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临床试验/NCT04268615
NCT04268615已完成不适用

Covert Saccade Triggers in Bilateral Vestibular Hypofunction

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2020年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
2
主要终点
Latency of covert-saccades

研究概览

简要总结

Patients with chronic bilateral vestibular hypofunction may suffer from a visual instability during head movement called oscillopsia. Visual consequence of vestibular deficit can lead to a severe impairment of their quality of life. However, correcting saccades during rapid head movement, called covert-saccades, have been more recently identified. These saccades, which occur during the head movement in patients with vestibular hypofunction, present a very short latency. They could compensate for the lack of vestibular-ocular reflex and greatly decrease oscillopsia and visual impairment. The triggering of these covert-saccade is still not known. They could be of visual origin but the short latency is unusual. The objective of this study is to evaluate the potential role of visual trigger in 12 patients with chronic bilateral areflexia, using different visuo-vestibular conditions. The latency of simple visually guided saccades will also be tested in the group of patients and a group of 12 healthy controls.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

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

  • For all :
  • Age from 18 to 90
  • Understanding of the experimental instructions
  • Informed Consent
  • For Patients :
  • Bilateral vestibular hypofunction with regards to the criteria of the of the Barany Society A. Chronic vestibular syndrome with at least three of the following symptoms
  • Postural imbalance
  • Unsteadiness of gait
  • Movement-induced blurred vision or oscillopsia during walking or quick head/body movements
  • Worsening of postural imbalance or unsteadiness of gait in darkness and/or on uneven ground B. No symptoms while sitting or lying down under static conditions C. Bilaterally reduced or absent angular VOR function documented by
  • bilaterally pathological horizontal angular VOR gain < 0.6, measured by the video-HIT5or scleral-coil technique and/or
  • reduced caloric response (sum of bithermal max. peak SPV on each side < 6°/sec7)and/or
  • reduced horizontal angular VOR gain < 0.1 upon sinusoidal stimulation on a rotatorychair (0.1 Hz, Vmax = 50°/sec).
  • D. Not better accounted for by another disease
  • * For Healthy control No ENT or neurological disorders

排除标准

  • Corrected Visual Acuity lower than 5/10
  • Other conditions leading to oscillopsia or ataxia
  • Oculomotor palsy, ocular instability in primary position
  • Treatment that may affect ocular motility (psychotropes)
  • Cervical rachis pathology with instability
  • Cochlear Implants
  • Non-stabilized medical disease
  • Pregnant women
  • Patients under tutelage
  • Patient without social security

结局指标

主要结局

Latency of covert-saccades

时间窗: Day 1

Latency of covert saccades correspond to the time between the beginning of head impulse and the initiation of the first covert-saccade

次要结局

  • Frequency of covert-saccades(Day 1)
  • Velocity of covert-saccades(day 1)
  • Amplitude of covert-saccades(Day 1)
  • Latency of visually-guided saccades(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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