<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/NCT03010670</url>
  </required_header>
  <id_info>
    <org_study_id>S56327b</org_study_id>
    <secondary_id>2014-000586-45</secondary_id>
    <nct_id>NCT03010670</nct_id>
  </id_info>
  <brief_title>Oxytocin and Interpersonal Motor Resonance</brief_title>
  <official_title>Oxytocin-based Pharmacotherapy: Investigating the Effect on Interpersonal Motor Resonance Upon Direct Eye Gaze</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Branco Weiss Fellowship</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Research Foundation Flanders</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>KU Leuven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Among different social cues from the environment, the eyes constitute a very salient source&#xD;
      for initiating social interaction or communication. Interestingly, previous work from our&#xD;
      (Prinsen et al., 2016) and other labs demonstrated that direct eye contact between two&#xD;
      individuals can readily evoke an increased propensity to 'mirror' other peoples' actions.&#xD;
      Particularly, using transcranial magnetic stimulation (TMS), the investigators showed that&#xD;
      mirror-motor mapping at the level of the primary motor cortex (M1), also known as&#xD;
      &quot;interpersonal motor resonance&quot; (IMR), is significantly increased upon the observation of&#xD;
      actions accompanied by direct eye contact, compared to the observation of actions accompanied&#xD;
      by averted eye gaze.&#xD;
&#xD;
      With the present study, the investigators aim to investigate the role of eye contact on IMR&#xD;
      further, and in particular, explore whether administration of the 'prosocial' neuropeptide&#xD;
      oxytocin (OT) can influence eye-contact induced IMR. In general, OT is known to play an&#xD;
      important role in promoting prosocial behavior and the perception of socially-relevant&#xD;
      stimuli, such as eye gaze. To date however, the link between OT and IMR is less clear.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the present study, the investigators want to explore how a single-dose of intranasally&#xD;
      administered OT can modulate interpersonal motor resonance (IMR) and/or the enhanced effects&#xD;
      of eye contact on IMR. To investigate the effects of exogenous OT administrations, the&#xD;
      investigators adopted a double-blind, within-subjects (cross-over), randomized,&#xD;
      placebo-controlled trial. The investigators will recruit approximately 30 neurotypical young&#xD;
      adults males between 18 - 35 years old. Since a cross-over design is included, subjects will&#xD;
      participate in two sessions, separated by one week. Participants will be randomly assigned to&#xD;
      receive a single dose of OT (24 international units) or placebo nasal spray at the first and&#xD;
      second session.&#xD;
&#xD;
      In each session, the non-invasive brain stimulation technique 'transcranial magnetic&#xD;
      stimulation' (TMS) will be used at the level of the primary motor cortex to obtain an&#xD;
      end-state measure of unconscious 'mirror-motor mapping' or IMR. During TMS, participants will&#xD;
      observe video stimuli of a model performing simple, intransitive hand movements combined with&#xD;
      either direct or averted gaze. Additionally, behavioral measures will be included: social&#xD;
      attachment and social responsiveness will be assessed via self-report questionnaires and eye&#xD;
      tracking technology will be included to monitor participant's spontaneous gaze behavior.&#xD;
&#xD;
      The main statistical analysis of the neurophysiological data will have the within-subjects&#xD;
      factor of administered nasal spray (OT or PL), observed gaze direction (direct or averted&#xD;
      gaze) and observed movement (opening hand movement or no movement). Furthermore, the link&#xD;
      between the neurophysiological (TMS) and behavioral measures (questionnaire data and gaze&#xD;
      behavior) will be investigated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</primary_completion_date>
  <phase>Phase 4</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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of interpersonal motor resonance (IMR)</measure>
    <time_frame>30 minutes</time_frame>
    <description>TMS will be applied to assess IMR during different observational conditions after a single dose of nasal spray</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>State Adult Attachment Measure (SAAM) (sub)scores</measure>
    <time_frame>10 minutes</time_frame>
    <description>Informant-based self-report questionnaire assessing social attachment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Responsiveness Scale (SRS) (sub)scores</measure>
    <time_frame>20 minutes</time_frame>
    <description>Informant-based self-report questionnaire assessing social responsiveness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spontaneous gaze behavior</measure>
    <time_frame>30 minutes</time_frame>
    <description>During movement observation, participants' viewing behavior will be monitored by means of eye tracking technology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants' mood</measure>
    <time_frame>10 minutes</time_frame>
    <description>Informant-based self-report score on Profiles of Mood States questionnaire to control for differences in mood between sessions.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Social Behavior</condition>
  <arm_group>
    <arm_group_label>Oxytocin (OT) spray</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Syntocinon nasal spray (product code RVG 03716) will be used to intranasally administer one single dose (24 IU) of OT (3 puffs of 4 IU per nostril).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (PL) spray</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>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).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin</intervention_name>
    <description>A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril) will be administered before the assessment of the neurophysiological measures.</description>
    <arm_group_label>Oxytocin (OT) spray</arm_group_label>
    <other_name>Syntocinon (product code RVG 03716)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril) will be administered before the assessment of the neurophysiological measures.</description>
    <arm_group_label>Placebo (PL) spray</arm_group_label>
    <other_name>Physiological water (sodium chloride (NaCl) solution)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  Young adults (between 18 - 35 y/o)&#xD;
&#xD;
          -  Right-handed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Left-handed&#xD;
&#xD;
          -  Any neuro(psycho)logical / psychiatric illness.&#xD;
&#xD;
          -  Motor dysfunctions of the hands / arms.&#xD;
&#xD;
          -  Any contradiction to TMS research as assessed with the TMS screening list: no&#xD;
             pacemaker, implanted defibrillator, ear implant / a cochlear implant, insulin or&#xD;
             implanted pump, a neurostimulator or ventriculoperitoneal shunt, any metallic object&#xD;
             in the eyes (metallic fragments)&#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>Katholieke Universiteit Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <reference>
    <citation>Prinsen J, Bernaerts S, Wang Y, de Beukelaar TT, Cuypers K, Swinnen SP, Alaerts K. Direct eye contact enhances mirroring of others' movements: A transcranial magnetic stimulation study. Neuropsychologia. 2017 Jan 27;95:111-118. doi: 10.1016/j.neuropsychologia.2016.12.011. Epub 2016 Dec 8.</citation>
    <PMID>27939365</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 23, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>January 3, 2017</last_update_submitted>
  <last_update_submitted_qc>January 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 5, 2017</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.</investigator_title>
  </responsible_party>
  <keyword>Oxytocin</keyword>
  <keyword>Gaze processing</keyword>
  <keyword>Interpersonal motor resonance</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxytocin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03010670
org study id: S56327b
secondary id: 2014-000586-45
nct id: NCT03010670
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Among different social cues from the environment, the eyes constitute a very salient source
      for initiating social interaction or communication. Interestingly, previous work from our
      (Prinsen et al., 2016) and other labs demonstrated that direct eye contact between two
      individuals can readily evoke an increased propensity to 'mirror' other peoples' actions.
      Particularly, using transcranial magnetic stimulation (TMS), the investigators showed that
      mirror-motor mapping at the level of the primary motor cortex (M1), also known as
      "interpersonal motor resonance" (IMR), is significantly increased upon the observation of
      actions accompanied by direct eye contact, compared to the observation of actions accompanied
      by averted eye gaze.

      With the present study, the investigators aim to investigate the role of eye contact on IMR
      further, and in particular, explore whether administration of the 'prosocial' neuropeptide
      oxytocin (OT) can influence eye-contact induced IMR. In general, OT is known to play an
      important role in promoting prosocial behavior and the perception of socially-relevant
      stimuli, such as eye gaze. To date however, the link between OT and IMR is less clear.
In the present study, the investigators want to explore how a single-dose of intranasally
      administered OT can modulate interpersonal motor resonance (IMR) and/or the enhanced effects
      of eye contact on IMR. To investigate the effects of exogenous OT administrations, the
      investigators adopted a double-blind, within-subjects (cross-over), randomized,
      placebo-controlled trial. The investigators will recruit approximately 30 neurotypical young
      adults males between 18 - 35 years old. Since a cross-over design is included, subjects will
      participate in two sessions, separated by one week. Participants will be randomly assigned to
      receive a single dose of OT (24 international units) or placebo nasal spray at the first and
      second session.

      In each session, the non-invasive brain stimulation technique 'transcranial magnetic
      stimulation' (TMS) will be used at the level of the primary motor cortex to obtain an
      end-state measure of unconscious 'mirror-motor mapping' or IMR. During TMS, participants will
      observe video stimuli of a model performing simple, intransitive hand movements combined with
      either direct or averted gaze. Additionally, behavioral measures will be included: social
      attachment and social responsiveness will be assessed via self-report questionnaires and eye
      tracking technology will be included to monitor participant's spontaneous gaze behavior.

      The main statistical analysis of the neurophysiological data will have the within-subjects
      factor of administered nasal spray (OT or PL), observed gaze direction (direct or averted
      gaze) and observed movement (opening hand movement or no movement). Furthermore, the link
      between the neurophysiological (TMS) and behavioral measures (questionnaire data and gaze
      behavior) will be investigated.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Assessment of interpersonal motor resonance (IMR)
time frame: 30 minutes
description: TMS will be applied to assess IMR during different observational conditions after a single dose of nasal spray
measure: State Adult Attachment Measure (SAAM) (sub)scores
time frame: 10 minutes
description: Informant-based self-report questionnaire assessing social attachment.
measure: Social Responsiveness Scale (SRS) (sub)scores
time frame: 20 minutes
description: Informant-based self-report questionnaire assessing social responsiveness.
measure: Spontaneous gaze behavior
time frame: 30 minutes
description: During movement observation, participants' viewing behavior will be monitored by means of eye tracking technology.
measure: Participants' mood
time frame: 10 minutes
description: Informant-based self-report score on Profiles of Mood States questionnaire to control for differences in mood between sessions.
arm group label: Oxytocin (OT) spray
arm group type: Experimental
description: Syntocinon nasal spray (product code RVG 03716) will be used to intranasally administer one single dose (24 IU) of OT (3 puffs of 4 IU per nostril).
arm group label: Placebo (PL) spray
arm group type: Placebo Comparator
description: 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).
intervention type: Drug
intervention name: Oxytocin
description: A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril) will be administered before the assessment of the neurophysiological measures.
arm group label: Oxytocin (OT) spray
other name: Syntocinon (product code RVG 03716)
intervention type: Other
intervention name: Placebo
description: A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril) will be administered before the assessment of the neurophysiological measures.
arm group label: Placebo (PL) spray
other name: Physiological water (sodium chloride (NaCl) solution)
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
citation: Prinsen J, Bernaerts S, Wang Y, de Beukelaar TT, Cuypers K, Swinnen SP, Alaerts K. Direct eye contact enhances mirroring of others' movements: A transcranial magnetic stimulation study. Neuropsychologia. 2017 Jan 27;95:111-118. doi: 10.1016/j.neuropsychologia.2016.12.011. Epub 2016 Dec 8.
PMID: 27939365
responsible party type: Principal Investigator
investigator affiliation: KU Leuven
investigator full name: Kaat Alaerts
investigator title: Prof. dr.
mesh term: Oxytocin
sharing ipd: No