation: Participants will receive both interventions for the last 4 months of their time on study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | up to 4 months |
|
8 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neuromuscular Retraining Therapy | Neuromuscular retraining therapy alone for four months, with botulinum toxin injection added during an additional four month period. 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. Neuromuscular Retraining + Chemodenervation: Participants will receive both interventions for the last 4 months of their time on study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Chaiet, MD | University of Wisconsin - Madison | 608-263-0192 | chaiet@surgery.wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 15, 2020 | Aug 2, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D046608 | Synkinesis |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D009407 | Nerve Block |
| D019274 | Botulinum Toxins, Type A |
| C545476 | incobotulinumtoxinA |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D003714 | Denervation |
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| Chemodenervation (4 months) | Drug | A neurotoxin that temporarily reduces muscle activity and minimizes the effects of uncoordinated muscle. |
|
|
| Neuromuscular Retraining + Chemodenervation | Other | Participants will receive both interventions for the last 4 months of their time on study. |
|
| 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 |
| 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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. | 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. | up to 4 months |
| BG001 | Chemodenervation | 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. Chemodenervation (4 months): A neurotoxin that temporarily reduces muscle activity and minimizes the effects of uncoordinated muscle. Neuromuscular Retraining + Chemodenervation: Participants will receive both interventions for the last 4 months of their time on study. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Diagnosis | Count of Participants | Participants |
|
| Laterality | Count of Participants | Participants |
|
| Cause of Facial Palsy | Count of Participants | Participants |
|
Neuromuscular retraining therapy alone for four months, with botulinum toxin injection added during an additional four month period.
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.
Neuromuscular Retraining + Chemodenervation: Participants will receive both interventions for the last 4 months of their time on study.
| OG001 | Chemodenervation | 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. Chemodenervation (4 months): A neurotoxin that temporarily reduces muscle activity and minimizes the effects of uncoordinated muscle. Neuromuscular Retraining + Chemodenervation: Participants will receive both interventions for the last 4 months of their time on study. |
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | 4 months |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | 8 months |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | 4 months |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | up to 8 months |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
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| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | 4 months |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | 8 months |
|
|
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| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
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| Secondary | 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). | 2 participants in the Chemodenervation arm did not progress to 4 months on study and therefore were not analyzed for this measure at this timepoint. | Posted | Mean | Standard Deviation | score on a scale | 4 months |
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| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | up to 8 months |
|
|
|
| Secondary | 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. | Data were not collected. | Posted | up to 8 months |
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | up to 4 months |
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| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 4 months |
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| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 8 months |
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| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Chemodenervation | 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. Chemodenervation (4 months): A neurotoxin that temporarily reduces muscle activity and minimizes the effects of uncoordinated muscle. Neuromuscular Retraining + Chemodenervation: Participants will receive both interventions for the last 4 months of their time on study. | 0 | 8 | 0 | 8 | 0 | 8 |
Not provided
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D019635 |
| Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| Got worse |
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| Not discussed |
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| Perception on Symptom Control |
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| Concern about the disease |
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| Disease Understanding |
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| Perception of Emotional Impact |
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| Overall facial tightness |
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| Tension in forehead |
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| Tightness in cheek |
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| Tightness in mouth |
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| Tightness in neck |
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| Pain from tightness/spasms |
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| Control while eating/drinking |
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| Smile |
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| Enunciation |
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| Other mouth control |
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| Control over eye trigger |
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| Eye closing too much (triggered) |
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| Eye closing too much (at rest) |
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| Eye watering |
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| General control of muscles |
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| Facial asymmetry |
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| Sounds in ear |
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