xml: <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/NCT05995496</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY-22-01587</org_study_id>
      <secondary_id>1R01MH132786</secondary_id>
      <nct_id>NCT05995496</nct_id>
    </id_info>
    <brief_title>Changes in Inhibition and Valuation After Eating</brief_title>
    <official_title>Dynamic Neural Computations Underlying Cognitive Control in Bulimia Nervosa</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Icahn School of Medicine at Mount Sinai</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute of Mental Health (NIMH)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Icahn School of Medicine at Mount Sinai</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        An impaired ability to exert control has been implicated in bulimia nervosa (BN), but this&#xD;
        impairment may not represent a stable trait or be the most effective focus for treatment.&#xD;
        This project aims to understand how predictions and value-based decisions about control may&#xD;
        be abnormally influenced by eating in individuals with BN, thereby maintaining cycles of&#xD;
        binge eating, purging, and restriction.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The overarching goal of this project is to test a neurocomputational model of BN that&#xD;
        incorporates learning and decision-making components of control. The study combines&#xD;
        functional magnetic resonance imaging (fMRI), computational modeling, and real-time mobile&#xD;
        assessments to examine the influences of acute fasting and eating on brain function and&#xD;
        associated control-related updating and effort-valuation processes in BN. More specifically,&#xD;
        the study has the following main objectives: 1) To determine the influence of eating on&#xD;
        control-related prediction updating in BN.; 2) To determine the influence of eating on&#xD;
        control-related cognitive effort valuation in BN; 3) To use state-specific neural activation&#xD;
        to predict BN symptoms.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2027</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>
      <intervention_model_description>Two participant groups (one with and one without bulimia nervosa) will be scanned using MRI after they have fasted and after they have consumed a standardized meal. The order of these two scans will be counterbalanced across groups.</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Frontostriatal Activation Associated with Prediction Errors on the Stop Signal Task</measure>
      <time_frame>1-2.5 hours after a 16-hour fast (fasted state)</time_frame>
      <description>Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with inhibitory control prediction errors</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Frontostriatal Activation Associated with Prediction Errors on the Stop Signal Task</measure>
      <time_frame>1-2.5 hours after a standardized meal (fed state)</time_frame>
      <description>Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with inhibitory control prediction errors</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Frontostriatal Activation Encoding the Subjective Value of Cognitive Effort on the Cognitive-Effort Discounting Task</measure>
      <time_frame>1-2.5 hours after a 16-hour fast (fasted state)</time_frame>
      <description>Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with the subjective value of expending cognitive effort on control</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Frontostriatal Activation Encoding the Subjective Value of Cognitive Effort on the Cognitive-Effort Discounting Task</measure>
      <time_frame>1-2.5 hours after a standardized meal (fed state)</time_frame>
      <description>Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with the subjective value of expending cognitive effort on control</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Percent correct responses to stop trials and the trial-by-trial association</measure>
      <time_frame>1-2.5 hours after a 16-hour fast (fasted state)</time_frame>
      <description>Behavioral performance on the stop signal task, as measured by percent correct responses to stop trials and the trial-by-trial association between the predicted likelihood that upcoming inhibition is needed (P(stop)) from a Bayesian ideal observer model and accuracy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percent correct responses to stop trials and the trial-by-trial association</measure>
      <time_frame>1-2.5 hours after a standardized meal (fed state)</time_frame>
      <description>Behavioral performance on the stop signal task, as measured by percent correct responses to stop trials and the trial-by-trial association between the predicted likelihood that upcoming inhibition is needed (P(stop)) from a Bayesian ideal observer model and accuracy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cognitive Effort Discounting Task Behavioral Performance</measure>
      <time_frame>1-2.5 hours after a 16-hour fast (fasted state)</time_frame>
      <description>The subjective value of cognitive effort estimated for each N-back load level and cost- and benefit-modulated drift rate parameters from a drift- diffusion model applied to behavioral performance data</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cognitive Effort Discounting Task Behavioral Performance</measure>
      <time_frame>1-2.5 hours after a standardized meal (fed state)</time_frame>
      <description>The subjective value of cognitive effort estimated for each N-back load level and cost- and benefit-modulated drift rate parameters from a drift- diffusion model applied to behavioral performance data</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Binge-eating Severity</measure>
      <time_frame>Baseline and 6-month follow-up</time_frame>
      <description>The frequency of binge-eating episodes as assessed by the Eating Disorder Examination (EDE) and Ecological Momentary Assessment (EMA). Binge-eating frequency has a minimum limit of 0 and no maximum limit. A higher score indicates a greater severity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Compensatory Behavior Severity</measure>
      <time_frame>Baseline and 6-month follow-up</time_frame>
      <description>The frequency of compensatory behaviors as assessed by the EDE and EMA. This frequency has a minimum limit of 0 and no maximum limit. A higher score indicates a greater severity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dietary Restriction Severity</measure>
      <time_frame>Baseline and 6-month follow-up</time_frame>
      <description>The frequency of fasting episodes as assessed by the EDE avoidance of eating item (minimum limit = 0, maximum limit = 6); the severity of dietary restriction as assessed by the Eating Pathology Symptoms Inventory (EPSI) - restricting subscale (minimum limit=0; maximum limit=24), and the frequency of restrictive eating behaviors as assessed by EMA (minimum limit=0; no maximum limit). On all measures, a higher score indicates a greater severity.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Bulimia Nervosa</condition>
    <arm_group>
      <arm_group_label>Participants with Bulimia Nervosa</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants are randomly assigned (in even numbers across the two groups) to scan order:&#xD;
  A. These participants are first scanned after 16 hours of fasting on one day, and are next scanned after a standardized meal on a second day.&#xD;
  B. These participants are first scanned after a standardized meal on one day, and are next scanned after 16 hours of fasting on a second day.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Participants without Bulimia Nervosa</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants are randomly assigned (in even numbers across the two groups) to scan order:&#xD;
  A. These participants are first scanned after 16 hours of fasting on one day, and are next scanned after a standardized meal on a second day.&#xD;
  B. These participants are first scanned after a standardized meal on one day, and are next scanned after 16 hours of fasting on a second day.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Fasting state</intervention_name>
      <description>16 hours of fasting</description>
      <arm_group_label>Participants with Bulimia Nervosa</arm_group_label>
      <arm_group_label>Participants without Bulimia Nervosa</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Fed state</intervention_name>
      <description>Fed a standardized meal</description>
      <arm_group_label>Participants with Bulimia Nervosa</arm_group_label>
      <arm_group_label>Participants without Bulimia Nervosa</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Magnetic Resonance Imaging</intervention_name>
      <description>Neuroimaging with computational modeling</description>
      <arm_group_label>Participants with Bulimia Nervosa</arm_group_label>
      <arm_group_label>Participants without Bulimia Nervosa</arm_group_label>
      <other_name>MRI</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Female&#xD;
  &#xD;
            -  Aged 18 to 45 years&#xD;
  &#xD;
            -  Current BMI greater than or equal to 18.5kg/m2 but under 30kg/m2&#xD;
  &#xD;
            -  Right-handed&#xD;
  &#xD;
            -  English-speaking&#xD;
  &#xD;
          Additional Inclusion Criteria for Women with Bulimia Nervosa:&#xD;
  &#xD;
            -  Meet DSM-5 criteria for bulimia nervosa&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Medical instability&#xD;
  &#xD;
            -  Ongoing medical treatment, medical condition, or psychiatric disorder that may&#xD;
               interfere with study variables or participation&#xD;
  &#xD;
            -  Shift work&#xD;
  &#xD;
            -  Pregnancy, planned pregnancy, or lactation during the study period&#xD;
  &#xD;
            -  Allergy to any of the ingredients in or unwillingness to consume the standardized meal&#xD;
               or unwillingness to drink water during the fasting period&#xD;
  &#xD;
            -  Any contraindication for fMRI&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>The prevalence of bulimia nervosa is substantially greater in women than in men. Moreover, prior research suggest that men and women show different neural response patterns during the engagement of inhibitory control, and that satiety differentially impacts the neural function of men and women.</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Laura A Berner, Ph.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mount Sinai Icahn School of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jiulin Dai, B.S.</last_name>
      <phone>212-824-9561</phone>
      <email>jiulin.dai@mssm.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Alexa R Krugel, B.S</last_name>
      <email>alexa.krugel@mssm.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10029</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Jiulin Dai, B.S.</last_name>
        <phone>212-824-9561</phone>
        <email>jiulin.dai@mssm.edu</email>
      </contact>
      <contact_backup>
        <last_name>Alexa R Krugel, B.S.</last_name>
        <email>alexa.krugel@mssm.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Laura A Berner</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Icahn School of Medicine at Mount Sinai</investigator_affiliation>
      <investigator_full_name>Laura Berner</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bulimia</mesh_term>
      <mesh_term>Bulimia Nervosa</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>All of the individual participant data collected during the trial, after deidentification.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>Specify Other Time FrameWithin one year of the completion of the funded project period or upon acceptance of the data for publication, whichever is earlier</ipd_time_frame>
      <ipd_access_criteria>Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose.&#xD;
  Any purpose. Specify Other Mechanism All data will be deposited to the National Data Archive (NDA) starting 12 months after the award begins and will be deposited every 6 months thereafter following the usual NDA data submission dates. The research community will be able to find the data through this study's NDA Collection C4723. The research community will have access to the data within one year of the completion of the funded project period or upon acceptance of the data for publication, whichever is earlier. NDA will make decisions about how long to preserve the data, but that data archive has not deleted any deposited data up to now.</ipd_access_criteria>
      <ipd_url>https://nda.nih.gov/edit_collection.html?id=4723</ipd_url>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05995496
  org study id: STUDY-22-01587
  secondary id: 1R01MH132786
  nct id: NCT05995496
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  An impaired ability to exert control has been implicated in bulimia nervosa (BN), but this
        impairment may not represent a stable trait or be the most effective focus for treatment.
        This project aims to understand how predictions and value-based decisions about control may
        be abnormally influenced by eating in individuals with BN, thereby maintaining cycles of
        binge eating, purging, and restriction.
  The overarching goal of this project is to test a neurocomputational model of BN that
        incorporates learning and decision-making components of control. The study combines
        functional magnetic resonance imaging (fMRI), computational modeling, and real-time mobile
        assessments to examine the influences of acute fasting and eating on brain function and
        associated control-related updating and effort-valuation processes in BN. More specifically,
        the study has the following main objectives: 1) To determine the influence of eating on
        control-related prediction updating in BN.; 2) To determine the influence of eating on
        control-related cognitive effort valuation in BN; 3) To use state-specific neural activation
        to predict BN symptoms.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: Two participant groups (one with and one without bulimia nervosa) will be scanned using MRI after they have fasted and after they have consumed a standardized meal. The order of these two scans will be counterbalanced across groups.
  primary purpose: Basic Science
  masking: Single (Outcomes Assessor)
  measure: Frontostriatal Activation Associated with Prediction Errors on the Stop Signal Task
  time frame: 1-2.5 hours after a 16-hour fast (fasted state)
  description: Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with inhibitory control prediction errors
  measure: Frontostriatal Activation Associated with Prediction Errors on the Stop Signal Task
  time frame: 1-2.5 hours after a standardized meal (fed state)
  description: Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with inhibitory control prediction errors
  measure: Frontostriatal Activation Encoding the Subjective Value of Cognitive Effort on the Cognitive-Effort Discounting Task
  time frame: 1-2.5 hours after a 16-hour fast (fasted state)
  description: Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with the subjective value of expending cognitive effort on control
  measure: Frontostriatal Activation Encoding the Subjective Value of Cognitive Effort on the Cognitive-Effort Discounting Task
  time frame: 1-2.5 hours after a standardized meal (fed state)
  description: Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with the subjective value of expending cognitive effort on control
  measure: Percent correct responses to stop trials and the trial-by-trial association
  time frame: 1-2.5 hours after a 16-hour fast (fasted state)
  description: Behavioral performance on the stop signal task, as measured by percent correct responses to stop trials and the trial-by-trial association between the predicted likelihood that upcoming inhibition is needed (P(stop)) from a Bayesian ideal observer model and accuracy
  measure: Percent correct responses to stop trials and the trial-by-trial association
  time frame: 1-2.5 hours after a standardized meal (fed state)
  description: Behavioral performance on the stop signal task, as measured by percent correct responses to stop trials and the trial-by-trial association between the predicted likelihood that upcoming inhibition is needed (P(stop)) from a Bayesian ideal observer model and accuracy
  measure: Cognitive Effort Discounting Task Behavioral Performance
  time frame: 1-2.5 hours after a 16-hour fast (fasted state)
  description: The subjective value of cognitive effort estimated for each N-back load level and cost- and benefit-modulated drift rate parameters from a drift- diffusion model applied to behavioral performance data
  measure: Cognitive Effort Discounting Task Behavioral Performance
  time frame: 1-2.5 hours after a standardized meal (fed state)
  description: The subjective value of cognitive effort estimated for each N-back load level and cost- and benefit-modulated drift rate parameters from a drift- diffusion model applied to behavioral performance data
  measure: Binge-eating Severity
  time frame: Baseline and 6-month follow-up
  description: The frequency of binge-eating episodes as assessed by the Eating Disorder Examination (EDE) and Ecological Momentary Assessment (EMA). Binge-eating frequency has a minimum limit of 0 and no maximum limit. A higher score indicates a greater severity.
  measure: Compensatory Behavior Severity
  time frame: Baseline and 6-month follow-up
  description: The frequency of compensatory behaviors as assessed by the EDE and EMA. This frequency has a minimum limit of 0 and no maximum limit. A higher score indicates a greater severity.
  measure: Dietary Restriction Severity
  time frame: Baseline and 6-month follow-up
  description: The frequency of fasting episodes as assessed by the EDE avoidance of eating item (minimum limit = 0, maximum limit = 6); the severity of dietary restriction as assessed by the Eating Pathology Symptoms Inventory (EPSI) - restricting subscale (minimum limit=0; maximum limit=24), and the frequency of restrictive eating behaviors as assessed by EMA (minimum limit=0; no maximum limit). On all measures, a higher score indicates a greater severity.
  arm group label: Participants with Bulimia Nervosa
  arm group type: Experimental
  description: Participants are randomly assigned (in even numbers across the two groups) to scan order:
  A. These participants are first scanned after 16 hours of fasting on one day, and are next scanned after a standardized meal on a second day.
  B. These participants are first scanned after a standardized meal on one day, and are next scanned after 16 hours of fasting on a second day.
  arm group label: Participants without Bulimia Nervosa
  arm group type: Active Comparator
  description: Participants are randomly assigned (in even numbers across the two groups) to scan order:
  A. These participants are first scanned after 16 hours of fasting on one day, and are next scanned after a standardized meal on a second day.
  B. These participants are first scanned after a standardized meal on one day, and are next scanned after 16 hours of fasting on a second day.
  intervention type: Other
  intervention name: Fasting state
  description: 16 hours of fasting
  arm group label: Participants with Bulimia Nervosa
  arm group label: Participants without Bulimia Nervosa
  intervention type: Other
  intervention name: Fed state
  description: Fed a standardized meal
  arm group label: Participants with Bulimia Nervosa
  arm group label: Participants without Bulimia Nervosa
  intervention type: Other
  intervention name: Magnetic Resonance Imaging
  description: Neuroimaging with computational modeling
  arm group label: Participants with Bulimia Nervosa
  arm group label: Participants without Bulimia Nervosa
  other name: MRI
  criteria: 
  gender: Female
  gender based: Yes
  gender description: The prevalence of bulimia nervosa is substantially greater in women than in men. Moreover, prior research suggest that men and women show different neural response patterns during the engagement of inhibitory control, and that satiety differentially impacts the neural function of men and women.
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Laura A Berner, Ph.D.
  role: Principal Investigator
  affiliation: Mount Sinai Icahn School of Medicine
  last name: Jiulin Dai, B.S.
  phone: 212-824-9561
  email: jiulin.dai@mssm.edu
  last name: Alexa R Krugel, B.S
  email: alexa.krugel@mssm.edu
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Icahn School of Medicine at Mount Sinai
  investigator full name: Laura Berner
  investigator title: Assistant Professor
  mesh term: Bulimia
  mesh term: Bulimia Nervosa
  sharing ipd: Yes
  ipd description: All of the individual participant data collected during the trial, after deidentification.
  ipd info type: Study Protocol
  ipd time frame: Specify Other Time FrameWithin one year of the completion of the funded project period or upon acceptance of the data for publication, whichever is earlier
  ipd access criteria: Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose.
  Any purpose. Specify Other Mechanism All data will be deposited to the National Data Archive (NDA) starting 12 months after the award begins and will be deposited every 6 months thereafter following the usual NDA data submission dates. The research community will be able to find the data through this study's NDA Collection C4723. The research community will have access to the data within one year of the completion of the funded project period or upon acceptance of the data for publication, whichever is earlier. NDA will make decisions about how long to preserve the data, but that data archive has not deleted any deposited data up to now.
  ipd url: https://nda.nih.gov/edit_collection.html?id=4723