Clinical trial NCT05191719: Neurotomy to Treat Synkinesis Following Peripheral Facial Palsy
Official title: Neurotomy to Treat Synkinesis Following Peripheral Facial Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Facial Paralysis
Facial Palsy
Peripheral Facial Palsy
Peripheral Facial Paralysis
Bell Palsy
Synkinesis
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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

Eligibility criteria: 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)

Primary outcomes:
measure: Sunnybrook facial grading scale
timeFrame: Baseline, 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery
Secondary outcomes:
measure: Quality of life questionnaire
timeFrame: 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery
measure: Quality of life questionnaire
timeFrame: 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery
measure: Quality of life questionnaire
timeFrame: 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery
measure: Neurophysiological examination, electromyography (EMG).
timeFrame: 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), just before surgery, 6 and 12 months after surgery
measure: Number of Botox injections
timeFrame: Baseline, 12 months after surgery
measure: Side effects
timeFrame: Baseline, 2-4 weeks after Botox (max effect), 6 and 12 months after surgery
measure: Side effects
timeFrame: Baseline, 2-4 weeks after Botox (max effect), 6 and 12 months after surgery
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital/Karolinska Institute
Study officials:
affiliation: Karolinska Institute/Karolinska University Hospital
name: Birgit Stark, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: