Prevalence of Endolymphatic Hydrops With a Hitory of Congenital Cytomegalovirus Infection
NCT ID: NCT05229744
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
18 participants
OBSERVATIONAL
2022-12-15
2025-04-22
Brief Summary
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Detailed Description
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Patients benefit as part of the care:
* A clinical cochleo-vestibular examination
* Functional otoneurological explorations: audiogram, caloric tests, vHIT, otolithic evoked potentials
* From an uninjected brain MRI
Participation in this research entails the addition of an MRI sequence and an injection of contrast product (Gadovist®):
\- 3D FLAIR MRI sequence dedicated to the exploration of the inner ear, lasting 6min30s, performed 4 hours after the initial injection of contrast product.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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sequence MRI 3D FLAIR
Participation in this research entails the addition of an MRI sequence and an injection of contrast product (Gadovist®):
\- 3D FLAIR MRI sequence dedicated to the exploration of the inner ear, lasting 6min30s, performed 4 hours after the initial injection of contrast product
Eligibility Criteria
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Inclusion Criteria
* With a history of confirmed congenital CMV infection
* Suffering from symptomatic cochleo-vestibular dysfunction (average hearing threshold\> 20dB in at least one ear and / or abnormal functioning of one or more sectors at the vestibular level)
* For adult patients, having received informed information about the study and having signed a consent to participate in the study
* For minor patients written consent of the two holders of the exercise of parental authority
* Affiliate or beneficiary of a social security scheme
Exclusion Criteria
* Pregnant or breastfeeding woman
* Contraindication to MRI (implanted electrical device, metallic foreign body, claustrophobia)
* Patient with a proven allergy to gadolinium
* Injection of gadolinium in the previous 7 days
* Known impairment of renal function ((estimated GFR \<60 mL / min / 1.73 m²)
6 Months
ALL
No
Sponsors
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Fondation Ophtalmologique Adolphe de Rothschild
NETWORK
Responsible Party
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Locations
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Hôpital Fondation Adolphe de Rothschild
Paris, PARIS, France
Hôpital Robert Debre
Paris, , France
Countries
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Other Identifiers
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GPN_2021_23
Identifier Type: -
Identifier Source: org_study_id
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