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Clinical Trials/NCT03272321
NCT03272321
Completed
Phase 1

Influence of Oxytocin on Neurophysiological Responses to Direct and Averted Gaze

KU Leuven1 site in 1 country56 target enrollmentJuly 24, 2017
ConditionsOxytocin
InterventionsOxytocinPlacebo

Overview

Phase
Phase 1
Intervention
Oxytocin
Conditions
Oxytocin
Sponsor
KU Leuven
Enrollment
56
Locations
1
Primary Endpoint
Change in EEG asymmetry after oxytocin administration
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
July 24, 2017
End Date
May 18, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
KU Leuven
Responsible Party
Principal Investigator
Principal Investigator

Kaat Alaerts

Prof. Dr. Kaat Alaerts

KU Leuven

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

Oxytocin

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)

Intervention: Oxytocin

Placebo

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

Intervention: Placebo

Outcomes

Primary Outcomes

Change in EEG asymmetry after oxytocin administration

Time Frame: 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

Time Frame: Average over several trials, baseline and 40 min after oxytocin or placebo administration

The influence of oxytocin administration on skin conductance response

Secondary Outcomes

  • 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)

Study Sites (1)

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