Neurotomy to Treat Synkinesis Following Peripheral Facial Palsy

Rebecka Ohm

Status: Enrolling

Conditions: Peripheral Facial Paralysis; Synkinesis; Bell Palsy; Facial Palsy; Peripheral Facial Palsy; Facial Paralysis

Treatments: Procedure: Neurotomy; Procedure: Botox injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05191719

K2018-5656

Details and patient eligibility

About

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

Full 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

Enrollment: 73 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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73 participants in 2 patient groups

Botox

Active Comparator group

Treatment:

Procedure: Neurotomy

Procedure: Botox injection

Neurotomy

Experimental group

Treatment:

Procedure: Neurotomy

Procedure: Botox injection