Binge Eating Disorder and Obesity : Functional MRI Study (NCT02868619) | Clinical Trial Compass
CompletedNot Applicable
Binge Eating Disorder and Obesity : Functional MRI Study
France32 participantsStarted 2014-12-05
Plain-language summary
Obesity, defined as BMI\> 30kg / m2, is a major public health problem, with devastating medical and psychological consequences. 30% of obese suffer from BED type of eating disorders. The optimal treatment of obesity remains bariatric surgery, failed in 20% of cases. Many arguments are in favor of the involvement of the reward circuitry, with the central role of NAc in the pathophysiology of BED and obesity. The recent application and effectiveness of DBS (Deep Brain Stimulation) in refractory psychiatric disorders suggest that DBS may be of interest in treating obesity and BED with potential target for the NAc. This project propose to study fMRI activation of the reward system in response to food stimuli to better direct the DBS targets. This is a pilot study to define indication criteria based on fMRI to obese BED patients are potential candidates for treatment with DBS.
Who can participate
Age range
12 Years – 16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Non specific inclusion criteria
* Age limits ≥ 12 et \< 16 years
* Collection of the informed consent. For the minor patients, signature of parents
* Affiliation or recipient with the mode of social security.
* No associated evolutionary pathologies
* Specific inclusion criteria for the patients
* Existence of a current food disorder of the conducts of type binge eating disorder according to the criteria Marcus and Kalarchian
* Diagnosis of obesity defined by a body mass index \> 97th percentile
* Severity criteria defined by: Evolution of the obesity and the BED for at least 5 years AND Not answer to a dietary, pharmacological, psychotherapeutic care during at least 6 months
* Specific inclusion criteria for the volunteers
* Absence of a current food disorder of the conducts of type binge eating disorder according to the criteria Marcus and Kalarchian
* Absence of antecedent of neurological disorder
* an actual body mass index \< 90th percentile
Exclusion Criteria:
* IRM contraindication
* Pacemaker
* Port(Bearing) of surgical clips in the cervico-cephalic region or implanted medical surgical material(equipment) susceptible to mobilize under the influence of magnetic gradients
* Intraocular foreign body
* Metalic foreign body
* claustrophobia
* The existence of possible psychiatric histories will be individually estimated
* Pregnancy and breastfeeding
* Loss of liberty by court or administrative order
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Differences in neural activation assessed during functional MRI