<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/NCT01733576</url>
  </required_header>
  <id_info>
    <org_study_id>CB64</org_study_id>
    <nct_id>NCT01733576</nct_id>
  </id_info>
  <brief_title>High-definition Transcranial Direct Current Stimulation (HD-tDCS) Verbal Learning</brief_title>
  <official_title>Enhancing Verbal Learning and Memory Using High-Definition Transcranial Direct Current Stimulation (HD-tDCS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of New South Wales</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of New South Wales</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project will use a new form of non-invasive brain stimulation called high-definition&#xD;
      transcranial direct current stimulation (HD-tDCS) to facilitate verbal learning. This form of&#xD;
      stimulation is similar to transcranial direct current stimulation (tDCS) but allows for more&#xD;
      spatially focused stimulation. We hypothesise that HD-tDCS when applied to regions of the&#xD;
      brain important for learning and memory will improve verbal learning and memory compared to&#xD;
      sham HD-tDCS.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <phase>Early Phase 1</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ray Auditory Verbal Learning Test (RAVLT)</measure>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Verbal Learning and Memory</condition>
  <arm_group>
    <arm_group_label>Sham HD-tDCS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Active HD-tDCS 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Active HD-tDCS 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Active HD-tDCS 3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HD-tDCS</intervention_name>
    <arm_group_label>Active HD-tDCS 1</arm_group_label>
    <arm_group_label>Active HD-tDCS 2</arm_group_label>
    <arm_group_label>Active HD-tDCS 3</arm_group_label>
    <arm_group_label>Sham HD-tDCS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages 18 - 40 years&#xD;
&#xD;
          -  Right-handed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  concurrent medication likely to affect mental performance&#xD;
&#xD;
          -  current history of drug or alcohol abuse or dependence&#xD;
&#xD;
          -  any psychiatric or neurological disorder, recent head injury, or history of seizure or&#xD;
             stroke.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Black Dog Institute</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2031</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>November 26, 2012</study_first_submitted>
  <study_first_submitted_qc>November 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>July 21, 2015</last_update_submitted>
  <last_update_submitted_qc>July 21, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 23, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of New South Wales</investigator_affiliation>
    <investigator_full_name>Melissa Pigot</investigator_full_name>
    <investigator_title>Research Assistant</investigator_title>
  </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/NCT01733576
org study id: CB64
nct id: NCT01733576
lead sponsor: 
has dmc: No
This project will use a new form of non-invasive brain stimulation called high-definition
      transcranial direct current stimulation (HD-tDCS) to facilitate verbal learning. This form of
      stimulation is similar to transcranial direct current stimulation (tDCS) but allows for more
      spatially focused stimulation. We hypothesise that HD-tDCS when applied to regions of the
      brain important for learning and memory will improve verbal learning and memory compared to
      sham HD-tDCS.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Ray Auditory Verbal Learning Test (RAVLT)
arm group label: Sham HD-tDCS
arm group type: Sham Comparator
arm group label: Active HD-tDCS 1
arm group type: Active Comparator
arm group label: Active HD-tDCS 2
arm group type: Active Comparator
arm group label: Active HD-tDCS 3
arm group type: Active Comparator
intervention type: Device
intervention name: HD-tDCS
arm group label: Active HD-tDCS 1
arm group label: Active HD-tDCS 2
arm group label: Active HD-tDCS 3
arm group label: Sham HD-tDCS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Australia
responsible party type: Principal Investigator
investigator affiliation: The University of New South Wales
investigator full name: Melissa Pigot
investigator title: Research Assistant