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

NCT ID: NCT05277714

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-25
• Study Completion Date: 2026-12-31

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.

Conditions

Obesity; Craving

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

NF

Group Type: EXPERIMENTAL

NF

Intervention Type: 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".

Sham

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: 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.

Interventions

Sham

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.

Intervention Type: OTHER

NF

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".

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Rennes

Rennes, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Marie-Laure GERVAIS

Role: CONTACT

marie-laure.gervais@chu-rennes.fr

0618454735

Facility Contacts

CHU Rennes

Role: primary

0299282591

Other Identifiers

35RC21_8946_08_CadOb

Identifier Type: -

Identifier Source: org_study_id