The purpose of this study is to evaluate neurotomy as an alternative treatment to Botox injections for severe synkinesis following peripheral facial palsy
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
73
Comparator, current gold standard
Surgical procedure
Karolinska University Hospital/Karolinska Institute
Stockholm, Sweden
RECRUITINGSunnybrook facial grading scale
Improvement through less synkinesis and better voluntary movement
Time frame: Baseline, 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery
Quality of life questionnaire
Facial Clinimetric Evaluation Scale (FaCE)
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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
Time frame: Baseline, 12 months after surgery
Side effects
Clavien-Dindo Classification
Time frame: Baseline, 2-4 weeks after Botox (max effect), 6 and 12 months after surgery
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Side effects
Free text, in order to capture all possible side effects of treatments.
Time frame: Baseline, 2-4 weeks after Botox (max effect), 6 and 12 months after surgery