Meniere's Disease Clinical Trial
— PROSPEROfficial title:
Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Patients With Meniere's Disease
Verified date | November 2020 |
Source | University Hospital, Grenoble |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
- This prospective study aims to better characterize inner ear's perilymphatic structures with Magnetic Resonance Imaging using contrast media and delayed injection in patient's with Meniere's disease. - MR Perfusion Imaging will be assess in both cochlea as well - Primary auditory brain pathways will be evaluated through MR diffusion imaging
Status | Terminated |
Enrollment | 23 |
Est. completion date | September 2020 |
Est. primary completion date | September 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | Inclusion Criteria: - Major subjects of over 40 years (mean age of Meniere's disease 40 to 50 years) - Informed consent signed - Medical examination performed prior to participation in research - Patients with clinical criteria of Meniere's disease according to the classification of the American Association of Otology (ie the combination of a sensorineural hearing loss at low frequencies, recurrent vertigo and tinnitus and / or clogged ear sensation) - Recipient of a French social security scheme Exclusion Criteria: - Patients minors - Patients on a legal protection regime type guardianship - Respiratory pathologies, cardiovascular, renal, diabetes - Claustrophobia - Contraindications to exposure to a magnetic field - Contraindications to injecting Dotarem ® |
Country | Name | City | State |
---|---|---|---|
France | GrenobleUniversityHospital | Grenoble |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Grenoble | Guerbet |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gadolinium enhancement in inner ear structures as measured by MR T1 Weighted-Imaging dynamic measurement | One MR scan (4 hours) |
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