Oxytocin and Interpersonal Motor Resonance

Social Behavior Clinical Trial

Official title:

Oxytocin-based Pharmacotherapy: Investigating the Effect on Interpersonal Motor Resonance Upon Direct Eye Gaze

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03010670
• Other study ID #: S56327b
• Secondary ID: 2014-000586-45
• Status: Completed
• Phase: Phase 4
• First received: December 23, 2016
• Last updated: January 3, 2017
• Start date: January 2016
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics CommitteeBelgium: Institutional Review BoardBelgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Male

• Young adults (between 18 - 35 y/o)

• Right-handed

Exclusion Criteria:

• Left-handed

• Any neuro(psycho)logical / psychiatric illness.

• Motor dysfunctions of the hands / arms.

• Any contradiction to TMS research as assessed with the TMS screening list: no pacemaker, implanted defibrillator, ear implant / a cochlear implant, insulin or implanted pump, a neurostimulator or ventriculoperitoneal shunt, any metallic object in the eyes (metallic fragments)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Social Behavior

Intervention

Drug:
• Oxytocin
A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril) will be administered before the assessment of the neurophysiological measures.

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.

Locations

Country	Name	City	State
Belgium	Katholieke Universiteit Leuven	Leuven

Sponsors (3)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven	Branco Weiss Fellowship, Research Foundation Flanders

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Prinsen J, Bernaerts S, Wang Y, de Beukelaar TT, Cuypers K, Swinnen SP, Alaerts K. Direct eye contact enhances mirroring of others' movements: A transcranial magnetic stimulation study. Neuropsychologia. 2016 Dec 8;95:111-118. doi: 10.1016/j.neuropsychologia.2016.12.011. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of interpersonal motor resonance (IMR)	TMS will be applied to assess IMR during different observational conditions after a single dose of nasal spray	30 minutes	No
Secondary	State Adult Attachment Measure (SAAM) (sub)scores	Informant-based self-report questionnaire assessing social attachment.	10 minutes	No
Secondary	Social Responsiveness Scale (SRS) (sub)scores	Informant-based self-report questionnaire assessing social responsiveness.	20 minutes	No
Secondary	Spontaneous gaze behavior	During movement observation, participants' viewing behavior will be monitored by means of eye tracking technology.	30 minutes	No
Secondary	Participants' mood	Informant-based self-report score on Profiles of Mood States questionnaire to control for differences in mood between sessions.	10 minutes	No