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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05200182
Acronym
Cemov
Enrollment
80
Registered
2022-01-20
Start date
2022-04-07
Completion date
2028-06-01
Last updated
2026-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperphagia

Keywords

emotional overeating, functional near infraRed spectroscopy, neurofeedback, cognitive control

Brief 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. 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.

Interventions

DEVICENeurofeedback with functional near infra-red spectroscopy

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

OTHERoral microbiota collection

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

OTHERQuestionnaires

questionnaires for pre-intervention behavioral characterization

characterize the brain function of volunteers by resting-state fMRI

DEVICEElectro gastrogram

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

BEHAVIORALDelay discount task

Delay discount task

Sponsors

Rennes University Hospital
Lead SponsorOTHER
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

Eligibility Study A : * Minimum age : 18 Years * Maximum Age : 50 Years * Sex : women or men Inclusion Criteria : * Normal Body Mass Index (18.5-25), * Right-handlers * Affiliated to a social security scheme * Having given a free, informed and written consent

Exclusion criteria

: 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; * 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 Inclusion Criteria : * Normal BMI (18.5-25), * Right-handlers * 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

Design outcomes

Primary

MeasureTime frameDescription
Change in cortico-striatal connectivity4 weeksSignificant 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

Secondary

MeasureTime frameDescription
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.from enrollment to week 6healthy 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)
Validate a NeuroFeedback. approach targeting the nucleus accumbens by fMRI during sweet taste stimulationfrom enrollment to week 6Statistical increase of fMRI BOLD responses in nucleus accumbens to sweet taste oral stimulation
Statistical decreased in the score on the Emotional Overeating Questionnaire, evaluating emotional overeating, after vs before neurofeedbackfrom enrollment to week 6healthy volunteers with emotional overeating number of "emotions" driving equal or more than 6 days of overeating in a month, from 0 to 5
Evaluate by brain imaging (Monetary and Food Incentive Delay task in fMRI and basal cerebral perfusion) and behavioral questionnaires the effect of neurofeedbackfrom enrollment to week 10healthy 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)
Evaluate the variation of the indicators of viscera-brain communicationfrom enrollment to week 6healthy 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)
Variation in responses to an emotional Stroop task adapted to food and body image representationfrom enrollment to week 6Variation in responses to an emotional Stroop task adapted to food and body image representation
Modification of behavioral scores : Global Physical Activity Questionnairefrom enrollment to week 1016 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)
Modification of behavioral scores : Internet Addiction Testfrom enrollment to week 1020 items, scale from 0 to 5, higher value corresponds to higher internet addiction
Modification of behavioral scores : Alcohol Use Disorders Identification Testfrom enrollment to week 1010 items, score from 0 to 4 for each, higher value corresponds to higher alcohol use disorder
Modification of behavioral scores : frequency of tobacco consumptionfrom enrollment to week 10—
Modification of behavioral scores : Holmes and Rahe questionnairefrom enrollment to week 1043 items to select or not, higher selected items number corresponds to higher life events stress value
Modification of behavioral scores : Barratt scalefrom enrollment to week 1034 items to select or not, higher selected items number corresponds to higher impulsivity
Link behavioral traits to neurofeedback success : CRAFFT (car, relax, alone, forget, friends, trouble)questionnairefrom enrollment to week 66 items, responses "yes" or "no", higher "yes" number corresponds to higher psychotropic substance consumption
Link behavioral traits to neurofeedback success : Boredom Proneness Scalefrom enrollment to week 628 items, "true" or "false" answers, higher score corresponds to higher boredom proneness
Link behavioral traits to neurofeedback success : World Health Organization-Five Well-Being Index (WHO-5)from enrollment to week 65 items, scores from 0 to 5, higher score corresponds to higher well-being
Link behavioral traits to neurofeedback success : Sick, Control, One stone, Fat Food (SCOFF)from enrollment to week 64 items, "yes" or "no", higher number of "yes" corresponds to higher risk for eating disorder
Link behavioral traits to neurofeedback success : Three Factor Eating Questionnaire-R18from enrollment to week 618 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
Link behavioral traits to neurofeedback success : Delay discount taskfrom enrollment to week 6multiple 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

Countries

France

Contacts

CONTACTLoïc JACOB
loic.jacob@chu-rennes.fr0299282555
CONTACTNicolas COQUERY, PhD
nicolas.coquery@inrae.fr
PRINCIPAL_INVESTIGATORRomain Moirand, MD

Rennes University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 29, 2026