About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Single group
Treatments tested in this trial
Sham
Other interventionThe 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.
NF
Other interventionThe 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 his/her own internal strategy to increase this "activity level".
Treatment groups
Trial outcomes
Primary outcomes
Number of patients who have a difference in resting state IRM after NF session
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 outcomes
Number of patients who have a difference in resting state IRM after NF training in the cognitive food anticipation task condition
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 blood pressure status 3 months after NF training
Evolution of health status using blood pressure (mmHg) between groups (NF vs sham) before and after participation (between V0 and V9).
Difference in blood pressure status 3 months after NF training
Evolution of health status using clinical exam criteria between groups (NF vs sham) before and after participation (between V0 and V9).
Difference in biological check up 3 months after NF training
Evolution of health status using biological check up between groups (NF vs sham) before and after participation (between V0 and V9).
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