Eye Soft Surgery for Facial Sinkynesis

NCT06538103 | Completed

• 1 other identifier: UniCT2022
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Facial Paralysis; Sinkynesis

Outcome Measures

Primary Outcomes (1)

• Sinkinesis

  Presence or absence

  3, 6, 12, 24 months

Secondary Outcomes (2)

• Recovery of Facial motility

  3, 6, 12, 24 months

• Time to recover facial motility

  3, 6, 12, 24 months

Study Arms (2)

Treatment

EXPERIMENTAL

Kabat therapy home NMR, and eyelid surgery at 90 days (if lagophthalmos with epiphora or ectropion was present)

Procedure: Eye soft surgery; Other: Physical Rehabilitation

Control

ACTIVE COMPARATOR

Kabat therapy and neuromuscular reeducation (NMR) at home

Other: Physical Rehabilitation

Interventions

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.

Also known as: Lower eyelid surgery

Treatment

Physical Rehabilitation OTHER

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

Also known as: Kabat

Control; Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Catania: lead

Study Sites (1)

Arianna Di Stadio

Catania, Sicily, 95121, Italy

Location

Related Publications (6)

• Di Stadio A. Eyelid lifting for ectropion and scleral show in facial palsy disease. ORL J Otorhinolaryngol Relat Spec. 2014;76(6):329-35. doi: 10.1159/000369623. Epub 2015 Jan 8.

  PMID: 25572490 RESULT

• Di Stadio A. Another Scale for the Assessment of Facial Paralysis? ADS Scale: Our Proposition, How to Use It. J Clin Diagn Res. 2015 Dec;9(12):MC08-11. doi: 10.7860/JCDR/2015/15366.6953. Epub 2015 Dec 1.

  PMID: 26814596 RESULT

• Di Stadio A, Gambacorta V, Ralli M, Pagliari J, Longari F, Greco A, Ricci G. Facial taping as biofeedback to improve the outcomes of physical rehab in Bell's palsy: preliminary results of a randomized case-control study. Eur Arch Otorhinolaryngol. 2021 May;278(5):1693-1698. doi: 10.1007/s00405-020-06193-3. Epub 2020 Jul 17.

  PMID: 32681234 RESULT

• Monini S, Iacolucci CM, Di Traglia M, Lazzarino AI, Barbara M. Role of Kabat rehabilitation in facial nerve palsy: a randomised study on severe cases of Bell's palsy. Acta Otorhinolaryngol Ital. 2016 Aug;36(4):282-288. doi: 10.14639/0392-100X-783.

  PMID: 27734980 RESULT

• Barbara M, Antonini G, Vestri A, Volpini L, Monini S. Role of Kabat physical rehabilitation in Bell's palsy: a randomized trial. Acta Otolaryngol. 2010;130(1):167-72. doi: 10.3109/00016480902882469.

  PMID: 19430987 RESULT

• Di Stadio A, Ralli M, De Luca P, Sossamon J, Frohman TC, Altieri M, La Mantia I, Ferlito S, Frohman EM, Brenner MJ. Combining early lower eyelid surgery with neuromuscular retraining for synkinesis prevention after facial palsy: the role of the eye in aberrant facial nerve regeneration. Front Neurol. 2024 Sep 18;15:1443591. doi: 10.3389/fneur.2024.1443591. eCollection 2024.

  PMID: 39359872 DERIVED

MeSH Terms

Conditions

Facial Paralysis

Condition Hierarchy (Ancestors)

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

Study Officials

• Arianna Di Stadio, MD, PhD

  UniCT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor (temporary)

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 5, 2024
• Study Start: January 18, 2022
• Primary Completion: March 15, 2023
• Study Completion: November 30, 2023
• Last Updated: August 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)