An interventional study of Neurofeedback with functional near infra-red spectroscopy and Sham Neurofeedback in Hyperphagia, sponsored by Rennes University Hospital. Recruiting at 1 site in France. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Rennes University Hospital · Not applicable, Interventional, and Prevention
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.
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.
39 studies on the registry are indexed under Hyperphagia; 4 are open to participants now.
This study's planned enrollment of 80 is above the median of 50 across 34 interventional studies indexed under Hyperphagia.
Browse Hyperphagia studies →Rennes University Hospital is the lead sponsor of 451 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Eligibility
Study A :
Inclusion Criteria :
Exclusion Criteria :
Related to the study - Insufficient command of French
Related to Magnetic Resonance Imagine
Study B
Inclusion Criteria :
Exclusion Criteria :
Related to the study
Related to magnetic resonance imaging
Related to near infraRed spectroscopy
- Hairs that do not allow proper near infraRed spectroscopy measurement upon ligh blockage
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Validation of the reward system-related fMRI task, as determined by an increased activation on the brain reward structure (striatum) under the task.
Device: Neurofeedback with functional near infra-red spectroscopy · Device: resting-state fMRI · Device: Electro gastrogram
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 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".
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
In 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.
Device: Sham Neurofeedback · Other: oral microbiota collection · Other: Questionnaires · Device: resting-state fMRI · Device: Electro gastrogram · Behavioral: Emotional Stroop task · Behavioral: Delay discount task
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".
the participants will receive the same instruction but will be shown a random signal
an examination and oral swab for oral microbiota analysis will be performed by a dentist
questionnaires for pre-intervention behavioral characterization
characterize the brain function of volunteers by resting-state fMRI
Volunteers will also be equipped with an MRI-compatible electro-gastrogram device to correlate gastric signals with brain activity during rsMRI acquisition.
an emotional Stroop task adapted to food and body image representation
Delay discount task
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
Time frame: 4 weeks
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)
Time frame: from enrollment to week 6
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
Time frame: from enrollment to week 6
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
Time frame: from enrollment to week 6
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)
Time frame: from enrollment to week 10
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)
Time frame: from enrollment to week 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
Time frame: from enrollment to week 6
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)
Time frame: from enrollment to week 10
Modification of behavioral scores : Internet Addiction Test
20 items, scale from 0 to 5, higher value corresponds to higher internet addiction
Time frame: from enrollment to week 10
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
Time frame: from enrollment to week 10
Modification of behavioral scores : frequency of tobacco consumption
Time frame: from enrollment to week 10
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
Time frame: from enrollment to week 10
Modification of behavioral scores : Barratt scale
34 items to select or not, higher selected items number corresponds to higher impulsivity
Time frame: from enrollment to week 10
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
Time frame: from enrollment to week 6
Link behavioral traits to neurofeedback success : Boredom Proneness Scale
28 items, "true" or "false" answers, higher score corresponds to higher boredom proneness
Time frame: from enrollment to week 6
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
Time frame: from enrollment to week 6
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
Time frame: from enrollment to week 6
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
Time frame: from enrollment to week 6
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
Time frame: from enrollment to week 6
Started Apr 2022 (actual). Primary completion is estimated for Jun 2028, 74 months after the start.
Of 16 interventional studies with no phase under Hyperphagia, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 54. This study's planned 74 months is above that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 28, 2026: primary completion May 2025 → Jun 2028 and completion May 2025 → Jun 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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