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临床试验/NCT03213119
NCT03213119暂停不适用

Boosting Reward-based Attention Through VEstibular STimulation

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年4月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
暂停
入组人数
60
试验地点
2
主要终点
Center of Gravity (pixels).

研究概览

简要总结

The exploration of space is more effective when intrinsically rewarding elements are located in the visual scene. Thus, rewards could be exploited as a novel rehabilitation approach to various attentional disorders. The first part of the project aims to characterize these effects at the behavioural level. The interventional part consists then in the administration of Caloric Vestibular Stimulation (CVS), which by means of injection of a small quantity of water in the external ear activates the vestibular organs and subsequently vestibular-related brain areas. Among the observed brain activations, the possibility to reach cingulate areas appears particularly interesting because it foreshadows the possibility to further enhance attentional capture by rewards.

CVS will be delivered to patients with brain lesion of the right hemisphere, engaged in cancellation tasks requiring the processing of targets of different nature (e.g. monetary or neutral). The main prediction is that CVS administration would enhance spatial exploration in terms of center of gravity of the cancellation and improved accuracy as a function of the type of target processed (e.g. its value).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •More than 18 years of age, less than 85
  • •right handed
  • •Benefit of social health security
  • •Normal or corrected-to-normal vision
  • •Brain lesion localised in the right hemisphere, confirmed by CT or MRI

排除标准

  • •Anamnesis of neurological of psychiatric illness
  • •Pregnancy or breastfeeding
  • •Administrative measures restricting legal rights
  • •Recent participation to other brain stimulation studies (< 1 week)
  • •Perforation of the tympanic membrane
  • •Anamnesis of recurrent otitis media

研究组 & 干预措施

Caloric Vestibular Stimulation, Left-Warm

Experimental

Caloric Vestibular Stimulation (CVS) stimulates the vestibular system through thermic currents applied through small quantity of water injected in the external ear. The Left-Warm condition uses water with a temperature of 44°. It induces a nystagmus with its slow phase towards the right.

干预措施: Non-invasive brain stimulation of the vestibular system through caloric vestibular stimulation. (Procedure)

Caloric Vestibular Stimulation, Left-Cold

Experimental

Caloric Vestibular Stimulation (CVS) stimulates the vestibular system through thermic currents applied through small quantity of water injected in the external ear. The Left-Cold condition uses water with a temperature of 30°. It induces a nystagmus with its slow phase towards the left.

干预措施: Non-invasive brain stimulation of the vestibular system through caloric vestibular stimulation. (Procedure)

Caloric Vestibular Stimulation, SHAM

Sham Comparator

The SHAM condition uses water with a temperature of 37°. It does not induce nystagmus

干预措施: Non-invasive brain stimulation of the vestibular system through caloric vestibular stimulation. (Procedure)

结局指标

主要结局

Center of Gravity (pixels).

时间窗: Days 1, 2, and 3

For line bisection defined as the difference between participants' mark and the objective center of the line. For cancellation tasks it is calculated as the grand average of horizontal and vertical coordinates of all the marks. In both cases smaller indices indicate a leftward exploration bias, whereas larger indices indicate rightward bias.

次要结局

  • Reaction times (ms).(Days 1, 2, and 3.)
  • Response accuracy (%)(Days 1, 2, and 3.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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