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Completed

NCT Number: NCT06538103

Eye Soft Surgery for Facial Sinkynesis

Facial synkinesis (FS) is a distressing sequela of facial palsy (FP) characterized by involuntary, simultaneous movements of facial muscles occurring during voluntary facial expressions. Treatment of synkinesis is challenging, and preventive methods are needed.

This study evaluates the efficacy of physical facial nerve rehabilitation (PFNR) therapy alone versus PNFR with eyelid surgery to correct lagophthalmos and prevent the onset of synkinesis.

25 outpatients are randomized to receive either PFNR alone (neuromuscular retraining and Kabat proprioceptive neuromuscular facilitation) or PNFR and early (90 days after FP onset) eyelid surgery (involving a conservative oculoplastic correction for lagophthalmos with epiphora or ectropion). Comprehensive otolaryngological assessments and Magnetic Resonance Imaging (MRI) will be conducted. Synkinesis progression was measured using Another Disease Scale (ADS) at baseline, 3 months 6 months, 12 months, and 24-months post-treatment. The data were analyzed with ANOVA, t-test, Chi-Square analyses.

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Key information

Conditions

Facial Paralysis Mouth Diseases Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Sinkynesis Stomatognathic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arianna Di Stadio

Catania, Sicily, 95121, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • people over 18 years old
  • willingness to participate
  • acute/new onset of FP (less than 15 days)

Exclusion criteria

  • neuro-inflammatory diseases (e.g., Multiple Sclerosis)
  • FP from systemic disorders (e.g., Guillain-Barré syndrome, Lyme disease, encephalitis)
  • FP from middle ear infections or untreated cholesteatoma
  • severe cognitive or psychological disorders
  • non-consent to participate in the study

Treatment and study plan

Eye soft surgery

Procedure

Early lower eyelid surgery will be performed in accordance with the protocol previously described by Di Stadio, with medial or lateral eyelid lifting surgery as indicated. The indication for eye surgery are in case of ectropion (exposure of the conjunctiva due to a reduction in tension of the anterior compartment of the eye muscle) and lagophthalmos (incomplete /abnormal closure of the eye with eyelid in closed position) a lateral lower eyelid lifting surgery is performed. otherwise, in presence of epiphora (the eversion of the lachrymal point) and lagophthalmos medial lower eyelid lifting surgery is done.

Other names: Lower eyelid surgery

Physical rehabilitation

Other

Kabat therapy and neuromuscular reeducation (NMR) at home Kabat therapy involved thrice-weekly 35-minute sessions.

Other names: Kabat

Primary outcomes

  1. Sinkinesis

    Time frame: 3, 6, 12, 24 months

    Presence or absence

Secondary outcomes

  1. Recovery of Facial motility

    Time frame: 3, 6, 12, 24 months

    ADS will be used to evaluate the recovery of facial motility

  2. Time to recover facial motility

    Time frame: 3, 6, 12, 24 months

    Evaluation of months needed to recover

Sponsors and collaborators

Lead sponsor

University of Catania

Other

Registry information

Official study title

Combining Early Lower Eyelid Surgery With Neuromuscular Retraining for Synkinesis Prevention After Facial Palsy.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 5, 2024
Registry last updated
Aug 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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