search
Back to results

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

Primary Purpose

Endolymphatic Hydrops

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI 3T
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Endolymphatic Hydrops

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHu Dijon BourgogneRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Certain or probable Meniere's disease

Arm Description

Outcomes

Primary Outcome Measures

Number of patients for whom an endolymphatic hydrops was diagnosed by electrocochleography
Number of patients for whom an endolymphatic hydrops was diagnosed by (Dephasing) of acoustic distortion products
Number of patients for whom an endolymphatic hydrops was diagnosed by 3T MRI 3T

Secondary Outcome Measures

Full Information

First Posted
June 26, 2017
Last Updated
October 9, 2017
Sponsor
Centre Hospitalier Universitaire Dijon
search

1. Study Identification

Unique Protocol Identification Number
NCT03215420
Brief Title
Comparison of 3 Methods to Diagnose Endolymphatic Hydrops in Meniere's Disease
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 8, 2016 (Actual)
Primary Completion Date
March 8, 2019 (Anticipated)
Study Completion Date
September 8, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endolymphatic Hydrops

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Certain or probable Meniere's disease
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI 3T
Primary Outcome Measure Information:
Title
Number of patients for whom an endolymphatic hydrops was diagnosed by electrocochleography
Time Frame
day one
Title
Number of patients for whom an endolymphatic hydrops was diagnosed by (Dephasing) of acoustic distortion products
Time Frame
day one
Title
Number of patients for whom an endolymphatic hydrops was diagnosed by 3T MRI 3T
Time Frame
day one

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexis BOZORG GRAYELI
Phone
3 80 29 37 58
Ext
+33
Email
alexis.bozorggrayeli@chu-dijon.fr
Facility Information:
Facility Name
CHu Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexis Bozorg Grayeli
Phone
3 80 29 37 58
Ext
+33
Email
alexis.bozorggrayeli@chu-dijon.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs