Neurofeedback Based on Near-infrared Spectroscopy as a Therapy for Food Addiction in Obese Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Number of patients who have a difference in resting state IRM after NF session
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
sham procedure
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Number of patients who have a difference in resting state IRM after NF session
时间窗: 1 month
Difference in resting state IRM at inclusion and at 1 month after the 8th NF session between sham and experimental. Resting state IRM will allow to determine the correlation coefficient of the IRM BOLD signal fluctuations between the dlPFC and the striatum. The evolution of cognitive control by NeuroFeedback (NF) will thus be determined by a variation of this correlation coefficient and thus of the cortico-striatal connectivity at inclusion and after the 8th NF session.
次要结局
- Change of degree of correlation between EGG results and resting state IRM after NF training(1 month)
- Difference in mental Heath status after NF training between groups(1 month)
- Difference in Food Cravings Questionnaire-Trait-reduced scores between groups 3 months after NF training(4 months)
- Number of patients who have a difference in resting state IRM after NF training in the cognitive food anticipation task condition(1 month)
- Difference in biological check up 3 months after NF training(4 months)
- Difference in Food frequency questionnaire scores between groups after NF training(1 month)
- Difference in Food Cravings Questionnaire-Trait-reduced scores between groups after NF training(1 month)
- Difference in Food frequency questionnaire scores between groups 3 months after NF training(4 months)
- Difference in Three Factor Eating Questionnaire-R18 scores between groups 3 months after NF training(4 months)
- Difference in Three Factor Eating Questionnaire-R18 scores between groups after NF training(1 month)
- Difference in mental Heath status training between groups after 3 months(4 months)
- Difference in blood pressure status 3 months after NF training(4 months)