Trials / Recruiting
RecruitingNCT05200182
fNIRS-based Neurofeedback Intervention for Cognitive Control Improvement in Emotional Overeating
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- Rennes University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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". |
| DEVICE | Sham Neurofeedback | the participants will receive the same instruction but will be shown a random signal |
| OTHER | oral microbiota collection | an examination and oral swab for oral microbiota analysis will be performed by a dentist |
| OTHER | Questionnaires | questionnaires for pre-intervention behavioral characterization |
| DEVICE | resting-state fMRI | characterize the brain function of volunteers by resting-state fMRI |
| DEVICE | Electro gastrogram | Volunteers will also be equipped with an MRI-compatible electro-gastrogram device to correlate gastric signals with brain activity during rsMRI acquisition. |
| BEHAVIORAL | Emotional Stroop task | an emotional Stroop task adapted to food and body image representation |
Timeline
- Start date
- 2022-04-07
- Primary completion
- 2025-05-01
- Completion
- 2025-05-01
- First posted
- 2022-01-20
- Last updated
- 2024-04-10
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT05200182. Inclusion in this directory is not an endorsement.