Identification of Decision Making Processes in Food, Risky and Steal Situations in Bulimia Nervosa
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- oxygen variation in the brain
研究概览
简要总结
This trial is a set of four independent experiments involving for each of them functional and structural MRI data acquisition. They aim at investigating decision making mechanisms in bulimia nervosa when participants have to make food or monetary choices under specific conditions that mimic binge eating episodes or kleptomania which are two major symptoms of bulimia nervosa. All experiments are cross sectional studies. Each experiment is subdivided into two parts: a first part without any MRI data acquisition and during which all the tasks are performed. This part aims at making sure that a behavioral effect is observed before starting MRI data acquisition. The second part aims at investigating the neural correlates observed in the first part and additionally, at reproducing the behavioral effects observed in the first part. Therefore the first part may be regarded as an independent study as compared to the second part.
详细描述
Each part of each experiment is built of a main task, a set of secondary tasks and questionnaires. Only the main task changes from one experiment to another. Within each experiment, the only difference between the two parts is that the main task is performed while participants are being scanned in an MRI scanner. Details of the tasks are provided below. Each part of each experiment is performed over one visit only and is a cross sectional study. The visit is dedicated to the tasks. Questionnaires may be filled during the visit or at participant's home within the week following the visit for questionnaires which are not assessing participant's state. Questionnaires assessing participant's state are filled during the visit at appropriate time. The total number of participants mentioned below is the sum of the planned number of participants within each group, i.e. patients and healthy participants, within each part of each experiment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •men and women aged 18 to 35 years with bulimia nervosa according to DSM 5 criteria for the patient's group
- •For the control group, men and women with the same age range being concerned by food intake and their body shape but without any history of eating disorder.
- •All participants must have signed an informed consent form and be affiliated to the French public health insurance.
- •for MRI scans, all participants must be right handed.
排除标准
- •antisocial personality disorder,
- •borderline personality disorder
- •addiction to alcohol or psychoactive agent, ADHD, any psychotic disorder,
- •obesity of class 1 or 2
- •istory of psychiatric disorder for the control group
- •history of neurological disorder for both groups
- •intermittent explosive disorder
- •any counter indication to MRI scans for the parts of experiments which take place in the MRI scanner.
研究组 & 干预措施
bulimia nervosa group
Patients with Bulimia Nervosa according to DSM 5 criteria aged between 18 and 35 years and specifically for participants attending MRI scans in the experiments: no counter indication to MRI scans and right handed.
干预措施: tasks and questionnaires (Other)
Control group
healthy participants without any history of eating disorder aged between 18 and 35 years and specifically for participants attending MRI scans in the experiments: no counter indication to MRI scans and right
干预措施: tasks and questionnaires (Other)
结局指标
主要结局
oxygen variation in the brain
时间窗: 10 days
Brain activity related to task performance collected in the MRI scanner.Blood Oxygen Level Dependent response synchronized with any event of interest during the task. Events of interests are: * Onset time of any visual stimulus * Onset time of any response of the participant.
次要结局
- Task related parameters(10 days)
- Skin conductance response related to events in the task performed while the signal is being collected(10 days)
- cardiac frequency in beats per minute related to events in the task performed while the signal is being collected(10 days)
- parameters of eye movements extracted from the eye tracking signal is being collected(10 days)
- Eating Disorders Examination (EDE-Q)(10 days)