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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A02314-37 | Other Identifier | ID-RCB |
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| Name | Class |
|---|---|
| Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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". |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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". |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Eligibility
Study A :
Inclusion Criteria :
Exclusion Criteria :
Related to the study - Insufficient command of French
Related to Magnetic Resonance Imagine
Study B
Inclusion Criteria :
Exclusion Criteria :
Related to the study
Related to magnetic resonance imaging
Related to near infraRed spectroscopy
- Hairs that do not allow proper near infraRed spectroscopy measurement upon ligh blockage
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Loïc JACOB | Contact | 0299282555 | loic.jacob@chu-rennes.fr | |
| Nicolas COQUERY, PhD | Contact | nicolas.coquery@inrae.fr |
| Name | Affiliation | Role |
|---|---|---|
| Romain Moirand, MD | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Rennes - Pontchaillou | Recruiting | Rennes | 35000 | France |
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| Sham Neurofeedback | Device | the participants will receive the same instruction but will be shown a random signal |
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| oral microbiota collection | Other | an examination and oral swab for oral microbiota analysis will be performed by a dentist |
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| Questionnaires | Other | questionnaires for pre-intervention behavioral characterization |
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| resting-state fMRI | Device | characterize the brain function of volunteers by resting-state fMRI |
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| 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. |
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| Emotional Stroop task | Behavioral | an emotional Stroop task adapted to food and body image representation |
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| ID | Term |
|---|---|
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D058765 | Neurofeedback |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D001676 | Biofeedback, Psychology |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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