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临床试验/NCT03272321
NCT03272321已完成1 期

Influence of Oxytocin on Neurophysiological Responses to Direct and Averted Gaze

KU Leuven1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2017年7月24日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
KU Leuven
入组人数
56
试验地点
1
主要终点
Change in EEG asymmetry after oxytocin administration

研究概览

简要总结

Previous research has indicated that direct eye gaze compared to averted gaze, elicits a higher skin conductance response (SCR), and a more pronounced left frontal cortex activity than right frontal cortex activity (resulting in positive asymmetry scores). On a behavioral level, participants tend to look shorter at live faces with a direct gaze as compared to averted gaze (Akechi et al., 2013). Further, subjective evaluations showed that a direct gaze is rated more arousing and less pleasant than an averted gaze (Akechi et al., 2013; Hietanen, Leppänen, Peltola, Linna-aho, & Ruuhiala, 2008).

Importantly, oxytocin administration increases the number of fixations and to looking time towards the eye region during live social interaction. Further, oxytocin has been shown to influence SCR and heart rate variability. Therefore, it is conceivable that oxytocin will not only influence the gaze duration of the participant, but also the physiological and neurological responses elicited by direct eye gaze.

In this study, the investigators will investigate whether oxytocin modulates the behavioural (eye gaze and subjective ratings), neurological (EEG) and physiological (skin conductance, heart rate and respiration) responses elicited by direct gaze.

详细描述

Previous research has indicated that direct eye gaze compared to averted gaze, elicits a higher skin conductance response (SCR), and a more pronounced left frontal cortex activity than right frontal cortex activity (resulting in positive asymmetry scores). On a behavioral level, participants tend to look shorter at live faces with a direct gaze as compared to averted gaze (Akechi et al., 2013). Further, subjective evaluations showed that a direct gaze is rated more arousing and less pleasant than an averted gaze (Akechi et al., 2013; Hietanen, Leppänen, Peltola, Linna-aho, & Ruuhiala, 2008).

Importantly, oxytocin administration increases the number of fixations and to looking time towards the eye region during live social interaction. Further, oxytocin has been shown to influence SCR and heart rate variability. Therefore, it is conceivable that oxytocin will not only influence the gaze duration of the participant, but also the physiological and neurological responses elicited by direct eye gaze.

In this randomized, placebo controlled, double blinded study, the investigators will investigate whether oxytocin modulates the behavioral and neurophysiological responses elicited by direct gaze. In order to do so, the investigators will measure behavioural (eye gaze and subjective feelings), physiological (skin conductance, blood volume pulse, and respiration) and neurological (EEG) responses during presentations of a live person's face with direct gaze and closed eyes, before and after oxytocin or placebo administration.

The investigators hypotheses that oxytocin attenuates the heightened SCR and pronounced EEG asymmetry during direct gaze. Further, they expect that oxytocin increases the number of fixations and duration of those fixations towards the eye region. Exploratory, the investigators will also investigate whether oxytocin administration influences respiration and the subjective reports on experience of live eye contact. Lastly (and also exploratory), they will explore whether certain personality traits (as measured by SAAM (state adult attachment measure) and SRS (social responsiveness scale)) influence the modulatory effect of oxytocin on neurological and behavioural responses.

Note that this study is part of a larger study in which the investigators also register several neurophysiological responses (blood volume pulse, respiration, heart rate, EEG, skin conductance) during rest before and after oxytocin or placebo administration.

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 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • right-handed
  • age between 18 and 35
  • Normal or adjusted-to-normal vision (with lenses only)
  • Dutch as mother tongue

排除标准

  • not right-handed
  • age below 18 or above 35
  • Need to wear glasses
  • Dutch not as mother tongue

研究组 & 干预措施

Oxytocin

Experimental

Syntocinon nasal spray (40 IU/ml; oxytocin, product code RVG 03716); single intranasal dose of 24 international units (IU; 3 puffs of 4 IU per nostril)

干预措施: Oxytocin (Drug)

Placebo

Placebo Comparator

saline natriumchloride solution nasal spray; single intranasal dose (3 puffs per nostril)

干预措施: Placebo (Drug)

结局指标

主要结局

Change in EEG asymmetry after oxytocin administration

时间窗: Average over several trials, baseline and 40 min after oxytocin or placebo administration

The influence of oxytocin administration on EEG asymmetry

Change in skin conductance (type of electrodermal activity) response after oxytocin administration

时间窗: Average over several trials, baseline and 40 min after oxytocin or placebo administration

The influence of oxytocin administration on skin conductance response

次要结局

  • Change in duration of fixations to face regions after oxytocin administration(Assesment over several trials, baseline and 40 min after oxytocin or placebo administration)
  • Change in number of fixations to face regions after oxytocin administration(Assesment over several trials, baseline and 40 min after oxytocin or placebo administration)

研究者

发起方
KU Leuven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kaat Alaerts

Prof. Dr. Kaat Alaerts

KU Leuven

研究点 (1)

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