<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/NCT04405089</url>
  </required_header>
  <id_info>
    <org_study_id>4740A</org_study_id>
    <nct_id>NCT04405089</nct_id>
  </id_info>
  <brief_title>tDCS for Impulsivity and Compulsivity in Obesity</brief_title>
  <official_title>Role of Transcranial Direct Current Stimulation to Decrease Impulsivity and Compulsivity in Individuals With Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Minneapolis Veterans Affairs Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Center for Veterans Research and Education</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Minneapolis Veterans Affairs Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Even when they know it can improve health, many individuals with loss of control eating&#xD;
      struggle when they are trying to make and sustain new health habits for weight loss and&#xD;
      maintenance of weight loss. Impulsivity, characterized by lack of foresight and planning and&#xD;
      excessive risk taking, and compulsivity, characterized by inability to break old habitual&#xD;
      behaviors, may play a role in refractory obesity. The primary objective of this pilot study&#xD;
      is to investigate the effect of a novel neuroplasticity based intervention, cognitive&#xD;
      training coupled with transcranial direct current stimulation (tDCS), on measures of&#xD;
      impulsivity and compulsivity in individuals with obesity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Impulsivity and compulsivity are two psychological factors which contribute to addictive&#xD;
      behaviors. Impulsivity is characterized by lack of foresight and planning, and excessive risk&#xD;
      taking. Impulsivity is a characteristic of poor executive functioning, and reflects deficits&#xD;
      in goal-oriented behavior and self-regulation. Compulsivity is characterized by inability to&#xD;
      break old habits. Both of these traits may play a role in refractory obesity. Transcranial&#xD;
      direct current stimulation (tDCS) coupled with cognitive training may strengthen key&#xD;
      circuitry involved in impulse control within the prefrontal cortex. tDCS coupled with&#xD;
      cognitive training has the potential to reduce impulsivity and compulsivity in individuals&#xD;
      with obesity, with the potential for therapeutic application as a non-pharmacologic approach&#xD;
      to management of food-related eating behaviors which may impact weight.&#xD;
&#xD;
      For this double-blind, randomized, placebo (sham) controlled study pilot study the&#xD;
      investigators aim to recruit and complete studies in approximately 20 individuals, randomly&#xD;
      assigned to receive either active or sham tDCS, both coupled with computerized cognitive&#xD;
      training tasks, for five days. Additionally, participants will attend follow up visits at&#xD;
      approximately 2, and 4 months after the course of intervention visits is completed. Testing&#xD;
      pre- and post-intervention will include the Binge Eating Scale (BES), PHQ-9 Depression&#xD;
      Screen, and 4 domains of the NIH Examiner Battery. Weight will be tracked throughout the&#xD;
      study. MN-BEST blast exposure screening tool is also conducted at baseline.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 3, 2018</start_date>
  <completion_date type="Anticipated">June 5, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 5, 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>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in NIH Examiner Flanker Score</measure>
    <time_frame>Change between baseline and 1 week follow-up, and 2, and 4 months post intervention</time_frame>
    <description>Differences in magnitude of changes in Flanker scores (numeric summary scores) between active tDCS-cognitive training and sham-cognitive training groups from baseline to follow-up sessions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in NIH Examiner Set Shifting Score</measure>
    <time_frame>Change between baseline and 1 week follow-up, and 2, and 4 months post intervention</time_frame>
    <description>Differences in magnitude of changes in Set Shifting scores (numeric summary scores) between active tDCS-cognitive training and sham-cognitive training groups from baseline to follow-up sessions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in NIH Examiner Dot Counting Score</measure>
    <time_frame>Change between baseline and 1 week follow-up, and 2, and 4 months post intervention</time_frame>
    <description>Differences in magnitude of changes in Dot Counting scores (numeric summary scores) between active tDCS-cognitive training and sham-cognitive training groups from baseline to follow-up sessions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in NIH Examiner Unstructured Planning Task Score</measure>
    <time_frame>Change between baseline and 1 week follow-up, and 2, and 4 months post intervention</time_frame>
    <description>Differences in magnitude of changes in Unstructured Planning Task scores (numeric summary scores) between active tDCS-cognitive training and sham-cognitive training groups from baseline to follow-up sessions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in weight</measure>
    <time_frame>Change between baseline and 1 week follow-up, and 2, and 4 months post intervention</time_frame>
    <description>Differences in magnitude of changes in weight (pounds) between active tDCS-cognitive training and sham-cognitive training groups from baseline to end of study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of history of traumatic brain injury on impulsive and compulsive eating behavior-Binge Scale</measure>
    <time_frame>Change between baseline and 4 months post intervention</time_frame>
    <description>Effect of traumatic brain injury history at baseline (none, single, multiple prior episodes), as measured with Minnesota Blast Exposure Screening Tool (MN-BEST), on differences in magnitude of changes in Binge Eating Scale Scores (numeric summary score) between active tDCS-cognitive training and sham-cognitive training groups from baseline to end of study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of history of traumatic brain injury on impulsive and compulsive eating behavior-NIH Flanker</measure>
    <time_frame>Change between baseline and 1 week follow-up, and 2, and 4 months post intervention</time_frame>
    <description>Effect of traumatic brain injury history at baseline (none, single, multiple prior episodes), as measured with Minnesota Blast Exposure Screening Tool (MN-BEST), on differences in magnitude of changes in Flanker scores between active tDCS-cognitive training and sham-cognitive training groups from baseline to end of study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of history of traumatic brain injury on impulsive and compulsive eating behavior-NIH Set Shifting</measure>
    <time_frame>Change between baseline and 1 week follow-up, and 2, and 4 months post intervention</time_frame>
    <description>Effect of traumatic brain injury history at baseline (none, single, multiple prior episodes), as measured with Minnesota Blast Exposure Screening Tool (MN-BEST) , on differences in magnitude of changes on Set Shifting scores between active tDCS-cognitive training and sham-cognitive training groups from baseline to end of study</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Impulsivity</condition>
  <condition>Compulsive Overeating</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Active tDCS with cognitive training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive 5 sessions of cognitive training concurrent with transcranial direct current stimulation (anode over right frontal cortex, cathode over left frontal cortex; 2 mAmps for 26 minutes).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham tDCS with cognitive training</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Participants will receive 5 sessions of cognitive training concurrent with sham tDCS. For sham tDCS, electrodes are placed at the same locations as for active tDCS, but current is ramped up for the initial 30 secs, then immediately ramped back down. This method mimics the initial physical sensation of stimulation, but there is no active current for the remainder of the session.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Device: Active Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training</intervention_name>
    <description>Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the right prefrontal cortex for total of 26 minutes.</description>
    <arm_group_label>Active tDCS with cognitive training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Device: Sham Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training</intervention_name>
    <description>Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning of session).</description>
    <arm_group_label>Sham tDCS with cognitive training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Obese (BMI&gt;30)&#xD;
&#xD;
          -  Adults ages 18 years or older receiving care through the Minneapolis VA Healthcare&#xD;
             System&#xD;
&#xD;
          -  Able to understand English, self-consent and follow study-related procedures&#xD;
&#xD;
          -  Willing to use a reliable form of birth control if they are of females of&#xD;
             child-bearing potential.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of any of the following issues: seizures, severe or moderate head injury, head&#xD;
             surgery, significant neurological disorder(significance based on Principal&#xD;
             Investigator's judgment), frequent severe headaches&#xD;
&#xD;
          -  History of scalp conditions such as eczema or seborrheic dermatitis&#xD;
&#xD;
          -  Metal in head (other than in mouth) including shrapnel/surgical clips/welding&#xD;
             fragments&#xD;
&#xD;
          -  Implanted medical devices (including pumps and cardiac pacemakers)&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Active substance abuse&#xD;
&#xD;
          -  Psychological or medical disorders requiring inpatient treatment&#xD;
&#xD;
          -  Presence of a known metabolic or hormonal disorder (such as Cushing's) which affects&#xD;
             weight/appetite. (History of hypothyroidism is acceptable if subject is on treatment&#xD;
             with normal thyroid stimulating hormone (TSH) and free thyroxine (FT4) on most recent&#xD;
             check within the last 3 months and has been on stable dosage of l-thyroxine for at&#xD;
             least 3 months, taking it as prescribed.)&#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>
  <overall_official>
    <last_name>Shalamar Sibley, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Minneapolis VAMC, University of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Minneapolis VA Medical Center</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55417</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 17, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>May 26, 2020</last_update_submitted>
  <last_update_submitted_qc>May 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Minneapolis Veterans Affairs Medical Center</investigator_affiliation>
    <investigator_full_name>Shalamar Sibley, MD, MPH</investigator_full_name>
    <investigator_title>Associate Professor of Medicine, University of Minnesota; Minneapolis VAMC Staff Physician</investigator_title>
  </responsible_party>
  <keyword>Impulsive Behavior</keyword>
  <keyword>Behavior Control</keyword>
  <keyword>Appetitive Behavior</keyword>
  <keyword>Health Risk Behaviors</keyword>
  <keyword>Compulsive Behavior</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Hyperphagia</mesh_term>
    <mesh_term>Impulsive Behavior</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>April 29, 2023</submitted>
    <returned>May 25, 2023</returned>
    <submitted>June 14, 2023</submitted>
    <returned>July 3, 2023</returned>
    <submitted>September 7, 2023</submitted>
  </pending_results>
  <!-- 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/NCT04405089
org study id: 4740A
nct id: NCT04405089
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
Even when they know it can improve health, many individuals with loss of control eating
      struggle when they are trying to make and sustain new health habits for weight loss and
      maintenance of weight loss. Impulsivity, characterized by lack of foresight and planning and
      excessive risk taking, and compulsivity, characterized by inability to break old habitual
      behaviors, may play a role in refractory obesity. The primary objective of this pilot study
      is to investigate the effect of a novel neuroplasticity based intervention, cognitive
      training coupled with transcranial direct current stimulation (tDCS), on measures of
      impulsivity and compulsivity in individuals with obesity.
Impulsivity and compulsivity are two psychological factors which contribute to addictive
      behaviors. Impulsivity is characterized by lack of foresight and planning, and excessive risk
      taking. Impulsivity is a characteristic of poor executive functioning, and reflects deficits
      in goal-oriented behavior and self-regulation. Compulsivity is characterized by inability to
      break old habits. Both of these traits may play a role in refractory obesity. Transcranial
      direct current stimulation (tDCS) coupled with cognitive training may strengthen key
      circuitry involved in impulse control within the prefrontal cortex. tDCS coupled with
      cognitive training has the potential to reduce impulsivity and compulsivity in individuals
      with obesity, with the potential for therapeutic application as a non-pharmacologic approach
      to management of food-related eating behaviors which may impact weight.

      For this double-blind, randomized, placebo (sham) controlled study pilot study the
      investigators aim to recruit and complete studies in approximately 20 individuals, randomly
      assigned to receive either active or sham tDCS, both coupled with computerized cognitive
      training tasks, for five days. Additionally, participants will attend follow up visits at
      approximately 2, and 4 months after the course of intervention visits is completed. Testing
      pre- and post-intervention will include the Binge Eating Scale (BES), PHQ-9 Depression
      Screen, and 4 domains of the NIH Examiner Battery. Weight will be tracked throughout the
      study. MN-BEST blast exposure screening tool is also conducted at baseline.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in NIH Examiner Flanker Score
time frame: Change between baseline and 1 week follow-up, and 2, and 4 months post intervention
description: Differences in magnitude of changes in Flanker scores (numeric summary scores) between active tDCS-cognitive training and sham-cognitive training groups from baseline to follow-up sessions
measure: Change in NIH Examiner Set Shifting Score
time frame: Change between baseline and 1 week follow-up, and 2, and 4 months post intervention
description: Differences in magnitude of changes in Set Shifting scores (numeric summary scores) between active tDCS-cognitive training and sham-cognitive training groups from baseline to follow-up sessions
measure: Change in NIH Examiner Dot Counting Score
time frame: Change between baseline and 1 week follow-up, and 2, and 4 months post intervention
description: Differences in magnitude of changes in Dot Counting scores (numeric summary scores) between active tDCS-cognitive training and sham-cognitive training groups from baseline to follow-up sessions
measure: Change in NIH Examiner Unstructured Planning Task Score
time frame: Change between baseline and 1 week follow-up, and 2, and 4 months post intervention
description: Differences in magnitude of changes in Unstructured Planning Task scores (numeric summary scores) between active tDCS-cognitive training and sham-cognitive training groups from baseline to follow-up sessions
measure: Change in weight
time frame: Change between baseline and 1 week follow-up, and 2, and 4 months post intervention
description: Differences in magnitude of changes in weight (pounds) between active tDCS-cognitive training and sham-cognitive training groups from baseline to end of study
measure: Effect of history of traumatic brain injury on impulsive and compulsive eating behavior-Binge Scale
time frame: Change between baseline and 4 months post intervention
description: Effect of traumatic brain injury history at baseline (none, single, multiple prior episodes), as measured with Minnesota Blast Exposure Screening Tool (MN-BEST), on differences in magnitude of changes in Binge Eating Scale Scores (numeric summary score) between active tDCS-cognitive training and sham-cognitive training groups from baseline to end of study
measure: Effect of history of traumatic brain injury on impulsive and compulsive eating behavior-NIH Flanker
time frame: Change between baseline and 1 week follow-up, and 2, and 4 months post intervention
description: Effect of traumatic brain injury history at baseline (none, single, multiple prior episodes), as measured with Minnesota Blast Exposure Screening Tool (MN-BEST), on differences in magnitude of changes in Flanker scores between active tDCS-cognitive training and sham-cognitive training groups from baseline to end of study
measure: Effect of history of traumatic brain injury on impulsive and compulsive eating behavior-NIH Set Shifting
time frame: Change between baseline and 1 week follow-up, and 2, and 4 months post intervention
description: Effect of traumatic brain injury history at baseline (none, single, multiple prior episodes), as measured with Minnesota Blast Exposure Screening Tool (MN-BEST) , on differences in magnitude of changes on Set Shifting scores between active tDCS-cognitive training and sham-cognitive training groups from baseline to end of study
arm group label: Active tDCS with cognitive training
arm group type: Experimental
description: Participants will receive 5 sessions of cognitive training concurrent with transcranial direct current stimulation (anode over right frontal cortex, cathode over left frontal cortex; 2 mAmps for 26 minutes).
arm group label: Sham tDCS with cognitive training
arm group type: Sham Comparator
description: Participants will receive 5 sessions of cognitive training concurrent with sham tDCS. For sham tDCS, electrodes are placed at the same locations as for active tDCS, but current is ramped up for the initial 30 secs, then immediately ramped back down. This method mimics the initial physical sensation of stimulation, but there is no active current for the remainder of the session.
intervention type: Device
intervention name: Device: Active Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training
description: Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the right prefrontal cortex for total of 26 minutes.
arm group label: Active tDCS with cognitive training
intervention type: Device
intervention name: Device: Sham Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training
description: Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning of session).
arm group label: Sham tDCS with cognitive training
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Shalamar Sibley, MD, MPH
role: Principal Investigator
affiliation: Minneapolis VAMC, University of Minnesota
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Minneapolis Veterans Affairs Medical Center
investigator full name: Shalamar Sibley, MD, MPH
investigator title: Associate Professor of Medicine, University of Minnesota; Minneapolis VAMC Staff Physician
mesh term: Obesity
mesh term: Hyperphagia
mesh term: Impulsive Behavior
submitted: April 29, 2023
returned: May 25, 2023
submitted: June 14, 2023
returned: July 3, 2023
submitted: September 7, 2023