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临床试验/NCT05995496
NCT05995496
招募中
不适用

Dynamic Neural Computations Underlying Cognitive Control in Bulimia Nervosa

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 150 人2023年12月12日

概览

阶段
不适用
干预措施
Fasting state
疾病 / 适应症
Bulimia Nervosa
发起方
Icahn School of Medicine at Mount Sinai
入组人数
150
试验地点
1
主要终点
Frontostriatal Activation Encoding the Subjective Value of Cognitive Effort on the Cognitive-Effort Discounting Task
状态
招募中
最后更新
2个月前

概览

简要总结

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.

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2023年12月12日
结束日期
2027年12月31日
最后更新
2个月前
研究类型
Interventional
研究设计
Crossover
性别
Female

研究者

责任方
Principal Investigator
主要研究者

Laura Berner

Assistant Professor

Icahn School of Medicine at Mount Sinai

入排标准

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Fasting state

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.

干预措施: Fed state

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.

干预措施: Magnetic Resonance Imaging

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.

干预措施: Fasting state

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.

干预措施: Fed state

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.

干预措施: Magnetic Resonance Imaging

结局指标

主要结局

Frontostriatal Activation Encoding the Subjective Value of Cognitive Effort on the Cognitive-Effort Discounting Task

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

次要结局

  • 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))

研究点 (1)

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