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Vestibular Cortex and TMS (CoVest)

Functional Organisation of the Vestibular Cortical Pathways in Human: Transcranial Magnetic Stimulation (TMS) Approach

In human, the cerebral cortex forms a network of vestibular cortical areas which functional role remains unknown. In patients with localised cortical lesions the investigator has previously demonstrated that the parieto-temporal cortex could regulate the inertial component of the vestibulo-ocular (VOR) responses whereas more ventral regions including the temporo-occipital cortex would be associated with gain regulation of these VOR responses.

The investigator's main purpose is to investigate the modalities of vestibular integration in these posterior parieto-temporal et temporo-occipital cortical regions. Thus, by using repetitive ttranscranial magnetic stimulation (rTMS) the investigator will induce a transitory inhibition of one of these 2 cortical regions and register its effect on VOR responses. Based on theta burst stimulation (TBS) paradigm, the investigator will stimulate the region of interest by applying on the scalp repetitive burst (at 50 HZ) during 44sec. Then, during the consecutive cortical inhibition lasting for the 15 minutes poststimulation, the investigator will record the subject's VOR responses. The VOR gain will be calculated and the time constant and phase will provide an estimation of the inertial component of the VOR responses. The healthy subjects recruited on the basis of inclusion criteria during medical examination will be divided into two groups of 20 subjects each depending of their sites of stimulation, temporo-parietal or temporo-occipital. Each subject will perform three experimental sessions (of 1h in average each) separated by at least one week and corresponding to : (1) the right cortical stimulation, (2) the left stimulation and (3) the vertex stimulation serving as the control session.

The TMS paradigm is used in routine in hospital and research field and had very few negative consequences (mainly transitory and occasional headache).

研究概览

研究类型

观察性的

注册 (实际的)

17

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 至 35年 (成人)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Healthy Subjects

描述

Inclusion Criteria:

  • Male and/or female healthy volunteers between 20 and 35 years old.
  • Considered healthy subject after medical examination and MRI images analysis
  • With social security affiliation
  • After informed and voluntary consent to participate to the study (signed written consent)
  • With normal ocular responses with a gain not less than 0.5 during preliminary VOR registration.

Exclusion Criteria:

  • Persons under guardianship, curatorship or any other administrative or judicial deprivation of rights and freedom
  • Persons with a medical history, or any acute or chronic disease which may affect the test results, or creating a risk to the subject in the protocol, in particular:

    • with personal or family history of seizure disorders
    • with previous or current psychiatric disease or schizotypal signs (RISC questionary)
    • with previous or current neurology or otology (audition or equilibrium) history
    • with visual corrected visual acuity inferior to 8/10
    • having taken hypnotics, psychotropic or other central nervous system depressants (opiates, barbiturates, antiepileptics, antidepressants, sedatives, antihistamines, anxiolytics, neuroleptics, clonidine and related) during the 8 months prior to experimentation
    • consuming more than 150 mg of caffeine per day (15 small cups of Italian coffee)
    • with a contra-indication for MRI: pacemaker or neural surgical clips ferromagnetic and metallic implants, intraocular foreign bodies, claustrophobia
    • pregnancy (diagnosed by a urine test)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:队列
  • 时间观点:预期

研究衡量的是什么?

主要结果指标

结果测量
大体时间
changes in gain of vestibulo-ocular reflex (VOR)
大体时间:Day 1, Day 7, Day 14, Day 21
Day 1, Day 7, Day 14, Day 21

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2013年1月20日

初级完成 (实际的)

2016年1月1日

研究完成 (实际的)

2016年1月1日

研究注册日期

首次提交

2013年1月17日

首先提交符合 QC 标准的

2013年1月28日

首次发布 (估计)

2013年1月30日

研究记录更新

最后更新发布 (实际的)

2021年9月1日

上次提交的符合 QC 标准的更新

2021年8月27日

最后验证

2021年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • C12-20
  • 2012-A00839-34 (注册表标识符:IDRCB)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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