Neurotomy to Treat Synkinesis Following Peripheral Facial Palsy

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

Study Overview

• Status: Recruiting
• Conditions: Facial Palsy; Bell Palsy; Facial Paralysis; Synkinesis; Peripheral Facial Palsy; Peripheral Facial Paralysis
• Intervention / Treatment: Procedure: Botox injection; Procedure: Neurotomy

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 Type: Interventional
• Enrollment (Estimated): 73
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rebecka Ohm, MD, PhDStud.; Phone Number: +4651770000; Email: rebecka.ohm@regionstockholm.se

Study Locations

• Sweden
  • Stockholm, Sweden
    • Recruiting
    • Karolinska University Hospital/Karolinska Institute
    • Contact: Rebecka Ohm
    • Contact: Birgit Stark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Botox	Procedure: Botox injection; Comparator, current gold standard; Procedure: Neurotomy; Surgical procedure
Experimental: Neurotomy	Procedure: Botox injection; Comparator, current gold standard; Procedure: Neurotomy; Surgical procedure

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rebecka Ohm
• Investigators: Principal Investigator: Birgit Stark, MD, PhD, Karolinska Institute/Karolinska University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: November 7, 2021
• First Submitted That Met QC Criteria: January 3, 2022
• First Posted (Actual): January 13, 2022

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Virus Diseases; Infections; Neurologic Manifestations; Disease Attributes; Stomatognathic Diseases; Mouth Diseases; DNA Virus Infections; Dyskinesias; Cranial Nerve Diseases; Herpesviridae Infections; Facial Nerve Diseases; Paralysis; Bell Palsy; Facial Paralysis; Facies; Synkinesis
• Other Study ID Numbers: K2018-5656

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No