Neurotomy to Treat Synkinesis Following Peripheral Facial Palsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2026-02-28

Brief Summary

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

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Detailed Description

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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

Conditions

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Facial Paralysis Facial Palsy Peripheral Facial Palsy Peripheral Facial Paralysis Bell Palsy Synkinesis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Botox

Group Type ACTIVE_COMPARATOR

Botox injection

Intervention Type PROCEDURE

Comparator, current gold standard

Neurotomy

Intervention Type PROCEDURE

Surgical procedure

Neurotomy

Group Type EXPERIMENTAL

Botox injection

Intervention Type PROCEDURE

Comparator, current gold standard

Neurotomy

Intervention Type PROCEDURE

Surgical procedure

Interventions

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Botox injection

Comparator, current gold standard

Intervention Type PROCEDURE

Neurotomy

Surgical procedure

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No