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Completed

NCT Number: NCT03282162

The Effects of Oxytocin on Affective Touch

The main aim of the study is to investigate whether intranasal oxytocin (24IU) increases the affective processing of touch in general or whether it's effect vary according to the affective valence of the touch (positive, neutral, negative). Moreover, associations with trait autism will be explored.

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Key information

Conditions

Healthy

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Electronic Science and Technology of China(UESTC)

Chengdu, Sichuan, 611731, China

About this study

A double-blind, within-subject, placebo controlled design will be employed in this study. In a randomized-order a total of 40 healthy male subjects will receive oxytocin- and placebo-nasalspray (interval between the administration > 2 weeks). 45 minutes after treatment subjects will be administered the touch-stimulation to the dorsal forearm by a trained experimenter (lengths: 8cm, rate 8cm/s). After each block of stimulation, the subjects will be asked to rate their subjective experience of the touch.The neural basis of touch processing will be measured via simultaneously acquired fMRI.

Levels of trait autism will be assessed using the Autism Spectrum Quotient (ASQ) and related scales such as the Empathy Quotient (EQ), Liebowitz Social Anxiety Scale (LSAS), or the Sensory over Responsivity Scale (SOR) and Under Responsively Scale (URS).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy subjects without any past or present psychiatric or neurological disorders

Exclusion criteria

  • History of brain injury Medical or mental illness

Treatment and study plan

Intranasal oxytocin

Drug

Each subject will be assigned to intranasal administration of oxytocin (24 IU).

Intranasal placebo

Drug

An identical amount of intranasal administration of placebo will be assigned to each subject.

Primary outcomes

  1. brain function: neural activity during affective touch as assessed via BOLD fMRI

    Time frame: 45-90 minutes after treatment administration

    fMRI data will be analyzed using a within-subject General Linear Model approach - to determine the effects of oxytocin neural activity following oxytocin administration will be compared with neural activity following placebo administration.

  2. Brain function: functional connectivity during affective touch as assessed via BOLD fMRI

    Time frame: 45-90 minutes after treatment administration

    fMRI data will be analyzed using a within-subject General Linear Model approach - to determine the effects of oxytocin on the brain network level, functional connectivity following oxytocin administration will be compared with functional connectivity following placebo administration.

Secondary outcomes

  1. Perceived affective quality of the touch

    Time frame: 45-90 minutes after treatment administration

    Pleasantness ratings of affective touch will be compared between the oxytocin and placebo administration

  2. Associations with trait autism as assessed via the Autism-Spectrum Quotient (AQ) - brain function: activity

    Time frame: 45-90 minutes after treatment administration

    Associations between individual differences in trait autism and brain activity differences between the oxytocin and placebo administration will be examined

  3. Associations with trait autism as assessed via the Autism-Spectrum Quotient (AQ) - brain function: functional connectivity

    Time frame: 45-90 minutes after treatment administration

    Associations between individual differences in trait autism and brain connectivity differences between the oxytocin and placebo administration will be examined

  4. Associations with trait autism as assessed via the Autism-Spectrum Quotient (AQ) - behaviour: pleasantness experience

    Time frame: 45-90 minutes after treatment administration

    Associations between individual differences in trait autism and differences in pleasantness ratings between the oxytocin and placebo administration will be examined

  5. Associations with Sensory Responsivity as assessed via the Sensory Responsivity Scale - brain function: activity

    Time frame: 45-90 minutes after treatment administration

    Associations between individual differences in Sensory Responsivity as assessed via the Sensory Responsivity Scale and brain activity differences between the oxytocin and placebo administration will be examined

  6. Associations with Sensory Responsivity as assessed via the Sensory Responsivity Scale - brain function: functional connectivity

    Time frame: 45-90 minutes after treatment administration

    Associations between individual differences in Sensory Responsivity as assessed via the Sensory Responsivity Scale and brain connectivity differences between the oxytocin and placebo administration will be examined

  7. Associations with Sensory Responsivity as assessed via the Sensory Responsivity Scale - behaviour: pleasantness experience

    Time frame: 45-90 minutes after treatment administration

    Associations between individual differences in Sensory Responsivity as assessed via the Sensory Responsivity Scale and differences in pleasantness ratings between the oxytocin and placebo administration will be examined

Sponsors and collaborators

Lead sponsor

University of Electronic Science and Technology of China

Other

Registry information

Official study title

Oxytocin Effects on Neural Processing of Affective Touch and Associations With Trait Autism

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 13, 2017
Registry last updated
Oct 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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