Neurotomy to Treat Synkinesis Following Peripheral Facial Palsy

Bell Palsy Clinical Trial

Official title:

Neurotomy to Treat Synkinesis Following Peripheral Facial Palsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05191719
• Other study ID #: K2018-5656
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: February 2026

Study information

• Verified date: October 2023
• Source: Karolinska University Hospital
• Contact: Rebecka Ohm, MD, PhDStud.
• Phone: +4651770000
• Email: rebecka.ohm[@]regionstockholm.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 73
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bell Palsy
• Facial Palsy
• Facial Paralysis
• Facies
• Paralysis
• Peripheral Facial Palsy
• Peripheral Facial Paralysis
• Synkinesis

Intervention

Procedure:
• Botox injection
Comparator, current gold standard
• Neurotomy
Surgical procedure

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital/Karolinska Institute	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Rebecka Ohm

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of Botox injections	Decrease to no future need	Baseline, 12 months after surgery
Secondary	Side effects	Clavien-Dindo Classification	Baseline, 2-4 weeks after Botox (max effect), 6 and 12 months after surgery
Secondary	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