跳至主要内容
临床试验/NCT03010670
NCT03010670已完成4 期

Oxytocin-based Pharmacotherapy: Investigating the Effect on Interpersonal Motor Resonance Upon Direct Eye Gaze

KU Leuven1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2016年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
KU Leuven
入组人数
27
试验地点
1
主要终点
Assessment of interpersonal motor resonance (IMR)

研究概览

简要总结

Among different social cues from the environment, the eyes constitute a very salient source for initiating social interaction or communication. Interestingly, previous work from our (Prinsen et al., 2016) and other labs demonstrated that direct eye contact between two individuals can readily evoke an increased propensity to 'mirror' other peoples' actions. Particularly, using transcranial magnetic stimulation (TMS), the investigators showed that mirror-motor mapping at the level of the primary motor cortex (M1), also known as "interpersonal motor resonance" (IMR), is significantly increased upon the observation of actions accompanied by direct eye contact, compared to the observation of actions accompanied by averted eye gaze.

With the present study, the investigators aim to investigate the role of eye contact on IMR further, and in particular, explore whether administration of the 'prosocial' neuropeptide oxytocin (OT) can influence eye-contact induced IMR. In general, OT is known to play an important role in promoting prosocial behavior and the perception of socially-relevant stimuli, such as eye gaze. To date however, the link between OT and IMR is less clear.

详细描述

In the present study, the investigators want to explore how a single-dose of intranasally administered OT can modulate interpersonal motor resonance (IMR) and/or the enhanced effects of eye contact on IMR. To investigate the effects of exogenous OT administrations, the investigators adopted a double-blind, within-subjects (cross-over), randomized, placebo-controlled trial. The investigators will recruit approximately 30 neurotypical young adults males between 18 - 35 years old. Since a cross-over design is included, subjects will participate in two sessions, separated by one week. Participants will be randomly assigned to receive a single dose of OT (24 international units) or placebo nasal spray at the first and second session.

In each session, the non-invasive brain stimulation technique 'transcranial magnetic stimulation' (TMS) will be used at the level of the primary motor cortex to obtain an end-state measure of unconscious 'mirror-motor mapping' or IMR. During TMS, participants will observe video stimuli of a model performing simple, intransitive hand movements combined with either direct or averted gaze. Additionally, behavioral measures will be included: social attachment and social responsiveness will be assessed via self-report questionnaires and eye tracking technology will be included to monitor participant's spontaneous gaze behavior.

The main statistical analysis of the neurophysiological data will have the within-subjects factor of administered nasal spray (OT or PL), observed gaze direction (direct or averted gaze) and observed movement (opening hand movement or no movement). Furthermore, the link between the neurophysiological (TMS) and behavioral measures (questionnaire data and gaze behavior) will be investigated.

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
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

  • Young adults (between 18 - 35 y/o)
  • Right-handed

排除标准

  • Left-handed
  • Any neuro(psycho)logical / psychiatric illness.
  • Motor dysfunctions of the hands / arms.
  • Any contradiction to TMS research as assessed with the TMS screening list: no pacemaker, implanted defibrillator, ear implant / a cochlear implant, insulin or implanted pump, a neurostimulator or ventriculoperitoneal shunt, any metallic object in the eyes (metallic fragments)

研究组 & 干预措施

Oxytocin (OT) spray

Experimental

Syntocinon nasal spray (product code RVG 03716) will be used to intranasally administer one single dose (24 IU) of OT (3 puffs of 4 IU per nostril).

干预措施: Oxytocin (Drug)

Placebo (PL) spray

Placebo Comparator

Physiological water (a solution of sodium chloride (NaCl) in water) will be used to intranasally administer one single dose (24 IU) of PL (3 puffs of 4 IU per nostril).

干预措施: Placebo (Other)

结局指标

主要结局

Assessment of interpersonal motor resonance (IMR)

时间窗: 30 minutes

TMS will be applied to assess IMR during different observational conditions after a single dose of nasal spray

次要结局

  • State Adult Attachment Measure (SAAM) (sub)scores(10 minutes)
  • Participants' mood(10 minutes)
  • Social Responsiveness Scale (SRS) (sub)scores(20 minutes)
  • Spontaneous gaze behavior(30 minutes)

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.

KU Leuven

研究点 (1)

Loading locations...

相似试验