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

Evaluation of the Diagnostic and Prognostic Efficacy of Magnetic Resonance Imaging in Patients With Acute Sensorineural Hearing Loss and Ménière's Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06278129
Acronym
MRI_SSHL/MD
Enrollment
64
Registered
2024-02-26
Start date
2018-06-19
Completion date
2025-12-31
Last updated
2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Detailed 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

Interventions

DIAGNOSTIC_TESTVestibular myogenic potentials

observational study

Sponsors

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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 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 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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of inner ear structures in MRI images1 dayMRI - ocular and cervical VEMPS - audiological and otoneurological evaluation

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026