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临床试验/NCT03426202
NCT03426202Unknown不适用

The Effect of Modafinil on Neural Processing During the Interference and Feedback Based Learning Task

University of Electronic Science and Technology of China1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
Neural processing during the interference processing

研究概览

简要总结

The study aims to examine whether a single dose of modafinil (200mg, p.o.) can affect feedback-based learning and interference processing in healthy male subjects.

详细描述

Based on previous animal and human research suggesting a catecholamine-mediated, potentially pro-cognitive, mechanism of action of modafinil, the present study seeks to explore effects of modafinil on feedback-based learning and interference processing in healthy subjects. To this end, the present randomized double-blind, between-subject, placebo-controlled pharmaco-fMRI experiment plans to determine the behavioral and neural effects of a single dose of p.o.modafinil (200mg) versus placebo on validated feedback-based learning and emotional/non-emotional cognitive conflict paradigms. To control for potential effects of pre-medication personality traits as well as effects of modafinil on subjective task performance, subjects will be administered pre-treatment assessing relevant personality traits and post-treatment assessments of meta-cognitive confidence estimation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •Healthy subjects without past or current psychiatric or neurological disorders
  • •Non-smokers
  • •Right-handedness

排除标准

  • •Medical or psychiatric illness
  • •Allergy against medications or general strong allergies
  • •Sleep disorders
  • •High blood pressure, general cardio-vascular alterations
  • •History of head injury
  • •Visual or motor impairments

研究组 & 干预措施

placebo group

Experimental

a single dose of p.o. placebo (200mg)

干预措施: Placebo Oral Tablet (Drug)

modafinil group

Experimental

a single dose of p.o. modafinil (200mg)

干预措施: Modafinil Oral Tablet (Drug)

结局指标

主要结局

Neural processing during the interference processing

时间窗: 4h after treatment

fMRI BOLD indices of neural processing in interference related brain regions will be compared between the treatment and placebo group.

Neural processing during feedback based learning

时间窗: 4h after treatment

fMRI BOLD indices of neural processing learning related brain regions will be compared between the treatment and placebo group.

次要结局

  • Behavioral interference performance - Response Time(4h after treatment)
  • Behavioral interference performance - Accuracy(4h after treatment)
  • Behavioral learning performance - Accuracy(4h after treatment)
  • Behavioral learning performance - Reaction time(4h after treatment)

研究者

发起方
University of Electronic Science and Technology of China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Benjamin Becker

Professor

University of Electronic Science and Technology of China

研究点 (1)

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