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Clinical Trials/NCT03096249
NCT03096249
Completed
Phase 1

Monitoring the Influence of Oxytocin on Socio-communicative Sensitivity Using Fast Periodic Visual Stimulation

KU Leuven1 site in 1 country31 target enrollmentNovember 21, 2016
ConditionsOxytocin
InterventionsOxytocinPlacebo

Overview

Phase
Phase 1
Intervention
Oxytocin
Conditions
Oxytocin
Sponsor
KU Leuven
Enrollment
31
Locations
1
Primary Endpoint
social salience frequency-tagging FPVS
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Oxytocin (OT) is a neuropeptide that acts as a neurotransmitter and neuromodulator in the brain. Previous studies have shown that intranasal administration of OT improves social cognition and behavior (e.g. emotion recognition). In the current study, we want to gain more insight into the underlying mechanisms by which OT influences emotion recognition. More specifically, we will investigate whether intranasal administration of OT enhances the salience of social (compared to non-social) information and whether it increases the neural sensitivity for subtle socio-emotional cues, by recording scalp electroencephalography (EEG) during Fast Periodic Visual Stimulation (FPVS).

Detailed Description

The present study is a double-blind, randomized, placebo-controlled, crossover clinical trial, in which (approximately 30) neurotypical male adults (18 to 30 years old) will participate. All participants will perform two sessions (OT and placebo), separated by two weeks. For the first session, the participants are randomly assigned to the placebo or the OT condition. Syntocinon nasal spray will be used for intranasal administration. In each session, we will measure the neural salience/sensitivity for socio-emotional information, by recording EEG during FPVS. Participants simply have to press a button when the fixation cross turns red, while watching rapidly alternating visual stimuli. Starting 20 minutes after substance intake, four FPVS paradigms are administered in randomized order: 1. A frequency-tagging FPVS paradigm, to measure the salience of social versus non-social stimuli. 2. The oddball face detection paradigm, to assess the neural sensitivity to faces embedded in a series of objects. 3. The oddball identity discrimination task, to examine the ability to discriminate between faces with a different identity. 4. The oddball expression generalization task, to investigate the sensitivity for facial emotional expressions embedded within neutral faces with varying identities. After two FPVS paradigms, a four minutes resting state EEG measure will be performed. At the end of the session, emotion recognition will be measures with the Palermo matching task (65 items). The primary aim is to investigate whether the performance on each of these paradigms/tasks differs between the OT and the placebo condition. Furthermore, we want to explore whether the effect of OT is influenced by the participant's attachment style, social responsiveness, social phobia, or mood, which will be assessed via self-reported questionnaires.

Registry
clinicaltrials.gov
Start Date
November 21, 2016
End Date
July 30, 2017
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Male

Investigators

Sponsor
KU Leuven
Responsible Party
Principal Investigator
Principal Investigator

Kaat Alaerts

Professor

KU Leuven

Eligibility Criteria

Inclusion Criteria

  • age between 18 and 30 years
  • right-handed
  • typically developing
  • Normal or adjusted-to-normal vision (with glasses or lenses)

Exclusion Criteria

  • psychiatric disorder
  • neurological disorder (e.g. epilepsy, migraine)
  • color blindness
  • psychoactive medication

Arms & Interventions

Oxytocin

Syntocinon nasal spray (40 IU/ml; oxytocin, product code RVG 03716) will be used for intranasal administration of a single intranasal dose of 24 international units (IU; 3 puffs of 4 IU per nostril)

Intervention: Oxytocin

Placebo

Physiological water (sodium chloride (NaCl) solution) Administration via nasal spray

Intervention: Placebo

Outcomes

Primary Outcomes

social salience frequency-tagging FPVS

Time Frame: random: 30-70 minutes after nasal spray

EEG recording during simultaneous (superimposed) presentation of social stimuli (faces) and non-social stimuli (objects or houses), at a frequency of 6 and 7.5Hz, respectively (counterbalanced).

Oddball face detection FPVS paradigm

Time Frame: random: 30-70 minutes after nasal spray

EEG recording during presentation of objects (at 6 Hz) and faces (inserted as an "oddball" every fifth image, thus at a frequency of 1.2 Hz)

Oddball identity discrimination FPVS paradigm

Time Frame: random: 30-70 minutes after nasal spray

EEG recording during presentation of neutral faces of the same person (same identity, presented at 6 Hz) and the face of another person (inserted as an "oddball" every fifth image, thus at a frequency of 1.2 Hz)

Oddball expression generalization FPVS paradigm

Time Frame: random: 30-70 minutes after nasal spray

EEG recording during presentation of neutral faces with different identities (at 6 Hz) and faces with an emotional expression (fear, anger, happy; inserted as an "oddball" every fifth image, thus at a frequency of 1.2 Hz)

Secondary Outcomes

  • Emotion recognition: accuracy on the Palermo Matching task (65 items)(80 minutes after nasal spray (after all EEG measures))
  • Attachment: State Adult Attachment Measure (SAAM)(Baseline)
  • Social responsiveness: Social Responsiveness Scale (SRS)(Baseline)
  • resting state EEG(45-50 minutes after nasal spray (after two FPVS paradigms))
  • Social phobia: Social Phobia Inventory (SPIN)(Baseline)
  • Mood: Positive And Negative Affect Schedule (PANAS)(90 minutes after nasal spray)

Study Sites (1)

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