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

Recruiting

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

• Registration Number: NCT06278129
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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

Study Timeline

• Study Start: 2018-06-19
• Primary Completion: 2021-04-23
• Status Verified: 2024-02
• Study First Submitted: 2024-02-19
• Study First Submitted QC: 2024-02-19
• Last Update Submitted: 2024-02-19
• Study First Posted: 2024-02-26
• Last Update Posted: 2024-02-26
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of inner ear structures in MRI images	1 day	MRI - ocular and cervical VEMPS - audiological and otoneurological evaluation

Trial Locations

Locations (1)

Audiology and Neuroradiology - Milan (Italy); 🇮🇹 Milan, Italy