Skip to content

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
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05200182
Acronym
Cemov
Enrollment
80
Registered
2022-01-20
Start date
2022-04-07
Completion date
2025-05-31
Last updated
2024-04-10

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

Sponsors

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

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

Countries

France

Contacts

Primary ContactLoïc JACOB
loic.jacob@chu-rennes.fr0299282555
Backup ContactNicolas COQUERY, PhD
nicolas.coquery@inrae.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026