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NCT05200182From ClinicalTrials.govRecruiting

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

  • Hyperphagia

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
Rennes University Hospital
Enrolment target
80
Started
7 April 2022
Main results due
June 2028
Study sites
1
Registry updated
28 September 2026

Can you take part?

  • Ages 18 years to 50 years.
  • Open to any sex.
  • Healthy volunteers can take part.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(1)

  • Chu Rennes - Pontchaillou

    Rennes, France

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT05200182. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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