Study of Emotional Regulation and Underlying Prefrontal Activity in Binge Eating Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Emotion regulation task (fNIRS recording during the emotional regulation task).
- Who it may be relevant to
- Registry conditions: Binge-Eating Disorder, Emotional Eating, Healthy Volunteers. Basic parameters: 18 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Interventions
- Behavioral 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.
Primary outcome measures
- Measurement of prefrontal cortex activity using functional near-infrared imaging (fNIRS). [Time frame: Day 1 during the viewing of images with negative valence]
Secondary outcome measures (3)
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 3 centers
- UFC - UFR Santé — Besançon
- CHU de Besançon — Besançon
- CHU de Dijon — Dijon
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. PMID 36995567
- 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. PMID 29165348
- 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. PMID 37950264
Identifiers
NCT: NCT06864065 · 2024/886