Study of Emotional Regulation and Underlying Prefrontal Activity in Binge Eating Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorCentre Hospitalier Universitaire de Besancon
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Emotion regulation task (fNIRS recording during the emotional regulation task)
BehavioralNo 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.
Treatment groups
80 Participants
are divided into 4 treatment groupsGroup A: Patients with binge eating desordersExperimental treatment 1 intervention
Group B: healthy volunteers with a low score at the emotion eating scale compare to medianExperimental treatment 1 intervention
Group C: healthy volunteers with a high score at the emotion eating scale compare to medianExperimental treatment 1 intervention
Group D: healthy volunteers normo-weight group with a low score at the emotion eating scale compare to medianExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Day 1 during the viewing of images with negative valenceSecondary outcomes
1
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.
Time frame
Day 1 during the viewing of images with negative valence2
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.
Time frame
Day 1 during the viewing of images with negative valence3
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.
Time frame
Day 1 during the viewing of images with negative valenceSponsors and contacts
Click on the lead sponsor to view all of their trials.
Centre Hospitalier Universitaire de Besancon
Lead sponsor
INSERM UMR 1322 LINC
Collaborator
Source ClinicalTrials.gov