RecruitingNot ApplicableNCT05277714

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


Sponsor

Rennes University Hospital

Enrollment

50 participants

Start Date

May 25, 2022

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 55 Years

Inclusion Criteria5

  • 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 Criteria10

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERSham

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.

OTHERNF

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".


Locations(1)

CHU Rennes

Rennes, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05277714


Related Trials