Clinical trial NCT05200182: fNIRS-based Neurofeedback Intervention for Cognitive Control Improvement in Emotional Overeating
Official title: fNIRS-based Neurofeedback Intervention for Cognitive Control Improvement in Emotional Overeating
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hyperphagia
Keywords: emotional overeating
functional near infraRed spectroscopy
neurofeedback
cognitive control
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
First posted: 2022-01-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

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 outcomes:
measure: Change in cortico-striatal connectivity
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Chu Rennes - Pontchaillou
Study officials:
affiliation: CHU Rennes
name: Romain Moirand, MD
role: PRINCIPAL_INVESTIGATOR
References: