Neurofeedback Based on Near-infrared Spectroscopy as a Therapy for Food Addiction in Obese Subjects.

Обзор

The hypothesis is that the increase in dlPFC brain activity via near-infrared spectroscopy-based Neurofeedback (fNIRS-based NF) training based on near-infrared spectroscopy would allow an improvement of the eating behavior, thus promoting a long-term weight loss in obese subjects. Patients will be trained during a month with 8 NF sessions and results based on clinical data and different questionnaires results will be compared between inclusion and 3 months later

Подробное описание

Obesity is a disease of increasing prevalence due in part to the greater availability of fatty, sugary and/or salty foods which, when consumed chronically and in excess, can lead to food addiction.

According to the neurocognitive model of addiction, the development and maintenance of addiction is associated with deficits in cognitive control, as well as a decrease prefrontal cortex (dlPFC). Self-control in food choice situations also depends on prefrontal network with the dlPFC as a hub, strongly connected with striatal and cingulate structures.

Neurofeedback (NF) is a technique that relies on the patient's positive or negative self-regulation of brain activity. It has been shown to be effective in several pathologies, in particular attention deficit/hyperactivity disorder in young people and more recently in depression and emotion regulation.

In this study, NF will be based on near-infrared spectroscopy (fNIRS), because its use is easy mobile and inexpensive. The hypothesis is that the increase in dlPFC brain activity via fNIR-based NF training based on fNIRS would allow an improvement of the eating behavior, thus promoting a long-term weight loss in obese subjects.

Вмешательства

• Другое Sham
  The sham protocol will last 15 minutes per session, and during each session, the participants will receive the same instruction but will be shown a random signal, the goal being that the control strategy that the participant tries to implement is not correlated with the visual feedback provided by the gauge.
• Другое NF
  The neurofeedback protocol will be the same during the 8 sessions constituting the protocol and taking place over a period of 4 weeks (2 neurofeedback sessions per week, the first and the last one in an MRI context). It will last 15 minutes per session, and during each session, the patient will have to increase the brain activity of her dlPFC using a visual gauge representing the "activity level" of her own dlPFC. No specific instructions will be given to the volunteer so that he/she can develop

Первичные конечные точки

• Number of patients who have a difference in resting state IRM after NF session [Срок оценки: 1 month]

Вторичные конечные точки (12)

• Number of patients who have a difference in resting state IRM after NF training in the cognitive food anticipation task condition [Срок оценки: 1 month]
• Difference in blood pressure status 3 months after NF training [Срок оценки: 4 months]
• Difference in blood pressure status 3 months after NF training [Срок оценки: 4 months]
• Difference in biological check up 3 months after NF training [Срок оценки: 4 months]
• Change of degree of correlation between EGG results and resting state IRM after NF training [Срок оценки: 1 month]
• Difference in mental Heath status after NF training between groups [Срок оценки: 1 month]
• Difference in mental Heath status training between groups after 3 months [Срок оценки: 4 months]
• Difference in Food frequency questionnaire scores between groups after NF training [Срок оценки: 1 month]
• Difference in Food Cravings Questionnaire-Trait-reduced scores between groups after NF training [Срок оценки: 1 month]
• Difference in Food Cravings Questionnaire-Trait-reduced scores between groups 3 months after NF training [Срок оценки: 4 months]
• Difference in Food frequency questionnaire scores between groups 3 months after NF training [Срок оценки: 4 months]
• Difference in Three Factor Eating Questionnaire-R18 scores between groups 3 months after NF training [Срок оценки: 4 months]

Критерии участия

Критерии включения

• Eligible for obesity surgery according to the 2009 French High Authority on Health (HAS) criteria (BMI ≥40 or BMI ≥35 with comorbidities)
• Right-handed
• Presenting a food addiction determined by the YFAS 2.0 questionnaire ;
• Affiliated to a social security system;
• Having given free and informed consent in writing.

Критерии исключения

• Psychotic psychiatric disorders (schizophrenic disorders and bipolar disorders);
• Psychotropic drugs, except antidepressants stabilized for at least 3 weeks and benzodiazepines
• Addiction to alcohol or other psychoactive substances (except tobacco);
• History of bariatric surgery;
• Current treatment in the nutrition unit;
• Insufficient command of French;
• Pregnant or breast-feeding woman;
• Persons of legal age under legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty.
• Contraindications to fMRI
• Inability to perform the fNIRS procedure due to blockage or attenuation of the light at the capillary level

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• CHU Rennes — Rennes

Публикации

• Renaud I, Coquery N, Guittiere MO, Godet A, Bannier E, Serrand Y, Moirand R, Thibault R, Val-Laillet D. Neurofeedback intervention based on functional near-infrared spectroscopy compared with sham control to improve inhibitory cognitive control in patients with severe obesity and food addiction: The protocol of a monocentric prospective randomized parallel-group single-blind interventional study. PMID 42435898

Идентификаторы

NCT: NCT05277714 · 35RC21_8946_08_CadOb

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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