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NCT Number: NCT04070937

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

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.

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Key information

Conditions

Hearing Loss, Sensorineural Bilateral Vestibular Deficiency Bilateral Vestibulopathy DFNA9 Ear Diseases Hearing Disorders Hearing Loss Labyrinth Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Radiology Sensation Disorders Signs and Symptoms Vestibular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Jessa Hospital

Hasselt, Limburg, 3500, Belgium

Location status: Recruiting

Location contact

sebastien P Janssens, MD

CONTACT

[email protected]

011 337420

sebastien PF Janssens, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vestibular test 1

Diagnostic Test

videonystagmography

vestibular test 2

Diagnostic Test

video head impulse test

vestibular evoked myogenic potentials

Diagnostic Test

vestibular evoked myogenic potentials to measure the function of otolith organs

audiometry

Diagnostic Test

tonal liminar audiometric thresholds

CT and MR imaging of temporal bone

Diagnostic Test

Ct and MR imaging of temporal bone

p.P51S mutation

Genetic

analysis of presence of p.P51S mutation in COCH

Primary outcomes

  1. CT and MR findings

    Time frame: at time of recruitment

    presence of focal sclerosis or signal loss on CT & MR at one or more semicircular canals

  2. genetic test

    Time frame: at time of recruitment

    p.P51S mutation in COCH gene

Secondary outcomes

  1. vestibular test 1

    Time frame: at time of recruitment

    video nystagmography using caloric tests ; caloric tests: °/s

  2. vestibular test 2

    Time frame: at time of recruitment

    video head impulse test; gain for each SCC in °/s

  3. vestibular test 3

    Time frame: at time of recruitment

    vestibular evoked myogenic potentials: threshold in decibel normal hearing loss (dB nHL)

  4. audiometry

    Time frame: at time of recruitment

    tonal liminar audiometry using calibrated audiometer, threshold in dB HL

Study contacts

Contact information is provided by the study sponsor or research team.

sebastien p JanssensdeVarebeke, MD

CONTACT

[email protected]

011337420

Sponsors and collaborators

Lead sponsor

Jessa Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Aug 28, 2019
Registry last updated
Aug 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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