Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT05277714

Recruiting nowNot applicableInterventional

What this study is about

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 55 Years

SexFemale

Healthy volunteersNot accepted

ConditionObesity, Craving

Full registry 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

Treatments and study arms

Sham

Other

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.

NF

Other

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 his/her own internal strategy to increase this "activity level".

Primary outcomes

Number of patients who have a difference in resting state IRM after NF session1 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.

Study locations

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CHU Rennes🇫🇷 Rennes, France

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CHU RennesContact

Call 0299282591

Ronan Thibault, PrPrincipal Investigator