Trial Outcomes & Findings for Mixed Methods Investigation of Chronic Facial Paralysis in Individuals With Synkinesis (NCT NCT04148872)

Last Updated: 2022-09-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

15 participants

Primary outcome timeframe

up to 4 months

Results posted on

2022-09-29

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	7	8
Overall Study COMPLETED	5	7
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mixed Methods Investigation of Chronic Facial Paralysis in Individuals With Synkinesis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Neuromuscular Retraining Therapy n=7 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.	Chemodenervation n=8 Participants 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.	Total n=15 Participants Total of all reporting groups
Age, Continuous	51.57 years n=5 Participants	49.88 years n=7 Participants	50.67 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	8 participants n=7 Participants	15 participants n=5 Participants
Diagnosis Facial nerve paralysis: mixed with Synkinesis	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Diagnosis Facial nerve paralysis: Synkinesis only	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Laterality Right	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Laterality Left	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Cause of Facial Palsy Bell's	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Cause of Facial Palsy Ramsay-Hunt	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Cause of Facial Palsy Trauma	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Cause of Facial Palsy Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 4 months

Outcome measures

Outcome measures
Measure	Neuromuscular Retraining Therapy n=7 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.	Chemodenervation n=7 Participants 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.
Change in Sunnybrook Facial Grading System (SFGS) Between Baseline and 4 Month Scoring	0.29 score on a scale Standard Deviation 4.72	5.86 score on a scale Standard Deviation 3.72

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Neuromuscular Retraining Therapy n=7 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.	Chemodenervation n=7 Participants 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.
Sunnybrook Facial Grading System (SFGS) at Baseline	65.71 score on a scale Standard Deviation 9.30	54.29 score on a scale Standard Deviation 13.21

PRIMARY outcome

Timeframe: 4 months

Outcome measures

Outcome measures
Measure	Neuromuscular Retraining Therapy n=7 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.	Chemodenervation n=7 Participants 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.
Sunnybrook Facial Grading System (SFGS) at 4 Months	66.00 score on a scale Standard Deviation 6.98	60.14 score on a scale Standard Deviation 10.90

PRIMARY outcome

Timeframe: 8 months

Outcome measures

Outcome measures
Measure	Neuromuscular Retraining Therapy n=3 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.	Chemodenervation n=4 Participants 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.
Sunnybrook Facial Grading System (SFGS) at 8 Months	73.00 score on a scale Standard Deviation 8.89	60.25 score on a scale Standard Deviation 4.03

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Neuromuscular Retraining Therapy n=7 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.	Chemodenervation n=7 Participants 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.
Synkinesis Assessment Questionnaire (SAQ) at Baseline	54.92 score on a scale Standard Deviation 11.67	52.70 score on a scale Standard Deviation 23.68

SECONDARY outcome

Timeframe: 4 months

Outcome measures

Outcome measures
Measure	Neuromuscular Retraining Therapy n=6 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.	Chemodenervation n=7 Participants 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.
Synkinesis Assessment Questionnaire (SAQ) at 4 Months	64.07 score on a scale Standard Deviation 15.55	63.18 score on a scale Standard Deviation 16.22

SECONDARY outcome

Timeframe: 8 months

Outcome measures

Outcome measures
Measure	Neuromuscular Retraining Therapy n=3 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.	Chemodenervation n=4 Participants 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.
Synkinesis Assessment Questionnaire (SAQ) at 8 Months	55.55 score on a scale Standard Deviation 16.02	56.67 score on a scale Standard Deviation 26.26

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Neuromuscular Retraining Therapy n=7 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.	Chemodenervation n=7 Participants 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.
Facial Clinimetric Evaluation Scale (FaCE) at Baseline	56.43 score on a scale Standard Deviation 15.85	42.14 score on a scale Standard Deviation 25.80

SECONDARY outcome

Timeframe: 4 months

Outcome measures

Outcome measures
Measure	Neuromuscular Retraining Therapy n=7 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.	Chemodenervation n=7 Participants 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.
Facial Clinimetric Evaluation Scale (FaCE) at 4 Months	63.10 score on a scale Standard Deviation 13.28	45.95 score on a scale Standard Deviation 21.45

SECONDARY outcome

Timeframe: up to 8 months

Outcome measures

Outcome measures
Measure	Neuromuscular Retraining Therapy n=3 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.	Chemodenervation n=4 Participants 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.
Facial Clinimetric Evaluation Scale (FaCE) at 8 Months	71.67 score on a scale Standard Deviation 9.28	61.67 score on a scale Standard Deviation 11.63

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Neuromuscular Retraining Therapy n=7 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.	Chemodenervation n=7 Participants 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.
Hospital Anxiety and Depression Scale (HADS) at Baseline Anxiety	6.14 score on a scale Standard Deviation 4.30	10.29 score on a scale Standard Deviation 4.15
Hospital Anxiety and Depression Scale (HADS) at Baseline Depression	5.71 score on a scale Standard Deviation 3.15	7.00 score on a scale Standard Deviation 4.47

SECONDARY outcome

Timeframe: 4 months

Outcome measures

Outcome measures
Measure	Neuromuscular Retraining Therapy n=7 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.	Chemodenervation n=5 Participants 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.
Hospital Anxiety and Depression Scale (HADS) at 4 Months Anxiety	6.57 score on a scale Standard Deviation 3.26	8.00 score on a scale Standard Deviation 3.74
Hospital Anxiety and Depression Scale (HADS) at 4 Months Depression	4.14 score on a scale Standard Deviation 2.34	5.60 score on a scale Standard Deviation 5.13

SECONDARY outcome

Timeframe: 8 months

Outcome measures

Outcome measures
Measure	Neuromuscular Retraining Therapy n=6 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.	Chemodenervation n=6 Participants 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.
Hospital Anxiety and Depression Scale (HADS) at 8 Months Anxiety	6.67 score on a scale Standard Deviation 2.88	7.50 score on a scale Standard Deviation 3.67
Hospital Anxiety and Depression Scale (HADS) at 8 Months Depression	5.50 score on a scale Standard Deviation 2.35	2.67 score on a scale Standard Deviation 1.75

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Neuromuscular Retraining Therapy n=7 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.	Chemodenervation n=7 Participants 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.
Brief-Illness Perception Questionnaire (BIPQ) at Baseline	40.00 score on a scale Standard Deviation 8.31	51.43 score on a scale Standard Deviation 6.45

SECONDARY outcome

Timeframe: 4 months

Population: 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.

Outcome measures

Outcome measures
Measure	Neuromuscular Retraining Therapy n=7 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.	Chemodenervation n=5 Participants 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.
Brief-Illness Perception Questionnaire (BIPQ) at 4 Months	31.71 score on a scale Standard Deviation 7.16	45.40 score on a scale Standard Deviation 11.17

SECONDARY outcome

Timeframe: up to 8 months

Outcome measures

Outcome measures
Measure	Neuromuscular Retraining Therapy n=7 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.	Chemodenervation n=6 Participants 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.
Brief-Illness Perception Questionnaire (BIPQ) at 8 Months	32.57 score on a scale Standard Deviation 8.52	42.17 score on a scale Standard Deviation 7.52

SECONDARY outcome

Timeframe: up to 8 months

Population: Data were not collected.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 4 months

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.

Outcome measures

Outcome measures
Measure	Neuromuscular Retraining Therapy n=7 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.	Chemodenervation n=7 Participants 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.
Post-Treatment Qualitative Interviews Facial asymmetry · Not discussed	3 Participants	3 Participants
Post-Treatment Qualitative Interviews Sounds in ear · Stayed the same	0 Participants	1 Participants
Post-Treatment Qualitative Interviews Sounds in ear · Got worse	0 Participants	0 Participants
Post-Treatment Qualitative Interviews Sounds in ear · Not discussed	6 Participants	6 Participants
Post-Treatment Qualitative Interviews Perception of Impact on Life · Improved	2 Participants	4 Participants
Post-Treatment Qualitative Interviews Perception of Impact on Life · Stayed the same	4 Participants	1 Participants
Post-Treatment Qualitative Interviews Perception of Impact on Life · Got worse	1 Participants	2 Participants
Post-Treatment Qualitative Interviews Perception of Impact on Life · Not discussed	0 Participants	0 Participants
Post-Treatment Qualitative Interviews Perception on Symptom Control · Improved	6 Participants	2 Participants
Post-Treatment Qualitative Interviews Perception on Symptom Control · Stayed the same	0 Participants	4 Participants
Post-Treatment Qualitative Interviews Perception on Symptom Control · Got worse	0 Participants	1 Participants
Post-Treatment Qualitative Interviews Perception on Symptom Control · Not discussed	1 Participants	0 Participants
Post-Treatment Qualitative Interviews Concern about the disease · Improved	5 Participants	2 Participants
Post-Treatment Qualitative Interviews Concern about the disease · Stayed the same	1 Participants	4 Participants
Post-Treatment Qualitative Interviews Concern about the disease · Got worse	0 Participants	1 Participants
Post-Treatment Qualitative Interviews Concern about the disease · Not discussed	1 Participants	0 Participants
Post-Treatment Qualitative Interviews Disease Understanding · Improved	7 Participants	4 Participants
Post-Treatment Qualitative Interviews Disease Understanding · Stayed the same	0 Participants	3 Participants
Post-Treatment Qualitative Interviews Disease Understanding · Got worse	0 Participants	0 Participants
Post-Treatment Qualitative Interviews Disease Understanding · Not discussed	0 Participants	0 Participants
Post-Treatment Qualitative Interviews Perception of Emotional Impact · Improved	2 Participants	2 Participants
Post-Treatment Qualitative Interviews Perception of Emotional Impact · Stayed the same	5 Participants	5 Participants
Post-Treatment Qualitative Interviews Perception of Emotional Impact · Got worse	0 Participants	0 Participants
Post-Treatment Qualitative Interviews Perception of Emotional Impact · Not discussed	0 Participants	0 Participants
Post-Treatment Qualitative Interviews Overall facial tightness · Improved	4 Participants	4 Participants
Post-Treatment Qualitative Interviews Overall facial tightness · Stayed the same	0 Participants	1 Participants
Post-Treatment Qualitative Interviews Overall facial tightness · Got worse	0 Participants	0 Participants
Post-Treatment Qualitative Interviews Overall facial tightness · Not discussed	3 Participants	2 Participants
Post-Treatment Qualitative Interviews Tension in forehead · Improved	1 Participants	1 Participants
Post-Treatment Qualitative Interviews Tension in forehead · Stayed the same	0 Participants	0 Participants
Post-Treatment Qualitative Interviews Tension in forehead · Got worse	0 Participants	0 Participants
Post-Treatment Qualitative Interviews Tension in forehead · Not discussed	6 Participants	6 Participants
Post-Treatment Qualitative Interviews Tightness in cheek · Improved	3 Participants	4 Participants
Post-Treatment Qualitative Interviews Tightness in cheek · Stayed the same	3 Participants	1 Participants
Post-Treatment Qualitative Interviews Tightness in cheek · Got worse	0 Participants	0 Participants
Post-Treatment Qualitative Interviews Tightness in cheek · Not discussed	1 Participants	2 Participants
Post-Treatment Qualitative Interviews Tightness in mouth · Improved	4 Participants	3 Participants
Post-Treatment Qualitative Interviews Tightness in mouth · Stayed the same	3 Participants	0 Participants
Post-Treatment Qualitative Interviews Tightness in mouth · Got worse	0 Participants	1 Participants
Post-Treatment Qualitative Interviews Tightness in mouth · Not discussed	0 Participants	3 Participants
Post-Treatment Qualitative Interviews Tightness in neck · Improved	0 Participants	3 Participants
Post-Treatment Qualitative Interviews Tightness in neck · Stayed the same	4 Participants	0 Participants
Post-Treatment Qualitative Interviews Tightness in neck · Got worse	0 Participants	0 Participants
Post-Treatment Qualitative Interviews Tightness in neck · Not discussed	3 Participants	4 Participants
Post-Treatment Qualitative Interviews Pain from tightness/spasms · Improved	3 Participants	4 Participants
Post-Treatment Qualitative Interviews Pain from tightness/spasms · Stayed the same	0 Participants	0 Participants
Post-Treatment Qualitative Interviews Pain from tightness/spasms · Got worse	0 Participants	0 Participants
Post-Treatment Qualitative Interviews Pain from tightness/spasms · Not discussed	4 Participants	3 Participants
Post-Treatment Qualitative Interviews Control while eating/drinking · Improved	6 Participants	6 Participants
Post-Treatment Qualitative Interviews Control while eating/drinking · Stayed the same	0 Participants	0 Participants
Post-Treatment Qualitative Interviews Control while eating/drinking · Got worse	0 Participants	1 Participants
Post-Treatment Qualitative Interviews Control while eating/drinking · Not discussed	1 Participants	0 Participants
Post-Treatment Qualitative Interviews Smile · Improved	6 Participants	4 Participants
Post-Treatment Qualitative Interviews Smile · Stayed the same	1 Participants	3 Participants
Post-Treatment Qualitative Interviews Smile · Got worse	0 Participants	0 Participants
Post-Treatment Qualitative Interviews Smile · Not discussed	0 Participants	0 Participants
Post-Treatment Qualitative Interviews Enunciation · Improved	1 Participants	2 Participants
Post-Treatment Qualitative Interviews Enunciation · Stayed the same	1 Participants	0 Participants
Post-Treatment Qualitative Interviews Enunciation · Got worse	0 Participants	1 Participants
Post-Treatment Qualitative Interviews Enunciation · Not discussed	5 Participants	4 Participants
Post-Treatment Qualitative Interviews Other mouth control · Improved	3 Participants	5 Participants
Post-Treatment Qualitative Interviews Other mouth control · Stayed the same	2 Participants	0 Participants
Post-Treatment Qualitative Interviews Other mouth control · Got worse	0 Participants	1 Participants
Post-Treatment Qualitative Interviews Other mouth control · Not discussed	2 Participants	1 Participants
Post-Treatment Qualitative Interviews Control over eye trigger · Improved	7 Participants	4 Participants
Post-Treatment Qualitative Interviews Control over eye trigger · Stayed the same	0 Participants	1 Participants
Post-Treatment Qualitative Interviews Control over eye trigger · Got worse	0 Participants	0 Participants
Post-Treatment Qualitative Interviews Control over eye trigger · Not discussed	0 Participants	2 Participants
Post-Treatment Qualitative Interviews Eye closing too much (triggered) · Improved	6 Participants	5 Participants
Post-Treatment Qualitative Interviews Eye closing too much (triggered) · Stayed the same	1 Participants	0 Participants
Post-Treatment Qualitative Interviews Eye closing too much (triggered) · Got worse	0 Participants	1 Participants
Post-Treatment Qualitative Interviews Eye closing too much (triggered) · Not discussed	0 Participants	1 Participants
Post-Treatment Qualitative Interviews Eye closing too much (at rest) · Improved	6 Participants	2 Participants
Post-Treatment Qualitative Interviews Eye closing too much (at rest) · Stayed the same	0 Participants	1 Participants
Post-Treatment Qualitative Interviews Eye closing too much (at rest) · Got worse	1 Participants	2 Participants
Post-Treatment Qualitative Interviews Eye closing too much (at rest) · Not discussed	0 Participants	2 Participants
Post-Treatment Qualitative Interviews Eye watering · Improved	5 Participants	2 Participants
Post-Treatment Qualitative Interviews Eye watering · Stayed the same	1 Participants	3 Participants
Post-Treatment Qualitative Interviews Eye watering · Got worse	0 Participants	1 Participants
Post-Treatment Qualitative Interviews Eye watering · Not discussed	1 Participants	1 Participants
Post-Treatment Qualitative Interviews General control of muscles · Improved	4 Participants	3 Participants
Post-Treatment Qualitative Interviews General control of muscles · Stayed the same	0 Participants	0 Participants
Post-Treatment Qualitative Interviews General control of muscles · Got worse	0 Participants	0 Participants
Post-Treatment Qualitative Interviews General control of muscles · Not discussed	3 Participants	4 Participants
Post-Treatment Qualitative Interviews Facial asymmetry · Improved	4 Participants	4 Participants
Post-Treatment Qualitative Interviews Facial asymmetry · Stayed the same	0 Participants	0 Participants
Post-Treatment Qualitative Interviews Facial asymmetry · Got worse	0 Participants	0 Participants
Post-Treatment Qualitative Interviews Sounds in ear · Improved	1 Participants	0 Participants

Adverse Events

Neuromuscular Retraining Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Chemodenervation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Scott Chaiet, MD

University of Wisconsin - Madison

Phone: 608-263-0192

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place