Binge Eating Disorder and Obesity : Functional MRI Study

Study Overview
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Brief Summary
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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.

Detailed Description
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The aim of this functional neuroimaging study is to analyze brain responses to visual food cues in obese (body mass index > 97th percentile) adolescents with BED (according to the criteria Marcus and Kalarchian) compared with healthy control adolescents in two situations : hunger et satiety. Fifteen obese adolescents (12/16 years) with BED and fifteen healthy control adolescents will be enrolled in the study protocol. Participants will be instructed not to eat food for at least 6 hours prior to the first imaging session. After the initial set of functional and anatomic scans, participants will be fed a standard calorie meal. Approximately 1 hour later, the experiment will be repeated while participants are in a satiated condition. The cortical fMRI activation will be measured during the following four experimental visual conditions : high calory food, low calory food, disgust and neutral presented in block design. First-level and second-level differences in neural activation assessed during functional MRI in the different conditions will then be analyzed.

Official Title
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Binge Eating Disorder and Obesity : Reward System Abnormalities in Response to Food Stimuli and Research Operability by Deep Brain Stimulation Criteria: Functional MRI Study

Conditions
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Binge Eating Disorder, Obesity

Intervention / Treatment
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* Other: Functional MRI
* Other: ADO-BEDS scale
* Other: R-CMAS scale


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy controls<br>Non obese adolescents without Binge Eating Disorder (BED) | Other: Functional MRI<br>* functional MRI assessed on all the volunteers in condition of hunger and in Condition of satiety<br>Other: ADO-BEDS scale<br>* Evaluate the severity of BED according to Marcus and Kalarchian temporary diagnosis criteria<br>Other: R-CMAS scale<br>* Evaluate the anxiety<br>|
| Other: Patients with BED<br>Obese adolescents with BED with Binge Eating Disorder (BED) | Other: Functional MRI<br>* functional MRI assessed on all the volunteers in condition of hunger and in Condition of satiety<br>Other: ADO-BEDS scale<br>* Evaluate the severity of BED according to Marcus and Kalarchian temporary diagnosis criteria<br>Other: R-CMAS scale<br>* Evaluate the anxiety<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in neural activation assessed during functional MRI | The main objective of this study is the identification in patients with obesity and Binge Eating Disorder (BED) of functional MRI activation profiles (reward system) in response to food stimuli. The activation profiles will be analyzed by varying physiological conditions of hunger and satiety, and motivational value attributed to the food (calorie). | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pairwise comparisons in neural activation assessed during functional MRI | Further pairwise comparisons in neural activation assessed during functional MRI help to define DBS indication criteria / operability for BED obese candidates. | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fMRI, Deep brain stimulation, Food, Eating, Reward