A Phase 4 interventional study of Oxytocin and Placebo in Social Behavior, sponsored by KU Leuven. Completed at 1 site in Belgium. Open to male participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-05.
Sponsored by KU Leuven · Phase 4, Interventional, and Basic science
Among different social cues from the environment, the eyes constitute a very salient source for initiating social interaction or communication. Interestingly, previous work from our (Prinsen et al., 2016) and other labs demonstrated that direct eye contact between two individuals can readily evoke an increased propensity to 'mirror' other peoples' actions. Particularly, using transcranial magnetic stimulation (TMS), the investigators showed that mirror-motor mapping at the level of the primary motor cortex (M1), also known as "interpersonal motor resonance" (IMR), is significantly increased upon the observation of actions accompanied by direct eye contact, compared to the observation of actions accompanied by averted eye gaze.
With the present study, the investigators aim to investigate the role of eye contact on IMR further, and in particular, explore whether administration of the 'prosocial' neuropeptide oxytocin (OT) can influence eye-contact induced IMR. In general, OT is known to play an important role in promoting prosocial behavior and the perception of socially-relevant stimuli, such as eye gaze. To date however, the link between OT and IMR is less clear.
In the present study, the investigators want to explore how a single-dose of intranasally administered OT can modulate interpersonal motor resonance (IMR) and/or the enhanced effects of eye contact on IMR. To investigate the effects of exogenous OT administrations, the investigators adopted a double-blind, within-subjects (cross-over), randomized, placebo-controlled trial. The investigators will recruit approximately 30 neurotypical young adults males between 18 - 35 years old. Since a cross-over design is included, subjects will participate in two sessions, separated by one week. Participants will be randomly assigned to receive a single dose of OT (24 international units) or placebo nasal spray at the first and second session.
In each session, the non-invasive brain stimulation technique 'transcranial magnetic stimulation' (TMS) will be used at the level of the primary motor cortex to obtain an end-state measure of unconscious 'mirror-motor mapping' or IMR. During TMS, participants will observe video stimuli of a model performing simple, intransitive hand movements combined with either direct or averted gaze. Additionally, behavioral measures will be included: social attachment and social responsiveness will be assessed via self-report questionnaires and eye tracking technology will be included to monitor participant's spontaneous gaze behavior.
The main statistical analysis of the neurophysiological data will have the within-subjects factor of administered nasal spray (OT or PL), observed gaze direction (direct or averted gaze) and observed movement (opening hand movement or no movement). Furthermore, the link between the neurophysiological (TMS) and behavioral measures (questionnaire data and gaze behavior) will be investigated.
KU Leuven is the lead sponsor of 358 studies on the registry; 62 are open to participants now.
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Exclusion Criteria:
Syntocinon nasal spray (product code RVG 03716) will be used to intranasally administer one single dose (24 IU) of OT (3 puffs of 4 IU per nostril).
Drug: Oxytocin
Physiological water (a solution of sodium chloride (NaCl) in water) will be used to intranasally administer one single dose (24 IU) of PL (3 puffs of 4 IU per nostril).
Other: Placebo
A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril) will be administered before the assessment of the neurophysiological measures.
Also known as: Syntocinon (product code RVG 03716)
A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril) will be administered before the assessment of the neurophysiological measures.
Also known as: Physiological water (sodium chloride (NaCl) solution)
Assessment of interpersonal motor resonance (IMR)
TMS will be applied to assess IMR during different observational conditions after a single dose of nasal spray
Time frame: 30 minutes
State Adult Attachment Measure (SAAM) (sub)scores
Informant-based self-report questionnaire assessing social attachment.
Time frame: 10 minutes
Social Responsiveness Scale (SRS) (sub)scores
Informant-based self-report questionnaire assessing social responsiveness.
Time frame: 20 minutes
Spontaneous gaze behavior
During movement observation, participants' viewing behavior will be monitored by means of eye tracking technology.
Time frame: 30 minutes
Participants' mood
Informant-based self-report score on Profiles of Mood States questionnaire to control for differences in mood between sessions.
Time frame: 10 minutes
Plan to share: No
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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KU Leuven