Changes in Inhibition and Valuation After Eating

Bulimia Nervosa Clinical Trial

Official title:

Dynamic Neural Computations Underlying Cognitive Control in Bulimia Nervosa

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05995496
• Other study ID #: STUDY-22-01587
• Secondary ID: 1R01MH132786
• Status: Recruiting
• Phase: N/A
• Start date: December 12, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: January 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Jiulin Dai, B.S.
• Phone: 212-824-9561
• Email: jiulin.dai[@]mssm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Bulimia
• Bulimia Nervosa

Intervention

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

Locations

Country	Name	City	State
United States	Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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