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Clinical Trials/NCT03282162
NCT03282162
Completed
Not Applicable

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

University of Electronic Science and Technology of China1 site in 1 country50 target enrollmentAugust 28, 2017

Overview

Phase
Not Applicable
Intervention
intranasal oxytocin
Conditions
Healthy
Sponsor
University of Electronic Science and Technology of China
Enrollment
50
Locations
1
Primary Endpoint
brain function: neural activity during affective touch as assessed via BOLD fMRI
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Detailed Description

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).

Registry
clinicaltrials.gov
Start Date
August 28, 2017
End Date
July 12, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Male

Investigators

Sponsor
University of Electronic Science and Technology of China
Responsible Party
Principal Investigator
Principal Investigator

Keith Kendrick

Professor

University of Electronic Science and Technology of China

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • History of brain injury Medical or mental illness

Arms & Interventions

Oxytocin then placebo

Subjects will first receive oxytocin (24 IU).They then will receive placebo (24 IU) 2 weeks later.

Intervention: intranasal oxytocin

Oxytocin then placebo

Subjects will first receive oxytocin (24 IU).They then will receive placebo (24 IU) 2 weeks later.

Intervention: intranasal placebo

Placebo then oxytocin

Subjects will first receive placebo (24 IU).They then will receive oxytocin (24 IU) 2 weeks later.

Intervention: intranasal oxytocin

Placebo then oxytocin

Subjects will first receive placebo (24 IU).They then will receive oxytocin (24 IU) 2 weeks later.

Intervention: intranasal placebo

Outcomes

Primary Outcomes

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.

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

  • Associations with trait autism as assessed via the Autism-Spectrum Quotient (AQ) - brain function: functional connectivity(45-90 minutes after treatment administration)
  • Associations with trait autism as assessed via the Autism-Spectrum Quotient (AQ) - behaviour: pleasantness experience(45-90 minutes after treatment administration)
  • Associations with Sensory Responsivity as assessed via the Sensory Responsivity Scale - behaviour: pleasantness experience(45-90 minutes after treatment administration)
  • Associations with trait autism as assessed via the Autism-Spectrum Quotient (AQ) - brain function: activity(45-90 minutes after treatment administration)
  • Associations with Sensory Responsivity as assessed via the Sensory Responsivity Scale - brain function: activity(45-90 minutes after treatment administration)
  • Perceived affective quality of the touch(45-90 minutes after treatment administration)
  • Associations with Sensory Responsivity as assessed via the Sensory Responsivity Scale - brain function: functional connectivity(45-90 minutes after treatment administration)

Study Sites (1)

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