Influence of Oxytocin on Neurophysiological Responses to Live Faces

NCT03272321 | Completed Phase 1

• 1 other identifier: SingleOT_EEG-SC_S56327
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxytocin

Keywords

biomedical intervention; oxytocin; EEG; skin conductance response; heart rate; gaze direction; eye contact

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• 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 Arms (2)

Oxytocin

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Oxytocin DRUG

Syntocinon nasal spray

Also known as: syntocinon

Oxytocin

Placebo DRUG

Placebo nasal spray

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• KU Leuven: lead
• Research Foundation Flanders: collaborator

Study Sites (1)

KU Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Kaat Alaerts, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Kaat Alaerts

Study Record Dates

• First Submitted: August 25, 2017
• First Posted: September 5, 2017
• Study Start: July 24, 2017
• Primary Completion: May 18, 2018
• Study Completion: May 18, 2018
• Last Updated: August 1, 2019

Record last verified: 2019-07

Locations

BE (1)