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临床试验/NCT03893006
NCT03893006Unknown不适用

On the Highway to Autonomous Driving: How is Automation Changing Humans: Investigations of Drivers' Behaviors, Representations and Neural Processes

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年10月8日最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
BOLD effect

研究概览

简要总结

In the context of ever-increasing automation in surface vehicles, automation impact on drivers will be investigated through three complementary research axes undertaken under simulated driving:

Axe 1 (Cognitive ergonomics), how automation is impacting driving behaviors and visual explorations? Axe 2 (Experimental psychology), how automation is impacting drivers' mental representations of their own driving abilities? Axe 3 (Neuroimaging), how automation is modifying the car driving neural network? And what are drivers' mental representations neural bases? The project tackle both applied and basic research issues using an original experimental neuro ergonomics approach. AUTODRIVE will bring original data on human-machine cooperation, mental representations, cognitive control and brain processes depending on the characteristics of the automation used over a significant period of time (six weeks) on a large sample (N=120) of experienced and inexperienced drivers.

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
22 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • To be between the ages of 22 and 45 years old
  • Having given an informed consent for the study
  • Being registered with the French Social Security System
  • No driving license for 60 participants
  • Driving license for 4 years or more for 60 participants

排除标准

  • No signature on the consent form
  • Inability to read or write French.
  • Neurologic or psychiatric illness, known or revealed during the inclusion visit
  • Substance intake ( taking psychoactive medications or recreational drugs) on the day of the experiment
  • Noise intolerance
  • Need of vision glasses to drive
  • Persons under curators or deprived of civil rights or deprived of their freedom
  • Unable to fill a questionnaire (severe cognitive troubles)
  • Subjects must not have metallic or electronic implants in the body : pacemakers or pacemaker wires, open heart surgery, artificial heart valve, brain aneurysm surgery, middle ear implant, hearing aid, braces or extensive dental work, cataract surgery or lens implant, implanted mechanical or electrical device, or artificial limb or joint o foreign metallic objects in the body (bullets, BBs, pellets, shrapnel, or metalwork fragments) or current or past employment as machinists, welders or metal workers, tattoos near the head or neck regions, permanent makeup
  • Claustrophobia

结局指标

主要结局

BOLD effect

时间窗: Repetition Time (TR) :every 3 seconds, during the 3 fMRI sessions of respectively 1 hour, 0,75 hour and 0,75 hour. fMRI session 2 occurs 3 weeks after fMRI session 1 and 3 weeks before fMRI session 3.

Functional magnetic resonance imaging measures brain activity by detecting changes associated with blood flow This technique relies on the fact that cerebral blood flow and neuronal activation are coupled. When an area of the brain is in use, blood flow to that region also increases. The primary form of fMRI uses the blood-oxygen-level dependent (BOLD) contrast in response to an experimental condition (Ogawa, Lee, Kay, \& Tank, 1990), allowing researchers to track changes in oxygen consumption on the brain, and therefore brain activity. BOLD effect is computed by assessing the different relaxation times (T1 and T2) in the brain, as T1 and T2 are different in function of regional cerebral blood flows. The outcome will be a change between mean BOLD effect oven session 1 versus session 2 versus session 3.

次要结局

  • Behavioral changes(Two experimental sessions of an hour, one before and one after the six weeks of automated driving. Plus six driving sessions of 0,5 hour, one driving session the first day of each experimental week.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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