Neurofeedback Based on Near-infrared Spectroscopy as a Therapy for Food Addiction in Obese Subjects.
- Conditions
- ObesityCraving
- Interventions
- Other: NFOther: Sham
- Registration Number
- NCT05277714
- Lead Sponsor
- Rennes University Hospital
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 50
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description NF NF - Sham Sham -
- Primary Outcome Measures
Name Time Method Number of patients who have a difference in resting state IRM after NF session 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.
- Secondary Outcome Measures
Name Time Method Change of degree of correlation between EGG results and resting state IRM after NF training 1 month Variation in the degree of correlation between electrogastrogramm plots and resting state MRI between V1 and V8 and between groups (NF vs sham).
Difference in mental Heath status after NF training between groups 1 month Difference in anxiety and depression questionnaire (Hospital Anxiety and Depression Scale, questionnaire with 2 subscores, one for anxiety and one for depression. 0 = no anxiety/depression, 11 and more : anxiety/depression) after NF training between groups
Difference in Food Cravings Questionnaire-Trait-reduced scores between groups 3 months after NF training 4 months Variation in Food Cravings Questionnaire-Trait-reduced scores as a function of NF effect from inclusion to 3 months after the end of intervention.
Food Cravings Questionnaire (FCQ), which consists of a trait (FCQ-T; 39 items) and state (FCQ-S; 15 items) version. FCQ-T-r is a self-administrated questionnaire consisted of 15-items scored using a Likert-type scale (1 = never, 2 = rarely, 3 = sometimes, 4 = usually, 6 = always), for possible total scores ranging from 15 to 90.Number of patients who have a difference in resting state IRM after NF training in the cognitive food anticipation task condition 1 month Variation in hemodynamic BOLD response in the cognitive food anticipation task condition between V1 and V8 between groups (NF vs sham).
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.Difference in biological check up 3 months after NF training 4 months Evolution of health status using biological check up between groups (NF vs sham) before and after participation (between V0 and V9).
Difference in Food frequency questionnaire scores between groups after NF training 1 month Variation in FF questionnaire scores as a function of NF effect from inclusion to end of intervention.
Food frequency questionnaire (FFQ) is a dietary assessment tool delivered as a questionnaire to estimate frequency and, in some cases, portion size information about food and beverage consumption over a specified period of timeDifference in Food Cravings Questionnaire-Trait-reduced scores between groups after NF training 1 month Variation in Food Cravings Questionnaire-Trait-reduced scores as a function of NF effect from inclusion to end of intervention.
Food Cravings Questionnaire (FCQ), which consists of a trait (FCQ-T; 39 items) and state (FCQ-S; 15 items) version. FCQ-T-r is a self-administrated questionnaire consisted of 15-items scored using a Likert-type scale (1 = never, 2 = rarely, 3 = sometimes, 4 = usually, 6 = always), for possible total scores ranging from 15 to 90.Difference in Food frequency questionnaire scores between groups 3 months after NF training 4 months Variation in Food Frequency questionnaire scores as a function of NF effect from inclusion to end of intervention.
Food frequency questionnaire (FFQ) is a dietary assessment tool delivered as a questionnaire to estimate frequency and, in some cases, portion size information about food and beverage consumption over a specified period of timeDifference in Three Factor Eating Questionnaire-R18 scores between groups 3 months after NF training 4 months Variation in Three Factor Eating Questionnaire-R18 questionnaire scores as a function of NF effect from inclusion to 3months after the end of intervention.
The Three Factor Eating Questionnaire-R18 (TFEQ-R18) consists of 18 items on a 4-point response scale (definitely true/mostly true/mostly false/definitely false). Responses to each of the 18 items are given a score between 1 and 4 and item scores are summated into scale scores for cognitive restraint, uncontrolled eating, and emotional eating. Higher scores in the respective scales are indicative of greater cognitive restraint, uncontrolled, or emotional eating.Difference in Three Factor Eating Questionnaire-R18 scores between groups after NF training 1 month Variation in Three Factor Eating Questionnaire-R18 questionnaire scores as a function of NF effect from inclusion to the end of intervention.
The Three Factor Eating Questionnaire-R18 (TFEQ-R18) consists of 18 items on a 4-point response scale (definitely true/mostly true/mostly false/definitely false). Responses to each of the 18 items are given a score between 1 and 4 and item scores are summated into scale scores for cognitive restraint, uncontrolled eating, and emotional eating. Higher scores in the respective scales are indicative of greater cognitive restraint, uncontrolled, or emotional eating.Difference in blood pressure status 3 months after NF training 4 months Evolution of health status using clinical exam criteria between groups (NF vs sham) before and after participation (between V0 and V9).
Difference in mental Heath status training between groups after 3 months 4 months Difference in anxiety and depression questionnaire (Hospital Anxiety and Depression Scale, questionnaire with 2 subscores, one for anxiety and one for depression. 0 = no anxiety/depression, 11 and more : anxiety/depression) 3 months after NF training between groups
Trial Locations
- Locations (1)
CHU Rennes
🇫🇷Rennes, France