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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06864065
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-11
• Study First Submitted QC: 2025-03-03
• Study First Posted: 2025-03-07
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-20
• Study Start: 2025-06-01
• Primary Completion: 2026-10-30
• Study Completion: 2026-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 80

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Measurement of prefrontal cortex activity using functional near-infrared imaging (fNIRS).	Day 1 during the viewing of images with negative valence	The fNIRS signal represents the concentration of oxyhemoglobin and deoxyhemoglobin over time. It provides information about the local oxygen demand of the brain and therefore its activity.; It is these concentrations during the regulatory task that are used as the primary outcome measure.

Secondary Outcome Measures

Name	Time	Method
Psychophysiological measurements: respiratory rate	Day 1 during the viewing of images with negative valence	Respiratory rate is recorded These provide information on the autonomic nervous system (sympathetic and parasympathetic) and thus on emotional processing and arousal.
Psychophysiological measurements: electrodermal activity	Day 1 during the viewing of images with negative valence	Skin conductance measures are recorded These provide information on the autonomic nervous system (sympathetic and parasympathetic) and thus on emotional processing and arousal.
Psychophysiological measurements: electrocardiogram	Day 1 during the viewing of images with negative valence	Electrocardiogram measures are recorded These provide information on the autonomic nervous system (sympathetic and parasympathetic) and thus on emotional processing and arousal.

Trial Locations

Locations (3)

UFC - UFR Santé; 🇫🇷 Besançon, France

CHU de Besançon; 🇫🇷 Besançon, France

CHU de Dijon; 🇫🇷 Dijon, France