Evaluation of the Diagnostic and Prognostic Efficacy of MRI in Acute Sensorineural Hearing Loss and Ménière's Disease

NCT06278129 | Recruiting DMC

• 1 other identifier: 4146
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of the diagnostic and prognostic efficacy of nuclear magnetic resonance imaging in patients with acute sensorineural hearing loss or in patients suffering from probable or definite MD. The neuroradiological and audiological evaluation are held on in the same day in order to better clarify the radiological and clinical correlates.

Conditions

Sudden Sensorineural Hearing Loss; Meniere Disease; Ménière's Vertigo; Meniere's Disease Aggravated; Inner Ear Disease

Outcome Measures

Primary Outcomes (1)

• Evaluation of inner ear structures in MRI images

  MRI - ocular and cervical VEMPS - audiological and otoneurological evaluation

  1 day

Interventions

Vestibular myogenic potentials DIAGNOSTIC_TEST

observational study

Also known as: Magnetic resonance imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients suffering from acute sudden hearing loss and Meniere's disease according to the criteria of the American Academy of Otolaryngology.

You may qualify if:

• age \> 18 years
• onset of symptoms less than 10 days
• no previous episodes of sudden ipsilateral hearing loss
• no systemic or oral corticosteroid intake in the previous month
• Informed consent

You may not qualify if:

• Current or previous otopathy and/or labyrinth diseases of known cause
• Known nervous system disorders
• Patients with renal insufficiency (creatinine level \> 1.5 mg/dL)
• Patients with pacemakers, other metal implants, claustrophobics and known psychiatric disorders
• Pregnant patients Materials and methods Diagnostic evaluation at enrollment (T0)
• Audiological or ENT examination
• Liminal tonal audiometric exam, vocal, impedance measurement, otoacoustic emissions, video-impulse test, oVEMPS, cVEMPS, stabilometry
• Hematological tests: complete blood count, ESR, PCR, creatininemia, CMV IgM, EBV IgM, ANA, glycemia, study of predisposing genetic factors

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Audiology and Neuroradiology - Milan (Italy)

Milan, 20133, Italy

RECRUITING

Related Publications (7)

• Conte G, Di Berardino F, Sina C, Zanetti D, Scola E, Gavagna C, Gaini L, Palumbo G, Capaccio P, Triulzi F. MR Imaging in Sudden Sensorineural Hearing Loss. Time to Talk. AJNR Am J Neuroradiol. 2017 Aug;38(8):1475-1479. doi: 10.3174/ajnr.A5230. Epub 2017 May 25.

  PMID: 28546251 BACKGROUND

• Conte G, Caschera L, Calloni S, Barozzi S, Di Berardino F, Zanetti D, Scuffi C, Scola E, Sina C, Triulzi F. MR Imaging in Meniere Disease: Is the Contact between the Vestibular Endolymphatic Space and the Oval Window a Reliable Biomarker? AJNR Am J Neuroradiol. 2018 Nov;39(11):2114-2119. doi: 10.3174/ajnr.A5841. Epub 2018 Oct 18.

  PMID: 30337432 BACKGROUND

• Conte G, Di Berardino F, Zanetti D, Avignone S, Sina C, Iofrida E, Triulzi F. The 'full-blown' MRI of sudden hearing loss: 3D FLAIR in a patient with bilateral metastases in the internal auditory canals. Neuroradiol J. 2018 Feb;31(1):39-41. doi: 10.1177/1971400917736927. Epub 2017 Oct 19.

  PMID: 29046124 BACKGROUND

• Berardino FD, Conte G, Turati F, Ferraroni M, Zanetti D. Cochlear implantation in Meniere's disease: a systematic review of literature and pooled analysis. Int J Audiol. 2020 Jun;59(6):406-415. doi: 10.1080/14992027.2020.1720922. Epub 2020 Feb 6.

  PMID: 32027195 BACKGROUND

• Conte G, Lo Russo F, Caschera L, Zanetti D, Castorina P, Sina C, Triulzi F, Di Berardino F. Audiovestibular Phenotypes and Advanced Magnetic Resonance Imaging Features of Cochlin Gene Mutation Carriers. Audiol Neurootol. 2019;24(4):166-173. doi: 10.1159/000501292. Epub 2019 Aug 7.

  PMID: 31390618 BACKGROUND

• Conte G, Di Berardino F, Zanetti D, Iofrida EF, Scola E, Sbaraini S, Filipponi E, Cinnante C, Gaini LM, Ambrosetti U, Triulzi F, Pignataro L, Capaccio P. Early Magnetic Resonance Imaging for Patients With Idiopathic Sudden Sensorineural Hearing Loss in an Emergency Setting. Otol Neurotol. 2019 Oct;40(9):1139-1147. doi: 10.1097/MAO.0000000000002389.

  PMID: 31498290 RESULT

• Conte G, Di Berardino F, Mastrapasqua RF, Casale S, Scola E, Capaccio P, Triulzi F, Pignataro L, Zanetti D. Prognostic Value of Early Magnetic Resonance Imaging Patterns in Sudden Hearing Loss. Audiol Neurootol. 2022;27(1):64-74. doi: 10.1159/000515153. Epub 2021 Apr 23.

  PMID: 33895732 RESULT

MeSH Terms

Conditions

Hearing Loss, Sudden; Meniere Disease; Labyrinth Diseases

Interventions

Vestibular Evoked Myogenic Potentials; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Endolymphatic Hydrops

Intervention Hierarchy (Ancestors)

Evoked Potentials, Motor; Evoked Potentials; Cortical Excitability; Electrophysiological Phenomena; Physiological Phenomena; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 26, 2024
• Study Start: June 19, 2018
• Primary Completion: April 23, 2021
• Study Completion: December 31, 2025
• Last Updated: February 26, 2024

Record last verified: 2024-02

Locations

IT (1)