<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/NCT03027869</url>
  </required_header>
  <id_info>
    <org_study_id>B2016:074</org_study_id>
    <nct_id>NCT03027869</nct_id>
  </id_info>
  <brief_title>Normal Brain Imaging Database for Brain Disorder Studies</brief_title>
  <acronym>Normal_tDCS</acronym>
  <official_title>Normal Brain Imaging Database for Brain Disorder Studies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Manitoba</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Healthy volunteers will be recruited. All subjects will be tested a battery of&#xD;
      neuropsychological tests, then undergo fluorodeoxyglucose-positron emission tomography (PET)&#xD;
      and magnetic resonance imaging (MRI). During the PET and MRI, they will be stimulated with&#xD;
      transcranial direct current stimulation (tDCS) for 15 minutes. A third of subjects will&#xD;
      receive real tDCS on the left prefrontal cortex, a third on the right prefrontal cortex, and&#xD;
      the other third will receive sham tDCS.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 28, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Actual">March 11, 2020</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>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>functional connectivity</measure>
    <time_frame>immediate (less than 30 minutes)</time_frame>
    <description>The functional connectivity of the right caudate nucleus will be estimated using graph theory analysis technique of resting-state fMRI.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stroop task performance</measure>
    <time_frame>immediate (less than 60 minutes)</time_frame>
    <description>the executive function that is thought to involve the caudate nucleus will be examined</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Real Left DLPFC tDCS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Real tDCS on the left dorsolateral prefrontal cortex</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham tDCS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>30sec ramp-up and 30sec ramp-down</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Real Right DLPFC tDCS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Real tDCS on the right dorsolateral prefrontal cortex</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>transcranial direct current stimulation</intervention_name>
    <description>15 minute anodal stimulation 1.5mA</description>
    <arm_group_label>Real Left DLPFC tDCS</arm_group_label>
    <arm_group_label>Real Right DLPFC tDCS</arm_group_label>
    <arm_group_label>Sham tDCS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  N/A&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of any neurological or psychiatric diseases;&#xD;
&#xD;
          -  Abnormal MRI;&#xD;
&#xD;
          -  metal implants or a cardiac pacemaker;&#xD;
&#xD;
          -  Pregnant or breastfeeding women (female subjects of child bearing potential will be&#xD;
             screened for pregnancy before MRI imaging).&#xD;
&#xD;
          -  severe hypertension.&#xD;
&#xD;
          -  cardiovascular disease.&#xD;
&#xD;
          -  Family history of epilepsy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Manitoba</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3E 0J9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>May 10, 2023</last_update_submitted>
  <last_update_submitted_qc>May 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Manitoba</investigator_affiliation>
    <investigator_full_name>Ji Hyun Ko, PhD</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Diseases</mesh_term>
  </condition_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/NCT03027869
org study id: B2016:074
nct id: NCT03027869
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Healthy volunteers will be recruited. All subjects will be tested a battery of
      neuropsychological tests, then undergo fluorodeoxyglucose-positron emission tomography (PET)
      and magnetic resonance imaging (MRI). During the PET and MRI, they will be stimulated with
      transcranial direct current stimulation (tDCS) for 15 minutes. A third of subjects will
      receive real tDCS on the left prefrontal cortex, a third on the right prefrontal cortex, and
      the other third will receive sham tDCS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Outcomes Assessor)
measure: functional connectivity
time frame: immediate (less than 30 minutes)
description: The functional connectivity of the right caudate nucleus will be estimated using graph theory analysis technique of resting-state fMRI.
measure: Stroop task performance
time frame: immediate (less than 60 minutes)
description: the executive function that is thought to involve the caudate nucleus will be examined
arm group label: Real Left DLPFC tDCS
arm group type: Active Comparator
description: Real tDCS on the left dorsolateral prefrontal cortex
arm group label: Sham tDCS
arm group type: Sham Comparator
description: 30sec ramp-up and 30sec ramp-down
arm group label: Real Right DLPFC tDCS
arm group type: Active Comparator
description: Real tDCS on the right dorsolateral prefrontal cortex
intervention type: Device
intervention name: transcranial direct current stimulation
description: 15 minute anodal stimulation 1.5mA
arm group label: Real Left DLPFC tDCS
arm group label: Real Right DLPFC tDCS
arm group label: Sham tDCS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Manitoba
investigator full name: Ji Hyun Ko, PhD
investigator title: Assistant Professor
mesh term: Brain Diseases