- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03452410
MRIPositive Diagnosis of Vestibular Neuritis Using Fluid Attenuated Inversion Recuperation (FLAIR) Sequence on a 1.5 Tesla
October 10, 2019 updated by: University Hospital, Strasbourg, France
Positive Diagnosis of Vestibular Neuritis Using Fluid Attenuated Inversion Recuperation (FLAIR) Sequence, One Hour After Intravenous Gadolinium Injection, on a 1.5 Tesla
Our objective is to allow positive MRI diagnosis of vestibular neuritis by highlighting contrast enhancement of the vestibular nerve on the pathological side of the FLAIR sequence acquired 1h after intravenous gadolinium injection in patients with typical vestibular neuritis.
At present, the diagnosis is based on a combination clinical examination / video-head impulse test, and no imaging examination allows the diagnosis to be positive.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
35
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Strasbourg, France, 67098
- Service Imagerie 1
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patient with typical unilateral vestibular neuritis during ENT examination with videonystagmograph
Description
Inclusion Criteria:
- Age 18-80 years
- Presence of a typical unilateral vestibular neuritis during the ENT examination with videonystagmography
- Subject having his agreement for the use of his medical data for research purposes.
Exclusion Criteria:
- Special clinical forms of the disease: doubtful or atypical forms, especially the presence of deafness
- Treatments and related interfering diseases, antecedents: antecedents of neuritis for controls, presence of vertigo, bilateral involvement
- Impossibility to give the subject information enlightened (subject in emergency situation, difficulties of understanding the subject, ...)
- Subject under the protection of justice
- Subject under guardianship or curatorship
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Diagnosis of vestibular neuritis
Time Frame: one hour after intravenous gadolinium injection
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one hour after intravenous gadolinium injection
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 23, 2018
Primary Completion (ACTUAL)
February 23, 2019
Study Completion (ACTUAL)
February 23, 2019
Study Registration Dates
First Submitted
February 26, 2018
First Submitted That Met QC Criteria
February 26, 2018
First Posted (ACTUAL)
March 2, 2018
Study Record Updates
Last Update Posted (ACTUAL)
October 11, 2019
Last Update Submitted That Met QC Criteria
October 10, 2019
Last Verified
February 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6786
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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