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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06864065
Acronym
EmoBED
Enrollment
80
Registered
2025-03-07
Start date
2025-06-24
Completion date
2026-10-30
Last updated
2025-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Binge-Eating Disorder, Emotional Eating, Healthy Volunteers

Keywords

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

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).

Interventions

BEHAVIORALEmotion 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.

Sponsors

INSERM UMR 1322 LINC
CollaboratorUNKNOWN
Centre Hospitalier Universitaire de Besancon
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Measurement of prefrontal cortex activity using functional near-infrared imaging (fNIRS).Day 1 during the viewing of images with negative valenceThe 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

MeasureTime frameDescription
Psychophysiological measurements: electrodermal activityDay 1 during the viewing of images with negative valenceSkin conductance measures are recorded These provide information on the autonomic nervous system (sympathetic and parasympathetic) and thus on emotional processing and arousal.
Psychophysiological measurements: electrocardiogramDay 1 during the viewing of images with negative valenceElectrocardiogram measures are recorded These provide information on the autonomic nervous system (sympathetic and parasympathetic) and thus on emotional processing and arousal.
Psychophysiological measurements: respiratory rateDay 1 during the viewing of images with negative valenceRespiratory rate is recorded These provide information on the autonomic nervous system (sympathetic and parasympathetic) and thus on emotional processing and arousal.

Countries

France

Contacts

Primary ContactBILLOT Pierre-Edouard, PhD
pierre-edouard.billot@univ-fcomte.fr+33363082216
Backup ContactPOZET Astrid
apozet@chu-besancon.fr+33381218988

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026