Neurotomy to Treat Synkinesis Following Peripheral Facial Palsy

Last updated: October 5, 2023
Sponsor: Rebecka Ohm
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cataplexy

Treatment

Botox injection

Neurotomy

Clinical Study ID

NCT05191719
K2018-5656
  • Ages 18-64
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 73
Treatment Group(s): 2
Primary Treatment: Botox injection
Phase:
Study Start date:
February 01, 2022
Estimated Completion Date:
February 28, 2026

Study 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

Connect with a study center

  • Karolinska University Hospital/Karolinska Institute

    Stockholm,
    Sweden

    Active - Recruiting

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