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

NCT06864065 | Recruiting

• 1 other identifier: 2024/886
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

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).

Conditions

Binge-Eating Disorder; Emotional Eating; Healthy Volunteers

Keywords

Binge-Eating Disorder; Emotion regulation; fNIRS; Prefrontal cortex; Eating disorder; Emotional Eating

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Psychophysiological measurements: electrodermal activity

  Day 1 during the viewing of images with negative valence

• Psychophysiological measurements: electrocardiogram

  Day 1 during the viewing of images with negative valence

• Psychophysiological measurements: respiratory rate

  Day 1 during the viewing of images with negative valence

Study Arms (4)

Patients with binge eating desorders

EXPERIMENTAL

Patients with binge eating desorders

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 matched with patients for age and body mass index

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 matched with patients for age and body mass index

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

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)

Interventions

Emotion regulation task (fNIRS recording during the emotional regulation task) BEHAVIORAL

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.

Patients with binge eating desorders; healthy volunteers normo-weight group with a low score at the emotion eating scale compare to median; healthy volunteers with a high score at the emotion eating scale compare to median; healthy volunteers with a low score at the emotion eating scale compare to median

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead
• INSERM UMR 1322 LINC: collaborator

Study Sites (3)

UFC - UFR Santé

Besançon, 25000, France

RECRUITING

CHU de Besançon

Besançon, 25030, France

NOT YET RECRUITING

CHU de Dijon

Dijon, 21000, France

RECRUITING

Related Publications (3)

• 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.

  PMID: 36995567 BACKGROUND

• 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.

  PMID: 29165348 BACKGROUND

• 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.

  PMID: 37950264 BACKGROUND

MeSH Terms

Conditions

Binge-Eating Disorder; Emotional Eating; Emotional Regulation; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Feeding Behavior; Behavior; Self-Control; Social Behavior; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• AMSALLEM Anne-Cécile, MD

  CHU de Besançon

  STUDY DIRECTOR

Central Study Contacts

BILLOT Pierre-Edouard, PhD

CONTACT

+33363082216; pierre-edouard.billot@univ-fcomte.fr

POZET Astrid

CONTACT

+33381218988; apozet@chu-besancon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: It is important to note that no drugs are tested. The task (emotion regulation) is consistent for all groups.

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: March 7, 2025
• Study Start: June 24, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)