Clinical Trials in Belgium / NCT04070937
Recruiting Observational

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

NCT04070937 · tracked via the Priya Life Science Belgium tracker
Phase
Observational
Started
2019-09-01
Last updated
2021-08-25

Condition(s) studied

Hearing Loss, SensorineuralBilateral Vestibular DeficiencyDFNA9Radiology

Investigational drug(s) / intervention(s)

vestibular test 1vestibular test 2vestibular evoked myogenic potentialsaudiometryCT and MR imaging of temporal bonep.P51S mutation

vestibular test 1: videonystagmography

vestibular test 2: video head impulse test

vestibular evoked myogenic potentials: vestibular evoked myogenic potentials to measure the function of otolith organs

audiometry: tonal liminar audiometric thresholds

CT and MR imaging of temporal bone: Ct and MR imaging of temporal bone

p.P51S mutation: analysis of presence of p.P51S mutation in COCH

Study summary

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

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Jessa Hospital Hasselt Limburg Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04070937 on ClinicalTrials.gov ↗ ← All trials in Belgium