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HyperphagiaCemovNCT05200182

fNIRS-based Neurofeedback Intervention for Cognitive Control Improvement in Emotional Overeating

A study testing Neurofeedback with functional near infra-red spectroscopy, oral microbiota collection and Questionnaires in people with Hyperphagia, run by Rennes University Hospital at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Emotional overeating is characterized by an excessive food intake in the context of intense emotional situations, such as acute stress one. Emotional overeating, as a behavioral trait, can increase the risk of to develop eating disorders or eating-related diseases, such as metabolic syndrome, obesity, type-2 diabetes. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Hyperphagia
What is being tested?
Neurofeedback with functional near infra-red spectroscopy, oral microbiota collection and Questionnaires
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteFrance
Study dates
7 Apr 2022to Jun 2028
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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Normal Body Mass Index (18.5-25),
  • Right-handlers
  • Affiliated to a social security scheme
  • Having given a free, informed and written consent
  • Normal BMI (18.5-25),
  • Right-handlers
Show all 9Show fewer
  • Affiliated to a social security scheme
  • Having given a free, informed and written consent
  • Based on emotional overeating questionary : having emotional overeating episodes > 6 days in a month for at least one negative emotion

Who cannot join

  • Related to the study - Insufficient command of French
  • Related to Magnetic Resonance Imagine
  • Implantable cardiac pacemaker or defibrillator;
  • Neurosurgical clips;
  • Cochlear implants;
  • Neural or peripheral stimulator;
Show all 31Show fewer
  • Foreign orbital or brain metallic foreign bodies;
  • Endoprostheses implanted for less than 4 weeks and osteosynthesis materials placed for less than 6 weeks;
  • Claustrophobia. Related to near infra Red spectroscopy
  • Hairs that do not allow proper near infra Red spectroscopy measurement upon ligh blockage
  • Study B
  • Minimum age : 18 Years
  • Maximum Age : 25 Years
  • Sex : women
  • Related to the study
  • Insufficient command of French
  • Excessive consumption of alcohol or other psychoactive substances (determined on the basis of the Alcohol Use Disorders Identification Test questionnaires - excluded if score > 12 and "Car, Relax, Alone, Forget, Friends, Trouble" questionnaire - excluded if score> 1 " yes ")
  • Eating disorders ("sick, control, one stone, fat, food" questionnaire >2)
  • Food addiction (Yale Food Addiction Score 2.0, score >2
  • With psychoactive treatment
  • Digestive or gastric disorders
  • Related to magnetic resonance imaging
  • Implantable cardiac pacemaker or defibrillator;
  • Neurosurgical clips;
  • Cochlear implants;
  • Neural or peripheral stimulator;
  • Foreign orbital or brain metallic foreign bodies;
  • Endoprostheses implanted for less than 4 weeks and osteosynthesis materials placed for less than 6 weeks;
  • Claustrophobia.
  • Related to near infraRed spectroscopy
  • Hairs that do not allow proper near infraRed spectroscopy measurement upon ligh blockage

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nicolas COQUERY, PhD contact

nicolas.coquery@inrae.fr

France1 site, 1 recruiting
  • Chu Rennes - Pontchaillou

    Rennes, 35000

    Romain Moirand, MD, romain.moirand@chu-rennes.fr

    Nicolas COQUERY, nicolas.coquery@inrae.fr

    Recruiting

Other trials in France

About this study

Emotional overeating is characterized by an excessive food intake in the context of intense emotional situations, such as acute stress one. Emotional overeating, as a behavioral trait, can increase the risk of to develop eating disorders or eating-related diseases, such as metabolic syndrome, obesity, type-2 diabetes. Recently, imaging modalities, such as magnetic resonance imaging (MRI) and electro-encephalography (EEG), have been adapted in order to perform neurofeedback consisting on presenting the brain activity instantaneously to the participant, that give him the possibility to modify this activity by his own mean. Neurofeedback has already shown some efficacy, either with explicit or implicit instruction.

Compared with functional MRI (fMRI), functional near infra-red spectroscopy (fNIRS) is easy to handle, less expensive, and does not require a lying position. fNIRS is consequently more adapted for repeated acquisitions. Neurofeedback has already shown some promising results for neurological and psychiatric diseases. For mental states and emotion regulation, neurofeedback targeting the prefrontal cortex (PFC) has also shown promising outcomes. In this project, the investigators want to assess the effect of neurofeedback targeting the dorsolateral PFC (dlPFC) in a population of young adult women presenting emotional overeating. The investigators aim to improve the cognitive control and to reduce the episodes of emotional overeating in order to prevent the occurrence of subsequent pathologies.

Read more

The intervention effect will be characterized with: (i) fMRI in order to evaluate the effect on cognitive control (with resting state fMRI or rsMRI) and on the reward system; (II) questionaries directly and one month after intervention in order to assess the behavioral effect.

Besides an expected effect on emotional overeating, the investigators will evaluate whether an improvement of cognitive control can also promote positive effect on other behavioral traits that could lead to some pathologies such as food addiction.

As a prerequisite to this study on emotional overeating (study B), the investigators will firstly validate on healthy subjects (study A) a reward anticipation fMRI task, which will be further used in study A in order to characterized the effect of neurofeedback on the reward system.

Conditions
Hyperphagia
Being tested
Neurofeedback with functional near infra-red spectroscopy, Sham Neurofeedback, oral microbiota collection, Questionnaires, resting-state fMRI
Keywords
emotional overeating, functional near infraRed spectroscopy, neurofeedback, cognitive control
Medical subject headings
Hyperphagia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neurofeedback with functional near infra-red spectroscopyDevice

    the neurofeedback protocol will last 15 minutes per session, and during each session, the volunteer will have to increase the brain activity of his/her dorsolateral prefrontal cortex using a visual gauge representing the "activity level" of his/her own dorsolateral prefrontal cortex. 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".

  • Sham NeurofeedbackDevice

    the participants will receive the same instruction but will be shown a random signal

  • oral microbiota collectionOther

    an examination and oral swab for oral microbiota analysis will be performed by a dentist

  • QuestionnairesOther

    questionnaires for pre-intervention behavioral characterization

  • resting-state fMRIDevice

    characterize the brain function of volunteers by resting-state fMRI

  • Electro gastrogramDevice

    Volunteers will also be equipped with an MRI-compatible electro-gastrogram device to correlate gastric signals with brain activity during rsMRI acquisition.

  • Emotional Stroop taskBehavioural

    an emotional Stroop task adapted to food and body image representation

  • Delay discount taskBehavioural

    Delay discount task

Study groups in NCT05200182
Study groupRoleWhat they receive
Study AOtherValidation of the reward system-related fMRI task, as determined by an increased activation on the brain reward structure (striatum) under the task.
Receives: Device: Neurofeedback with functional near infra-red spectroscopy; Device: resting-state fMRI; Device: Electro gastrogram
Study B - NeurofeedbackExperimentalThe 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 volunteer will have to increase the brain activity of his/her dlPFC using a visual gauge representing the "activity level" of his/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".
Receives: Device: Neurofeedback with functional near infra-red spectroscopy; Other: oral microbiota collection; Other: Questionnaires; Device: resting-state fMRI; Device: Electro gastrogram; Behavioral: Emotional Stroop task; Behavioral: Delay discount task
Study B - ControlSham comparatorIn the control group with neurofeedback sham, the participants will receive the same instruction but will be shown a random signal, the goal being that the control strategy the participant tries to implement is not correlated with the visual feedback provided by the gauge.
Receives: Device: Sham Neurofeedback; Other: oral microbiota collection; Other: Questionnaires; Device: resting-state fMRI; Device: Electro gastrogram; Behavioral: Emotional Stroop task; Behavioral: Delay discount task

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in cortico-striatal connectivity

    Significant change in cortico-striatal connectivity as determined with resting state functional magnetic resonance imaging correlation coefficient between the first magnetic resonance imaging and the last magnetic resonance imaging visit

    Measured: 4 weeks

Secondary outcomes (18)
  1. Validate during a pilot study in a healthy population without emotional hyperphagia a functional MRI task of reward anticipation (Monetary and Food Incentive Delay task) to characterize the effect of NeuroFeedback.

    healthy volunteers

    Statistical increase of brain responses (BOLD signal variation) in motivation and reward brain regions determined with fMRI task to reward anticipation (Monetary and Food Incentive Delay task)

    Measured: from enrollment to week 6

  2. Validate a NeuroFeedback. approach targeting the nucleus accumbens by fMRI during sweet taste stimulation

    Statistical increase of fMRI BOLD responses in nucleus accumbens to sweet taste oral stimulation

    Measured: from enrollment to week 6

  3. Statistical decreased in the score on the Emotional Overeating Questionnaire, evaluating emotional overeating, after vs before neurofeedback

    healthy volunteers with emotional overeating

    number of "emotions" driving equal or more than 6 days of overeating in a month, from 0 to 5

    Measured: from enrollment to week 6

  4. Evaluate by brain imaging (Monetary and Food Incentive Delay task in fMRI and basal cerebral perfusion) and behavioral questionnaires the effect of neurofeedback

    healthy volunteers with emotional overeating

    Neurofeedback will statistically decrease brain response (BOLD signal variation) in motivation and reward brain regions determined with fMRI task of reward anticipation for food (Monetary and Food Incentive Delay task)

    Neurofeedback will increase basal cerebral perfusion in prefrontal brain regions.

    Neurofeedback can modify statistically the outcome of behavioral questionaries (increase of controlling feeling during neurofeedback, from 1 : no control feeling, to 10: high control feeling)

    Measured: from enrollment to week 10

  5. Evaluate the variation of the indicators of viscera-brain communication

    healthy volunteers with emotional overeating : oral microbiota and correlation of gastric rhythm by electrogastrogram and cerebral rhythm by resting state MRI

    Neurofeedback will statistically increase the correlation between gastric oscillations measured with electrogastrogram and BOLD signal oscillations in brain stem regions involved in autonomic control of gastric rhythm, measured with resting state fMRI

    Neurofeedback will statistically modify oral microbiota composition, considered as a proxy of eating habits, and measured as the percentage of each microbiota phylum (detected with DNA sequencing)

    Measured: from enrollment to week 6

  6. Variation in responses to an emotional Stroop task adapted to food and body image representation

    Variation in responses to an emotional Stroop task adapted to food and body image representation

    Measured: from enrollment to week 6

  7. Modification of behavioral scores : Global Physical Activity Questionnaire

    16 items, each of them corresponds, depending of the duration of physical activity, to a specific metabolic equivalent, with higher metabolic equivalent corresponding to higher physical activity)

    Measured: from enrollment to week 10

  8. Modification of behavioral scores : Internet Addiction Test

    20 items, scale from 0 to 5, higher value corresponds to higher internet addiction

    Measured: from enrollment to week 10

  9. Modification of behavioral scores : Alcohol Use Disorders Identification Test

    10 items, score from 0 to 4 for each, higher value corresponds to higher alcohol use disorder

    Measured: from enrollment to week 10

  10. Modification of behavioral scores : frequency of tobacco consumption

    Measured: from enrollment to week 10

  11. Modification of behavioral scores : Holmes and Rahe questionnaire

    43 items to select or not, higher selected items number corresponds to higher life events stress value

    Measured: from enrollment to week 10

  12. Modification of behavioral scores : Barratt scale

    34 items to select or not, higher selected items number corresponds to higher impulsivity

    Measured: from enrollment to week 10

  13. Link behavioral traits to neurofeedback success : CRAFFT (car, relax, alone, forget, friends, trouble)questionnaire

    6 items, responses "yes" or "no", higher "yes" number corresponds to higher psychotropic substance consumption

    Measured: from enrollment to week 6

  14. Link behavioral traits to neurofeedback success : Boredom Proneness Scale

    28 items, "true" or "false" answers, higher score corresponds to higher boredom proneness

    Measured: from enrollment to week 6

  15. Link behavioral traits to neurofeedback success : World Health Organization-Five Well-Being Index (WHO-5)

    5 items, scores from 0 to 5, higher score corresponds to higher well-being

    Measured: from enrollment to week 6

  16. Link behavioral traits to neurofeedback success : Sick, Control, One stone, Fat Food (SCOFF)

    4 items, "yes" or "no", higher number of "yes" corresponds to higher risk for eating disorder

    Measured: from enrollment to week 6

  17. Link behavioral traits to neurofeedback success : Three Factor Eating Questionnaire-R18

    18 items, score from 1 to 4, higher score, depending of the different questions, correspond to higher dimension of eating behavior: cognitive restriction, disinhibition or control

    Measured: from enrollment to week 6

  18. Link behavioral traits to neurofeedback success : Delay discount task

    multiple choice for different reward amount, for different delay before receiving this amount, higher amount for a short time to receive it corresponds to high impulsivity toward reward

    Measured: from enrollment to week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2022
  2. Study start7 Apr 2022
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05200182
Sponsor's protocol ID
35RC20_9849_Cemov
Other IDs
2021-A02314-37
Acronym
Cemov
Status last verified
Sep 2026
First submitted
6 Jan 2022
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Neurofeedback with functional near infra-red spectroscopy, oral microbiota collection and Questionnaires in people with Hyperphagia, 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 9 inclusion and 31 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 28 Sep 2026. 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 Loïc JACOB (0299282555, loic.jacob@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in cortico-striatal connectivity (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 28 Sep 2026.

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