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

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).

Study Overview

• Status: Recruiting
• Conditions: Binge-Eating Disorder; Healthy Volunteers; Emotional Eating
• Intervention / Treatment: Behavioral: Emotion regulation task (fNIRS recording during the emotional regulation task)

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: POZET Astrid; Phone Number: +33381218988; Email: apozet@chu-besancon.fr
• Study Contact Backup: Name: BILLOT Pierre-Edouard, PhD; Phone Number: +33363082216; Email: pierre-edouard.billot@univ-fcomte.fr

Study Locations

• France
  • Besançon, France, 25030
    • Not yet recruiting
    • CHU de Besancon
    • Contact: Anne-Cécile AMSALLEM, MD; Phone Number: +33363082216; Email: acamsallem@chu-besancon.fr
  • Besançon, France, 25000
    • Recruiting
    • UFC - UFR Santé
    • Contact: Pierre-Edouard BILLOT, PhD; Phone Number: +33363082216; Email: pierre-edouard.billot@univ-fcomte.fr
  • Dijon, France, 21000
    • Recruiting
    • Chu de Dijon
    • Contact: Marie-Claude BRINDISI, MD-PhD; Phone Number: +33380293453; Email: marie-claude.brindisi@chu-dijon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with binge eating desorders	Behavioral: Emotion regulation task (fNIRS recording during the emotional regulation task); No drugs were used in this study. All participants perform an emotion regulation task. More precisely, they have to down regulate negative emotions elicited by negative pictures using a cognitive reaprasal strategy. To this end, they have to change the meaning of the picture they are watching in order to decrease motional intensity.
Experimental: healthy volunteers with a low score at the emotion eating scale compare to median; group matched with patients for age and body mass index	Behavioral: Emotion regulation task (fNIRS recording during the emotional regulation task); No drugs were used in this study. All participants perform an emotion regulation task. More precisely, they have to down regulate negative emotions elicited by negative pictures using a cognitive reaprasal strategy. To this end, they have to change the meaning of the picture they are watching in order to decrease motional intensity.
Experimental: healthy volunteers with a high score at the emotion eating scale compare to median; group matched with patients for age and body mass index	Behavioral: Emotion regulation task (fNIRS recording during the emotional regulation task); No drugs were used in this study. All participants perform an emotion regulation task. More precisely, they have to down regulate negative emotions elicited by negative pictures using a cognitive reaprasal strategy. To this end, they have to change the meaning of the picture they are watching in order to decrease motional intensity.
Experimental: healthy volunteers normo-weight group with a low score at the emotion eating scale compare to median; 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	Behavioral: Emotion regulation task (fNIRS recording during the emotional regulation task); No drugs were used in this study. All participants perform an emotion regulation task. More precisely, they have to down regulate negative emotions elicited by negative pictures using a cognitive reaprasal strategy. To this end, they have to change the meaning of the picture they are watching in order to decrease motional intensity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of prefrontal cortex activity using functional near-infrared imaging (fNIRS).	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.	Day 1 during the viewing of images with negative valence

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Collaborators: INSERM UMR 1322 LINC
• Investigators: Study Director: AMSALLEM Anne-Cécile, MD, CHU de Besancon

Publications and helpful links

General Publications

• Parker MN, Burton Murray H, Piers AD, Muratore A, Lowe MR, Manasse SM, Ayaz H, Juarascio AS. Prefrontal cortex activation by binge-eating status in individuals with obesity while attempting to reappraise responses to food using functional near infrared spectroscopy. Eat Weight Disord. 2023 Mar 30;28(1):34. doi: 10.1007/s40519-023-01558-z.
• Dingemans A, Danner U, Parks M. Emotion Regulation in Binge Eating Disorder: A Review. Nutrients. 2017 Nov 22;9(11):1274. doi: 10.3390/nu9111274.
• Arexis M, Feron G, Brindisi MC, Billot PE, Chambaron S. A scoping review of emotion regulation and inhibition in emotional eating and binge-eating disorder: what about a continuum? J Eat Disord. 2023 Nov 10;11(1):197. doi: 10.1186/s40337-023-00916-7.

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: February 11, 2025
• First Submitted That Met QC Criteria: March 3, 2025
• First Posted (Actual): March 7, 2025

Study Record Updates

• Last Update Posted (Actual): July 22, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: fNIRS; Eating disorder; Emotion regulation; Binge-Eating Disorder; Prefrontal cortex; Emotional Eating
• Additional Relevant MeSH Terms: Mental Disorders; Hyperphagia; Signs and Symptoms, Digestive; Bulimia; Binge-Eating Disorder; Feeding and Eating Disorders
• Other Study ID Numbers: 2024/886

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No