Endolymphatic Hydrops Clinical Trial
— MRI MeniereOfficial 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)
Verified date | February 2024 |
Source | Centre Hospitalier Universitaire Dijon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | CHu Dijon Bourgogne | Dijon |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire Dijon |
France,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
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