Clinical trial NCT05995496: Changes in Inhibition and Valuation After Eating
Official title: Dynamic Neural Computations Underlying Cognitive Control in Bulimia Nervosa
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bulimia Nervosa
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-08-16
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Frontostriatal Activation Associated with Prediction Errors on the Stop Signal Task
timeFrame: 1-2.5 hours after a 16-hour fast (fasted state)
measure: Frontostriatal Activation Associated with Prediction Errors on the Stop Signal Task
timeFrame: 1-2.5 hours after a standardized meal (fed state)
measure: Frontostriatal Activation Encoding the Subjective Value of Cognitive Effort on the Cognitive-Effort Discounting Task
timeFrame: 1-2.5 hours after a 16-hour fast (fasted state)
measure: Frontostriatal Activation Encoding the Subjective Value of Cognitive Effort on the Cognitive-Effort Discounting Task
timeFrame: 1-2.5 hours after a standardized meal (fed state)
Secondary outcomes:
measure: Percent correct responses to stop trials and the trial-by-trial association
timeFrame: 1-2.5 hours after a 16-hour fast (fasted state)
measure: Percent correct responses to stop trials and the trial-by-trial association
timeFrame: 1-2.5 hours after a standardized meal (fed state)
measure: Cognitive Effort Discounting Task Behavioral Performance
timeFrame: 1-2.5 hours after a 16-hour fast (fasted state)
measure: Cognitive Effort Discounting Task Behavioral Performance
timeFrame: 1-2.5 hours after a standardized meal (fed state)
measure: Binge-eating Severity
timeFrame: Baseline and 6-month follow-up
measure: Compensatory Behavior Severity
timeFrame: Baseline and 6-month follow-up
measure: Dietary Restriction Severity
timeFrame: Baseline and 6-month follow-up
Other outcomes:
Locations:
city: New York
country: United States
facility: Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Mount Sinai Icahn School of Medicine
name: Laura A Berner, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: