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Modulating Socially Adaptive Mirror System Functioning in Autism by Oxytocin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03640156
Recruitment Status : Completed
First Posted : August 21, 2018
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Kaat Alaerts, 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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Drug: Oxytocin Other: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: To Mirror or Not to Mirror Upon Perceived Eye Contact? The Effect of Oxytocin on Socially Adaptive Mirror System Functioning in Autism
Actual Study Start Date : July 26, 2018
Actual Primary Completion Date : December 19, 2019
Actual Study Completion Date : December 19, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

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 Name: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03640156


Locations
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Belgium
Katholieke Universiteit Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
KU Leuven
Investigators
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Principal Investigator: Kaat Alaerts KU Leuven
Additional Information:
Publications:
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Responsible Party: Kaat Alaerts, Professor, KU Leuven
ClinicalTrials.gov Identifier: NCT03640156    
Other Study ID Numbers: S56327c
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kaat Alaerts, KU Leuven:
Oxytocin
Eye Contact
Mirror System
Transcranial Magnetic Stimulation
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs