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Changes in Inhibition and Valuation After Eating

Dynamic Neural Computations Underlying Cognitive Control in Bulimia Nervosa

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05995496
Enrollment
150
Registered
2023-08-16
Start date
2023-12-12
Completion date
2027-12-31
Last updated
2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bulimia Nervosa

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.

Interventions

16 hours of fasting

Fed a standardized meal

OTHERMagnetic Resonance Imaging

Neuroimaging with computational modeling

Sponsors

Icahn School of Medicine at Mount Sinai
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Frontostriatal Activation Associated with Prediction Errors on the Stop Signal Task1-2.5 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 Task1-2.5 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

MeasureTime frameDescription
Percent correct responses to stop trials and the trial-by-trial association1-2.5 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
Cognitive Effort Discounting Task Behavioral Performance1-2.5 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
Binge-eating SeverityBaseline and 6-month follow-upThe 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.
Compensatory Behavior SeverityBaseline and 6-month follow-upThe 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.
Dietary Restriction SeverityBaseline and 6-month follow-upThe 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.

Countries

United States

Contacts

CONTACTRiley Macks, B.A.
riley.macks@mssm.edu(212) 824-9545
CONTACTRiley Macks
riley.macks@mssm.edu(212) 824-9545
PRINCIPAL_INVESTIGATORLaura A Berner, Ph.D.

Mount Sinai Icahn School of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026