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临床试验/NCT04070937
NCT04070937招募中不适用

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

Jessa Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
CT and MR findings

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • does not meet Barany criteria for BV
  • contraindication for CT and MR imaging

结局指标

主要结局

CT and MR findings

时间窗: at time of recruitment

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

genetic test

时间窗: at time of recruitment

p.P51S mutation in COCH gene

次要结局

  • vestibular test 1(at time of recruitment)
  • vestibular test 3(at time of recruitment)
  • audiometry(at time of recruitment)
  • vestibular test 2(at time of recruitment)

研究者

发起方
Jessa Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sebastien Janssens de Varebeke

principal investigator

Jessa Hospital

研究点 (1)

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