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

Last updated: February 19, 2024
Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dizzy/fainting Spells

Ear Infections

Ear Infections (Pediatric)

Treatment

Vestibular myogenic potentials

Clinical Study ID

NCT06278129
4146
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: 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

Exclusion

Exclusion Criteria:

  • 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 psychiatricdisorders
  • 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

Study Design

Total Participants: 64
Treatment Group(s): 1
Primary Treatment: Vestibular myogenic potentials
Phase:
Study Start date:
June 19, 2018
Estimated Completion Date:
December 31, 2025

Study Description

Aims of the study:

  1. Evaluate the diagnostic accuracy of MRI with the collection of more specific sequences for the inner ear (3D-FLAIR) in identifying intralabyrinthine anomalies in patients with Ménière's disease or acute/subacute sudden hearing loss and not only the retrochlear pathology/neurological causes .

  2. Characterize the vascular and inflammatory MRI patterns

  3. Define the prognostic role of MRI with pre- and post-contrast 3D-FLAIR sequence, eliminating confounding factors such as MRI execution time, the methodology used, the effect of previous therapy and the criteria for defining improvement.

  4. Correlate 4-hour 3D-FLAIR MRI imaging data with clinical and hematological data

Connect with a study center

  • Audiology and Neuroradiology - Milan (Italy)

    Milan, 20133
    Italy

    Active - Recruiting

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