Facial Paralysis, Facial Palsy, Peripheral Facial Palsy, Peripheral Facial Paralysis, Bell Palsy, Synkinesis
Conditions
Brief summary
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
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
Interventions
PROCEDUREBotox injection
Comparator, current gold standard
PROCEDURENeurotomy
Surgical procedure
Sponsors
Rebecka Ohm
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sunnybrook facial grading scale | Baseline, 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery | Improvement through less synkinesis and better voluntary movement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life questionnaire | 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery | Facial Clinimetric Evaluation Scale (FaCE) |
| Neurophysiological examination, electromyography (EMG). | 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), just before surgery, 6 and 12 months after surgery | Severity of synkinesis evaluation using EMG calculations (turns and root mean square (RMS)) compared to the healthy hemiface (reference). |
| Number of Botox injections | Baseline, 12 months after surgery | Decrease to no future need |
| Side effects | Baseline, 2-4 weeks after Botox (max effect), 6 and 12 months after surgery | Clavien-Dindo Classification |
Countries
Sweden
Contacts
Primary ContactRebecka Ohm, MD, PhDStud.
Outcome results
None listed