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

NCT ID: NCT06864065

Last Updated: 2025-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-24

Study Completion Date

2026-10-30

Brief Summary

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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

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Conditions

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Binge-Eating Disorder Emotional Eating Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

It is important to note that no drugs are tested. The task (emotion regulation) is consistent for all groups.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients with binge eating desorders

Patients with binge eating desorders

Group Type EXPERIMENTAL

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

Intervention Type 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.

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

group matched with patients for age and body mass index

Group Type EXPERIMENTAL

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

Intervention Type 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.

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

group matched with patients for age and body mass index

Group Type EXPERIMENTAL

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

Intervention Type 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.

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.


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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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INSERM UMR 1322 LINC

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AMSALLEM Anne-Cécile, MD

Role: STUDY_DIRECTOR

CHU de Besançon

Locations

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UFC - UFR Santé

Besançon, , France

Site Status RECRUITING

CHU de Besançon

Besançon, , France

Site Status NOT_YET_RECRUITING

CHU de Dijon

Dijon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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BILLOT Pierre-Edouard, PhD

Role: CONTACT

+33363082216

POZET Astrid

Role: CONTACT

+33381218988

Facility Contacts

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Pierre-Edouard BILLOT, PhD

Role: primary

+33363082216

Anne-Cécile AMSALLEM, MD

Role: primary

+33363082216

Marie-Claude BRINDISI, MD-PhD

Role: primary

+33380293453

References

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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.

Reference Type BACKGROUND
PMID: 36995567 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29165348 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37950264 (View on PubMed)

Other Identifiers

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2024/886

Identifier Type: -

Identifier Source: org_study_id

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