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

Meniere Disease Clinical Trial

— MRI_SSHL/MD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06278129
• Other study ID #: 4146
• Status: Recruiting
• Start date: June 19, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: December 31, 2025
• Est. primary completion date: April 23, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Ear Diseases
• Hearing Loss
• Hearing Loss, Sensorineural
• Inner Ear Disease
• Labyrinth Diseases
• Labyrinthitis
• Meniere Disease
• Ménière's Vertigo
• Sudden Sensorineural Hearing Loss
• Vertigo

Intervention

Diagnostic Test:
• Vestibular myogenic potentials
observational study

Locations

Country	Name	City	State
Italy	Audiology and Neuroradiology - Milan (Italy)	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. E — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of inner ear structures in MRI images	MRI - ocular and cervical VEMPS - audiological and otoneurological evaluation	1 day