<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/NCT03302130</url>
  </required_header>
  <id_info>
    <org_study_id>EC/2015/0528</org_study_id>
    <nct_id>NCT03302130</nct_id>
  </id_info>
  <brief_title>The Effects of Mood on Cerebral Perfusion</brief_title>
  <official_title>The Effects of Mood on Cerebral Perfusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Ghent</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>
      Measuring brain perfusion is biased by a inter- and intrasubject variability, caused by&#xD;
      physiological and lifestyle factors. In this study, the investigators want to investigate the&#xD;
      effects of a different mood state (neutral, positive and negative mood), induced using&#xD;
      subjects own memories, on both global and regional cerebral perfusion, measured with arterial&#xD;
      spin labeling.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 8, 2016</start_date>
  <completion_date type="Actual">November 17, 2017</completion_date>
  <primary_completion_date type="Actual">October 30, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Regional Cerebral perfusion (ml/100g/min) during positive mood induction</measure>
    <time_frame>2 minutes (ASL scan during mood state induction)</time_frame>
    <description>Effect of positive mood induction (using volunteer's own memories) on cerebral perfusion using arterial spin labeling MRI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Regional Cerebral perfusion (ml/100g/min) during negative mood induction</measure>
    <time_frame>2 minutes (ASL scan during mood state induction)</time_frame>
    <description>Effect of negative mood induction (using volunteer's own memories) on cerebral perfusion using arterial spin labeling MRI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Regional Cerebral perfusion (ml/100g/min) during neutral mood induction</measure>
    <time_frame>2 minutes (ASL scan during mood state induction)</time_frame>
    <description>Effect of neutral mood induction (using volunteer's own memories) on cerebral perfusion using arterial spin labeling MRI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Regional Cerebral perfusion (ml/100g/min) after positive mood induction</measure>
    <time_frame>2 minutes (ASL scan after mood state induction)</time_frame>
    <description>Effect of positive mood (using volunteer's own memories) on cerebral perfusion using arterial spin labeling MRI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Regional Cerebral perfusion (ml/100g/min) after negative mood induction</measure>
    <time_frame>2 minutes (ASL scan after mood state induction)</time_frame>
    <description>Effect of negative mood (using volunteer's own memories) on cerebral perfusion using arterial spin labeling MRI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Regional Cerebral perfusion (ml/100g/min) after neutral mood induction</measure>
    <time_frame>2 minutes (ASL scan after mood state induction)</time_frame>
    <description>Effect of neutral mood (using volunteer's own memories) on cerebral perfusion using arterial spin labeling MRI.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Cerebral Perfusion</condition>
  <arm_group>
    <arm_group_label>Imaging healthy volunteers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mood induction: positive, negative, neutral mood (using subjects own memories) Arterial spin labeling MRI Physiological monitoring</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mood induction (using own memories)</intervention_name>
    <description>Subjects deliver three positive, three negative and three neutral memories 30 seconds reliving a memory - answering questions about the memory - reliving memory for 2 minutes during ASL-MRI</description>
    <arm_group_label>Imaging healthy volunteers</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Arterial spin labeling MRI</intervention_name>
    <description>Single PLD PCASL</description>
    <arm_group_label>Imaging healthy volunteers</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Physiological monitoring</intervention_name>
    <description>During MRI: heart rate, end-tidal CO2, respiratory rate and skin conductance</description>
    <arm_group_label>Imaging healthy volunteers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy university students&#xD;
&#xD;
          -  between 18 and 30 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No informed consent&#xD;
&#xD;
          -  Not using hormonal contraception&#xD;
&#xD;
          -  MRI-contraindications&#xD;
&#xD;
          -  Claustrophobia&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Chronic diseases and chronic medication use&#xD;
      </textblock>
    </criteria>
    <gender>All</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>Eric Achten, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Ghent</affiliation>
  </overall_official>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>October 6, 2016</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>November 8, 2022</last_update_submitted>
  <last_update_submitted_qc>November 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03302130
org study id: EC/2015/0528
nct id: NCT03302130
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Measuring brain perfusion is biased by a inter- and intrasubject variability, caused by
      physiological and lifestyle factors. In this study, the investigators want to investigate the
      effects of a different mood state (neutral, positive and negative mood), induced using
      subjects own memories, on both global and regional cerebral perfusion, measured with arterial
      spin labeling.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Regional Cerebral perfusion (ml/100g/min) during positive mood induction
time frame: 2 minutes (ASL scan during mood state induction)
description: Effect of positive mood induction (using volunteer's own memories) on cerebral perfusion using arterial spin labeling MRI.
measure: Regional Cerebral perfusion (ml/100g/min) during negative mood induction
time frame: 2 minutes (ASL scan during mood state induction)
description: Effect of negative mood induction (using volunteer's own memories) on cerebral perfusion using arterial spin labeling MRI.
measure: Regional Cerebral perfusion (ml/100g/min) during neutral mood induction
time frame: 2 minutes (ASL scan during mood state induction)
description: Effect of neutral mood induction (using volunteer's own memories) on cerebral perfusion using arterial spin labeling MRI.
measure: Regional Cerebral perfusion (ml/100g/min) after positive mood induction
time frame: 2 minutes (ASL scan after mood state induction)
description: Effect of positive mood (using volunteer's own memories) on cerebral perfusion using arterial spin labeling MRI.
measure: Regional Cerebral perfusion (ml/100g/min) after negative mood induction
time frame: 2 minutes (ASL scan after mood state induction)
description: Effect of negative mood (using volunteer's own memories) on cerebral perfusion using arterial spin labeling MRI.
measure: Regional Cerebral perfusion (ml/100g/min) after neutral mood induction
time frame: 2 minutes (ASL scan after mood state induction)
description: Effect of neutral mood (using volunteer's own memories) on cerebral perfusion using arterial spin labeling MRI.
arm group label: Imaging healthy volunteers
arm group type: Experimental
description: Mood induction: positive, negative, neutral mood (using subjects own memories) Arterial spin labeling MRI Physiological monitoring
intervention type: Behavioral
intervention name: Mood induction (using own memories)
description: Subjects deliver three positive, three negative and three neutral memories 30 seconds reliving a memory - answering questions about the memory - reliving memory for 2 minutes during ASL-MRI
arm group label: Imaging healthy volunteers
intervention type: Device
intervention name: Arterial spin labeling MRI
description: Single PLD PCASL
arm group label: Imaging healthy volunteers
intervention type: Device
intervention name: Physiological monitoring
description: During MRI: heart rate, end-tidal CO2, respiratory rate and skin conductance
arm group label: Imaging healthy volunteers
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eric Achten, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Ghent
responsible party type: Sponsor