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

Hearing Loss, Sensorineural Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04070937
• Other study ID #: JessaH-4
• Status: Recruiting
• Start date: September 1, 2019
• Est. completion date: October 30, 2026

Study information

• Verified date: August 2021
• Source: Jessa Hospital
• Contact: sebastien p JanssensdeVarebeke, MD
• Phone: 011337420
• Email: drsjanssens[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 30, 2026
• Est. primary completion date: October 30, 2026
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Bilateral Vestibular Deficiency
• Bilateral Vestibulopathy
• DFNA9
• Hearing Loss
• Hearing Loss, Sensorineural
• Radiology

Intervention

Diagnostic Test:
• 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

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

Locations

Country	Name	City	State
Belgium	Jessa Hospital	Hasselt	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CT and MR findings	presence of focal sclerosis or signal loss on CT & MR at one or more semicircular canals	at time of recruitment
Primary	genetic test	p.P51S mutation in COCH gene	at time of recruitment
Secondary	vestibular test 1	video nystagmography using caloric tests ; caloric tests: °/s	at time of recruitment
Secondary	vestibular test 2	video head impulse test; gain for each SCC in °/s	at time of recruitment
Secondary	vestibular test 3	vestibular evoked myogenic potentials: threshold in decibel normal hearing loss (dB nHL)	at time of recruitment
Secondary	audiometry	tonal liminar audiometry using calibrated audiometer, threshold in dB HL	at time of recruitment