Clinical trial NCT03640156: Modulating Socially Adaptive Mirror System Functioning in Autism by Oxytocin
Official title: To Mirror or Not to Mirror Upon Perceived Eye Contact? The Effect of Oxytocin on Socially Adaptive Mirror System Functioning in Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Autism Spectrum Disorder
Keywords: Oxytocin
Eye Contact
Mirror System
Transcranial Magnetic Stimulation
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in socially adaptive mirroring as measured by TMS
timeFrame: 30 minutes after spray administration
Secondary outcomes:
measure: Change from baseline in mirroring of others' actions as measured by TMS
timeFrame: 30 minutes after spray administration
measure: Change from baseline in corticospinal excitability as measured by TMS
timeFrame: 30 minutes after spray administration
measure: Change from baseline in total fixation duration towards the eye region of the model.
timeFrame: 30 minutes after spray administration
Other outcomes:
measure: Change from baseline in saliva-based oxytocin concentrations
timeFrame: Before and 60 minutes after spray administration
measure: Change from baseline in Public Self-Awareness Score on Situational Self-Awareness Scale (SSAS)
timeFrame: 60 minutes after spray administration
measure: Change from baseline in Arousal and Pleasure on the Self-Assessment Manikin (SAM)
timeFrame: 60 minutes after spray administration
Locations:
city: Leuven
country: Belgium
facility: Katholieke Universiteit Leuven
Study officials:
affiliation: KU Leuven
name: Kaat Alaerts
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Prinsen J, Brams S, Alaerts K. To mirror or not to mirror upon mutual gaze, oxytocin can pave the way: A cross-over randomized placebo-controlled trial. Psychoneuroendocrinology. 2018 Apr;90:148-156. doi: 10.1016/j.psyneuen.2018.02.016. Epub 2018 Feb 22.