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

NCT05277714 | Recruiting

• 1 other identifier: 35RC21_8946_08_CadOb
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity; Craving

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month

Secondary Outcomes (13)

• Number of patients who have a difference in resting state IRM after NF training in the cognitive food anticipation task condition

  1 month

• Difference in blood pressure status 3 months after NF training

  4 months

• Difference in blood pressure status 3 months after NF training

  4 months

• Difference in biological check up 3 months after NF training

  4 months

• Change of degree of correlation between EGG results and resting state IRM after NF training

  1 month

Study Arms (2)

NF

EXPERIMENTAL

Other: NF

Sham

SHAM COMPARATOR

Other: Sham

Interventions

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.

Sham

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".

NF

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

CHU Rennes

Rennes, 35033, France

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Marie-Laure GERVAIS

CONTACT

0618454735; marie-laure.gervais@chu-rennes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: sham procedure
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 14, 2022
• Study Start: May 25, 2022
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

FR (1)