Influence of Oxytocin on Neurophysiological Responses to Live Faces

Sponsor

KU Leuven (Other)

Overall Status

Completed

CT.gov ID

NCT03272321

Collaborator

Research Foundation Flanders (Other)

Enrollment

Location

Arms

9.8

Actual Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oxytocin	Drug: Oxytocin Drug: Placebo	Phase 1/Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Influence of Oxytocin on Neurophysiological Responses to Direct and Averted Gaze

Actual Study Start Date :

Jul 24, 2017

Actual Primary Completion Date :

May 18, 2018

Actual Study Completion Date :

May 18, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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)	Drug: Oxytocin Syntocinon nasal spray Other Names: syntocinon
Placebo Comparator: Placebo saline natriumchloride solution nasal spray; single intranasal dose (3 puffs per nostril)	Drug: Placebo Placebo nasal spray

Arm

Intervention/Treatment

Experimental: 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)

Drug: Oxytocin

Syntocinon nasal spray

Other Names:

syntocinon

Placebo Comparator: Placebo

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

Drug: Placebo

Placebo nasal spray

Outcome Measures

Primary Outcome Measures

Change in EEG asymmetry after oxytocin administration [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 [Average over several trials, baseline and 40 min after oxytocin or placebo administration]
The influence of oxytocin administration on skin conductance response

Secondary Outcome Measures

Change in duration of fixations to face regions after oxytocin administration [Assesment over several trials, baseline and 40 min after oxytocin or placebo administration]
The influence of oxytocin administration on gaze behavior (duration of fixation to upper and lower face regions)
Change in number of fixations to face regions after oxytocin administration [Assesment over several trials, baseline and 40 min after oxytocin or placebo administration]
The influence of oxytocin administration on gaze behavior (number of fixation to upper and lower face regions)