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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03272321
Other study ID # SingleOT_EEG-SC_S56327
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date July 24, 2017
Est. completion date May 18, 2018

Study information

Verified date July 2019
Source KU Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date May 18, 2018
Est. primary completion date May 18, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- right-handed

- male

- age between 18 and 35

- Normal or adjusted-to-normal vision (with lenses only)

- Dutch as mother tongue

Exclusion Criteria:

- not right-handed

- female

- age below 18 or above 35

- Need to wear glasses

- Dutch not as mother tongue

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Oxytocin
Syntocinon nasal spray
Placebo
Placebo nasal spray

Locations

Country Name City State
Belgium KU Leuven Leuven

Sponsors (2)

Lead Sponsor Collaborator
KU Leuven Research Foundation Flanders

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in EEG asymmetry after oxytocin administration The influence of oxytocin administration on EEG asymmetry Average over several trials, baseline and 40 min after oxytocin or placebo administration
Primary Change in skin conductance (type of electrodermal activity) response after oxytocin administration The influence of oxytocin administration on skin conductance response Average over several trials, baseline and 40 min after oxytocin or placebo administration
Secondary Change in duration of fixations to face regions after oxytocin administration The influence of oxytocin administration on gaze behavior (duration of fixation to upper and lower face regions) Assesment over several trials, baseline and 40 min after oxytocin or placebo administration
Secondary Change in number of fixations to face regions after oxytocin administration The influence of oxytocin administration on gaze behavior (number of fixation to upper and lower face regions) Assesment over several trials, baseline and 40 min after oxytocin or placebo administration
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