Study of Emotional Regulation and Underlying Prefrontal Activity in Binge Eating Disorder (EmoBED)

Centre Hospitalier Universitaire de Besancon

Status: Enrolling

Conditions: Binge-Eating Disorder; Healthy Volunteers; Emotional Eating

Treatments: Behavioral: Emotion regulation task (fNIRS recording during the emotional regulation task)

Study type: Interventional

Funder types: Other

Identifiers

NCT06864065

2024/886

Details and patient eligibility

About

The goal of this exploratory, interventional, multicentre study is to compare the prefrontal activity during a negative emotion regulation task in women with Binge-Eating Disorder (BED) and healthy women with and without Emotional Eating (EE).

The aim of this study is to compare the prefrontal processing of cognitive control of emotions between BED and EE and to compare the emotional processing and emotional experience between BED and EE.

The study will thus compare four experimental groups: patients with BED, BMI-matched healthy volunteers with EE, BMI-matched healthy volunteers, and healthy volunteers of normal weight without BED.

Participants will perform a down-regulation task of negative emotions elicited by negative pictures. During this task, their cerebral activity will be recorded using functional near-infrared spectroscopy (fNIRS), as well as their autonomous activity (skin conductance, pulse rate, respiration rate).

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Women between 18 and 60 years old (including 60)
• Right-handed.
• For patients only : diagnosed with Binge Eating Desordors according to DSM criteria.
• Membership of a French social security scheme or beneficiary of such a scheme.
• Non-opposition of the subject to participate in the study.

Non inclusion Criteria:

Healthy volunteers only :

• Suffering from an eating disorder or any other psychiatric disorder.
• History of bariatric surgery.

All subjects (healthy volunteers and patients) :

• Rare obesity (genetic or syndromic).
• Specific addictions (substances or behaviors).
• Neurological disorders and/or history of stroke or head trauma.
• Presence of lesions, wounds or dermatitis at the sites where the recording devices are applied.
• Any serious acute or chronic illness other than the pathology under study, or any treatment likely to interfere with the evaluation of the parameter under study.
• Inability to follow protocol requirements.
• Subject unlikely to cooperate with the study and/or poor cooperation anticipated by the investigator.
• Subject unable to speak French and/or unable to read.
• Pregnant or breast-feeding women.
• Persons deprived of their liberty by judicial or administrative decision; persons under compulsory psychiatric care; persons admitted to a health or social institution for purposes other than research.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

Patients with binge eating desorders

Experimental group

Description:

Patients with binge eating desorders

Treatment:

Behavioral: Emotion regulation task (fNIRS recording during the emotional regulation task)

healthy volunteers with a low score at the emotion eating scale compare to median

Experimental group

Description:

group matched with patients for age and body mass index

Treatment:

Behavioral: Emotion regulation task (fNIRS recording during the emotional regulation task)

healthy volunteers with a high score at the emotion eating scale compare to median

Experimental group

Description:

group matched with patients for age and body mass index

Treatment:

Behavioral: Emotion regulation task (fNIRS recording during the emotional regulation task)

healthy volunteers normo-weight group with a low score at the emotion eating scale compare to median

Experimental group

Description:

healthy volunteers with normo-weight group matched with patients only in age but not in Body Mass Iindex with an Emotional Eating score below the median

Treatment:

Behavioral: Emotion regulation task (fNIRS recording during the emotional regulation task)