Comparison of 3 Methods to Diagnose Endolymphatic Hydrops in Meniere’s Disease

Overview

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.

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 8, 2019

Interventions

  • Diagnostic Test: MRI 3T

Arms, Groups and Cohorts

  • Experimental: Certain or probable Meniere’s disease

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • persons who have provided written consent – persons aged 18 to 75 years – persons with certain or probable 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire Dijon
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Alexis BOZORG GRAYELI, 3 80 29 37 58, alexis.bozorggrayeli@chu-dijon.fr

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