Modulating Socially Adaptive Mirror System Functioning in Autism by Oxytocin

NCT03640156 | Completed Phase 3

• 1 other identifier: S56327c
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

Oxytocin; Eye Contact; Mirror System; Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

• Change from baseline in socially adaptive mirroring as measured by TMS

  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 Outcomes (3)

• 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

Other Outcomes (3)

• Change from baseline in saliva-based oxytocin concentrations

  Before and 60 minutes after spray administration

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

  60 minutes after spray administration

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

  60 minutes after spray administration

Study Arms (2)

Oxytocin (OXT) spray

EXPERIMENTAL

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

Placebo (PL) spray

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: Syntocinon (product code RVG 03716)

Oxytocin (OXT) spray

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.

Placebo (PL) spray

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

Katholieke Universiteit Leuven

Leuven, 3000, Belgium

Location

Related Publications (2)

• 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.

  PMID: 27939365 BACKGROUND

• 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.

  PMID: 29494953 BACKGROUND

Related Links

• Related Information

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Kaat Alaerts

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 21, 2018
• Study Start: July 26, 2018
• Primary Completion: December 19, 2019
• Study Completion: December 19, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)