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Идёт набор NCT06864065

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

Без фазы С лечением Binge-Eating Disorder Emotional Eating Healthy Volunteers

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Emotion regulation task (fNIRS recording during the emotional regulation task).
Кому может быть актуально
Состояния в реестре: Binge-Eating Disorder, Emotional Eating, Healthy Volunteers. Базовые параметры: 18 лет — 60 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Обзор

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).

Вмешательства

  • Поведенческое 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.

Первичные конечные точки

  • Measurement of prefrontal cortex activity using functional near-infrared imaging (fNIRS). [Срок оценки: Day 1 during the viewing of images with negative valence]
Вторичные конечные точки (3)
  • Psychophysiological measurements: electrodermal activity [Срок оценки: Day 1 during the viewing of images with negative valence]
  • Psychophysiological measurements: electrocardiogram [Срок оценки: Day 1 during the viewing of images with negative valence]
  • Psychophysiological measurements: respiratory rate [Срок оценки: Day 1 during the viewing of images with negative valence]

Критерии участия

Критерии включения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Франция · 3 центра
  • UFC - UFR Santé — Besançon
  • CHU de Besançon — Besançon
  • CHU de Dijon — Dijon

Публикации

  • 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

Идентификаторы

NCT: NCT06864065 · 2024/886

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗