Binge-Eating DisorderEmoBEDNCT06864065
Study of Emotional Regulation and Underlying Prefrontal Activity in Binge Eating Disorder
A study testing Emotion regulation task (fNIRS recording during the emotional regulation task) in people with Binge-Eating Disorder and Emotional Eating, run by Centre Hospitalier Universitaire de Besancon at 3 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Binge-Eating Disorder, Emotional Eating, Healthy Volunteers
- What is being tested?
- Emotion regulation task (fNIRS recording during the emotional regulation task)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesFrance
- Study dates
- 24 Jun 2025to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
Show all 20Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
UFC - UFR Santé
Besançon, 25000
Pierre-Edouard BILLOT, PhD, +33363082216, pierre-edouard.billot@univ-fcomte.fr
- Not yet recruiting
CHU de Besançon
Besançon, 25030
Anne-Cécile AMSALLEM, MD, +33363082216, acamsallem@chu-besancon.fr
- Recruiting
CHU de Dijon
Dijon, 21000
Marie-Claude BRINDISI, MD-PhD, +33380293453, marie-claude.brindisi@chu-dijon.fr
About this study
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.
Read more
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).
- Conditions
- Binge-Eating Disorder, Emotional Eating, Healthy Volunteers
- Being tested
- Emotion regulation task (fNIRS recording during the emotional regulation task)
- Keywords
- Binge-Eating Disorder, Emotion regulation, fNIRS, Prefrontal cortex, Eating disorder, Emotional Eating
- Medical subject headings
- Binge-Eating Disorder, Emotional Eating, Emotional Regulation, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion regulation task (fNIRS recording during the emotional regulation task)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with binge eating desorders | Experimental | Patients with binge eating desorders Receives: Behavioral: Emotion regulation task (fNIRS recording during the emotional regulation task) |
| healthy volunteers with a low score at the emotion eating scale compare to median | Experimental | group matched with patients for age and body mass index Receives: Behavioral: Emotion regulation task (fNIRS recording during the emotional regulation task) |
| healthy volunteers with a high score at the emotion eating scale compare to median | Experimental | group matched with patients for age and body mass index Receives: Behavioral: Emotion regulation task (fNIRS recording during the emotional regulation task) |
| healthy volunteers normo-weight group with a low score at the emotion eating scale compare to median | Experimental | healthy volunteers with normo-weight group matched with patients only in age but not in Body Mass Iindex with an Emotional Eating score below the median Receives: Behavioral: Emotion regulation task (fNIRS recording during the emotional regulation task) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of prefrontal cortex activity using functional near-infrared imaging (fNIRS).
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.
Measured: Day 1 during the viewing of images with negative valence
Secondary outcomes (3)
Psychophysiological measurements: electrodermal activity
Skin conductance measures are recorded These provide information on the autonomic nervous system (sympathetic and parasympathetic) and thus on emotional processing and arousal.
Measured: Day 1 during the viewing of images with negative valence
Psychophysiological measurements: electrocardiogram
Electrocardiogram measures are recorded These provide information on the autonomic nervous system (sympathetic and parasympathetic) and thus on emotional processing and arousal.
Measured: Day 1 during the viewing of images with negative valence
Psychophysiological measurements: respiratory rate
Respiratory rate is recorded These provide information on the autonomic nervous system (sympathetic and parasympathetic) and thus on emotional processing and arousal.
Measured: Day 1 during the viewing of images with negative valence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start24 Jun 2025
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Binge-Eating DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- It is important to note that no drugs are tested. The task (emotion regulation) is consistent for all groups.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM UMR 1322 LINC
- Responsible party
- Sponsor
- Investigators
- AMSALLEM Anne-Cécile, MD, Study director, CHU de Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864065
- Sponsor's protocol ID
- 2024/886
- Acronym
- EmoBED
- Status last verified
- Jul 2025
- First submitted
- 11 Feb 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36995567Dingemans A, Danner U, Parks M. Emotion Regulation in Binge Eating Disorder: A Review. Nutrients. 2017 Nov 22;9(11):1274. doi: 10.3390/nu9111274.
PubMed 29165348Arexis 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.
PubMed 37950264
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Emotional Regulation and Underlying Prefrontal Activity in Binge Eating Disorder
- ClinicalTrials.gov ID
- NCT06864065
- Acronym / sponsor ID
- EmoBED / 2024/886
- Conditions
- Binge-Eating Disorder, Emotional Eating, Healthy Volunteers
- Keywords
- Binge-Eating Disorder, Emotion regulation, fNIRS, Prefrontal cortex, Eating disorder, Emotional Eating
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- INSERM UMR 1322 LINC
- Study start
- 24 Jun 2025 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- It is important to note that no drugs are tested. The task (emotion regulation) is consistent for all groups.
| Arm | Type | Receives |
|---|---|---|
| Patients with binge eating desorders | Experimental | Behavioral: Emotion regulation task (fNIRS recording during the emotional regulation task)Patients with binge eating desorders |
| healthy volunteers with a low score at the emotion eating scale compare to median | Experimental | Behavioral: Emotion regulation task (fNIRS recording during the emotional regulation task)group matched with patients for age and body mass index |
| healthy volunteers with a high score at the emotion eating scale compare to median | Experimental | Behavioral: Emotion regulation task (fNIRS recording during the emotional regulation task)group matched with patients for age and body mass index |
| healthy volunteers normo-weight group with a low score at the emotion eating scale compare to median | Experimental | Behavioral: Emotion regulation task (fNIRS recording during the emotional regulation task)healthy volunteers with normo-weight group matched with patients only in age but not in Body Mass Iindex with an Emotional Eating score below the median |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotion 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. | Behavioural | Patients with binge eating desorders, healthy volunteers normo-weight group with a low score at the emotion eating scale compare to median, healthy volunteers with a high score at the emotion eating scale compare to median, healthy volunteers with a low score at the emotion eating scale compare to median |
Primary outcome
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.
3 secondary outcomes
Psychophysiological measurements: electrodermal activity
Time frame: Day 1 during the viewing of images with negative valence
Psychophysiological measurements: electrocardiogram
Time frame: Day 1 during the viewing of images with negative valence
Psychophysiological measurements: respiratory rate
Time frame: Day 1 during the viewing of images with negative valence
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Background: PubMed 36995567Parker 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.
- Background: PubMed 29165348Dingemans A, Danner U, Parks M. Emotion Regulation in Binge Eating Disorder: A Review. Nutrients. 2017 Nov 22;9(11):1274. doi: 10.3390/nu9111274.
- Background: PubMed 37950264Arexis 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.
- Individual participant dataSharing planned: No
Related trials for Binge-Eating Disorder
Enrolling by invitationPhase 3
A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder
Binge-Eating Disorder
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
Enrolling by invitation
Sleep and Activity For Eating Disorders
Eating Disorders, Anorexia Nervosa
Active, not recruiting
Project VIBE: Virtual Intervention for Binge Eating in Adolescents
Obesity, Binge-Eating Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AMSALLEM Anne-Cécile, MD study director
CHU de Besançon
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotion regulation task (fNIRS recording during the emotional regulation task) in people with Binge-Eating Disorder and Emotional Eating, run by Centre Hospitalier Universitaire de Besancon at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BILLOT Pierre-Edouard, PhD (+33363082216, pierre-edouard.billot@univ-fcomte.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of prefrontal cortex activity using functional near-infrared imaging (fNIRS). (time frame: Day 1 during the viewing of images with negative valence). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06864065, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.