跳至主要内容
临床试验/NCT03562676
NCT03562676Unknown不适用

VESTIBULAR EVOKED MYOGENIC POTENTIALS IN ALTERED GRAVITY

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2017年11月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
9
试验地点
1
主要终点
vestibular-evoked myogenic potentials (P13-N23)

研究概览

简要总结

Recently, new clinical testing of saccular and utricular function have been developed and validated, the so-called vestibular-evoked myogenic potentials - VEMP (Brantberg et al. 2009, Cornell et al. 2009, Curthoys 2010, Manzari et al. 2012). Among them, the cervical VEMP (cVEMP) are short-latency electromyographic (EMG) modulations of the contracted sternocleidomastoid muscles in responses to vibration applied on the forehead. The clinical literature suggests that cVEMP are almost entirely saccular in origin (Halmagyi et al 1995).

The aim of our research is to evaluate changes in the otolith function in microgravity and hypergravity using this clinical test. Cervical vestibular-evoked myogenic potentials (cVEMP) will be recorded by surface EMG electrodes in response to bone conducted vibration to specifically assess saccular function (Halmagyi et al 1995). The primary measures will include muscle activity response amplitudes and the stimulus intensity threshold at which the cVEMP is detected.

Given that there is an off-loading of the saccules in microgravity and an increased loading in hypergravity, we hypothesize that there will be a reduction in cVEMP amplitude in microgravity and an increase in cVEMP amplitude in hypregravity compared to normal gravity. These changes in amplitude will be accompanied by changes in the threshold of the stimulus level required to elicit a cVEMP.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 67 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy volunteers (men or women)
  • Aged from 18 to 67
  • Affiliated to a Social Security system and, for non-French resident, holding a European Health Insurance Card (EHIC)
  • Who accepted to take part in the study
  • Who have given their written stated consent
  • With normal cVEMP
  • Who have passed a medical examination similar to a standard aviation medical examination for private pilot aptitude (JAR FCL3 Class 2 medical examination). There will be no additional test performed for subject selection.

排除标准

  • Persons who took part in a previous biomedical research protocol, of which exclusion period is not terminated
  • Pregnant women (urine pregnancy test for women of childbearing potential)

研究组 & 干预措施

weightlessness

Experimental

干预措施: weightlessness (Other)

结局指标

主要结局

vestibular-evoked myogenic potentials (P13-N23)

时间窗: baseline

amplitude and treshold

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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