Neurofeedback Based on Near-infrared Spectroscopy as a Therapy for Food Addiction in Obese Subjects.
Recruiting · NCT05277714 · Interventional (participants receive a specific treatment) · Lead sponsor: Rennes University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
NFSham
What this trial 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
Who can take part
Age range
18 Years to 55 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- CHU Rennes - Rennes, France