NCT03452410

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 23, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 2, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2019

Completed
Last Updated

October 11, 2019

Status Verified

February 1, 2018

Enrollment Period

1 year

First QC Date

February 26, 2018

Last Update Submit

October 10, 2019

Conditions

Vestibular Neuritis

Keywords

Vestibular neuritisMagnetic resonance imaging (MRI)VertigoFluid attenuated inversion recuperation (FLAIR)

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of vestibular neuritis

    one hour after intravenous gadolinium injection

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with typical unilateral vestibular neuritis during ENT examination with videonystagmograph

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service Imagerie 1

Strasbourg, 67098, France

Location

MeSH Terms

Conditions

Vestibular NeuronitisVertigo

Condition Hierarchy (Ancestors)

Vestibulocochlear Nerve DiseasesRetrocochlear DiseasesEar DiseasesOtorhinolaryngologic DiseasesCranial Nerve DiseasesNervous System DiseasesVestibular DiseasesLabyrinth DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2018

First Posted

March 2, 2018

Study Start

February 23, 2018

Primary Completion

February 23, 2019

Study Completion

February 23, 2019

Last Updated

October 11, 2019

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)