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Completed

NCT Number: NCT03640156

Modulating Socially Adaptive Mirror System Functioning in Autism by Oxytocin

This study investigates the efficacy of a single-dose of exogenous oxytocin administration on socially adaptive mirror-motor mapping in participants with Autism Spectrum Disorders. A placebo-controlled cross-over trial will be conducted: each participant will receive both a single-dose of placebo and oxytocin in two sessions separated by one week. The order of nasal spray will be randomised across participants. Mirror-motor mapping will be assessed by transcranial magnetic stimulation (TMS), a standard technique to investigate mirror system activity.

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Key information

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Katholieke Universiteit Leuven

Leuven, 3000, Belgium

About this study

The brain's action observation network or 'mirror system' supports a variety of socio-cognitive functions, as it enables us to internally simulate and understand others' actions, emotions and intentions. Generally, mirror responses are larger upon the observation of actions accompanied by relevant information for the observer, such as direct eye contact from the actor. In other words, 'mirroring' is adaptively modulated according to the social salience of the observed actions (i.e. it is socially adaptive).

Individuals with Autism Spectrum Disorders (ASD) are known to endure difficulties with correctly recognizing eye contact as a communicative cue. Instead, they tend to experience eye contact as stressful and arousing. It is therefore hypothesized that, upon the observation of actions combined with salient gaze cues from the actor, these mirroring processes will not be adaptively modulated in participants with ASD.

As appropriate processing of eye contact is a key aspect of (non-verbal) communicative behavior, the investigator will investigate the efficacy of a single dose of intranasal oxytocin administration for enhancing socially-adaptive mirroring in ASD. Oxytocin is a neuropeptide that acts as a regulator social brain areas. On a behavioral level, it is known to enhance the saliency of observed social cues and to improve prosocial behavior. As such, it is regarded a promising intervention for alleviating the social and communicative deficits in ASD.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male
  • Young adults (between 18 - 35 y/o)
  • Right-handed
  • Official diagnosis of Autism Spectrum Disorders (for ASD participants)

Exclusion criteria

  • Female
  • Left-handed
  • Any neuro(psycho)logical / psychiatric illness (for healthy controls)
  • Motor dysfunctions of the hands / arms
  • Any contradiction to TMS research as assessed with the TMS screening list: no metal objects in the body (e.g. pacemaker, coronary bypass clips, implants, medication pumps, ...), history of brain trauma in the past (e.g. meningitis, epilepsy, surgery, ...) or history of drug and/or alcohol abuse.

Treatment and study plan

Oxytocin

Drug

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

Other names: Syntocinon (product code RVG 03716)

Placebo

Other

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

Primary outcomes

  1. Change from baseline in socially adaptive mirroring as measured by TMS

    Time frame: 30 minutes after spray administration

    After a single dose of nasal spray, TMS will be applied to assess mirror-motor mapping during the observation of socially relevant vs. irrelevant visuomotor information.

Secondary outcomes

  1. Change from baseline in mirroring of others' actions as measured by TMS

    Time frame: 30 minutes after spray administration

    After a single dose of nasal spray, TMS will be applied to assess basic mirror-motor mapping of observed actions.

  2. Change from baseline in corticospinal excitability as measured by TMS

    Time frame: 30 minutes after spray administration

    After a single dose of nasal spray, TMS will be applied to assess corticospinal excitability when the participant is at rest (without any visuomotor information).

  3. Change from baseline in total fixation duration towards the eye region of the model.

    Time frame: 30 minutes after spray administration

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

Other outcomes

  1. Change from baseline in saliva-based oxytocin concentrations

    Time frame: Before and 60 minutes after spray administration

    Saliva samples will be collected before nasal spray administration and after the experimental procedure to be able to monitor the pharmacokinetics of oxytocin.

  2. Change from baseline in Public Self-Awareness Score on Situational Self-Awareness Scale (SSAS)

    Time frame: 60 minutes after spray administration

    Informant-based self-report scale to assess public self-awareness in a specific situation as measured by SSAS. Likert scale: I totally agree (1) - I totally disagree (10); lower scores indicate more public self-awareness.

  3. Change from baseline in Arousal and Pleasure on the Self-Assessment Manikin (SAM)

    Time frame: 60 minutes after spray administration

    Informant-based scale to assess self-reported arousal and pleasure in a specific situation as measured by SAM. Likert scale: Pleasant / Not aroused (1) - Unpleasant / Aroused (9). Higher scores indicate more arousal and less pleasure.

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

To Mirror or Not to Mirror Upon Perceived Eye Contact? The Effect of Oxytocin on Socially Adaptive Mirror System Functioning in Autism

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 21, 2018
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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