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Recruiting NCT05995496

Changes in Inhibition and Valuation After Eating

No phase Interventional Bulimia Nervosa

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fasting state, Fed state, Magnetic Resonance Imaging.
Who it may be relevant to
Registry conditions: Bulimia Nervosa. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Dynamic Neural Computations Underlying Cognitive Control in Bulimia Nervosa

Overview

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.

Detailed description

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.

Interventions

  • Other Fasting state
    16 hours of fasting
  • Other Fed state
    Fed a standardized meal
  • Other Magnetic Resonance Imaging
    Neuroimaging with computational modeling

Primary outcome measures

  • Frontostriatal Activation Associated with Prediction Errors on the Stop Signal Task [Time frame: 1-2.5 hours after a 16-hour fast (fasted state)]
  • Frontostriatal Activation Associated with Prediction Errors on the Stop Signal Task [Time frame: 1-2.5 hours after a standardized meal (fed state)]
  • 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)]
  • 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)]
Secondary outcome measures (7)
  • 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)]
  • Percent correct responses to stop trials and the trial-by-trial association [Time frame: 1-2.5 hours after a standardized meal (fed state)]
  • Cognitive Effort Discounting Task Behavioral Performance [Time frame: 1-2.5 hours after a 16-hour fast (fasted state)]
  • Cognitive Effort Discounting Task Behavioral Performance [Time frame: 1-2.5 hours after a standardized meal (fed state)]
  • Binge-eating Severity [Time frame: Baseline and 6-month follow-up]
  • Compensatory Behavior Severity [Time frame: Baseline and 6-month follow-up]
  • Dietary Restriction Severity [Time frame: Baseline and 6-month follow-up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Other

Study locations

United States · 1 center
  • Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mou — New York

Identifiers

NCT: NCT05995496 · STUDY-22-01587 · 1R01MH132786

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗