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临床试验/NCT03096249
NCT03096249已完成1 期

Monitoring the Influence of Oxytocin on Socio-communicative Sensitivity Using Fast Periodic Visual Stimulation

KU Leuven1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2016年11月21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
31
试验地点
1
主要终点
social salience frequency-tagging FPVS

研究概览

简要总结

Oxytocin (OT) is a neuropeptide that acts as a neurotransmitter and neuromodulator in the brain. Previous studies have shown that intranasal administration of OT improves social cognition and behavior (e.g. emotion recognition). In the current study, we want to gain more insight into the underlying mechanisms by which OT influences emotion recognition. More specifically, we will investigate whether intranasal administration of OT enhances the salience of social (compared to non-social) information and whether it increases the neural sensitivity for subtle socio-emotional cues, by recording scalp electroencephalography (EEG) during Fast Periodic Visual Stimulation (FPVS).

详细描述

The present study is a double-blind, randomized, placebo-controlled, crossover clinical trial, in which (approximately 30) neurotypical male adults (18 to 30 years old) will participate. All participants will perform two sessions (OT and placebo), separated by two weeks. For the first session, the participants are randomly assigned to the placebo or the OT condition. Syntocinon nasal spray will be used for intranasal administration.

In each session, we will measure the neural salience/sensitivity for socio-emotional information, by recording EEG during FPVS. Participants simply have to press a button when the fixation cross turns red, while watching rapidly alternating visual stimuli. Starting 20 minutes after substance intake, four FPVS paradigms are administered in randomized order:

  1. A frequency-tagging FPVS paradigm, to measure the salience of social versus non-social stimuli.
  2. The oddball face detection paradigm, to assess the neural sensitivity to faces embedded in a series of objects.
  3. The oddball identity discrimination task, to examine the ability to discriminate between faces with a different identity.
  4. The oddball expression generalization task, to investigate the sensitivity for facial emotional expressions embedded within neutral faces with varying identities.

After two FPVS paradigms, a four minutes resting state EEG measure will be performed. At the end of the session, emotion recognition will be measures with the Palermo matching task (65 items).

The primary aim is to investigate whether the performance on each of these paradigms/tasks differs between the OT and the placebo condition. Furthermore, we want to explore whether the effect of OT is influenced by the participant's attachment style, social responsiveness, social phobia, or mood, which will be assessed via self-reported questionnaires.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Quadruple (Participant, Care Provider, 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

  • age between 18 and 30 years
  • right-handed
  • typically developing
  • Normal or adjusted-to-normal vision (with glasses or lenses)

排除标准

  • psychiatric disorder
  • neurological disorder (e.g. epilepsy, migraine)
  • color blindness
  • psychoactive medication

研究组 & 干预措施

Oxytocin

Experimental

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

干预措施: Oxytocin (Drug)

Placebo

Placebo Comparator

Physiological water (sodium chloride (NaCl) solution) Administration via nasal spray

干预措施: Placebo (Other)

结局指标

主要结局

social salience frequency-tagging FPVS

时间窗: random: 30-70 minutes after nasal spray

EEG recording during simultaneous (superimposed) presentation of social stimuli (faces) and non-social stimuli (objects or houses), at a frequency of 6 and 7.5Hz, respectively (counterbalanced).

Oddball face detection FPVS paradigm

时间窗: random: 30-70 minutes after nasal spray

EEG recording during presentation of objects (at 6 Hz) and faces (inserted as an "oddball" every fifth image, thus at a frequency of 1.2 Hz)

Oddball identity discrimination FPVS paradigm

时间窗: random: 30-70 minutes after nasal spray

EEG recording during presentation of neutral faces of the same person (same identity, presented at 6 Hz) and the face of another person (inserted as an "oddball" every fifth image, thus at a frequency of 1.2 Hz)

Oddball expression generalization FPVS paradigm

时间窗: random: 30-70 minutes after nasal spray

EEG recording during presentation of neutral faces with different identities (at 6 Hz) and faces with an emotional expression (fear, anger, happy; inserted as an "oddball" every fifth image, thus at a frequency of 1.2 Hz)

次要结局

  • Emotion recognition: accuracy on the Palermo Matching task (65 items)(80 minutes after nasal spray (after all EEG measures))
  • Attachment: State Adult Attachment Measure (SAAM)(Baseline)
  • Social responsiveness: Social Responsiveness Scale (SRS)(Baseline)
  • resting state EEG(45-50 minutes after nasal spray (after two FPVS paradigms))
  • Social phobia: Social Phobia Inventory (SPIN)(Baseline)
  • Mood: Positive And Negative Affect Schedule (PANAS)(90 minutes after nasal spray)

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

Professor

KU Leuven

研究点 (1)

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