<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/NCT03027687</url>
  </required_header>
  <id_info>
    <org_study_id>NL58190.078.16</org_study_id>
    <nct_id>NCT03027687</nct_id>
  </id_info>
  <brief_title>Effects of Repetitive tDCS on ad Libitum Smoking Behavior: EMA and EEG Study</brief_title>
  <official_title>Effects of Repetitive tDCS on ad Libitum Smoking Behavior: An EMA and EEG Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Erasmus Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Erasmus Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Bilateral (left cathodal/ right anodal) transcranial Direct Current Stimulation (tDCS) over&#xD;
      the dorsolateral prefrontal cortex (DLPFC) seems to reduce craving and to increase the time&#xD;
      till smoking the first cigarette after the intervention. The current study explores whether&#xD;
      actual cigarette consumption decreases after repetitive tDCS. Cigarette consumption and&#xD;
      craving will therefore be measured by means of EMA, before (at baseline), during and after&#xD;
      multiple tDCS sessions, and at 3 months follow-up.&#xD;
&#xD;
      To study the working mechanism behind the effects of tDCS, electrophysiological responses&#xD;
      (ERPs) and behavioral measures of cognitive control functioning will be taken into account at&#xD;
      baseline, one day after the last tDCS session and at three months follow up.&#xD;
&#xD;
      We hypothesize that cigarette consumption will decrease after repetitive tDCS, and that this&#xD;
      effect is associated with better cognitive control functioning.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed experiment is a double-blind randomized placebo-controlled trial. 60 smokers&#xD;
      will be randomly assigned to two conditions, namely tDCS or sham (placebo).&#xD;
&#xD;
      Participants will receive real tDCS or sham for three days in one week. The interventions&#xD;
      contain twice daily sessions for 13 minutes with an interval of 20 min. Moreover, on the&#xD;
      first treatment day and the day after the treatment week, participants complete a number of&#xD;
      questionnaires, and perform two psychological tasks (a gambling task and the Go/NoGo task) to&#xD;
      measure cognitive control functioning (e.g. risky decision making and inhibitory control&#xD;
      respectively). During these tasks, event-related potentials will be recorded by means of EEG.&#xD;
      After three months, participants are asked to return to fill out the same questionnaires and&#xD;
      perform the same psychological tasks as before, to measure the lasting effect of tDCS. During&#xD;
      this last session, event-related potentials will also be recorded. In addition, carbon&#xD;
      monoxide levels will be measured on all days where subjects perform the tasks.&#xD;
&#xD;
      EMA:&#xD;
&#xD;
      For three weeks, starting the week before tDCS treatment, participants are asked to log every&#xD;
      cigarette before they smoke one. During these weeks, participants complete EMA questionnaires&#xD;
      on their mobile phone about cigarette consumption, craving, and affect that will take&#xD;
      approximately 5 minutes. The EMA questionnaire will be presented four times daily on a&#xD;
      quasi-random basis. Finally, during end-of-day assessments participants have the possibility&#xD;
      to indicate any missed cigarettes. At three months follow-up, participants are asked to&#xD;
      undergo the same EMA procedure for one more week, to study the lasting effects of tDCS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">March 2018</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean number of cigarettes a day at 3 months follow up</measure>
    <time_frame>3 months</time_frame>
    <description>The mean number of cigarettes will be measured at three months follow-up by means of Ecological Momentary Assessments (EMA). This means that participants are asked to report every cigarette they smoke at the moment they're about to smoke it with an app on their mobile phone. Participants do this during the week before the last EEG session at three months follow-up.The mean number will be calculated over this week</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean number of cigarettes a day one week after tDCS</measure>
    <time_frame>1 week</time_frame>
    <description>The mean number of cigarettes will be measured at one week after the last tDCS session by means of Ecological Momentary Assessments (EMA). This means that participants are asked to report every cigarette they smoke at the moment they're about to smoke it with an app on their mobile phone. Participants do this for one week starting from the last tDCS session. The mean number will be calculated over this week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Craving at 3 months follow-up</measure>
    <time_frame>3 months</time_frame>
    <description>Participants receive 4 prompts a day in the app on the smartphone to fill out questions about craving for 1 week starting the week before the last EEG session at three months follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Affect 3 months after tDCS</measure>
    <time_frame>3 months</time_frame>
    <description>Participants receive 4 prompts a day in the app on the smartphone to fill out questions about affect for 1 week starting the week before the last EEG session at three months follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Craving one week after tDCS</measure>
    <time_frame>1 week</time_frame>
    <description>Participants receive 4 prompts a day in the app on the smartphone to fill out questions about craving for 1 week starting the day after the last tDCS session</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Affect one week after tDCS</measure>
    <time_frame>1 week</time_frame>
    <description>Participants receive 4 prompts a day in the app on the smartphone to fill out questions about affect for 1 week starting the day after the last tDCS session</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioral responses of risk-taking</measure>
    <time_frame>3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up</time_frame>
    <description>Measured with the two-choice gambling task: proportion of high-risk (higher values) choices</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioral responses of inhibitory control</measure>
    <time_frame>3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up</time_frame>
    <description>Measured by proportion correctly inhibited NoGo trials on the Go/NoGo task</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feedback Related Negativity (FRN): Event Related potential (ERP) of reward processing</measure>
    <time_frame>3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up</time_frame>
    <description>Measured with the two choice gambling task. After the choice (high/low risk) is made, participants receive feedback (either they lose or win). The Feedback Related Negativity (FRN) will be measured after feedback by means of EEG.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reward related P300: Event related potential (ERP) of reward processing</measure>
    <time_frame>3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up</time_frame>
    <description>Measured with the two choice gambling task. After the choice (high/low risk) is made, participants receive feedback (either they lose or win). The reward related P300 will be measured 300-500 ms after feedback by means of EEG.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>N200: Event related potential (ERP) of inhibitory control</measure>
    <time_frame>3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up</time_frame>
    <description>The N200 will be measured after NoGo trials in the Go/NoGo task</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>P300: Event related potential (ERP) of inhibitory control</measure>
    <time_frame>3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up</time_frame>
    <description>The P300 will be measured after NoGo trials in the Go/NoGo task</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Error related negativity: Event related potential (ERP) of error processing</measure>
    <time_frame>3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up</time_frame>
    <description>Wrong responses to Go and NoGo trials in the Go/NoGo task will be used to assess the error related negativity (ERN)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Course of cigarette consumption</measure>
    <time_frame>2 weeks</time_frame>
    <description>Number of cigarettes (and craving) a day starting on the first tDCS day until one week after the last tDCS intervention</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">73</enrollment>
  <condition>Addiction</condition>
  <arm_group>
    <arm_group_label>Real transcranial Direct Current Stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will receive bilateral tDCS (left cathodal/right anodal) over the DLPFC. The stimulation will take place two times daily for 13 minutes with a rest interval of 20 minutes for three days in one week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham tDCS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The control group receives sham, for which the stimulator will be gradually turned off after 30 seconds.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>tDCS</intervention_name>
    <description>tDCS is an electrical brain stimulation method</description>
    <arm_group_label>Real transcranial Direct Current Stimulation</arm_group_label>
    <arm_group_label>Sham tDCS</arm_group_label>
    <other_name>transcranial direct current stimulation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Currently smoking 10 or more cigarettes a day&#xD;
&#xD;
          -  The ability to speak, read, and write in Dutch at an eight-grade literacy level&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The current abuse of a substance other than nicotine or caffeine&#xD;
&#xD;
          -  History of neurological or psychiatric disorders&#xD;
&#xD;
          -  Any contraindication for electrical brain stimulation procedures such as electronic&#xD;
             implants or metal implants&#xD;
&#xD;
          -  Pregnancy or breast-feeding&#xD;
&#xD;
          -  In the process of quitting smoking&#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>
  <location>
    <facility>
      <name>Erasmus University</name>
      <address>
        <city>Rotterdam</city>
        <state>Zuid-Holland</state>
        <zip>3000 DR</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>November 15, 2018</last_update_submitted>
  <last_update_submitted_qc>November 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Erasmus Medical Center</investigator_affiliation>
    <investigator_full_name>Ingmar Franken</investigator_full_name>
    <investigator_title>Prof. Dr.</investigator_title>
  </responsible_party>
  <keyword>Smoking</keyword>
  <keyword>EMA</keyword>
  <keyword>ERPs</keyword>
  <keyword>tDCS</keyword>
  <keyword>Cigarette consumption</keyword>
  <keyword>Inhibitory control</keyword>
  <keyword>Reward processing</keyword>
  <keyword>Tobacco addiction</keyword>
  <keyword>Craving</keyword>
  <keyword>electrophysiological</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Behavior, Addictive</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/NCT03027687
org study id: NL58190.078.16
nct id: NCT03027687
lead sponsor: 
has dmc: No
Bilateral (left cathodal/ right anodal) transcranial Direct Current Stimulation (tDCS) over
      the dorsolateral prefrontal cortex (DLPFC) seems to reduce craving and to increase the time
      till smoking the first cigarette after the intervention. The current study explores whether
      actual cigarette consumption decreases after repetitive tDCS. Cigarette consumption and
      craving will therefore be measured by means of EMA, before (at baseline), during and after
      multiple tDCS sessions, and at 3 months follow-up.

      To study the working mechanism behind the effects of tDCS, electrophysiological responses
      (ERPs) and behavioral measures of cognitive control functioning will be taken into account at
      baseline, one day after the last tDCS session and at three months follow up.

      We hypothesize that cigarette consumption will decrease after repetitive tDCS, and that this
      effect is associated with better cognitive control functioning.
The proposed experiment is a double-blind randomized placebo-controlled trial. 60 smokers
      will be randomly assigned to two conditions, namely tDCS or sham (placebo).

      Participants will receive real tDCS or sham for three days in one week. The interventions
      contain twice daily sessions for 13 minutes with an interval of 20 min. Moreover, on the
      first treatment day and the day after the treatment week, participants complete a number of
      questionnaires, and perform two psychological tasks (a gambling task and the Go/NoGo task) to
      measure cognitive control functioning (e.g. risky decision making and inhibitory control
      respectively). During these tasks, event-related potentials will be recorded by means of EEG.
      After three months, participants are asked to return to fill out the same questionnaires and
      perform the same psychological tasks as before, to measure the lasting effect of tDCS. During
      this last session, event-related potentials will also be recorded. In addition, carbon
      monoxide levels will be measured on all days where subjects perform the tasks.

      EMA:

      For three weeks, starting the week before tDCS treatment, participants are asked to log every
      cigarette before they smoke one. During these weeks, participants complete EMA questionnaires
      on their mobile phone about cigarette consumption, craving, and affect that will take
      approximately 5 minutes. The EMA questionnaire will be presented four times daily on a
      quasi-random basis. Finally, during end-of-day assessments participants have the possibility
      to indicate any missed cigarettes. At three months follow-up, participants are asked to
      undergo the same EMA procedure for one more week, to study the lasting effects of tDCS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Mean number of cigarettes a day at 3 months follow up
time frame: 3 months
description: The mean number of cigarettes will be measured at three months follow-up by means of Ecological Momentary Assessments (EMA). This means that participants are asked to report every cigarette they smoke at the moment they're about to smoke it with an app on their mobile phone. Participants do this during the week before the last EEG session at three months follow-up.The mean number will be calculated over this week
measure: Mean number of cigarettes a day one week after tDCS
time frame: 1 week
description: The mean number of cigarettes will be measured at one week after the last tDCS session by means of Ecological Momentary Assessments (EMA). This means that participants are asked to report every cigarette they smoke at the moment they're about to smoke it with an app on their mobile phone. Participants do this for one week starting from the last tDCS session. The mean number will be calculated over this week
measure: Craving at 3 months follow-up
time frame: 3 months
description: Participants receive 4 prompts a day in the app on the smartphone to fill out questions about craving for 1 week starting the week before the last EEG session at three months follow-up
measure: Affect 3 months after tDCS
time frame: 3 months
description: Participants receive 4 prompts a day in the app on the smartphone to fill out questions about affect for 1 week starting the week before the last EEG session at three months follow-up
measure: Craving one week after tDCS
time frame: 1 week
description: Participants receive 4 prompts a day in the app on the smartphone to fill out questions about craving for 1 week starting the day after the last tDCS session
measure: Affect one week after tDCS
time frame: 1 week
description: Participants receive 4 prompts a day in the app on the smartphone to fill out questions about affect for 1 week starting the day after the last tDCS session
measure: Behavioral responses of risk-taking
time frame: 3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
description: Measured with the two-choice gambling task: proportion of high-risk (higher values) choices
measure: Behavioral responses of inhibitory control
time frame: 3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
description: Measured by proportion correctly inhibited NoGo trials on the Go/NoGo task
measure: Feedback Related Negativity (FRN): Event Related potential (ERP) of reward processing
time frame: 3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
description: Measured with the two choice gambling task. After the choice (high/low risk) is made, participants receive feedback (either they lose or win). The Feedback Related Negativity (FRN) will be measured after feedback by means of EEG.
measure: Reward related P300: Event related potential (ERP) of reward processing
time frame: 3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
description: Measured with the two choice gambling task. After the choice (high/low risk) is made, participants receive feedback (either they lose or win). The reward related P300 will be measured 300-500 ms after feedback by means of EEG.
measure: N200: Event related potential (ERP) of inhibitory control
time frame: 3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
description: The N200 will be measured after NoGo trials in the Go/NoGo task
measure: P300: Event related potential (ERP) of inhibitory control
time frame: 3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
description: The P300 will be measured after NoGo trials in the Go/NoGo task
measure: Error related negativity: Event related potential (ERP) of error processing
time frame: 3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
description: Wrong responses to Go and NoGo trials in the Go/NoGo task will be used to assess the error related negativity (ERN)
measure: Course of cigarette consumption
time frame: 2 weeks
description: Number of cigarettes (and craving) a day starting on the first tDCS day until one week after the last tDCS intervention
arm group label: Real transcranial Direct Current Stimulation
arm group type: Experimental
description: This group will receive bilateral tDCS (left cathodal/right anodal) over the DLPFC. The stimulation will take place two times daily for 13 minutes with a rest interval of 20 minutes for three days in one week.
arm group label: Sham tDCS
arm group type: Sham Comparator
description: The control group receives sham, for which the stimulator will be gradually turned off after 30 seconds.
intervention type: Device
intervention name: tDCS
description: tDCS is an electrical brain stimulation method
arm group label: Real transcranial Direct Current Stimulation
arm group label: Sham tDCS
other name: transcranial direct current stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Erasmus Medical Center
investigator full name: Ingmar Franken
investigator title: Prof. Dr.
mesh term: Behavior, Addictive
sharing ipd: No