<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03282162</url>
  </required_header>
  <id_info>
    <org_study_id>UESTC-neuSCAN-40</org_study_id>
    <nct_id>NCT03282162</nct_id>
  </id_info>
  <brief_title>The Effects of Oxytocin on Affective Touch</brief_title>
  <official_title>Oxytocin Effects on Neural Processing of Affective Touch and Associations With Trait Autism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Electronic Science and Technology of China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Electronic Science and Technology of China</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main aim of the study is to investigate whether intranasal oxytocin (24IU) increases the&#xD;
      affective processing of touch in general or whether it's effect vary according to the&#xD;
      affective valence of the touch (positive, neutral, negative). Moreover, associations with&#xD;
      trait autism will be explored.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A double-blind, within-subject, placebo controlled design will be employed in this study. In&#xD;
      a randomized-order a total of 40 healthy male subjects will receive oxytocin- and&#xD;
      placebo-nasalspray (interval between the administration &gt; 2 weeks). 45 minutes after&#xD;
      treatment subjects will be administered the touch-stimulation to the dorsal forearm by a&#xD;
      trained experimenter (lengths: 8cm, rate 8cm/s). After each block of stimulation, the&#xD;
      subjects will be asked to rate their subjective experience of the touch.The neural basis of&#xD;
      touch processing will be measured via simultaneously acquired fMRI.&#xD;
&#xD;
      Levels of trait autism will be assessed using the Autism Spectrum Quotient (ASQ) and related&#xD;
      scales such as the Empathy Quotient (EQ), Liebowitz Social Anxiety Scale (LSAS), or the&#xD;
      Sensory over Responsivity Scale (SOR) and Under Responsively Scale (URS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 28, 2017</start_date>
  <completion_date type="Actual">July 12, 2018</completion_date>
  <primary_completion_date type="Actual">January 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Randomized placebo-controlled double-blind within-subject design</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>brain function: neural activity during affective touch as assessed via BOLD fMRI</measure>
    <time_frame>45-90 minutes after treatment administration</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brain function: functional connectivity during affective touch as assessed via BOLD fMRI</measure>
    <time_frame>45-90 minutes after treatment administration</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perceived affective quality of the touch</measure>
    <time_frame>45-90 minutes after treatment administration</time_frame>
    <description>Pleasantness ratings of affective touch will be compared between the oxytocin and placebo administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Associations with trait autism as assessed via the Autism-Spectrum Quotient (AQ) - brain function: activity</measure>
    <time_frame>45-90 minutes after treatment administration</time_frame>
    <description>Associations between individual differences in trait autism and brain activity differences between the oxytocin and placebo administration will be examined</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Associations with trait autism as assessed via the Autism-Spectrum Quotient (AQ) - brain function: functional connectivity</measure>
    <time_frame>45-90 minutes after treatment administration</time_frame>
    <description>Associations between individual differences in trait autism and brain connectivity differences between the oxytocin and placebo administration will be examined</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Associations with trait autism as assessed via the Autism-Spectrum Quotient (AQ) - behaviour: pleasantness experience</measure>
    <time_frame>45-90 minutes after treatment administration</time_frame>
    <description>Associations between individual differences in trait autism and differences in pleasantness ratings between the oxytocin and placebo administration will be examined</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Associations with Sensory Responsivity as assessed via the Sensory Responsivity Scale - brain function: activity</measure>
    <time_frame>45-90 minutes after treatment administration</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Associations with Sensory Responsivity as assessed via the Sensory Responsivity Scale - brain function: functional connectivity</measure>
    <time_frame>45-90 minutes after treatment administration</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Associations with Sensory Responsivity as assessed via the Sensory Responsivity Scale - behaviour: pleasantness experience</measure>
    <time_frame>45-90 minutes after treatment administration</time_frame>
    <description>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</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Oxytocin then placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will first receive oxytocin (24 IU).They then will receive placebo (24 IU) 2 weeks later.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo then oxytocin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will first receive placebo (24 IU).They then will receive oxytocin (24 IU) 2 weeks later.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>intranasal oxytocin</intervention_name>
    <description>Each subject will be assigned to intranasal administration of oxytocin (24 IU).</description>
    <arm_group_label>Oxytocin then placebo</arm_group_label>
    <arm_group_label>Placebo then oxytocin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>intranasal placebo</intervention_name>
    <description>An identical amount of intranasal administration of placebo will be assigned to each subject.</description>
    <arm_group_label>Oxytocin then placebo</arm_group_label>
    <arm_group_label>Placebo then oxytocin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy subjects without any past or present psychiatric or neurological disorders&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of brain injury Medical or mental illness&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yuanshu Chen, B.S.</last_name>
    <role>Study Chair</role>
    <affiliation>University of Electronic Science and Technology of China</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Electronic Science and Technology of China(UESTC)</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>611731</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>October 26, 2018</last_update_submitted>
  <last_update_submitted_qc>October 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Electronic Science and Technology of China</investigator_affiliation>
    <investigator_full_name>Keith Kendrick</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Oxytocin</keyword>
  <keyword>affective touch</keyword>
  <keyword>trait autism</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxytocin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03282162
org study id: UESTC-neuSCAN-40
nct id: NCT03282162
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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).
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Randomized placebo-controlled double-blind within-subject design
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: brain function: neural activity during affective touch as assessed via BOLD fMRI
time frame: 45-90 minutes after treatment administration
description: 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.
measure: Brain function: functional connectivity during affective touch as assessed via BOLD fMRI
time frame: 45-90 minutes after treatment administration
description: 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.
measure: Perceived affective quality of the touch
time frame: 45-90 minutes after treatment administration
description: Pleasantness ratings of affective touch will be compared between the oxytocin and placebo administration
measure: Associations with trait autism as assessed via the Autism-Spectrum Quotient (AQ) - brain function: activity
time frame: 45-90 minutes after treatment administration
description: Associations between individual differences in trait autism and brain activity differences between the oxytocin and placebo administration will be examined
measure: Associations with trait autism as assessed via the Autism-Spectrum Quotient (AQ) - brain function: functional connectivity
time frame: 45-90 minutes after treatment administration
description: Associations between individual differences in trait autism and brain connectivity differences between the oxytocin and placebo administration will be examined
measure: Associations with trait autism as assessed via the Autism-Spectrum Quotient (AQ) - behaviour: pleasantness experience
time frame: 45-90 minutes after treatment administration
description: Associations between individual differences in trait autism and differences in pleasantness ratings between the oxytocin and placebo administration will be examined
measure: Associations with Sensory Responsivity as assessed via the Sensory Responsivity Scale - brain function: activity
time frame: 45-90 minutes after treatment administration
description: 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
measure: Associations with Sensory Responsivity as assessed via the Sensory Responsivity Scale - brain function: functional connectivity
time frame: 45-90 minutes after treatment administration
description: 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
measure: Associations with Sensory Responsivity as assessed via the Sensory Responsivity Scale - behaviour: pleasantness experience
time frame: 45-90 minutes after treatment administration
description: 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
arm group label: Oxytocin then placebo
arm group type: Experimental
description: Subjects will first receive oxytocin (24 IU).They then will receive placebo (24 IU) 2 weeks later.
arm group label: Placebo then oxytocin
arm group type: Experimental
description: Subjects will first receive placebo (24 IU).They then will receive oxytocin (24 IU) 2 weeks later.
intervention type: Drug
intervention name: intranasal oxytocin
description: Each subject will be assigned to intranasal administration of oxytocin (24 IU).
arm group label: Oxytocin then placebo
arm group label: Placebo then oxytocin
intervention type: Drug
intervention name: intranasal placebo
description: An identical amount of intranasal administration of placebo will be assigned to each subject.
arm group label: Oxytocin then placebo
arm group label: Placebo then oxytocin
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yuanshu Chen, B.S.
role: Study Chair
affiliation: University of Electronic Science and Technology of China
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: University of Electronic Science and Technology of China
investigator full name: Keith Kendrick
investigator title: Professor
mesh term: Oxytocin