Clinical Trials Logo
  1. Home
  2. Meniere Disease
  3. NCT02529475
  4. Details
NCT02529475 Clinical Trial

Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Healthy Subjects (HYDROPS)

Meniere Disease Clinical Trial

— HYDROPS  

Official title:
Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Healthy Subjects (HYDROPS)

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02529475
Other study ID # 38RC14.428
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date February 1, 2016
Est. completion date September 2020

Study information
Verified date November 2020
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

- This prospective study aims to better characterize inner ear's perilymphatic structures with Magnetic Resonance Imaging using contrast media and delayed injection in healthy subjects - MR Perfusion Imaging will be assess in both cochlea as well - Primary auditory brain pathways will be evaluated through MR diffusion imaging

Recruitment information / eligibility
Status Terminated
Enrollment 25
Est. completion date September 2020
Est. primary completion date September 2020
Accepts healthy volunteers Accepts Healthy Volunteers
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 without history of inner ear disease - 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 ®

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Gadoteric acid
Comparison with patients with Meniere's disease

Locations
Country Name City State
France GrenobleUniversityHospital Grenoble
France Hôpital Lariboisière Paris
France Hôpital Charles Nicolle Rouen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Gadolinium enhancement in inner ear structures as measured by MR T1 Weighted Imaging One MR scan (4 hours)
See also
  Status Clinical Trial Phase
Recruiting NCT04835688 - Ventilation Tube Insertion for Unilateral Menière's Disease N/A
Recruiting NCT05851508 - The Effecttiveness of Intratympanic Methylprednisolon Injections Compared to Placebo in the Treatment of Vertigo Attacks in Meniere's Disease Phase 3
Not yet recruiting NCT05322538 - Menier's Disease - Bone Density Study N/A
Completed NCT05328895 - Transcutaneous Auricular Vagus Nerve Stimulation for Meniere Disease N/A
Completed NCT04569175 - Non Enhanced Labyrinth Imaging for the Detection of Endolymphatic Hydrops in Meniere's Disease "NELI Study" N/A
Not yet recruiting NCT05582148 - Meniere Disease and Hearing Aids N/A
Completed NCT05844657 - Comprehensive Evaluation in Patients With Meniere's Disease
Completed NCT04902963 - What is the Tympanic Membrane Healing Time After Insertion of a Gelfoam PE Tube? N/A
Completed NCT04686695 - Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Meniere Disease N/A
Recruiting NCT04815187 - Repurposed Use of Allergic Rhinitis and Allergic Asthma Drug to Reduce Vertigo and Hearing Loss in Meniere's Disease Phase 4
Recruiting NCT06278129 - Evaluation of the Diagnostic and Prognostic Efficacy of MRI in Acute Sensorineural Hearing Loss and Ménière's Disease
Recruiting NCT04766853 - Verification of the Efficacy/Safety of the Intratympanic Drug Delivery for Hearing Loss Phase 1/Phase 2
Recruiting NCT04370366 - Imaging of Endolymphatic Hydrops at 7T MRI
Enrolling by invitation NCT03520322 - A Study of a Mastoid Device in Subjects With Ménière's Disease N/A
Not yet recruiting NCT05424302 - Effect of Peripheral Vestibular Disease Location on Outcomes Following Home-based Virtual Reality Vestibular Therapy N/A
Withdrawn NCT04674735 - Safety of APSLXR in Patients Presenting Vertigo of Vestibular Origin or Meniere's Disease Phase 1
Recruiting NCT03795675 - CI Following VS Removal or Labyrinthectomy N/A
Completed NCT04218123 - Assessing the Efficacy of a Serotonin and Norepinephrine Reuptake Inhibitor for Improving Meniere's Disease Outcomes Phase 2/Phase 3
Withdrawn NCT02371798 - Unilateral Meniere Disease: Can Double Dose Gadolinium and Delayed Imaging Make the Diagnosis? N/A
Completed NCT05960786 - Treating the Symptoms of Vertigo in a Real-world Setting Using the OtoBand N/A