Clinical trial NCT06864065: Study of Emotional Regulation and Underlying Prefrontal Activity in Binge Eating Disorder
Official title: Study of Emotional Regulation and Underlying Prefrontal Activity in Binge Eating Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Binge-Eating Disorder
Emotional Eating
Healthy Volunteers
Keywords: Binge-Eating Disorder
Emotion regulation
fNIRS
Prefrontal cortex
Eating disorder
Emotional Eating
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: INSERM UMR 1322 LINC
First posted: 2025-03-07
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is important to note that no drugs are tested. The task (emotion regulation) is consistent for all groups.
Primary purpose: OTHER

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Measurement of prefrontal cortex activity using functional near-infrared imaging (fNIRS).
timeFrame: Day 1 during the viewing of images with negative valence
Secondary outcomes:
measure: Psychophysiological measurements: electrodermal activity
timeFrame: Day 1 during the viewing of images with negative valence
measure: Psychophysiological measurements: electrocardiogram
timeFrame: Day 1 during the viewing of images with negative valence
measure: Psychophysiological measurements: respiratory rate
timeFrame: Day 1 during the viewing of images with negative valence
Other outcomes:
Locations:
city: Besançon
country: France
facility: UFC - UFR Santé
city: Besançon
country: France
facility: CHU de Besançon
city: Dijon
country: France
facility: CHU de Dijon
Study officials:
affiliation: CHU de Besançon
name: AMSALLEM Anne-Cécile, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.