Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-27 @ 12:31 PM
Study NCT ID:
NCT06538103
Status:
COMPLETED
Last Update Posted:
2024-08-05
First Post:
2024-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eye Soft Surgery for Facial Sinkynesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005158', 'term': 'Facial Paralysis'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-31', 'studyFirstSubmitDate': '2024-07-31', 'studyFirstSubmitQcDate': '2024-07-31', 'lastUpdatePostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sinkinesis', 'timeFrame': '3, 6, 12, 24 months', 'description': 'Presence or absence'}], 'secondaryOutcomes': [{'measure': 'Recovery of Facial motility', 'timeFrame': '3, 6, 12, 24 months', 'description': 'ADS will be used to evaluate the recovery of facial motility'}, {'measure': 'Time to recover facial motility', 'timeFrame': '3, 6, 12, 24 months', 'description': 'Evaluation of months needed to recover'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Facial Paralysis', 'Sinkynesis']}, 'referencesModule': {'references': [{'pmid': '25572490', 'type': 'RESULT', 'citation': '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': '26814596', 'type': 'RESULT', 'citation': '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': '32681234', 'type': 'RESULT', 'citation': "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': '27734980', 'type': 'RESULT', 'citation': "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': '19430987', 'type': 'RESULT', 'citation': "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': '39359872', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.\n\n25 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* people over 18 years old\n* willingness to participate\n* acute/new onset of FP (less than 15 days)\n\nExclusion Criteria:\n\n* neuro-inflammatory diseases (e.g., Multiple Sclerosis)\n* FP from systemic disorders (e.g., Guillain-Barré syndrome, Lyme disease, encephalitis)\n* FP from middle ear infections or untreated cholesteatoma\n* severe cognitive or psychological disorders\n* non-consent to participate in the study'}, 'identificationModule': {'nctId': 'NCT06538103', 'briefTitle': 'Eye Soft Surgery for Facial Sinkynesis', 'organization': {'class': 'OTHER', 'fullName': 'University of Catania'}, 'officialTitle': 'Combining Early Lower Eyelid Surgery With Neuromuscular Retraining for Synkinesis Prevention After Facial Palsy.', 'orgStudyIdInfo': {'id': 'UniCT2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Kabat therapy home NMR, and eyelid surgery at 90 days (if lagophthalmos with epiphora or ectropion was present)', 'interventionNames': ['Procedure: Eye soft surgery', 'Other: Physical Rehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Kabat therapy and neuromuscular reeducation (NMR) at home', 'interventionNames': ['Other: Physical Rehabilitation']}], 'interventions': [{'name': 'Eye soft surgery', 'type': 'PROCEDURE', 'otherNames': ['Lower eyelid surgery'], 'description': '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.', 'armGroupLabels': ['Treatment']}, {'name': 'Physical Rehabilitation', 'type': 'OTHER', 'otherNames': ['Kabat'], 'description': 'Kabat therapy and neuromuscular reeducation (NMR) at home Kabat therapy involved thrice-weekly 35-minute sessions.', 'armGroupLabels': ['Control', 'Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95121', 'city': 'Catania', 'state': 'Sicily', 'country': 'Italy', 'facility': 'Arianna Di Stadio', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}], 'overallOfficials': [{'name': 'Arianna Di Stadio, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UniCT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data will be shared after data publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Catania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor (temporary)', 'investigatorFullName': 'Arianna Di Stadio', 'investigatorAffiliation': 'University of Catania'}}}}