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临床试验/NCT02228031
NCT02228031已完成早期 1 期

The Influence of Oxytocin on the Mirror Neuron System: Developing Brain Imaging Paradigms for Future Therapeutic Interventions

University of Maryland, Baltimore1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2014年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
44
试验地点
1
主要终点
EEG mu rhythm suppression

研究概览

简要总结

The purpose of this project is to investigate the possible effect of intranasally administered Oxytocin (OT) on specific mirror neuron areas in human brain. The mirror neuron system (MNS) is thought to be involved in action perception and understanding, and may also underlie more complex cognitive processes such as imitation. We will use electroencephalographic (EEG) investigations to examine brain activity while participants complete two different tasks, consisting of the observation and imitation of emotional facial expressions (video presented) and the observation and execution of simple grasping actions (live presented), respectively. In addition, before the beginning of the EEG recording session, subjects will be randomly assigned to two different groups (Oxytocin or Placebo group) and will receive a dose of either intranasal Oxytocin or Placebo solution. Oxytocin is a polypeptide hormone that plays a critical role in social behavior. We will identify mu and beta rhythm from the ongoing EEG and examine suppression as a function of emotion and goal directed action perception and imitation/execution.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Right-hand dominant
  • Sufficient spoken English so as to be able to complete testing validly and give informed consent

排除标准

  • Currently taking any psychotropic or cognition enhancing medication
  • History of schizophrenia or any other psychotic disorder, including Bipolar Disorder
  • Family history of psychosis
  • Neurological disease or clinically significant head injury
  • Physical disability that substantially impairs motor function
  • Current diagnosis of polydypsic-induced hyponatremia
  • Substance dependence or abuse in the past 6 months

研究组 & 干预措施

Oxytocin

Experimental

The experimental oxytocin group will receive 24 international units (IU) of oxytocin using an intranasal administration (self-administered nasal spray) one time before the experimental session.

干预措施: Oxytocin (Drug)

Placebo

Placebo Comparator

The placebo comparator group will receive sterile saline through intranasal administration, consisting of the same salt solution in which the hormone will be dissolved , but lacking the hormone itself.

干预措施: Placebo (Other)

结局指标

主要结局

EEG mu rhythm suppression

时间窗: Before oxytocin/placebo administration and 45 minutes after

The EEG mu rhythm suppression is an index of the human mirror neuron system (alpha and lower beta band activity (8-13 and \~20Hz) recorded over the sensorimotor cortex. EEG will be recorded during the performance of an emotion imitation task (Carr et al., 2003) in which participants will be asked to imitate and internally generate facial emotions seen on a computer screen, or to simply observe, as well as performing a simple grasping action task. Changes in the mu suppression while the performance of these tasks, before and after oxytocin/placebo administration, will be the primary outcome measure.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert Buchanan

Interim Director, Maryland Psychiatric Research Center

University of Maryland, Baltimore

研究点 (1)

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