Changes in Inhibition and Valuation After Eating

Dynamic Neural Computations Underlying Cognitive Control in Bulimia Nervosa

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.

Study Overview

• Status: Recruiting
• Conditions: Bulimia Nervosa
• Intervention / Treatment: Other: Fasting state; Other: Fed state; Other: Magnetic Resonance Imaging

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 Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiulin Dai, B.S.; Phone Number: 212-824-9561; Email: jiulin.dai@mssm.edu
• Study Contact Backup: Name: Alexa R Krugel, B.S; Email: alexa.krugel@mssm.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai
      • Contact: Jiulin Dai, B.S.; Phone Number: 212-824-9561; Email: jiulin.dai@mssm.edu
      • Contact: Alexa R Krugel, B.S.; Email: alexa.krugel@mssm.edu
      • Principal Investigator: Laura A Berner

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants with Bulimia Nervosa; 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.	Other: Fasting state; 16 hours of fasting; Other: Fed state; Fed a standardized meal; Other: Magnetic Resonance Imaging; Neuroimaging with computational modeling; Other Names: MRI
Active Comparator: Participants without Bulimia Nervosa; 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.	Other: Fasting state; 16 hours of fasting; Other: Fed state; Fed a standardized meal; Other: Magnetic Resonance Imaging; Neuroimaging with computational modeling; Other Names: MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frontostriatal Activation Associated with Prediction Errors on the Stop Signal Task	Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with inhibitory control prediction errors	1-2.5 hours after a 16-hour fast (fasted state)
Frontostriatal Activation Associated with Prediction Errors on the Stop Signal Task	Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with inhibitory control prediction errors	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	Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with the subjective value of expending cognitive effort on control	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	Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with the subjective value of expending cognitive effort on control	1-2.5 hours after a standardized meal (fed state)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Laura A Berner, Ph.D., Mount Sinai Icahn School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: August 1, 2023
• First Submitted That Met QC Criteria: August 15, 2023
• First Posted (Actual): August 16, 2023

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Hyperphagia; Bulimia; Bulimia Nervosa
• Other Study ID Numbers: STUDY-22-01587; 1R01MH132786 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification.
• IPD Sharing 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 Sharing 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 Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No