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Neurotomy to Treat Synkinesis Following Peripheral Facial Palsy

Recruiting
18 - 64 years of age
Both
Phase N/A

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Overview

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

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)

Study details

Facial Paralysis, Facial Palsy, Peripheral Facial Palsy, Peripheral Facial Paralysis, Bell Palsy

NCT05191719

Rebecka Ohm

25 January 2024

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