Neurotomy to Treat Synkinesis Following Peripheral Facial Palsy

Not Applicable

Recruiting

• Conditions: Peripheral Facial Palsy; Peripheral Facial Paralysis; Facial Palsy; Facial Paralysis; Bell Palsy; Synkinesis
• Interventions: Procedure: Botox injection; Procedure: Neurotomy

• Registration Number: NCT05191719
• Lead Sponsor: Rebecka Ohm

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

Study Timeline

• Study First Submitted: 2021-11-07
• Study First Submitted QC: 2022-01-03
• Study First Posted: 2022-01-13
• Study Start: 2022-02-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-05
• Last Update Posted: 2023-10-06
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 73

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Neurotomy	Botox injection	-
Neurotomy	Neurotomy	-
Botox	Botox injection	-
Botox	Neurotomy	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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	Free text, in order to capture all possible side effects of treatments.
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).
Quality of life questionnaire	4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery	Synkinesis Assessment Questionnaire (SAQ)

Trial Locations

Locations (1)

Karolinska University Hospital/Karolinska Institute; 🇸🇪 Stockholm, Sweden