Study of Emotional Regulation and Underlying Prefrontal Activity in Binge Eating Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Measurement of prefrontal cortex activity using functional near-infrared imaging (fNIRS).
研究概览
简要总结
The goal of this exploratory, interventional, multicentre study is to compare the prefrontal activity during a negative emotion regulation task in women with Binge-Eating Disorder (BED) and healthy women with and without Emotional Eating (EE).
The aim of this study is to compare the prefrontal processing of cognitive control of emotions between BED and EE and to compare the emotional processing and emotional experience between BED and EE.
The study will thus compare four experimental groups: patients with BED, BMI-matched healthy volunteers with EE, BMI-matched healthy volunteers, and healthy volunteers of normal weight without BED.
Participants will perform a down-regulation task of negative emotions elicited by negative pictures. During this task, their cerebral activity will be recorded using functional near-infrared spectroscopy (fNIRS), as well as their autonomous activity (skin conductance, pulse rate, respiration rate).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women between 18 and 60 years old (including 60)
- •Right-handed.
- •For patients only : diagnosed with Binge Eating Desordors according to DSM criteria.
- •Membership of a French social security scheme or beneficiary of such a scheme.
- •Non-opposition of the subject to participate in the study.
- •Non inclusion Criteria:
- •Healthy volunteers only :
- •Suffering from an eating disorder or any other psychiatric disorder.
- •History of bariatric surgery.
- •All subjects (healthy volunteers and patients) :
- •Rare obesity (genetic or syndromic).
- •Specific addictions (substances or behaviors).
- •Neurological disorders and/or history of stroke or head trauma.
- •Presence of lesions, wounds or dermatitis at the sites where the recording devices are applied.
- •Any serious acute or chronic illness other than the pathology under study, or any treatment likely to interfere with the evaluation of the parameter under study.
- •Inability to follow protocol requirements.
- •Subject unlikely to cooperate with the study and/or poor cooperation anticipated by the investigator.
- •Subject unable to speak French and/or unable to read.
- •Pregnant or breast-feeding women.
- •Persons deprived of their liberty by judicial or administrative decision; persons under compulsory psychiatric care; persons admitted to a health or social institution for purposes other than research.
排除标准
- 未提供
研究组 & 干预措施
Patients with binge eating desorders
Patients with binge eating desorders
干预措施: Emotion regulation task (fNIRS recording during the emotional regulation task) (Behavioral)
healthy volunteers with a low score at the emotion eating scale compare to median
group matched with patients for age and body mass index
干预措施: Emotion regulation task (fNIRS recording during the emotional regulation task) (Behavioral)
healthy volunteers with a high score at the emotion eating scale compare to median
group matched with patients for age and body mass index
干预措施: Emotion regulation task (fNIRS recording during the emotional regulation task) (Behavioral)
healthy volunteers normo-weight group with a low score at the emotion eating scale compare to median
healthy volunteers with normo-weight group matched with patients only in age but not in Body Mass Iindex with an Emotional Eating score below the median
干预措施: Emotion regulation task (fNIRS recording during the emotional regulation task) (Behavioral)
结局指标
主要结局
Measurement of prefrontal cortex activity using functional near-infrared imaging (fNIRS).
时间窗: Day 1 during the viewing of images with negative valence
The fNIRS signal represents the concentration of oxyhemoglobin and deoxyhemoglobin over time. It provides information about the local oxygen demand of the brain and therefore its activity. It is these concentrations during the regulatory task that are used as the primary outcome measure.
次要结局
- Psychophysiological measurements: respiratory rate(Day 1 during the viewing of images with negative valence)
- Psychophysiological measurements: electrodermal activity(Day 1 during the viewing of images with negative valence)
- Psychophysiological measurements: electrocardiogram(Day 1 during the viewing of images with negative valence)