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New treatment option for Obesity
Official title Neurofeedback Based on Near-infrared Spectroscopy as a Therapy for Food Addiction in Obese Subjects.
ClinicalTrials.gov ID: NCT05277714
What this study is testing
- What it's testing
- 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
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55, women only
You may be able to join 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 likely can't join 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;
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Rennes, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rennes, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.