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Social BehaviorPhase 4NCT03010670

Oxytocin and Interpersonal Motor Resonance

A Phase 4 study testing Oxytocin in people with Social Behavior, run by KU Leuven at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for
Social Behavior
What is being tested?
Oxytocin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
27 participants
Where
1 siteBelgium
Study dates
Jan 2016to Dec 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Katholieke Universiteit Leuven

    Leuven, 3000

Other trials in Belgium

About this study

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

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.

Read the detailed 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.

Conditions
Social Behavior
Being tested
Oxytocin, Placebo
Keywords
Oxytocin, Gaze processing, Interpersonal motor resonance
Medical subject headings
Social Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OxytocinDrug

    Also called 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.

  • PlaceboOther

    Also called Physiological water (sodium chloride (NaCl) solution)

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

Study groups in NCT03010670
Study groupRoleWhat they receive
Oxytocin (OT) sprayExperimentalSyntocinon 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).
Receives: Drug: Oxytocin
Placebo (PL) sprayPlacebo comparatorPhysiological 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).
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 30 minutes

Secondary outcomes (4)

  1. State Adult Attachment Measure (SAAM) (sub)scores

    Informant-based self-report questionnaire assessing social attachment.

    Measured: 10 minutes

  2. Social Responsiveness Scale (SRS) (sub)scores

    Informant-based self-report questionnaire assessing social responsiveness.

    Measured: 20 minutes

  3. Spontaneous gaze behavior

    During movement observation, participants' viewing behavior will be monitored by means of eye tracking technology.

    Measured: 30 minutes

  4. Participants' mood

    Informant-based self-report score on Profiles of Mood States questionnaire to control for differences in mood between sessions.

    Measured: 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2017 (estimated)
  2. Study startJan 2016
  3. Primary completionAug 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03010670
Sponsor's protocol ID
S56327b
Other IDs
2014-000586-45, 2014
Status last verified
Dec 2016
First submitted
23 Dec 2016
Last updated
5 Jan 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27939365

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Oxytocin in people with Social Behavior, run by KU Leuven at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of interpersonal motor resonance (IMR) (time frame: 30 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03010670, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2017.

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