Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Patients With Meniere's Disease (PROSPER)

Grenoble Alpes University Hospital Center (CHU)

Status and phase: Terminated; Phase 4

Conditions: Meniere's Disease

Treatments: Drug: Gadolinium

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02530931

38RC15.173

Details and patient eligibility

About

• 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

Enrollment: 23 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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 ®

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

patients with Meniere's disease

Experimental group

Treatment:

Drug: Gadolinium