<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/NCT03272321</url>
  </required_header>
  <id_info>
    <org_study_id>SingleOT_EEG-SC_S56327</org_study_id>
    <nct_id>NCT03272321</nct_id>
  </id_info>
  <brief_title>Influence of Oxytocin on Neurophysiological Responses to Live Faces</brief_title>
  <official_title>Influence of Oxytocin on Neurophysiological Responses to Direct and Averted Gaze</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Research Foundation Flanders</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>KU Leuven</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>
      Previous research has indicated that direct eye gaze compared to averted gaze, elicits a&#xD;
      higher skin conductance response (SCR), and a more pronounced left frontal cortex activity&#xD;
      than right frontal cortex activity (resulting in positive asymmetry scores). On a behavioral&#xD;
      level, participants tend to look shorter at live faces with a direct gaze as compared to&#xD;
      averted gaze (Akechi et al., 2013). Further, subjective evaluations showed that a direct gaze&#xD;
      is rated more arousing and less pleasant than an averted gaze (Akechi et al., 2013; Hietanen,&#xD;
      Leppänen, Peltola, Linna-aho, &amp; Ruuhiala, 2008).&#xD;
&#xD;
      Importantly, oxytocin administration increases the number of fixations and to looking time&#xD;
      towards the eye region during live social interaction. Further, oxytocin has been shown to&#xD;
      influence SCR and heart rate variability. Therefore, it is conceivable that oxytocin will not&#xD;
      only influence the gaze duration of the participant, but also the physiological and&#xD;
      neurological responses elicited by direct eye gaze.&#xD;
&#xD;
      In this study, the investigators will investigate whether oxytocin modulates the behavioural&#xD;
      (eye gaze and subjective ratings), neurological (EEG) and physiological (skin conductance,&#xD;
      heart rate and respiration) responses elicited by direct gaze.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Previous research has indicated that direct eye gaze compared to averted gaze, elicits a&#xD;
      higher skin conductance response (SCR), and a more pronounced left frontal cortex activity&#xD;
      than right frontal cortex activity (resulting in positive asymmetry scores). On a behavioral&#xD;
      level, participants tend to look shorter at live faces with a direct gaze as compared to&#xD;
      averted gaze (Akechi et al., 2013). Further, subjective evaluations showed that a direct gaze&#xD;
      is rated more arousing and less pleasant than an averted gaze (Akechi et al., 2013; Hietanen,&#xD;
      Leppänen, Peltola, Linna-aho, &amp; Ruuhiala, 2008).&#xD;
&#xD;
      Importantly, oxytocin administration increases the number of fixations and to looking time&#xD;
      towards the eye region during live social interaction. Further, oxytocin has been shown to&#xD;
      influence SCR and heart rate variability. Therefore, it is conceivable that oxytocin will not&#xD;
      only influence the gaze duration of the participant, but also the physiological and&#xD;
      neurological responses elicited by direct eye gaze.&#xD;
&#xD;
      In this randomized, placebo controlled, double blinded study, the investigators will&#xD;
      investigate whether oxytocin modulates the behavioral and neurophysiological responses&#xD;
      elicited by direct gaze. In order to do so, the investigators will measure behavioural (eye&#xD;
      gaze and subjective feelings), physiological (skin conductance, blood volume pulse, and&#xD;
      respiration) and neurological (EEG) responses during presentations of a live person's face&#xD;
      with direct gaze and closed eyes, before and after oxytocin or placebo administration.&#xD;
&#xD;
      The investigators hypotheses that oxytocin attenuates the heightened SCR and pronounced EEG&#xD;
      asymmetry during direct gaze. Further, they expect that oxytocin increases the number of&#xD;
      fixations and duration of those fixations towards the eye region. Exploratory, the&#xD;
      investigators will also investigate whether oxytocin administration influences respiration&#xD;
      and the subjective reports on experience of live eye contact. Lastly (and also exploratory),&#xD;
      they will explore whether certain personality traits (as measured by SAAM (state adult&#xD;
      attachment measure) and SRS (social responsiveness scale)) influence the modulatory effect of&#xD;
      oxytocin on neurological and behavioural responses.&#xD;
&#xD;
      Note that this study is part of a larger study in which the investigators also register&#xD;
      several neurophysiological responses (blood volume pulse, respiration, heart rate, EEG, skin&#xD;
      conductance) during rest before and after oxytocin or placebo administration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 24, 2017</start_date>
  <completion_date type="Actual">May 18, 2018</completion_date>
  <primary_completion_date type="Actual">May 18, 2018</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in EEG asymmetry after oxytocin administration</measure>
    <time_frame>Average over several trials, baseline and 40 min after oxytocin or placebo administration</time_frame>
    <description>The influence of oxytocin administration on EEG asymmetry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in skin conductance (type of electrodermal activity) response after oxytocin administration</measure>
    <time_frame>Average over several trials, baseline and 40 min after oxytocin or placebo administration</time_frame>
    <description>The influence of oxytocin administration on skin conductance response</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in duration of fixations to face regions after oxytocin administration</measure>
    <time_frame>Assesment over several trials, baseline and 40 min after oxytocin or placebo administration</time_frame>
    <description>The influence of oxytocin administration on gaze behavior (duration of fixation to upper and lower face regions)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in number of fixations to face regions after oxytocin administration</measure>
    <time_frame>Assesment over several trials, baseline and 40 min after oxytocin or placebo administration</time_frame>
    <description>The influence of oxytocin administration on gaze behavior (number of fixation to upper and lower face regions)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Oxytocin</condition>
  <arm_group>
    <arm_group_label>Oxytocin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Syntocinon nasal spray (40 IU/ml; oxytocin, product code RVG 03716); single intranasal dose of 24 international units (IU; 3 puffs of 4 IU per nostril)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>saline natriumchloride solution nasal spray; single intranasal dose (3 puffs per nostril)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin</intervention_name>
    <description>Syntocinon nasal spray</description>
    <arm_group_label>Oxytocin</arm_group_label>
    <other_name>syntocinon</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo nasal spray</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  right-handed&#xD;
&#xD;
          -  male&#xD;
&#xD;
          -  age between 18 and 35&#xD;
&#xD;
          -  Normal or adjusted-to-normal vision (with lenses only)&#xD;
&#xD;
          -  Dutch as mother tongue&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not right-handed&#xD;
&#xD;
          -  female&#xD;
&#xD;
          -  age below 18 or above 35&#xD;
&#xD;
          -  Need to wear glasses&#xD;
&#xD;
          -  Dutch not as mother tongue&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kaat Alaerts, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>KU Leuven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>KU Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>July 31, 2019</last_update_submitted>
  <last_update_submitted_qc>July 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>KU Leuven</investigator_affiliation>
    <investigator_full_name>Kaat Alaerts</investigator_full_name>
    <investigator_title>Prof. Dr. Kaat Alaerts</investigator_title>
  </responsible_party>
  <keyword>biomedical intervention</keyword>
  <keyword>oxytocin</keyword>
  <keyword>EEG</keyword>
  <keyword>skin conductance response</keyword>
  <keyword>heart rate</keyword>
  <keyword>gaze direction</keyword>
  <keyword>eye contact</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/NCT03272321
org study id: SingleOT_EEG-SC_S56327
nct id: NCT03272321
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Previous research has indicated that direct eye gaze compared to averted gaze, elicits a
      higher skin conductance response (SCR), and a more pronounced left frontal cortex activity
      than right frontal cortex activity (resulting in positive asymmetry scores). On a behavioral
      level, participants tend to look shorter at live faces with a direct gaze as compared to
      averted gaze (Akechi et al., 2013). Further, subjective evaluations showed that a direct gaze
      is rated more arousing and less pleasant than an averted gaze (Akechi et al., 2013; Hietanen,
      Leppänen, Peltola, Linna-aho, & Ruuhiala, 2008).

      Importantly, oxytocin administration increases the number of fixations and to looking time
      towards the eye region during live social interaction. Further, oxytocin has been shown to
      influence SCR and heart rate variability. Therefore, it is conceivable that oxytocin will not
      only influence the gaze duration of the participant, but also the physiological and
      neurological responses elicited by direct eye gaze.

      In this study, the investigators will investigate whether oxytocin modulates the behavioural
      (eye gaze and subjective ratings), neurological (EEG) and physiological (skin conductance,
      heart rate and respiration) responses elicited by direct gaze.
Previous research has indicated that direct eye gaze compared to averted gaze, elicits a
      higher skin conductance response (SCR), and a more pronounced left frontal cortex activity
      than right frontal cortex activity (resulting in positive asymmetry scores). On a behavioral
      level, participants tend to look shorter at live faces with a direct gaze as compared to
      averted gaze (Akechi et al., 2013). Further, subjective evaluations showed that a direct gaze
      is rated more arousing and less pleasant than an averted gaze (Akechi et al., 2013; Hietanen,
      Leppänen, Peltola, Linna-aho, & Ruuhiala, 2008).

      Importantly, oxytocin administration increases the number of fixations and to looking time
      towards the eye region during live social interaction. Further, oxytocin has been shown to
      influence SCR and heart rate variability. Therefore, it is conceivable that oxytocin will not
      only influence the gaze duration of the participant, but also the physiological and
      neurological responses elicited by direct eye gaze.

      In this randomized, placebo controlled, double blinded study, the investigators will
      investigate whether oxytocin modulates the behavioral and neurophysiological responses
      elicited by direct gaze. In order to do so, the investigators will measure behavioural (eye
      gaze and subjective feelings), physiological (skin conductance, blood volume pulse, and
      respiration) and neurological (EEG) responses during presentations of a live person's face
      with direct gaze and closed eyes, before and after oxytocin or placebo administration.

      The investigators hypotheses that oxytocin attenuates the heightened SCR and pronounced EEG
      asymmetry during direct gaze. Further, they expect that oxytocin increases the number of
      fixations and duration of those fixations towards the eye region. Exploratory, the
      investigators will also investigate whether oxytocin administration influences respiration
      and the subjective reports on experience of live eye contact. Lastly (and also exploratory),
      they will explore whether certain personality traits (as measured by SAAM (state adult
      attachment measure) and SRS (social responsiveness scale)) influence the modulatory effect of
      oxytocin on neurological and behavioural responses.

      Note that this study is part of a larger study in which the investigators also register
      several neurophysiological responses (blood volume pulse, respiration, heart rate, EEG, skin
      conductance) during rest before and after oxytocin or placebo administration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in EEG asymmetry after oxytocin administration
time frame: Average over several trials, baseline and 40 min after oxytocin or placebo administration
description: The influence of oxytocin administration on EEG asymmetry
measure: Change in skin conductance (type of electrodermal activity) response after oxytocin administration
time frame: Average over several trials, baseline and 40 min after oxytocin or placebo administration
description: The influence of oxytocin administration on skin conductance response
measure: Change in duration of fixations to face regions after oxytocin administration
time frame: Assesment over several trials, baseline and 40 min after oxytocin or placebo administration
description: The influence of oxytocin administration on gaze behavior (duration of fixation to upper and lower face regions)
measure: Change in number of fixations to face regions after oxytocin administration
time frame: Assesment over several trials, baseline and 40 min after oxytocin or placebo administration
description: The influence of oxytocin administration on gaze behavior (number of fixation to upper and lower face regions)
arm group label: Oxytocin
arm group type: Experimental
description: Syntocinon nasal spray (40 IU/ml; oxytocin, product code RVG 03716); single intranasal dose of 24 international units (IU; 3 puffs of 4 IU per nostril)
arm group label: Placebo
arm group type: Placebo Comparator
description: saline natriumchloride solution nasal spray; single intranasal dose (3 puffs per nostril)
intervention type: Drug
intervention name: Oxytocin
description: Syntocinon nasal spray
arm group label: Oxytocin
other name: syntocinon
intervention type: Drug
intervention name: Placebo
description: Placebo nasal spray
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kaat Alaerts, PhD
role: Principal Investigator
affiliation: KU Leuven
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: KU Leuven
investigator full name: Kaat Alaerts
investigator title: Prof. Dr. Kaat Alaerts
mesh term: Oxytocin