Actively Recruiting

Phase Not Applicable
Age: 18Years - 55Years
FEMALE
ID05277714

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

Led by Rennes University Hospital · Updated on 2025-08-08

50

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying obesity and food addiction by evaluating a neurofeedback therapy based on near-infrared spectroscopy (fNIRS) to increase brain activity in the dorsolateral prefrontal cortex (dlPFC). This approach aims to improve eating behavior and promote long-term weight loss in obese individuals. The trial is sponsored by Rennes University Hospital and focuses on the connection between brain control areas and food addiction behaviors. Participants will undergo eight neurofeedback sessions over four weeks, with two sessions per week. The training involves using a visual gauge to help increase dlPFC brain activity. The first and last sessions take place during MRI scans. There is also a control group receiving sham neurofeedback, where participants see random signals unrelated to their brain activity. Each session lasts 15 minutes. During the study, researchers will assess changes through clinical data, questionnaires, and brain imaging before and after the neurofeedback training, including follow-ups three months later. They will measure brain activity differences, blood pressure, biological tests, mental health status, and eating behavior questionnaires. The trial includes monitoring patients’ progress and responses to the therapy to evaluate its impact on food addiction and obesity.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 55Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Eligible for obesity surgery according to 2009 French High Authority on Health criteria (BMI ≥40 or BMI ≥35 with comorbidities)
  • Right-handed
  • Diagnosed with food addiction by YFAS 2.0 questionnaire
  • Affiliated with a social security system
  • Provided free and informed written consent
Not Eligible

You will not qualify if you...

  • Psychotic psychiatric disorders such as schizophrenia and bipolar disorder
  • Use of psychotropic drugs except stable antidepressants for at least 3 weeks and benzodiazepines
  • Addiction to alcohol or other psychoactive substances except tobacco
  • History of bariatric surgery
  • Currently receiving treatment in a nutrition unit
  • Insufficient command of French language
  • Pregnant or breastfeeding women
  • Persons under legal protection or deprived of liberty
  • Contraindications to MRI
  • Inability to perform fNIRS due to light blockage or attenuation at capillary level

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 4 weeks

Participants receive neurofeedback training based on near-infrared spectroscopy to increase brain activity in the dlPFC. The protocol includes 8 sessions over 4 weeks, with 2 sessions per week. The first and last sessions occur in an MRI context. Each session lasts 15 minutes.

2 visits per week for 4 weeks (total 8 sessions)

Follow-up

Duration - Up to 4 months

Participants are monitored for changes in brain activity, eating behavior, blood pressure, biological markers, and mental health up to 4 months after completing neurofeedback training.

Visits timed at 1 month and 4 months after treatment completion

Trial Site Locations

Total: 1 location

1

CHU Rennes

Rennes, France, 35033

Actively Recruiting

Loading map...

Research Team

M

Marie-Laure GERVAIS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

2

Similar Trials

A Bilingual Virtually-based Intervention (PEDALL) for the Pr...

Acute Lymphoblastic Leukemia

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here