<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/NCT03039387</url>
  </required_header>
  <id_info>
    <org_study_id>01EE1403D</org_study_id>
    <nct_id>NCT03039387</nct_id>
  </id_info>
  <brief_title>Effects of tDCS on Cognitive Control and Emotion Regulation in Depressed Patients</brief_title>
  <official_title>The Effect of Transcranial Direct Current Stimulation (tDCS) on Cognitive Control and Emotion Regulation in Depressed Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Tuebingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>German Federal Ministry of Education and Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universität Tübingen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital Tuebingen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Deficient cognitive control (CC) and the use of dysfunctional emotion regulation strategies&#xD;
      (ERS) are both central characteristics of major depression. Both are associated with reduced&#xD;
      activity of the dorsolateral prefrontal cortex (dlPFC). Transcranial direct current&#xD;
      stimulation (tDCS) is a safe, simple and effective non-invasive method to modulate the&#xD;
      cortical excitability. The goal of this randomized, sham-controlled, double blind clinical&#xD;
      trial is to examine the effect of transcranial direct current stimulation (tDCS) on the CC&#xD;
      and ERS in depressed patients compared to healthy subjects. Overall, the study will include&#xD;
      44 participants (22 depressed Patients and 22 healthy subjects). Each participant will&#xD;
      complete a CC task while receiving sham tDCS in one session and anodal tDCS in the other&#xD;
      session (counterbalanced). Afterwards the ERS 'rumination' will be measured during a resting&#xD;
      phase by means of a questionnaire and psychophysiological measures (heart rate variability).&#xD;
      The investigators hypothesize (a) an amelioration of CC by anodal tDCS and (b) a reduced use&#xD;
      of the dysfunctional emotion regulation strategy 'rumination' after anodal tDCS. Overall this&#xD;
      experiment will provide new and reliable data for the development of new treatment methods.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Working hypothesis: anodal transcranial direct current stimulation (tDCS) of the&#xD;
           dorsolateral prefrontal cortex (dlPFC) can enhance healthy and impaired cognitive&#xD;
           control (CC) and reduce the use of dysfunctional emotion regulation strategies.&#xD;
&#xD;
        2. Previous work of the investigators: The investigators previous work has provided&#xD;
           decisive evidence for polarity-specific activity-dependent effects of tDCS to the left&#xD;
           dlPFC on cognitive planning and control of emotional information processing in healthy&#xD;
           subjects and patients with MD. Particularly, reduced prefrontal brain activity during a&#xD;
           working memory task in patients with MD was found by using near infrared spectroscopy&#xD;
           (NIRS). In addition, the investigators demonstrated that a single session, anodal,&#xD;
           activity enhancing tDCS to the left dlPFC ameliorates deficient CC in patients with&#xD;
           depression, whereas cathodal, activity reducing tDCS, induces a depression-like&#xD;
           negativity bias in healthy subjects. Furthermore, the investigators showed that during&#xD;
           anodal tDCS of the left dlPFC healthy subjects showed (a) better performance in a CC&#xD;
           task (b) no increase in angry mood after the task compared to a control group and (c)&#xD;
           that elevated angry mood was associated to a worse performance in the CC task.&#xD;
&#xD;
        3. Aims and workplan: to investigate the effects of anodal tDCS of the left dLPFC in&#xD;
           healthy and depressed subjects the investigators will conduct a double-blind,&#xD;
           randomized, sham-controlled, cross-over design. In two sessions each participant (22&#xD;
           depressed and 22 healthy subjects, N= 44) will complete a CC task while receiving anodal&#xD;
           tDCS (1 mA) to the left dlPFC in one session and sham tDCS in the other session&#xD;
           (counterbalanced). Afterwards the ERS 'rumination' will be measured during a resting&#xD;
           phase by means of a questionnaire and psychophysiological measures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2016</start_date>
  <completion_date type="Anticipated">April 2017</completion_date>
  <primary_completion_date type="Anticipated">April 2017</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Interstimulusintervall and number of correct trials in the PASAT</measure>
    <time_frame>Assessment during stimulation/ sham stimulation in two sessions through study completion, on average 10 days.</time_frame>
    <description>To measure the performance in the PASAT the number of correct trials as well as the mean Interstimulusintervall will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of positive and negative affect</measure>
    <time_frame>The positive and negative affect is assessed (a) right before and after the PASAT in two sessions through study completion, on average 10 days. And (b) also after the resting phase in two sessions through study completion, on average 10 days.</time_frame>
    <description>Change of positive and negative affect after, compared to before performing the PASAT and also change of the affect during the resting phase.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>in two sessions through study completion, on average 10 days</time_frame>
    <description>The Heart Rate Variability will be measured during the resting phase right after the measurement of the affect.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Score in state rumination questionnaire</measure>
    <time_frame>in two sessions through study completion, on average 10 days</time_frame>
    <description>The state rumination will be measured after the resting phase</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">44</enrollment>
  <condition>Anodal Stimulation tDCS</condition>
  <condition>Major Depression</condition>
  <condition>Cognitive Control</condition>
  <condition>Emotion Regulation</condition>
  <arm_group>
    <arm_group_label>anodal tDCS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>transcranial direct current stimulation of the left dlPFC with 1mA</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham stimulation</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Double blind sham stimulation (stimulation will be ramped down after 30 sec.)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>anodal transcranial direct current stimulation</intervention_name>
    <arm_group_label>anodal tDCS</arm_group_label>
    <other_name>anodal tDCS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>transcranial direct current stimulation (sham)</intervention_name>
    <description>for the placebo control condition, the transcranial direct current stimulation will only last for 30 seconds and will then be ramped down.</description>
    <arm_group_label>Sham stimulation</arm_group_label>
    <other_name>sham tDCS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for depressed patients&#xD;
&#xD;
          -  diagnosed major depression (DSM-V)&#xD;
&#xD;
          -  stable medication for four weeks&#xD;
&#xD;
        Inclusion Criteria for all participants&#xD;
&#xD;
          -  right handedness&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of seizures&#xD;
&#xD;
          -  metal device throughout the body&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  use of von antipsychotics / mood stabilizer&#xD;
&#xD;
          -  diagnosed bipolar disorder&#xD;
&#xD;
          -  current substance abuse (nicotine excluded)&#xD;
&#xD;
          -  diagnosed psychotic diseases&#xD;
&#xD;
          -  diagnosed anorexia nervosa&#xD;
&#xD;
          -  diagnosed personality disorders: cluster A, antisocial personality disorder,&#xD;
             borderline personality disorder&#xD;
&#xD;
        Exclusion Criteria for healthy participants:&#xD;
&#xD;
          -  history of affective disorders or current affective disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Christian Plewnia, MD</last_name>
    <phone>+49 (0)7071-2986121</phone>
    <email>christian.plewnia@uni-tuebingen.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Hospital Tuebingen</name>
      <address>
        <city>Tubingen</city>
        <state>Baden-Württemberg</state>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christian Plewnia, Prof., MD</last_name>
      <phone>0049 7071 29 86121</phone>
      <email>christian.plewnia@uni-tuebingen.de</email>
    </contact>
    <contact_backup>
      <last_name>Anja Sommer, M.Sc.</last_name>
      <phone>0049 7071 29 86127</phone>
      <email>anja.sommer@med.uni-tuebingen.de</email>
    </contact_backup>
    <investigator>
      <last_name>Christian Plewnia, Prof., MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>October 28, 2016</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>January 30, 2017</last_update_submitted>
  <last_update_submitted_qc>January 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_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/NCT03039387
org study id: 01EE1403D
nct id: NCT03039387
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Deficient cognitive control (CC) and the use of dysfunctional emotion regulation strategies
      (ERS) are both central characteristics of major depression. Both are associated with reduced
      activity of the dorsolateral prefrontal cortex (dlPFC). Transcranial direct current
      stimulation (tDCS) is a safe, simple and effective non-invasive method to modulate the
      cortical excitability. The goal of this randomized, sham-controlled, double blind clinical
      trial is to examine the effect of transcranial direct current stimulation (tDCS) on the CC
      and ERS in depressed patients compared to healthy subjects. Overall, the study will include
      44 participants (22 depressed Patients and 22 healthy subjects). Each participant will
      complete a CC task while receiving sham tDCS in one session and anodal tDCS in the other
      session (counterbalanced). Afterwards the ERS 'rumination' will be measured during a resting
      phase by means of a questionnaire and psychophysiological measures (heart rate variability).
      The investigators hypothesize (a) an amelioration of CC by anodal tDCS and (b) a reduced use
      of the dysfunctional emotion regulation strategy 'rumination' after anodal tDCS. Overall this
      experiment will provide new and reliable data for the development of new treatment methods.
1. Working hypothesis: anodal transcranial direct current stimulation (tDCS) of the
           dorsolateral prefrontal cortex (dlPFC) can enhance healthy and impaired cognitive
           control (CC) and reduce the use of dysfunctional emotion regulation strategies.

        2. Previous work of the investigators: The investigators previous work has provided
           decisive evidence for polarity-specific activity-dependent effects of tDCS to the left
           dlPFC on cognitive planning and control of emotional information processing in healthy
           subjects and patients with MD. Particularly, reduced prefrontal brain activity during a
           working memory task in patients with MD was found by using near infrared spectroscopy
           (NIRS). In addition, the investigators demonstrated that a single session, anodal,
           activity enhancing tDCS to the left dlPFC ameliorates deficient CC in patients with
           depression, whereas cathodal, activity reducing tDCS, induces a depression-like
           negativity bias in healthy subjects. Furthermore, the investigators showed that during
           anodal tDCS of the left dlPFC healthy subjects showed (a) better performance in a CC
           task (b) no increase in angry mood after the task compared to a control group and (c)
           that elevated angry mood was associated to a worse performance in the CC task.

        3. Aims and workplan: to investigate the effects of anodal tDCS of the left dLPFC in
           healthy and depressed subjects the investigators will conduct a double-blind,
           randomized, sham-controlled, cross-over design. In two sessions each participant (22
           depressed and 22 healthy subjects, N= 44) will complete a CC task while receiving anodal
           tDCS (1 mA) to the left dlPFC in one session and sham tDCS in the other session
           (counterbalanced). Afterwards the ERS 'rumination' will be measured during a resting
           phase by means of a questionnaire and psychophysiological measures.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Triple (Participant, Care Provider, Investigator)
measure: Interstimulusintervall and number of correct trials in the PASAT
time frame: Assessment during stimulation/ sham stimulation in two sessions through study completion, on average 10 days.
description: To measure the performance in the PASAT the number of correct trials as well as the mean Interstimulusintervall will be assessed.
measure: Change of positive and negative affect
time frame: The positive and negative affect is assessed (a) right before and after the PASAT in two sessions through study completion, on average 10 days. And (b) also after the resting phase in two sessions through study completion, on average 10 days.
description: Change of positive and negative affect after, compared to before performing the PASAT and also change of the affect during the resting phase.
measure: Heart rate variability
time frame: in two sessions through study completion, on average 10 days
description: The Heart Rate Variability will be measured during the resting phase right after the measurement of the affect.
measure: Score in state rumination questionnaire
time frame: in two sessions through study completion, on average 10 days
description: The state rumination will be measured after the resting phase
arm group label: anodal tDCS
arm group type: Active Comparator
description: transcranial direct current stimulation of the left dlPFC with 1mA
arm group label: Sham stimulation
arm group type: Placebo Comparator
description: Double blind sham stimulation (stimulation will be ramped down after 30 sec.)
intervention type: Device
intervention name: anodal transcranial direct current stimulation
arm group label: anodal tDCS
other name: anodal tDCS
intervention type: Device
intervention name: transcranial direct current stimulation (sham)
description: for the placebo control condition, the transcranial direct current stimulation will only last for 30 seconds and will then be ramped down.
arm group label: Sham stimulation
other name: sham tDCS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Christian Plewnia, MD
phone: +49 (0)7071-2986121
email: christian.plewnia@uni-tuebingen.de
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Germany
responsible party type: Sponsor
mesh term: Depressive Disorder, Major
sharing ipd: No