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NCT Number: NCT05995496

Changes in Inhibition and Valuation After Eating

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.

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Key information

Conditions

Bulimia Nervosa Feeding and Eating Disorders Mental Disorders

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai

New York, 10029, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female
  • Aged 18 to 45 years
  • Current BMI greater than or equal to 18.5kg/m2 but under 30kg/m2
  • Right-handed
  • English-speaking

Additional Inclusion Criteria for Women with Bulimia Nervosa:

  • Meet DSM-5 criteria for bulimia nervosa

Exclusion criteria

  • Medical instability
  • Ongoing medical treatment, medical condition, or psychiatric disorder that may interfere with study variables or participation
  • Shift work
  • Pregnancy, planned pregnancy, or lactation during the study period
  • Allergy to any of the ingredients in or unwillingness to consume the standardized meal or unwillingness to drink water during the fasting period
  • Any contraindication for fMRI

Treatment and study plan

fasting state

Other

16 hours of fasting

Fed State

Other

Fed a standardized meal

Magnetic Resonance Imaging

Other

Neuroimaging with computational modeling

Other names: MRI

Primary outcomes

  1. Frontostriatal Activation Associated with Prediction Errors on the Stop Signal Task

    Time frame: 1-2.5 hours after a 16-hour fast (fasted state)

    Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with inhibitory control prediction errors

  2. Frontostriatal Activation Associated with Prediction Errors on the Stop Signal Task

    Time frame: 1-2.5 hours after a standardized meal (fed state)

    Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with inhibitory control prediction errors

  3. 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)

    Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with the subjective value of expending cognitive effort on control

  4. 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)

    Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with the subjective value of expending cognitive effort on control

Secondary outcomes

  1. 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)

    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

  2. Percent correct responses to stop trials and the trial-by-trial association

    Time frame: 1-2.5 hours after a standardized meal (fed state)

    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

  3. Cognitive Effort Discounting Task Behavioral Performance

    Time frame: 1-2.5 hours after a 16-hour fast (fasted state)

    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

  4. Cognitive Effort Discounting Task Behavioral Performance

    Time frame: 1-2.5 hours after a standardized meal (fed state)

    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

  5. Binge-eating Severity

    Time frame: Baseline and 6-month follow-up

    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.

  6. Compensatory Behavior Severity

    Time frame: Baseline and 6-month follow-up

    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.

  7. Dietary Restriction Severity

    Time frame: Baseline and 6-month follow-up

    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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Dynamic Neural Computations Underlying Cognitive Control in Bulimia Nervosa

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Aug 16, 2023
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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