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

Last updated: June 4, 2024
Sponsor: Rennes University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Bulimia

Binge Eating Disorder

Treatment

NF

Sham

Clinical Study ID

NCT05277714
35RC21_8946_08_CadOb
  • Ages 18-55
  • Female

Study 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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Psychotic psychiatric disorders (schizophrenic disorders and bipolar disorders);

  • Psychotropic drugs, except antidepressants stabilized for at least 3 weeks andbenzodiazepines

  • 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 lightat the capillary level

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: NF
Phase:
Study Start date:
May 25, 2022
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • CHU Rennes

    Rennes, 35033
    France

    Active - Recruiting

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