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NCT Number: NCT06864065

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

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).

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Key information

Conditions

Binge-Eating Disorder Behavior Emotional Eating Emotional Regulation Feeding Behavior Feeding and Eating Disorders Healthy Volunteers Mental Disorders Pathological Conditions, Signs and Symptoms Self-Control Signs and Symptoms Signs and Symptoms, Digestive Social Behavior

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Besançon, Besançon, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Measurement of prefrontal cortex activity using functional near-infrared imaging (fNIRS).

    Time frame: Day 1 during the viewing of images with negative valence

    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.

Secondary outcomes

  1. Psychophysiological measurements: electrodermal activity

    Time frame: Day 1 during the viewing of images with negative valence

    Skin conductance measures are recorded These provide information on the autonomic nervous system (sympathetic and parasympathetic) and thus on emotional processing and arousal.

  2. Psychophysiological measurements: electrocardiogram

    Time frame: Day 1 during the viewing of images with negative valence

    Electrocardiogram measures are recorded These provide information on the autonomic nervous system (sympathetic and parasympathetic) and thus on emotional processing and arousal.

  3. Psychophysiological measurements: respiratory rate

    Time frame: Day 1 during the viewing of images with negative valence

    Respiratory rate is recorded These provide information on the autonomic nervous system (sympathetic and parasympathetic) and thus on emotional processing and arousal.

Study contacts

Contact information is provided by the study sponsor or research team.

BILLOT Pierre-Edouard, PhD

CONTACT

[email protected]

+33363082216

POZET Astrid

CONTACT

[email protected]

+33381218988

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Collaborators

  • INSERM UMR 1322 LINC

Registry information

Acronym: EmoBED

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 7, 2025
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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