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

ConditionHyperphagia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorRennes University Hospital

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Minimum age : 18 Years

Maximum Age : 50 Years

Sex : women or men

Normal Body Mass Index (18.5-25),

Disqualifiers

Implantable cardiac pacemaker or defibrillator;

Neurosurgical clips;

Cochlear implants;

Neural or peripheral stimulator;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Neurofeedback with functional near infra-red spectroscopy

    Device

    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

    Device

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

  • oral microbiota collection

    Other intervention

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

  • Questionnaires

    Other intervention

    questionnaires for pre-intervention behavioral characterization

  • resting-state fMRI

    Device

    characterize the brain function of volunteers by resting-state fMRI

  • Electro gastrogram

    Device

    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

    Behavioral

    an emotional Stroop task adapted to food and body image representation

  • Delay discount task

    Behavioral

    Delay discount task

Treatment groups

80 Participants
are divided into 3 treatment groups
Group A: Study AOther 3 interventions
Group B: Study B - NeurofeedbackExperimental treatment 7 interventions
Group C: Study B - ControlSham comparator 7 interventions

Trial outcomes

Primary outcomes

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

Time frame
4 weeks

Secondary outcomes

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)

Time frame
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

Time frame
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

Time frame
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)

Time frame
from enrollment to week 10

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rennes University Hospital

Lead sponsor

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Collaborator