Comparison of 3 Methods to Diagnose Endolymphatic Hydrops in Meniere's Disease (MRI Meniere)

University Hospital Center (CHU) Dijon Bourgogne

Status: Completed

Conditions: Endolymphatic Hydrops

Treatments: Diagnostic Test: MRI 3T

Study type: Interventional

Funder types: Other

Identifiers

NCT03215420

DIORFLAR- BOZORG 2016

Details and patient eligibility

About

The aim of this study is to compare 3 methods for the diagnosis of endolymphatic hydrops (EH) in patients with Meniere's disease: MRI 3 Tesla (to visualise EH directly), and functional explorations, namely electrocochleography and dephasing of acoustic distortion products (which are modified by the EH).

The research hypothesis is that the examinations will show agreement in the diagnosis of EH, and that the results obtained (quantitative values) will vary in the same direction over time and during flares of MD.

Enrollment: 41 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• persons who have provided written consent
• persons aged 18 to 75 years
• persons with certain, probable or possible Meniere's disease according to the international classification AAO-HNS

Exclusion criteria

• persons without health insurance cover
• adults under guardianship
• persons with a history of hypersensitivity to the active substance or to one of the excipients of the contrast agent used for the MRI or to any gadolinium chelate
• pregnant or breast-feeding women
• severe acute or chronic kidney failure
• other identified causes of cochleo-vestibular syndromes
• Impossibility to follow-up or carry out any of the examinations necessary for the protocol

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

Certain or probable Meniere's disease

Experimental group

Treatment:

Diagnostic Test: MRI 3T