BED: Binge Eating Disorder and Obesity : Functional MRI Study

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Completed

CT.gov ID

NCT02868619

Collaborator

(none)

Enrollment

Location

Arms

75.1

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Binge Eating Disorder Obesity	Other: Functional MRI Other: ADO-BEDS scale Other: R-CMAS scale	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Dec 5, 2014

Actual Primary Completion Date :

Mar 10, 2021

Actual Study Completion Date :

Mar 10, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Other: Healthy controls

Non obese adolescents without Binge Eating Disorder (BED)

Other: Functional MRI

functional MRI assessed on all the volunteers in condition of hunger and in Condition of satiety

Other: ADO-BEDS scale

Evaluate the severity of BED according to Marcus and Kalarchian temporary diagnosis criteria

Other: R-CMAS scale

Evaluate the anxiety

Other: Patients with BED

Obese adolescents with BED with Binge Eating Disorder (BED)

Other: Functional MRI

functional MRI assessed on all the volunteers in condition of hunger and in Condition of satiety

Other: ADO-BEDS scale

Evaluate the severity of BED according to Marcus and Kalarchian temporary diagnosis criteria

Other: R-CMAS scale

Evaluate the anxiety

Outcome Measures

Primary Outcome Measures

Differences in neural activation assessed during functional MRI [4 years]
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).

Secondary Outcome Measures

Pairwise comparisons in neural activation assessed during functional MRI [4 years]
Further pairwise comparisons in neural activation assessed during functional MRI help to define DBS indication criteria / operability for BED obese candidates.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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