<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/NCT02999607</url>
  </required_header>
  <id_info>
    <org_study_id>3.0.30.11.16</org_study_id>
    <nct_id>NCT02999607</nct_id>
  </id_info>
  <brief_title>Brain Glucose Metabolism During Transcranial Direct Current Stimulation</brief_title>
  <official_title>Brain Glucose Metabolism in Healthy Subjects and Depressive Patients During Transcranial Direct Current Stimulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      With this study we will be able to dose-dependently measure real-time glucose metabolism&#xD;
      changes after non-invasively stimulating superficial parts of the dlPFC, a commonly used&#xD;
      target in therapeutic tDCS applications. This will provide further insight if and how tDCS is&#xD;
      capable to change one of most reliable parameters of brain metabolism.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      With this study, we will be able to substantiate if regional and whole brain glucose&#xD;
      metabolism is affected by tDCS, assess the amount of signal change in relation to different&#xD;
      currents and measure differences in glucose metabolism under stimulation reactivity between&#xD;
      healthy subjects and depressive patients. The objective is to investigate the changes of&#xD;
      regional cerebral metabolic rate of glucose (rCMRglu) in the brain after transcranial direct&#xD;
      current stimulation in healthy subjects and depressive patients. The design is a&#xD;
      cross-sectional proof of principle study in 20 healthy subjects and 20 depressed patients.&#xD;
      During the PET scan tDCS will be applied with varying stimulus intensity. Furthermore,&#xD;
      subjects will undergo a second PET scan with single-blind sham stimulation in order to&#xD;
      validate the effects of tDCS. rCMRglu will be quantified using voxel-wise and ROI-based&#xD;
      approaches. Changes in rCMRglu associated with tDCS-application will be calculated with a&#xD;
      general linear model in a ramp function of the task-specific glucose uptake, according to&#xD;
      previous work in our group. Exploratory statistical testing will be done using a paired&#xD;
      samples t-test between task and rest conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">September 1, 2017</completion_date>
  <primary_completion_date type="Actual">September 1, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>FDG-rCMRglu</measure>
    <time_frame>70 minutes</time_frame>
    <description>regional cerebral metabolic rate of glucose</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>active transcranial direct current stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stimulation at three different intensities during FDG-PET scan</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham tDCS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Comparator to active arm</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>transcranial direct current stimulation</intervention_name>
    <description>0.5 mA, 1mA, 2mA for 10 minutes each</description>
    <arm_group_label>Sham tDCS</arm_group_label>
    <arm_group_label>active transcranial direct current stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Healthy controls:&#xD;
&#xD;
        - Aged 18 to 55 years Somatic and psychiatric health based on medical history, physical&#xD;
        examination, ECG, laboratory screening, SCID-I and II Willingness and competence to&#xD;
        complete the informed consent process&#xD;
&#xD;
        Depressed Patients:&#xD;
&#xD;
        Current major depressive episode during unipolar major depression (MD) according to SCID-I&#xD;
        (with HAMD&gt;17) No other concomitant axis-I disease apart from anxiety disorder, which must&#xD;
        be secondary to MD Standard antidepressant medication stable during the last 4 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concomitant major medical or neurological illness, including history of seizures Any&#xD;
             current substance abuse disorder according to DSM-V (urinary test and history)&#xD;
             including current sedative usage in MDD patients ECT, TMS or NMDA-antagonists&#xD;
             (ketamine) during the past 6 months. Current augmentation with anti-epileptics, or&#xD;
             other drugs affecting seizure threshold Failure to comply with the study protocol or&#xD;
             follow the instructions of the investigators Pregnancy Participants with previous&#xD;
             total radiation exposure dose of 30mSv over the last 10 years (according to&#xD;
             legislation on radiation protection).&#xD;
&#xD;
        Left-handedness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Psychiatry and Psychotherapy, Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>December 18, 2016</study_first_submitted>
  <study_first_submitted_qc>December 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>January 12, 2018</last_update_submitted>
  <last_update_submitted_qc>January 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Rupert Lanzenberger</investigator_full_name>
    <investigator_title>Assoc. Prof. Priv.-Doz.</investigator_title>
  </responsible_party>
  <keyword>Transcranial direct current stimulation</keyword>
  <keyword>Positron emission tomography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</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/NCT02999607
org study id: 3.0.30.11.16
nct id: NCT02999607
lead sponsor: 
has dmc: No
With this study we will be able to dose-dependently measure real-time glucose metabolism
      changes after non-invasively stimulating superficial parts of the dlPFC, a commonly used
      target in therapeutic tDCS applications. This will provide further insight if and how tDCS is
      capable to change one of most reliable parameters of brain metabolism.
With this study, we will be able to substantiate if regional and whole brain glucose
      metabolism is affected by tDCS, assess the amount of signal change in relation to different
      currents and measure differences in glucose metabolism under stimulation reactivity between
      healthy subjects and depressive patients. The objective is to investigate the changes of
      regional cerebral metabolic rate of glucose (rCMRglu) in the brain after transcranial direct
      current stimulation in healthy subjects and depressive patients. The design is a
      cross-sectional proof of principle study in 20 healthy subjects and 20 depressed patients.
      During the PET scan tDCS will be applied with varying stimulus intensity. Furthermore,
      subjects will undergo a second PET scan with single-blind sham stimulation in order to
      validate the effects of tDCS. rCMRglu will be quantified using voxel-wise and ROI-based
      approaches. Changes in rCMRglu associated with tDCS-application will be calculated with a
      general linear model in a ramp function of the task-specific glucose uptake, according to
      previous work in our group. Exploratory statistical testing will be done using a paired
      samples t-test between task and rest conditions.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: FDG-rCMRglu
time frame: 70 minutes
description: regional cerebral metabolic rate of glucose
arm group label: active transcranial direct current stimulation
arm group type: Experimental
description: Stimulation at three different intensities during FDG-PET scan
arm group label: Sham tDCS
arm group type: Sham Comparator
description: Comparator to active arm
intervention type: Other
intervention name: transcranial direct current stimulation
description: 0.5 mA, 1mA, 2mA for 10 minutes each
arm group label: Sham tDCS
arm group label: active transcranial direct current stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Rupert Lanzenberger
investigator title: Assoc. Prof. Priv.-Doz.
mesh term: Depression