Clinical trial NCT05277714: Neurofeedback Based on Near-infrared Spectroscopy as a Therapy for Food Addiction in Obese Subjects.
Official title: Neurofeedback Based on Near-infrared Spectroscopy as a Therapy for Food Addiction in Obese Subjects.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Craving
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of patients who have a difference in resting state IRM after NF session
timeFrame: 1 month
Secondary outcomes:
measure: Number of patients who have a difference in resting state IRM after NF training in the cognitive food anticipation task condition
timeFrame: 1 month
measure: Difference in blood pressure status 3 months after NF training
timeFrame: 4 months
measure: Difference in blood pressure status 3 months after NF training
timeFrame: 4 months
measure: Difference in biological check up 3 months after NF training
timeFrame: 4 months
measure: Change of degree of correlation between EGG results and resting state IRM after NF training
timeFrame: 1 month
measure: Difference in mental Heath status after NF training between groups
timeFrame: 1 month
measure: Difference in mental Heath status training between groups after 3 months
timeFrame: 4 months
measure: Difference in Food frequency questionnaire scores between groups after NF training
timeFrame: 1 month
measure: Difference in Food Cravings Questionnaire-Trait-reduced scores between groups after NF training
timeFrame: 1 month
measure: Difference in Food Cravings Questionnaire-Trait-reduced scores between groups 3 months after NF training
timeFrame: 4 months
measure: Difference in Food frequency questionnaire scores between groups 3 months after NF training
timeFrame: 4 months
measure: Difference in Three Factor Eating Questionnaire-R18 scores between groups 3 months after NF training
timeFrame: 4 months
measure: Difference in Three Factor Eating Questionnaire-R18 scores between groups after NF training
timeFrame: 1 month
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Rennes
Study officials:
References: