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

ConditionsHearing Loss, SensorineuralBilateral Vestibular DeficiencyDFNA9Radiology
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorJessa Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

< 18 y

does not meet Barany criteria for BV

contraindication for CT and MR imaging

Trial population

all patients presenting at our Department of ENT with vestibular or balance disorders, in whom videonystagmography, video head impulse test and VEMP tests meet the Barany criteria for bilateral vestibulopathy.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: study group6 interventions
Group B: control group6 interventions

Trial outcomes

Primary outcomes

1

CT and MR findings

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

Time frame
at time of recruitment
2

genetic test

p.P51S mutation in COCH gene

Time frame
at time of recruitment

Secondary outcomes

1

vestibular test 1

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

Time frame
at time of recruitment
2

vestibular test 2

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

Time frame
at time of recruitment
3

vestibular test 3

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

Time frame
at time of recruitment
4

audiometry

tonal liminar audiometry using calibrated audiometer, threshold in dB HL

Time frame
at time of recruitment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jessa Hospital

Lead sponsor

Source ClinicalTrials.gov
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