An interventional study of Functional MRI and ADO-BEDS scale in Binge Eating Disorder and Obesity, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 12 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-18.
Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Other
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.
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 32 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
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Non specific inclusion criteria
Specific inclusion criteria for the patients
Specific inclusion criteria for the volunteers
Exclusion Criteria:
Non obese adolescents without Binge Eating Disorder (BED)
Other: Functional MRI · Other: ADO-BEDS scale · Other: R-CMAS scale
Obese adolescents with BED with Binge Eating Disorder (BED)
Other: Functional MRI · Other: ADO-BEDS scale · Other: R-CMAS scale
functional MRI assessed on all the volunteers in condition of hunger and in Condition of satiety
Evaluate the severity of BED according to Marcus and Kalarchian temporary diagnosis criteria
Evaluate the anxiety
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).
Time frame: 4 years
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.
Time frame: 4 years
Plan to share: No
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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University Hospital, Montpellier