NCT03010670

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

December 23, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 5, 2017

Completed
Last Updated

January 5, 2017

Status Verified

December 1, 2016

Enrollment Period

7 months

First QC Date

December 23, 2016

Last Update Submit

January 3, 2017

Conditions

Keywords

OxytocinGaze processingInterpersonal motor resonance

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • State Adult Attachment Measure (SAAM) (sub)scores

    10 minutes

  • Social Responsiveness Scale (SRS) (sub)scores

    20 minutes

  • Spontaneous gaze behavior

    30 minutes

  • Participants' mood

    10 minutes

Study Arms (2)

Oxytocin (OT) spray

EXPERIMENTAL

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

Placebo (PL) spray

PLACEBO COMPARATOR

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

Interventions

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)
Oxytocin (OT) spray
PlaceboOTHER

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)
Placebo (PL) spray

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • Young adults (between 18 - 35 y/o)
  • Right-handed

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Katholieke Universiteit Leuven

Leuven, 3000, Belgium

Location

Related 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. 2017 Jan 27;95:111-118. doi: 10.1016/j.neuropsychologia.2016.12.011. Epub 2016 Dec 8.

    PMID: 27939365BACKGROUND

MeSH Terms

Conditions

Social Behavior

Interventions

OxytocinSodium ChlorideSolutions

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsPharmaceutical Preparations

Study Officials

  • Kaat Alaerts, PhD

    KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr.

Study Record Dates

First Submitted

December 23, 2016

First Posted

January 5, 2017

Study Start

January 1, 2016

Primary Completion

August 1, 2016

Study Completion

December 1, 2016

Last Updated

January 5, 2017

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations