Ireland
--:--IST
Recruiting Not applicable

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

NCT05200182 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2022-04-07
Last updated
2026-09-28

Condition(s) studied

Hyperphagia

Investigational drug(s) / intervention(s)

Neurofeedback with functional near infra-red spectroscopySham Neurofeedbackoral microbiota collectionQuestionnairesresting-state fMRIElectro gastrogramEmotional Stroop taskDelay discount task

Neurofeedback 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".

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

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

Questionnaires: questionnaires for pre-intervention behavioral characterization

resting-state fMRI: characterize the brain function of volunteers by resting-state fMRI

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

Emotional Stroop task: an emotional Stroop task adapted to food and body image representation

Delay discount task: Delay discount task

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
Accepted
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 Exclusion Criteria : 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

Primary outcome measure(s)

  • Change in cortico-striatal connectivity — 4 weeks
    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

Trial sites (1)

FacilityCityRegionStatus
Chu Rennes - Pontchaillou Rennes France Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05200182 on ClinicalTrials.gov ↗ ← All trials in France