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Clinical Trials/NCT05995496
NCT05995496RecruitingNot Applicable

Dynamic Neural Computations Underlying Cognitive Control in Bulimia Nervosa

Icahn School of Medicine at Mount Sinai1 site in 1 country150 target enrollmentStarted: December 12, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
150
Locations
1
Primary Endpoint
Frontostriatal Activation Encoding the Subjective Value of Cognitive Effort on the Cognitive-Effort Discounting Task

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Arms & Interventions

Participants with Bulimia Nervosa

Experimental

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: Fasting state (Other)

Participants with Bulimia Nervosa

Experimental

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: Fed state (Other)

Participants with Bulimia Nervosa

Experimental

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: Magnetic Resonance Imaging (Other)

Participants without Bulimia Nervosa

Active Comparator

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: Fasting state (Other)

Participants without Bulimia Nervosa

Active Comparator

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: Fed state (Other)

Participants without Bulimia Nervosa

Active Comparator

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: Magnetic Resonance Imaging (Other)

Outcomes

Primary Outcomes

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

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

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

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

Secondary Outcomes

  • Binge-eating Severity(Baseline and 6-month follow-up)
  • Percent correct responses to stop trials and the trial-by-trial association(1-2.5 hours after a standardized meal (fed state))
  • Cognitive Effort Discounting Task Behavioral Performance(1-2.5 hours after a standardized meal (fed state))
  • Compensatory Behavior Severity(Baseline and 6-month follow-up)
  • Dietary Restriction Severity(Baseline and 6-month follow-up)
  • Percent correct responses to stop trials and the trial-by-trial association(1-2.5 hours after a 16-hour fast (fasted state))
  • Cognitive Effort Discounting Task Behavioral Performance(1-2.5 hours after a 16-hour fast (fasted state))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Laura Berner

Assistant Professor

Icahn School of Medicine at Mount Sinai

Study Sites (1)

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