<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/NCT04424745</url>
  </required_header>
  <id_info>
    <org_study_id>TANDEM01</org_study_id>
    <nct_id>NCT04424745</nct_id>
  </id_info>
  <brief_title>Neuromodulation With Attention Bias Modification Training for Binge Eating Disorder</brief_title>
  <acronym>TANDEM</acronym>
  <official_title>A Feasibility Study of Transcranial Direct Current Stimulation With Attention Bias Modification Training for Binge Eating Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King's College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King's College London</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Binge eating disorder (BED) is a common and disabling eating disorder (ED) which has&#xD;
      significant effects on psychological wellbeing, physical health, and quality of life. Talking&#xD;
      therapies, most notably cognitive behaviour therapy (CBT), are presently recommended for the&#xD;
      treatment of BED. However, outcomes from treatment are inadequate. Therefore, there is a need&#xD;
      for development of new treatments.&#xD;
&#xD;
      This study aims to investigate the feasibility of combining Attention Bias Modification&#xD;
      Training (ABMT) and Transcranial Direct Current Stimulation (tDCS) to reduce binge-eating&#xD;
      behaviour and craving for food in people with BED.&#xD;
&#xD;
      ABMT is a computerised training that seeks to alter responses towards food that people are&#xD;
      not consciously aware of. During ABMT, participants are trained to 'look towards' low-calorie&#xD;
      food and 'look away' from high-calorie food. TDCS is a safe, well tolerated, non-invasive&#xD;
      form of brain stimulation which is suitable for supervised self-administration. It stimulates&#xD;
      specific brain areas using a mild electrical current (2 mA) via small electrodes placed on&#xD;
      the scalp. In this study, participants will be randomly allocated to receive either ABMT with&#xD;
      real tDCS or ABMT with sham tDCS. ABMT and real/sham tDCS will be delivered simultaneously,&#xD;
      i.e. participants will engage in ABM training whilst receiving tDCS. All participants will be&#xD;
      remotely supervised by the study researcher for the duration of each treatment session.&#xD;
&#xD;
      Biological male and female adults (aged 18-60) of any gender will be eligible to take part if&#xD;
      they have a DSM-V of BED and they are overweight or obese.&#xD;
&#xD;
      Taking part will involve completing 10 sessions of combined ABMT and real or sham tDCS over&#xD;
      2-3 weeks. Binge frequency, food craving and other outcomes will be measured at the start of&#xD;
      the study, end of the study, and at the 6-week follow-up.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 25, 2021</start_date>
  <completion_date type="Anticipated">September 30, 2022</completion_date>
  <primary_completion_date type="Actual">January 31, 2022</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Achievement of a 'steady state' of recruitment</measure>
    <time_frame>Start of Recruitment to 12 months</time_frame>
    <description>Recruitment rate/month over months will be assessed to demonstrate that recruitment targets for the main trial can be met within an adequate time-frame. An average of 3 patients per month must be recruited (randomised) over a consecutive 12 month period (a minimum of 36 patients) in order to demonstrate a 'steady state' of recruitment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Eating Disorder Symptoms</measure>
    <time_frame>Baseline to 6 week follow up (on average, 8 weeks after baseline assessment)</time_frame>
    <description>The Eating Disorder Examination Questionnaire (EDE-Q) will be used to assess eating disorders symptoms. The EDE-Q is a 36-item self-report quesitonnaire, and a higher global score indicates more severe eating disorder symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Craving for food</measure>
    <time_frame>Baseline to 6 week follow up (on average, 8 weeks after baseline assessment)</time_frame>
    <description>The Food Craving Questionnaire (FCQ) will be used to assess trait-level craving for food. Total scores can range between 15 and 90, with higher scores indicating more frequent and intense food cravings.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General psychopathology</measure>
    <time_frame>Baseline to 6 week follow up (on average, 8 weeks after baseline assessment)</time_frame>
    <description>The Depression, Anxiety and Stress- Scale (DASS-21) is a 21-item self-report questionnaire which aims to evaluate mood, anxiety and stress levels over the previous week. Sum scores for the total DASS range between 0 and 120, with higher scores indicating more severe psychopathology. Sub-scales assess depression, anxiety and stress symptoms specifically, and scores range from 0 to 42, with higher scores indicating more severe symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Health</measure>
    <time_frame>Baseline to 6 week follow up (on average, 8 weeks after baseline assessment)</time_frame>
    <description>Weight and height will be combined to report body mass index in kg/m^2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Food related attention</measure>
    <time_frame>Baseline to 6 week follow up (on average, 8 weeks after baseline assessment)</time_frame>
    <description>The Food Attention Network Task (Food-ANT) will be used to assess three components of attention (i.e. orienting, alerting and executive function) using food (low- and high-calorie) versus non-food pictures (neutral items). Change in reaction time will be used to assess change in orienting, alerting and executive function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attention Bias for Food</measure>
    <time_frame>Baseline to 6 week follow up (on average, 8 weeks after baseline assessment)</time_frame>
    <description>The Visual Probe Task (VP) will be used to assess visuo-spatial attention biases for food cues. Change in dwell time measured by eye tracking and reaction time will be used to assess change in attention bias for food cues.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Working Memory</measure>
    <time_frame>Baseline to post treatment (on average 18 days after baseline assessment)</time_frame>
    <description>Participants are presented with a continuous stream of stimuli (either faces or words), and for every stimulus, the participant must indicate (yes/no) whether or not the current stimulus is the same as the one presented three trials back. This is known as the N-Back and is a measure of working memory. Higher numbers of correct responses indicates superior working memory function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Face Affective Go/No Go</measure>
    <time_frame>Baseline to post treatment (on average 18 days after baseline assessment)</time_frame>
    <description>Neuropsychological task measuring information processing biases for positive and negative facial expressions. The participant is told a target emotion and asked to press a button only when the target emotion is present. The task consists of six blocks, each of which presents a series of faces showing either the target emotion or a differently valenced distractor. Reaction times are calculated for correct responses for each condition. Affective bias scores are calculated by subtracting the sad target/happy distractor condition reaction time from the happy target/sad distractor condition reaction time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Flexibility</measure>
    <time_frame>Baseline to post treatment (on average 18 days after baseline assessment)</time_frame>
    <description>In Wisconsin Card Sorting Test (WCST) participants are asked to sort 64 cards to match either color (red, blue, yellow, or green), form (crosses, circles, triangles, or stars), or number of figures (one, two, three, four). During the task, the sorting rule changes discreetly from color to form or number of figures without the participants being informed. The participants have to shift sets accordingly and sort cards following the new sorting rule. Set shifting difficulties are indicated by preservative errors; thus, higher scores on this test represent poorer cognitive flexibility.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">84</enrollment>
  <condition>Binge-Eating Disorder</condition>
  <arm_group>
    <arm_group_label>Attention Bias Modification Training with real tDCS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Attention Bias Modification Training with sham tDCS</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Simultaneous Attention Bias Modification Training and Transcranial Direct Current Stimulation (tDCS)</intervention_name>
    <description>Participants will receive 10 sessions of computerised attention bias modification training with either real or sham tDCS. Participants will self-administer tDCS at home, with research supervision, and complete attention bias modification training on a laptop or desktop computer while receiving stimulation. Sessions will be completed week daily for 2-3 weeks.</description>
    <arm_group_label>Attention Bias Modification Training with real tDCS</arm_group_label>
    <arm_group_label>Attention Bias Modification Training with sham tDCS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Overweight or obese according to WHO criteria (BMI&gt;25 kg/m²)&#xD;
&#xD;
          -  Meet criteria for full-syndrome DSM-5 Binge Eating Disorder (BED)&#xD;
&#xD;
          -  Right-handed&#xD;
&#xD;
          -  Must use and understand English as a language for everyday conversation&#xD;
&#xD;
          -  Access to a laptop or desktop computer with webcam&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Visual impairments that cannot be corrected with contact lenses or glasses&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  History of neurological disease and/or seizure&#xD;
&#xD;
          -  Having any metallic implants anywhere in the head or body&#xD;
&#xD;
          -  History of head or eye injury&#xD;
&#xD;
          -  Significant health problems in the previous six months&#xD;
&#xD;
          -  Lifetime diagnosis of substance dependence, psychosis, bipolar disorder, borderline&#xD;
             personality disorder&#xD;
&#xD;
          -  Other primary psychiatric disorder requiring treatment in its own right&#xD;
&#xD;
          -  Taking psychotropic medication other than a stable dosage of selective serotonin&#xD;
             reuptake inhibitors (SSRI) for at least 14 days prior to study enrollment&#xD;
&#xD;
          -  Adults consuming more than 14 units of alcohol per week who are unwilling to reduce&#xD;
             their alcohol intake for the duration of the treatment.&#xD;
&#xD;
          -  Current illicit drug use.&#xD;
&#xD;
          -  Learning difficulties that would preclude safe tDCS self-administration and/or&#xD;
             completion of questionnaire measures and neurocognitive tasks.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ulrike Schmidt, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>King's College London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>King's College London</name>
      <address>
        <city>London</city>
        <zip>SE58AF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>March 29, 2022</last_update_submitted>
  <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2022</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>Bulimia</mesh_term>
    <mesh_term>Feeding and Eating Disorders</mesh_term>
    <mesh_term>Binge-Eating Disorder</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/NCT04424745
org study id: TANDEM01
nct id: NCT04424745
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Binge eating disorder (BED) is a common and disabling eating disorder (ED) which has
      significant effects on psychological wellbeing, physical health, and quality of life. Talking
      therapies, most notably cognitive behaviour therapy (CBT), are presently recommended for the
      treatment of BED. However, outcomes from treatment are inadequate. Therefore, there is a need
      for development of new treatments.

      This study aims to investigate the feasibility of combining Attention Bias Modification
      Training (ABMT) and Transcranial Direct Current Stimulation (tDCS) to reduce binge-eating
      behaviour and craving for food in people with BED.

      ABMT is a computerised training that seeks to alter responses towards food that people are
      not consciously aware of. During ABMT, participants are trained to 'look towards' low-calorie
      food and 'look away' from high-calorie food. TDCS is a safe, well tolerated, non-invasive
      form of brain stimulation which is suitable for supervised self-administration. It stimulates
      specific brain areas using a mild electrical current (2 mA) via small electrodes placed on
      the scalp. In this study, participants will be randomly allocated to receive either ABMT with
      real tDCS or ABMT with sham tDCS. ABMT and real/sham tDCS will be delivered simultaneously,
      i.e. participants will engage in ABM training whilst receiving tDCS. All participants will be
      remotely supervised by the study researcher for the duration of each treatment session.

      Biological male and female adults (aged 18-60) of any gender will be eligible to take part if
      they have a DSM-V of BED and they are overweight or obese.

      Taking part will involve completing 10 sessions of combined ABMT and real or sham tDCS over
      2-3 weeks. Binge frequency, food craving and other outcomes will be measured at the start of
      the study, end of the study, and at the 6-week follow-up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Achievement of a 'steady state' of recruitment
time frame: Start of Recruitment to 12 months
description: Recruitment rate/month over months will be assessed to demonstrate that recruitment targets for the main trial can be met within an adequate time-frame. An average of 3 patients per month must be recruited (randomised) over a consecutive 12 month period (a minimum of 36 patients) in order to demonstrate a 'steady state' of recruitment.
measure: Eating Disorder Symptoms
time frame: Baseline to 6 week follow up (on average, 8 weeks after baseline assessment)
description: The Eating Disorder Examination Questionnaire (EDE-Q) will be used to assess eating disorders symptoms. The EDE-Q is a 36-item self-report quesitonnaire, and a higher global score indicates more severe eating disorder symptoms.
measure: Craving for food
time frame: Baseline to 6 week follow up (on average, 8 weeks after baseline assessment)
description: The Food Craving Questionnaire (FCQ) will be used to assess trait-level craving for food. Total scores can range between 15 and 90, with higher scores indicating more frequent and intense food cravings.
measure: General psychopathology
time frame: Baseline to 6 week follow up (on average, 8 weeks after baseline assessment)
description: The Depression, Anxiety and Stress- Scale (DASS-21) is a 21-item self-report questionnaire which aims to evaluate mood, anxiety and stress levels over the previous week. Sum scores for the total DASS range between 0 and 120, with higher scores indicating more severe psychopathology. Sub-scales assess depression, anxiety and stress symptoms specifically, and scores range from 0 to 42, with higher scores indicating more severe symptoms.
measure: Physical Health
time frame: Baseline to 6 week follow up (on average, 8 weeks after baseline assessment)
description: Weight and height will be combined to report body mass index in kg/m^2
measure: Food related attention
time frame: Baseline to 6 week follow up (on average, 8 weeks after baseline assessment)
description: The Food Attention Network Task (Food-ANT) will be used to assess three components of attention (i.e. orienting, alerting and executive function) using food (low- and high-calorie) versus non-food pictures (neutral items). Change in reaction time will be used to assess change in orienting, alerting and executive function.
measure: Attention Bias for Food
time frame: Baseline to 6 week follow up (on average, 8 weeks after baseline assessment)
description: The Visual Probe Task (VP) will be used to assess visuo-spatial attention biases for food cues. Change in dwell time measured by eye tracking and reaction time will be used to assess change in attention bias for food cues.
measure: Working Memory
time frame: Baseline to post treatment (on average 18 days after baseline assessment)
description: Participants are presented with a continuous stream of stimuli (either faces or words), and for every stimulus, the participant must indicate (yes/no) whether or not the current stimulus is the same as the one presented three trials back. This is known as the N-Back and is a measure of working memory. Higher numbers of correct responses indicates superior working memory function.
measure: Face Affective Go/No Go
time frame: Baseline to post treatment (on average 18 days after baseline assessment)
description: Neuropsychological task measuring information processing biases for positive and negative facial expressions. The participant is told a target emotion and asked to press a button only when the target emotion is present. The task consists of six blocks, each of which presents a series of faces showing either the target emotion or a differently valenced distractor. Reaction times are calculated for correct responses for each condition. Affective bias scores are calculated by subtracting the sad target/happy distractor condition reaction time from the happy target/sad distractor condition reaction time.
measure: Cognitive Flexibility
time frame: Baseline to post treatment (on average 18 days after baseline assessment)
description: In Wisconsin Card Sorting Test (WCST) participants are asked to sort 64 cards to match either color (red, blue, yellow, or green), form (crosses, circles, triangles, or stars), or number of figures (one, two, three, four). During the task, the sorting rule changes discreetly from color to form or number of figures without the participants being informed. The participants have to shift sets accordingly and sort cards following the new sorting rule. Set shifting difficulties are indicated by preservative errors; thus, higher scores on this test represent poorer cognitive flexibility.
arm group label: Attention Bias Modification Training with real tDCS
arm group type: Active Comparator
arm group label: Attention Bias Modification Training with sham tDCS
arm group type: Placebo Comparator
intervention type: Other
intervention name: Simultaneous Attention Bias Modification Training and Transcranial Direct Current Stimulation (tDCS)
description: Participants will receive 10 sessions of computerised attention bias modification training with either real or sham tDCS. Participants will self-administer tDCS at home, with research supervision, and complete attention bias modification training on a laptop or desktop computer while receiving stimulation. Sessions will be completed week daily for 2-3 weeks.
arm group label: Attention Bias Modification Training with real tDCS
arm group label: Attention Bias Modification Training with sham tDCS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Ulrike Schmidt, MD PhD
role: Principal Investigator
affiliation: King's College London
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Bulimia
mesh term: Feeding and Eating Disorders
mesh term: Binge-Eating Disorder
sharing ipd: No