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

Endolymphatic Hydrops Clinical Trial

— MRI Meniere  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03215420
• Other study ID #: DIORFLAR- BOZORG 2016
• Status: Completed
• Phase: N/A
• Start date: September 8, 2016
• Est. completion date: October 3, 2018

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 3, 2018
• Est. primary completion date: July 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Edema
• Endolymphatic Hydrops
• Meniere Disease

Intervention

Diagnostic Test:
• MRI 3T

Locations

Country	Name	City	State
France	CHu Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients for whom an endolymphatic hydrops was diagnosed by electrocochleography		day one
Primary	Number of patients for whom an endolymphatic hydrops was diagnosed by (Dephasing) of acoustic distortion products		day one
Primary	Number of patients for whom an endolymphatic hydrops was diagnosed by 3T MRI 3T		day one