Neurotomy to Treat Synkinesis Following Peripheral Facial Palsy

Study Overview
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Brief Summary
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The purpose of this study is to evaluate neurotomy as an alternative treatment to Botox injections for severe synkinesis following peripheral facial palsy

Detailed Description
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Patients with severe synkinesis treated at Karolinska University Hospital with Botox injections with unsatisfying results are invited to participate in this study aiming to evaluate surgical neurotomy to synkinesis causing branches of the facial nerve. Surgical procedure: Small branches of the facial nerve are identified under microscopic magnification. Using a precise nerve stimulator the movement each nerve branch elicits is evaluated as normal or synkinetic. Pathological branches are then parted while normal functioning nerve branches are left intact. Evaluation procedure: Study participants are measured in a multimodal manner at 5 different time points during the study period; at study start, with and without Botox effect before surgery, and at 6 and 12 months after surgery. Evaluation methods: Clinical evaluation with Sunnybrook facial grading scale, blinded to observer from video recordings at the end of the study Neurophysiological measurements, Quality of life, measured with validated questionnaires FaCE, FDI, SAQ Reports of potential side effects, using Clavien-Dindo classification as well as free text

Official Title
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Neurotomy to Treat Synkinesis Following Peripheral Facial Palsy

Conditions
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Facial Paralysis, Facial Palsy, Peripheral Facial Palsy, Peripheral Facial Paralysis, Bell Palsy, Synkinesis

Intervention / Treatment
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* Procedure: Botox injection
* Procedure: Neurotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Synkinesis following peripheral facial palsy Sunnybrook score <61 Botox injections at least 3 times a year Have received at least 3 Botox injections Botox injections not satisfying treatment Read and signed written consent Exclusion Criteria: Synkinesis since less than 2 years Contractures in facial muscles Other planned surgery in the face during study period Smoking Uncontrolled hypertension Diabetes mellitus Pregnancy or breast feeding Severe systemic disease (ASA 3-4)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: All study participants are evaluated with and without the effect Botox treatment before surgery. Botox is the gold standard treatment and used as a comparator. As all study patients have failed current evidence based treatment options, a comparative group not receiving treatment would imply a strong information bias.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Botox<br> | Procedure: Botox injection<br>* Comparator, current gold standard<br>Procedure: Neurotomy<br>* Surgical procedure<br>|
| Experimental: Neurotomy<br> | Procedure: Botox injection<br>* Comparator, current gold standard<br>Procedure: Neurotomy<br>* Surgical procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sunnybrook facial grading scale | Improvement through less synkinesis and better voluntary movement | Baseline, 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life questionnaire | Facial Clinimetric Evaluation Scale (FaCE) | 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery | 
| Quality of life questionnaire | Facial Disability Index (FDI) | 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery | 
| Quality of life questionnaire | Synkinesis Assessment Questionnaire (SAQ) | 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery | 
| Neurophysiological examination, electromyography (EMG). | Severity of synkinesis evaluation using EMG calculations (turns and root mean square (RMS)) compared to the healthy hemiface (reference). | 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), just before surgery, 6 and 12 months after surgery | 
| Number of Botox injections | Decrease to no future need | Baseline, 12 months after surgery | 
| Side effects | Clavien-Dindo Classification | Baseline, 2-4 weeks after Botox (max effect), 6 and 12 months after surgery | 
| Side effects | Free text, in order to capture all possible side effects of treatments. | Baseline, 2-4 weeks after Botox (max effect), 6 and 12 months after surgery |