Correlation of Radiological Lesions With Vestibular Function in Patients With Bilateral Vestibulopathy

NCT ID: NCT04070937

Last Updated: 2021-08-25

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2026-10-30

Brief Summary

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In 2014 radiologic lesions were detected at one or more semicircular canals using CT and MR imaging of temporal bone in subjects carrying the p.P51S mutation in COCH. These lesions are believed to present at more advanced stages of the hearing and vestibular deterioration. Since then, other authors have described similar lesions in advanced non-genetic hearing and vestibular impairment as well.

The purpose of this study is therefore to assess the radiologic investigation using CT and MR imaging of temporal bone to all subjects presenting with bilateral vestibulopathy, using the Barany criteria, compared to the p.P51S population.

Detailed Description

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Conditions

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Hearing Loss, Sensorineural Bilateral Vestibular Deficiency DFNA9 Radiology

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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study group

all patients at least 18 years of age who present bilateral vestibulopathy on vestibular investigations according to the Barany criteria

vestibular test 1

Intervention Type DIAGNOSTIC_TEST

videonystagmography

vestibular test 2

Intervention Type DIAGNOSTIC_TEST

video head impulse test

vestibular evoked myogenic potentials

Intervention Type DIAGNOSTIC_TEST

vestibular evoked myogenic potentials to measure the function of otolith organs

audiometry

Intervention Type DIAGNOSTIC_TEST

tonal liminar audiometric thresholds

CT and MR imaging of temporal bone

Intervention Type DIAGNOSTIC_TEST

Ct and MR imaging of temporal bone

p.P51S mutation

Intervention Type GENETIC

analysis of presence of p.P51S mutation in COCH

control group

DFNA9 patients carrying the p.P51S mutation in COCH gene presenting bilateral vestibulopathy according to the Barany criteria

vestibular test 1

Intervention Type DIAGNOSTIC_TEST

videonystagmography

vestibular test 2

Intervention Type DIAGNOSTIC_TEST

video head impulse test

vestibular evoked myogenic potentials

Intervention Type DIAGNOSTIC_TEST

vestibular evoked myogenic potentials to measure the function of otolith organs

audiometry

Intervention Type DIAGNOSTIC_TEST

tonal liminar audiometric thresholds

CT and MR imaging of temporal bone

Intervention Type DIAGNOSTIC_TEST

Ct and MR imaging of temporal bone

p.P51S mutation

Intervention Type GENETIC

analysis of presence of p.P51S mutation in COCH

Interventions

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vestibular test 1

videonystagmography

Intervention Type DIAGNOSTIC_TEST

vestibular test 2

video head impulse test

Intervention Type DIAGNOSTIC_TEST

vestibular evoked myogenic potentials

vestibular evoked myogenic potentials to measure the function of otolith organs

Intervention Type DIAGNOSTIC_TEST

audiometry

tonal liminar audiometric thresholds

Intervention Type DIAGNOSTIC_TEST

CT and MR imaging of temporal bone

Ct and MR imaging of temporal bone

Intervention Type DIAGNOSTIC_TEST

p.P51S mutation

analysis of presence of p.P51S mutation in COCH

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* must meet the Barany criteria for bilateral vestibulopathy: bilaterally pathological horizontal angu- lar VOR gain \<0.6, measured by the video-HIT5 or scleral-coil technique and/or
* reduced caloric response6 (sum of bither- mal max. peak SPV on each side \<6◦/sec7) and/or
* reduced horizontal angular VOR gain \<0.1 upon sinusoidal stimulation on a rota- tory chair (0.1 Hz, Vmax = 50◦ /sec) and a phase lead \>68 degrees (time constant \<5 sec).
* must be 18 or older

Exclusion Criteria

* \< 18 y
* does not meet Barany criteria for BV
* contraindication for CT and MR imaging
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jessa Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sebastien Janssens de Varebeke

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Jessa Hospital

Hasselt, Limburg, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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sebastien p JanssensdeVarebeke, MD

Role: CONTACT

011337420

Facility Contacts

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sebastien P Janssens, MD

Role: primary

011 337420

Other Identifiers

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JessaH-4

Identifier Type: -

Identifier Source: org_study_id

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