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Recruiting NCT04070937

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

— Observational Hearing Loss, Sensorineural Bilateral Vestibular Deficiency DFNA9 Radiology

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: vestibular test 1, vestibular test 2, vestibular evoked myogenic potentials, audiometry.
Who it may be relevant to
Registry conditions: Hearing Loss, Sensorineural, Bilateral Vestibular Deficiency, DFNA9, Radiology. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Diagnostic test vestibular test 1
    videonystagmography
  • Diagnostic test vestibular test 2
    video head impulse test
  • Diagnostic test vestibular evoked myogenic potentials
    vestibular evoked myogenic potentials to measure the function of otolith organs
  • Diagnostic test audiometry
    tonal liminar audiometric thresholds
  • Diagnostic test CT and MR imaging of temporal bone
    Ct and MR imaging of temporal bone
  • Genetic p.P51S mutation
    analysis of presence of p.P51S mutation in COCH

Primary outcome measures

  • CT and MR findings [Time frame: at time of recruitment]
  • genetic test [Time frame: at time of recruitment]
Secondary outcome measures (4)
  • vestibular test 1 [Time frame: at time of recruitment]
  • vestibular test 2 [Time frame: at time of recruitment]
  • vestibular test 3 [Time frame: at time of recruitment]
  • audiometry [Time frame: at time of recruitment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-control

Study locations

Belgium · 1 center
  • Jessa Hospital — Hasselt

Identifiers

NCT: NCT04070937 · JessaH-4

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗