Vestibular NeuritisNCT03452410
MRIPositive Diagnosis of Vestibular Neuritis Using Fluid Attenuated Inversion Recuperation (FLAIR) Sequence on a 1.5 Tesla
An observational study of Vestibular Neuritis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Vestibular Neuritis
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 23 Feb 2018to 23 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Patient with typical unilateral vestibular neuritis during ENT examination with videonystagmograph
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Vestibular Neuritis
- Keywords
- Vestibular neuritis, Magnetic resonance imaging (MRI), Vertigo, Fluid attenuated inversion recuperation (FLAIR)
- Medical subject headings
- Vestibular Neuronitis, Vertigo
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of vestibular neuritis
Measured: one hour after intravenous gadolinium injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start23 Feb 2018
- Primary completion23 Feb 2019
- Study completion23 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular NeuritisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452410
- Sponsor's protocol ID
- 6786
- Status last verified
- Feb 2018
- First submitted
- 26 Feb 2018
- Last updated
- 11 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Diagnosis of Vestibular Neuritis Using Fluid Attenuated Inversion Recuperation (FLAIR) Sequence, One Hour After Intravenous Gadolinium Injection, on a 1.5 Tesla
- ClinicalTrials.gov ID
- NCT03452410
- Acronym / sponsor ID
- 6786
- Conditions
- Vestibular Neuritis
- Keywords
- Vestibular neuritis, Magnetic resonance imaging (MRI), Vertigo, Fluid attenuated inversion recuperation (FLAIR)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- 23 Feb 2019 (actual)
- Study completion
- 23 Feb 2019 (actual)
- First posted
- 2 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient with typical unilateral vestibular neuritis during ENT examination with videonystagmograph
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnosis of vestibular neuritis
Time frame: one hour after intravenous gadolinium injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2019.
- Individual participant dataSharing planned: No
Related trials for Vestibular Neuritis
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Boarding Ring Glasses Versus Placebo Glasses or Not Glasses in the Treatment of Vestibular Neuritis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vestibular Neuritis, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of vestibular neuritis (time frame: one hour after intravenous gadolinium injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2019.