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Trial · Interventional

CompletedPhase 3Registry data

Modulating Socially Adaptive Mirror System Functioning in Autism by Oxytocin

NCTNCT03640156 (opens ClinicalTrials.gov in a new tab)Other idS56327c
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
25 participants (actual)
Sponsor
KU Leuven · Other
Design
Randomized · Triple masking
Countries
1 country

Belgium

Start
26 Jul 2018
Primary completion
19 Dec 2019
Completion
19 Dec 2019
First posted
21 Aug 2018
Last update posted
5 Feb 2020
Conditions
Autism Spectrum Disorder

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201820192020
  1. Ph 3

    Modulating Socially Adaptive Mirror System Functioning in Autism by Oxytocin

    NCT03640156

    26 Jul 2018 to 19 Dec 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • OxytocinDrug
  • PlaceboOther

Arms2

  • 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).

  • 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).

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change from baseline in socially adaptive mirroring as measured by TMS

    Time frame · 30 minutes after spray administration

    Registry description

    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 outcomes(3)

  1. Change from baseline in mirroring of others' actions as measured by TMS

    Time frame · 30 minutes after spray administration

    Registry description

    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

    Registry description

    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

    Registry description

    During movement observation, participants' viewing behavior will be monitored by means of head-mounted eye tracking technology.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2018

2 results

To mirror or not to mirror upon mutual gaze, oxytocin can pave the way: A cross-over randomized placebo-controlled trial.

Prinsen et al. 2018Psychoneuroendocrinologycited by 14

PMID 29494953DOI 10.1016/j.psyneuen.2018.02.016PUB-29494953

Rights unknown2 results
Source linkSee results (2)

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 35 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

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