Back to resultsDecision-making and Risk-taking in Bulimia (FaciB)
Primary Purpose
Bulimia Nervosa
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
tasks and questionnaires
tasks and questionnaires
Sponsored by
About this trial
This is an interventional basic science trial for Bulimia Nervosa focused on measuring computational psychiatry, decision making, risk, food, monetary, eating disorder
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Hopital Vinatier
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
bulimia nervosa group
Control group
Arm Description
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.
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
Outcomes
Primary Outcome Measures
oxygen variation in the brain
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.
Secondary Outcome Measures
Task related parameters
reaction times computed as the duration in ms between the onset time of the stimulus and the onset time of the participant's answer. Several tasks may be involved in each experiment including in the MRI scan.
These rules apply to all tasks.
Skin conductance response related to events in the task performed while the signal is being collected
Skin conductance response in microSiemens 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
cardiac frequency in beats per minute related to events in the task performed while the signal is being collected
cardiac frequency is computed from the pulse plethysmogram sensor signal while the participant is performing the task. Task during which this signal is collected may be one of the tasks performed in the scanner as well as tasks performed outside the scanner.
parameters of eye movements extracted from the eye tracking signal is being collected
The parameters computed are X and Y position of the eye by amplitude of variation of pupil size over a time window synchronized with events in the task
Eating Disorders Examination (EDE-Q)
The EDE is a semi-structured interview conducted by a trained clinician to assess the psychopathology associated with the diagnosis of an eating disorder. The EDE is rated through the use of four subscales (restraint, eating concern, weight concern, shape concern) and global score.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04041024
Brief Title
Decision-making and Risk-taking in Bulimia
Acronym
FaciB
Official Title
Identification of Decision Making Processes in Food, Risky and Steal Situations in Bulimia Nervosa
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
The PI has left the hospital and no one is replacing him
Study Start Date
October 28, 2020 (Actual)
Primary Completion Date
June 15, 2021 (Actual)
Study Completion Date
June 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital le Vinatier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bulimia Nervosa
Keywords
computational psychiatry, decision making, risk, food, monetary, eating disorder
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bulimia nervosa group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
tasks and questionnaires
Intervention Description
Each of the 4 experiments is built of a main task. The first task involves a first phase of subjective valuation of food items.
The second phase requires from the participant to make a choice between two out of three food items selected by the computer.
Intervention Type
Other
Intervention Name(s)
tasks and questionnaires
Intervention Description
Each of the 4 experiments is built of a main task. The first task involves a first phase of subjective valuation of food items.
The second phase requires from the participant to make a choice between two out of three food items selected by the computer.
Primary Outcome Measure Information:
Title
oxygen variation in the brain
Description
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.
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Task related parameters
Description
reaction times computed as the duration in ms between the onset time of the stimulus and the onset time of the participant's answer. Several tasks may be involved in each experiment including in the MRI scan.
These rules apply to all tasks.
Time Frame
10 days
Title
Skin conductance response related to events in the task performed while the signal is being collected
Description
Skin conductance response in microSiemens 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
Time Frame
10 days
Title
cardiac frequency in beats per minute related to events in the task performed while the signal is being collected
Description
cardiac frequency is computed from the pulse plethysmogram sensor signal while the participant is performing the task. Task during which this signal is collected may be one of the tasks performed in the scanner as well as tasks performed outside the scanner.
Time Frame
10 days
Title
parameters of eye movements extracted from the eye tracking signal is being collected
Description
The parameters computed are X and Y position of the eye by amplitude of variation of pupil size over a time window synchronized with events in the task
Time Frame
10 days
Title
Eating Disorders Examination (EDE-Q)
Description
The EDE is a semi-structured interview conducted by a trained clinician to assess the psychopathology associated with the diagnosis of an eating disorder. The EDE is rated through the use of four subscales (restraint, eating concern, weight concern, shape concern) and global score.
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Hopital Vinatier
City
Lyon
State/Province
Rhone Alpes
ZIP/Postal Code
69678
Country
France
12. IPD Sharing Statement
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Decision-making and Risk-taking in Bulimia
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