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

NCT05200182 | Recruiting

• 2 other identifiers: 35RC20_9849_Cemov2021-A02314-37
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperphagia

Keywords

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

Outcome Measures

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

  4 weeks

Study Arms (3)

Study A

OTHER

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

Study B - Neurofeedback

EXPERIMENTAL

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

Study B - Control

SHAM COMPARATOR

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

Interventions

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".

Study A; Study B - Neurofeedback

Sham Neurofeedback DEVICE

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

Study B - Control

oral microbiota collection OTHER

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

Study B - Control; Study B - Neurofeedback

Questionnaires OTHER

questionnaires for pre-intervention behavioral characterization

Study B - Control; Study B - Neurofeedback

resting-state fMRI DEVICE

characterize the brain function of volunteers by resting-state fMRI

Study A; Study B - Control; Study B - Neurofeedback

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.

Study A; Study B - Control; Study B - Neurofeedback

Emotional Stroop task BEHAVIORAL

an emotional Stroop task adapted to food and body image representation

Study B - Control; Study B - Neurofeedback

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Normal Body Mass Index (18.5-25),
• Right-handlers
• Affiliated to a social security scheme
• Having given a free, informed and written consent

You may not qualify if:

• 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
• Normal BMI (18.5-25),

Sponsors & Collaborators

• Rennes University Hospital: lead
• Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement: collaborator

Study Sites (1)

Chu Rennes - Pontchaillou

Rennes, 35000, France

RECRUITING

MeSH Terms

Conditions

Hyperphagia

Interventions

Neurofeedback; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Romain Moirand, MD

  CHU Rennes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Loïc JACOB

CONTACT

0299282555; loic.jacob@chu-rennes.fr

Nicolas COQUERY, PhD

CONTACT

nicolas.coquery@inrae.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: January 20, 2022
• Study Start: April 7, 2022
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: April 10, 2024

Record last verified: 2024-04

Locations

FR (1)