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

Diagnostic Agreement of Electrophysiological Audiovestibular Examinations With Magnetic Resonance Imaging (MRI) of the Inner Ear in Revealing Endolymphatic Hydrops (EH) in Patients With Certain or Probable Meniere's Disease (MD)

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.

Study Overview

• Status: Completed
• Conditions: Endolymphatic Hydrops
• Intervention / Treatment: Diagnostic test: MRI 3T

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexis Bozorg Grayeli; Phone Number: +33 3 80 29 37 58; Email: alexis.bozorggrayeli@chu-dijon.fr

Study Locations

• France
  • Dijon, France, 21079
    • Chu Dijon Bourgogne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Certain or probable Meniere's disease	Diagnostic test: MRI 3T

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients for whom an endolymphatic hydrops was diagnosed by electrocochleography	day one
Number of patients for whom an endolymphatic hydrops was diagnosed by (Dephasing) of acoustic distortion products	day one
Number of patients for whom an endolymphatic hydrops was diagnosed by 3T MRI 3T	day one

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2016
• Primary Completion (Actual): July 3, 2018
• Study Completion (Actual): October 3, 2018

Study Registration Dates

• First Submitted: June 26, 2017
• First Submitted That Met QC Criteria: July 10, 2017
• First Posted (Actual): July 12, 2017

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Endolymphatic Hydrops; Edema; Meniere Disease
• Other Study ID Numbers: DIORFLAR- BOZORG 2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No