Prefrontal brain activity during emotion regulation in women with binge-eating

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

This study tests whether women with binge-eating show different prefrontal brain and bodily responses when trying to down-regulate negative emotions compared with healthy women with and without emotional eating.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 60 Years
• Sex: Female
• Sponsor: Centre Hospitalier Universitaire de Besancon (Academic / other)
• Locations: 3 sites (Besançon and 2 other locations)
• Trial ID: NCT06864065 on ClinicalTrials.gov

What this trial studies

This multicenter exploratory interventional study compares four groups of right-handed women (BED, BMI-matched healthy with emotional eating, BMI-matched healthy without emotional eating, and normal-weight healthy controls) while they perform a task to down-regulate negative emotions elicited by pictures. Cerebral activity over the prefrontal cortex will be recorded using functional near-infrared spectroscopy (fNIRS) alongside autonomic measures (skin conductance, pulse, respiration). The protocol focuses on between-group differences in cognitive control of negative emotion and subjective emotional experience. Sites in Besançon and Dijon will enroll participants who meet inclusion and exclusion criteria and complete the laboratory task under standardized conditions.

Who should consider this trial

Good fit: Ideal participants are right-handed women aged 18–60 with a DSM diagnosis of binge-eating disorder, able to travel to a participating French center and covered by the French social security system.

Not a fit: People with current other psychiatric disorders, neurological disease or significant medical conditions, prior bariatric surgery, substance or behavioral addictions, or skin problems at recording sites are unlikely to benefit and are excluded.

Why it matters

Potential benefit: If successful, the results could help identify brain and physiological markers of impaired emotion regulation in BED that inform future targeted therapies or diagnostics.

How similar studies have performed: Previous neuroimaging work (primarily fMRI) has reported altered prefrontal responses during emotion regulation in eating disorders, so the general approach has supporting evidence, but using fNIRS plus autonomic measures in BED is relatively novel.

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.

Where this trial is running

Besançon and 2 other locations

• UFC - UFR Santé — Besançon, France (Recruiting)
• CHU de Besançon — Besançon, France (Not_yet_recruiting)
• CHU de Dijon — Dijon, France (Recruiting)

Study contacts

• Study coordinator: BILLOT Pierre-Edouard, PhD

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