ObesityCaDObNCT05277714
Neurofeedback Based on Near-infrared Spectroscopy as a Therapy for Food Addiction in Obese Subjects.
A study testing NF in people with Obesity and Craving, run by Rennes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- What is being tested?
- NF
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 25 May 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Rennes
Rennes, 35033
CHU Rennes, 0299282591
Ronan Thibault, Pr
About this study
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
Read the detailed description
Obesity is a disease of increasing prevalence due in part to the greater availability of fatty, sugary and/or salty foods which, when consumed chronically and in excess, can lead to food addiction.
According to the neurocognitive model of addiction, the development and maintenance of addiction is associated with deficits in cognitive control, as well as a decrease prefrontal cortex (dlPFC). Self-control in food choice situations also depends on prefrontal network with the dlPFC as a hub, strongly connected with striatal and cingulate structures.
Neurofeedback (NF) is a technique that relies on the patient's positive or negative self-regulation of brain activity. It has been shown to be effective in several pathologies, in particular attention deficit/hyperactivity disorder in young people and more recently in depression and emotion regulation.
In this study, NF will be based on near-infrared spectroscopy (fNIRS), because its use is easy mobile and inexpensive. The hypothesis is that the increase in dlPFC brain activity via fNIR-based NF training based on fNIRS would allow an improvement of the eating behavior, thus promoting a long-term weight loss in obese subjects.
- Being tested
- Sham, NF
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShamOther
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.
NFOther
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".
| Study group | Role | What they receive |
|---|---|---|
| NF | Experimental | Not described Receives: Other: NF |
| Sham | Sham comparator | Not described Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Variation in hemodynamic BOLD response in the cognitive food anticipation task condition between V1 and V8 between groups (NF vs sham).
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.
Measured: 1 month
Difference in blood pressure status 3 months after NF training
Evolution of health status using blood pressure (mmHg) between groups (NF vs sham) before and after participation (between V0 and V9).
Measured: 4 months
Difference in blood pressure status 3 months after NF training
Evolution of health status using clinical exam criteria between groups (NF vs sham) before and after participation (between V0 and V9).
Measured: 4 months
Difference in biological check up 3 months after NF training
Evolution of health status using biological check up between groups (NF vs sham) before and after participation (between V0 and V9).
Measured: 4 months
Change of degree of correlation between EGG results and resting state IRM after NF training
Variation in the degree of correlation between electrogastrogramm plots and resting state MRI between V1 and V8 and between groups (NF vs sham).
Measured: 1 month
Difference in mental Heath status after NF training between groups
Difference in anxiety and depression questionnaire (Hospital Anxiety and Depression Scale, questionnaire with 2 subscores, one for anxiety and one for depression. 0 = no anxiety/depression, 11 and more : anxiety/depression) after NF training between groups
Measured: 1 month
Difference in mental Heath status training between groups after 3 months
Difference in anxiety and depression questionnaire (Hospital Anxiety and Depression Scale, questionnaire with 2 subscores, one for anxiety and one for depression. 0 = no anxiety/depression, 11 and more : anxiety/depression) 3 months after NF training between groups
Measured: 4 months
Difference in Food frequency questionnaire scores between groups after NF training
Variation in FF questionnaire scores as a function of NF effect from inclusion to end of intervention.
Food frequency questionnaire (FFQ) is a dietary assessment tool delivered as a questionnaire to estimate frequency and, in some cases, portion size information about food and beverage consumption over a specified period of time
Measured: 1 month
Difference in Food Cravings Questionnaire-Trait-reduced scores between groups after NF training
Variation in Food Cravings Questionnaire-Trait-reduced scores as a function of NF effect from inclusion to end of intervention.
Food Cravings Questionnaire (FCQ), which consists of a trait (FCQ-T; 39 items) and state (FCQ-S; 15 items) version. FCQ-T-r is a self-administrated questionnaire consisted of 15-items scored using a Likert-type scale (1 = never, 2 = rarely, 3 = sometimes, 4 = usually, 6 = always), for possible total scores ranging from 15 to 90.
Measured: 1 month
Difference in Food Cravings Questionnaire-Trait-reduced scores between groups 3 months after NF training
Variation in Food Cravings Questionnaire-Trait-reduced scores as a function of NF effect from inclusion to 3 months after the end of intervention.
Food Cravings Questionnaire (FCQ), which consists of a trait (FCQ-T; 39 items) and state (FCQ-S; 15 items) version. FCQ-T-r is a self-administrated questionnaire consisted of 15-items scored using a Likert-type scale (1 = never, 2 = rarely, 3 = sometimes, 4 = usually, 6 = always), for possible total scores ranging from 15 to 90.
Measured: 4 months
Difference in Food frequency questionnaire scores between groups 3 months after NF training
Variation in Food Frequency questionnaire scores as a function of NF effect from inclusion to end of intervention.
Food frequency questionnaire (FFQ) is a dietary assessment tool delivered as a questionnaire to estimate frequency and, in some cases, portion size information about food and beverage consumption over a specified period of time
Measured: 4 months
Difference in Three Factor Eating Questionnaire-R18 scores between groups 3 months after NF training
Variation in Three Factor Eating Questionnaire-R18 questionnaire scores as a function of NF effect from inclusion to 3months after the end of intervention.
The Three Factor Eating Questionnaire-R18 (TFEQ-R18) consists of 18 items on a 4-point response scale (definitely true/mostly true/mostly false/definitely false). Responses to each of the 18 items are given a score between 1 and 4 and item scores are summated into scale scores for cognitive restraint, uncontrolled eating, and emotional eating. Higher scores in the respective scales are indicative of greater cognitive restraint, uncontrolled, or emotional eating.
Measured: 4 months
Difference in Three Factor Eating Questionnaire-R18 scores between groups after NF training
Variation in Three Factor Eating Questionnaire-R18 questionnaire scores as a function of NF effect from inclusion to the end of intervention.
The Three Factor Eating Questionnaire-R18 (TFEQ-R18) consists of 18 items on a 4-point response scale (definitely true/mostly true/mostly false/definitely false). Responses to each of the 18 items are given a score between 1 and 4 and item scores are summated into scale scores for cognitive restraint, uncontrolled eating, and emotional eating. Higher scores in the respective scales are indicative of greater cognitive restraint, uncontrolled, or emotional eating.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start25 May 2022
- Primary completionMay 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277714
- Sponsor's protocol ID
- 35RC21_8946_08_CadOb
- Acronym
- CaDOb
- Status last verified
- Aug 2025
- First submitted
- 2 Mar 2022
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Renaud I, Coquery N, Guittiere MO, Godet A, Bannier E, Serrand Y, Moirand R, Thibault R, Val-Laillet D. Neurofeedback intervention based on functional near-infrared spectroscopy compared with sham control to improve inhibitory cognitive control in patients with severe obesity and food addiction: The protocol of a monocentric prospective randomized parallel-group single-blind interventional study. Clin Nutr ESPEN. 2026 Jul 11:103589. doi: 10.1016/j.clnesp.2026.103589. Online ahead of print.
PubMed 42435898
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurofeedback Based on Near-infrared Spectroscopy as a Therapy for Food Addiction in Obese Subjects.
- ClinicalTrials.gov ID
- NCT05277714
- Acronym / sponsor ID
- CaDOb / 35RC21_8946_08_CadOb
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Obesity is a disease of increasing prevalence due in part to the greater availability of fatty, sugary and/or salty foods which, when consumed chronically and in excess, can lead to food addiction.
According to the neurocognitive model of addiction, the development and maintenance of addiction is associated with deficits in cognitive control, as well as a decrease prefrontal cortex (dlPFC). Self-control in food choice situations also depends on prefrontal network with the dlPFC as a hub, strongly connected with striatal and cingulate structures.
Neurofeedback (NF) is a technique that relies on the patient's positive or negative self-regulation of brain activity. It has been shown to be effective in several pathologies, in particular attention deficit/hyperactivity disorder in young people and more recently in depression and emotion regulation.
In this study, NF will be based on near-infrared spectroscopy (fNIRS), because its use is easy mobile and inexpensive. The hypothesis is that the increase in dlPFC brain activity via fNIR-based NF training based on fNIRS would allow an improvement of the eating behavior, thus promoting a long-term weight loss in obese subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NF | Experimental | Other: NF |
| Sham | Sham comparator | Other: Sham |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ShamThe 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. | Other | Sham |
| NFThe 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". | Other | NF |
Primary outcome
Number of patients who have a difference in resting state IRM after NF session
Time frame: 1 month
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.
13 secondary outcomes
Number of patients who have a difference in resting state IRM after NF training in the cognitive food anticipation task condition
Time frame: 1 month
Difference in blood pressure status 3 months after NF training
Time frame: 4 months
Difference in blood pressure status 3 months after NF training
Time frame: 4 months
Difference in biological check up 3 months after NF training
Time frame: 4 months
Change of degree of correlation between EGG results and resting state IRM after NF training
Time frame: 1 month
Difference in mental Heath status after NF training between groups
Time frame: 1 month
Difference in mental Heath status training between groups after 3 months
Time frame: 4 months
Difference in Food frequency questionnaire scores between groups after NF training
Time frame: 1 month
Difference in Food Cravings Questionnaire-Trait-reduced scores between groups after NF training
Time frame: 1 month
Difference in Food Cravings Questionnaire-Trait-reduced scores between groups 3 months after NF training
Time frame: 4 months
Difference in Food frequency questionnaire scores between groups 3 months after NF training
Time frame: 4 months
Difference in Three Factor Eating Questionnaire-R18 scores between groups 3 months after NF training
Time frame: 4 months
Difference in Three Factor Eating Questionnaire-R18 scores between groups after NF training
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Derived from this study: PubMed 42435898Renaud I, Coquery N, Guittiere MO, Godet A, Bannier E, Serrand Y, Moirand R, Thibault R, Val-Laillet D. Neurofeedback intervention based on functional near-infrared spectroscopy compared with sham control to improve inhibitory cognitive control in patients with severe obesity and food addiction: The protocol of a monocentric prospective randomized parallel-group single-blind interventional study. Clin Nutr ESPEN. 2026 Jul 11:103589. doi: 10.1016/j.clnesp.2026.103589. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NF in people with Obesity and Craving, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Laure GERVAIS (0618454735, marie-laure.gervais@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who have a difference in resting state IRM after NF session (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05277714, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.