Modulating Socially Adaptive Mirror System Functioning in Autism by Oxytocin

February 3, 2020 updated by: Kaat Alaerts, KU Leuven

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Katholieke Universiteit Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oxytocin (OXT) spray
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).
Drug: Oxytocin
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 Comparator: Placebo (PL) spray
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
A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril) will be administered before the assessment of the neurophysiological measures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 minutes after spray administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 minutes after spray administration
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).
30 minutes after spray administration
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.
30 minutes after spray administration

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before and 60 minutes after spray administration
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.
60 minutes after spray administration
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.
60 minutes after spray administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Investigators

  • Principal Investigator: Kaat Alaerts, KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2018

Primary Completion (Actual)

December 19, 2019

Study Completion (Actual)

December 19, 2019

Study Registration Dates

First Submitted

August 16, 2018

First Submitted That Met QC Criteria

August 17, 2018

First Posted (Actual)

August 21, 2018

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 3, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S56327c

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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