NCT06864065 Study of Emotional Regulation and Underlying Prefrontal Activity in Binge Eating Disorder
| NCT ID | NCT06864065 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Besancon |
| Condition | Binge-Eating Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-06-24 |
| Primary Completion | 2026-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-06-24 with a primary completion date of 2026-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
AMSALLEM Anne-Cécile, MD
STUDY DIRECTOR
CHU de Besançon
Frequently Asked Questions
Who can join the NCT06864065 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 60 Years, studying Binge-Eating Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06864065 currently recruiting?
Yes, NCT06864065 is actively recruiting participants. Contact the research team at pierre-edouard.billot@univ-fcomte.fr for enrollment information.
Where is the NCT06864065 trial being conducted?
This trial is being conducted at Besançon, France, Besançon, France, Dijon, France.
Who is sponsoring the NCT06864065 clinical trial?
NCT06864065 is sponsored by Centre Hospitalier Universitaire de Besancon. The principal investigator is AMSALLEM Anne-Cécile, MD at CHU de Besançon. The trial plans to enroll 80 participants.