Modulating Socially Adaptive Mirror System Functioning in Autism by Oxytocin

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

Sponsors

Lead Sponsor: KU Leuven

Source KU Leuven
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.

Overall Status Completed
Start Date July 26, 2018
Completion Date December 19, 2019
Primary Completion Date December 19, 2019
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Change from baseline in socially adaptive mirroring as measured by TMS 30 minutes after spray administration
Secondary Outcome
Measure Time Frame
Change from baseline in mirroring of others' actions as measured by TMS 30 minutes after spray administration
Change from baseline in corticospinal excitability as measured by TMS 30 minutes after spray administration
Change from baseline in total fixation duration towards the eye region of the model. 30 minutes after spray administration
Enrollment 25
Condition
Intervention

Intervention Type: Drug

Intervention Name: Oxytocin

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

Arm Group Label: Oxytocin (OXT) spray

Other Name: Syntocinon (product code RVG 03716)

Intervention Type: Other

Intervention Name: Placebo

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

Arm Group Label: Placebo (PL) spray

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.

Gender: Male

Minimum Age: 18 Years

Maximum Age: 35 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Kaat Alaerts Principal Investigator KU Leuven
Location
Facility: Katholieke Universiteit Leuven
Location Countries

Belgium

Verification Date

February 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: KU Leuven

Investigator Full Name: Kaat Alaerts

Investigator Title: Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Oxytocin (OXT) spray

Type: Experimental

Description: Syntocinon nasal spray (product code RVG 03716) will be used to intranasally administer one single dose (24 IU) of OXT (3 puffs of 4 IU per nostril).

Label: Placebo (PL) spray

Type: Placebo Comparator

Description: 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).

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Basic Science

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov