[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100454641":3},{"organization":4,"outcomesModule":7,"designInfo":69,"detailedDescription":44,"studyPopulation":44,"armGroups":77,"interventions":100,"overallOfficials":134,"centralContacts":138,"locations":147,"responsibleParty":167,"collaborators":169,"id":172,"slug":173,"hasResults":174,"nctId":175,"briefTitle":176,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":179,"sex":180,"minAge":181,"maxAge":182,"enrollmentInfo":183,"targetDuration":44,"studyType":186,"phases":187,"briefSummary":189,"conditions":190,"keywords":192,"overallStatus":150,"whyStopped":44,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":206},{"fullName":5,"class":6},"Rennes University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":44},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14,18,21,24,28,31,33,36,39,42,45,48,51,54,57,60,63,66],{"measure":15,"description":16,"timeFrame":17},"Validate during a pilot study in a healthy population without emotional hyperphagia a functional MRI task of reward anticipation (Monetary and Food Incentive Delay task) to characterize the effect of NeuroFeedback.","healthy volunteers\n\nStatistical increase of brain responses (BOLD signal variation) in motivation and reward brain regions determined with fMRI task to reward anticipation (Monetary and Food Incentive Delay task)","from enrollment to week 6",{"measure":19,"description":20,"timeFrame":17},"Validate a NeuroFeedback. approach targeting the nucleus accumbens by fMRI during sweet taste stimulation","Statistical increase of fMRI BOLD responses in nucleus accumbens to sweet taste oral stimulation",{"measure":22,"description":23,"timeFrame":17},"Statistical decreased in the score on the Emotional Overeating Questionnaire, evaluating emotional overeating, after vs before neurofeedback","healthy volunteers with emotional overeating\n\nnumber of \"emotions\" driving equal or more than 6 days of overeating in a month, from 0 to 5",{"measure":25,"description":26,"timeFrame":27},"Evaluate by brain imaging (Monetary and Food Incentive Delay task in fMRI and basal cerebral perfusion) and behavioral questionnaires the effect of neurofeedback","healthy volunteers with emotional overeating\n\nNeurofeedback will statistically decrease brain response (BOLD signal variation) in motivation and reward brain regions determined with fMRI task of reward anticipation for food (Monetary and Food Incentive Delay task)\n\nNeurofeedback will increase basal cerebral perfusion in prefrontal brain regions.\n\nNeurofeedback can modify statistically the outcome of behavioral questionaries (increase of controlling feeling during neurofeedback, from 1 : no control feeling, to 10: high control feeling)","from enrollment to week 10",{"measure":29,"description":30,"timeFrame":17},"Evaluate the variation of the indicators of viscera-brain communication","healthy volunteers with emotional overeating : oral microbiota and correlation of gastric rhythm by electrogastrogram and cerebral rhythm by resting state MRI\n\nNeurofeedback will statistically increase the correlation between gastric oscillations measured with electrogastrogram and BOLD signal oscillations in brain stem regions involved in autonomic control of gastric rhythm, measured with resting state fMRI\n\nNeurofeedback will statistically modify oral microbiota composition, considered as a proxy of eating habits, and measured as the percentage of each microbiota phylum (detected with DNA sequencing)",{"measure":32,"description":32,"timeFrame":17},"Variation in responses to an emotional Stroop task adapted to food and body image representation",{"measure":34,"description":35,"timeFrame":27},"Modification of behavioral scores : Global Physical Activity Questionnaire","16 items, each of them corresponds, depending of the duration of physical activity, to a specific metabolic equivalent, with higher metabolic equivalent corresponding to higher physical activity)",{"measure":37,"description":38,"timeFrame":27},"Modification of behavioral scores : Internet Addiction Test","20 items, scale from 0 to 5, higher value corresponds to higher internet addiction",{"measure":40,"description":41,"timeFrame":27},"Modification of behavioral scores : Alcohol Use Disorders Identification Test","10 items, score from 0 to 4 for each, higher value corresponds to higher alcohol use disorder",{"measure":43,"description":44,"timeFrame":27},"Modification of behavioral scores : frequency of tobacco consumption",null,{"measure":46,"description":47,"timeFrame":27},"Modification of behavioral scores : Holmes and Rahe questionnaire","43 items to select or not, higher selected items number corresponds to higher life events stress value",{"measure":49,"description":50,"timeFrame":27},"Modification of behavioral scores : Barratt scale","34 items to select or not, higher selected items number corresponds to higher impulsivity",{"measure":52,"description":53,"timeFrame":17},"Link behavioral traits to neurofeedback success : CRAFFT (car, relax, alone, forget, friends, trouble)questionnaire","6 items, responses \"yes\" or \"no\", higher \"yes\" number corresponds to higher psychotropic substance consumption",{"measure":55,"description":56,"timeFrame":17},"Link behavioral traits to neurofeedback success : Boredom Proneness Scale","28 items, \"true\" or \"false\" answers, higher score corresponds to higher boredom proneness",{"measure":58,"description":59,"timeFrame":17},"Link behavioral traits to neurofeedback success : World Health Organization-Five Well-Being Index (WHO-5)","5 items, scores from 0 to 5, higher score corresponds to higher well-being",{"measure":61,"description":62,"timeFrame":17},"Link behavioral traits to neurofeedback success : Sick, Control, One stone, Fat Food (SCOFF)","4 items, \"yes\" or \"no\", higher number of \"yes\" corresponds to higher risk for eating disorder",{"measure":64,"description":65,"timeFrame":17},"Link behavioral traits to neurofeedback success : Three Factor Eating Questionnaire-R18","18 items, score from 1 to 4, higher score, depending of the different questions, correspond to higher dimension of eating behavior: cognitive restriction, disinhibition or control",{"measure":67,"description":68,"timeFrame":17},"Link behavioral traits to neurofeedback success : Delay discount task","multiple choice for different reward amount, for different delay before receiving this amount, higher amount for a short time to receive it corresponds to high impulsivity toward reward",{"allocation":70,"interventionModel":71,"interventionModelDescription":44,"primaryPurpose":72,"observationalModel":44,"timePerspective":44,"maskingInfo":73},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":74,"maskingDescription":44,"whoMasked":75},"SINGLE",[76],"PARTICIPANT",[78,85,94],{"label":79,"type":6,"description":80,"interventionNames":81},"Study A","Validation of the reward system-related fMRI task, as determined by an increased activation on the brain reward structure (striatum) under the task.",[82,83,84],"Device: Neurofeedback with functional near infra-red spectroscopy","Device: resting-state fMRI","Device: Electro gastrogram",{"label":86,"type":87,"description":88,"interventionNames":89},"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\u002Fher dlPFC using a visual gauge representing the \"activity level\" of his\u002Fher own dlPFC. No specific instructions will be given to the volunteer so that he\u002Fshe can develop his\u002Fher own internal strategy to increase this \"activity level\".",[82,90,91,83,84,92,93],"Other: oral microbiota collection","Other: Questionnaires","Behavioral: Emotional Stroop task","Behavioral: Delay discount task",{"label":95,"type":96,"description":97,"interventionNames":98},"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.",[99,90,91,83,84,92,93],"Device: Sham Neurofeedback",[101,106,110,114,118,122,126,131],{"type":102,"name":103,"description":104,"armGroupLabels":105,"otherNames":44},"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\u002Fher dorsolateral prefrontal cortex using a visual gauge representing the \"activity level\" of his\u002Fher own dorsolateral prefrontal cortex. No specific instructions will be given to the volunteer so that he\u002Fshe can develop his\u002Fher own internal strategy to increase this \"activity level\".",[79,86],{"type":102,"name":107,"description":108,"armGroupLabels":109,"otherNames":44},"Sham Neurofeedback","the participants will receive the same instruction but will be shown a random signal",[95],{"type":6,"name":111,"description":112,"armGroupLabels":113,"otherNames":44},"oral microbiota collection","an examination and oral swab for oral microbiota analysis will be performed by a dentist",[95,86],{"type":6,"name":115,"description":116,"armGroupLabels":117,"otherNames":44},"Questionnaires","questionnaires for pre-intervention behavioral characterization",[95,86],{"type":102,"name":119,"description":120,"armGroupLabels":121,"otherNames":44},"resting-state fMRI","characterize the brain function of volunteers by resting-state fMRI",[79,95,86],{"type":102,"name":123,"description":124,"armGroupLabels":125,"otherNames":44},"Electro gastrogram","Volunteers will also be equipped with an MRI-compatible electro-gastrogram device to correlate gastric signals with brain activity during rsMRI acquisition.",[79,95,86],{"type":127,"name":128,"description":129,"armGroupLabels":130,"otherNames":44},"BEHAVIORAL","Emotional Stroop task","an emotional Stroop task adapted to food and body image representation",[95,86],{"type":127,"name":132,"description":132,"armGroupLabels":133,"otherNames":44},"Delay discount task",[95,86],[135],{"name":136,"affiliation":5,"role":137},"Romain Moirand, MD","PRINCIPAL_INVESTIGATOR",[139,144],{"name":140,"role":141,"phone":142,"phoneExt":44,"email":143},"Loïc JACOB","CONTACT","0299282555","loic.jacob@chu-rennes.fr",{"name":145,"role":141,"phone":44,"phoneExt":44,"email":146},"Nicolas COQUERY, PhD","nicolas.coquery@inrae.fr",[148],{"facility":149,"status":150,"city":151,"state":44,"zip":152,"country":153,"countryCode":154,"cosmosGeoPoint":155,"geoPoint":160,"contacts":161},"Chu Rennes - Pontchaillou","RECRUITING","Rennes","35000","France","FR",{"type":156,"coordinates":157},"Point",[158,159],-1.67431,48.11109,{"lat":159,"lon":158},[162,164,166],{"name":136,"role":141,"phone":44,"phoneExt":44,"email":163},"romain.moirand@chu-rennes.fr",{"name":165,"role":141,"phone":44,"phoneExt":44,"email":146},"Nicolas COQUERY",{"name":136,"role":137,"phone":44,"phoneExt":44,"email":44},{"type":168,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR",[170],{"name":171,"class":6},"Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement","100454641","fnirs-based-neurofeedback-intervention-for-cognitive-control-improvement-in-emotional-overeating-100454641",false,"NCT05200182","fNIRS-based Neurofeedback Intervention for Cognitive Control Improvement in Emotional Overeating","Cemov","Eligibility\n\nStudy A :\n\n* Minimum age : 18 Years\n* Maximum Age : 50 Years\n* Sex : women or men\n\nInclusion Criteria :\n\n* Normal Body Mass Index (18.5-25),\n* Right-handlers\n* Affiliated to a social security scheme\n* Having given a free, informed and written consent\n\nExclusion Criteria :\n\nRelated to the study - Insufficient command of French\n\nRelated to Magnetic Resonance Imagine\n\n* Implantable cardiac pacemaker or defibrillator;\n* Neurosurgical clips;\n* Cochlear implants;\n* Neural or peripheral stimulator;\n* Foreign orbital or brain metallic foreign bodies;\n* Endoprostheses implanted for less than 4 weeks and osteosynthesis materials placed for less than 6 weeks;\n* Claustrophobia. Related to near infra Red spectroscopy\n* Hairs that do not allow proper near infra Red spectroscopy measurement upon ligh blockage\n\nStudy B\n\n* Minimum age : 18 Years\n* Maximum Age : 25 Years\n* Sex : women\n\nInclusion Criteria :\n\n* Normal BMI (18.5-25),\n* Right-handlers\n* Affiliated to a social security scheme\n* Having given a free, informed and written consent\n* Based on emotional overeating questionary : having emotional overeating episodes \\> 6 days in a month for at least one negative emotion\n\nExclusion Criteria :\n\nRelated to the study\n\n* Insufficient command of French\n* 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 \")\n* Eating disorders (\"sick, control, one stone, fat, food\" questionnaire \\>2)\n* Food addiction (Yale Food Addiction Score 2.0, score \\>2\n* With psychoactive treatment\n* Digestive or gastric disorders\n\nRelated to magnetic resonance imaging\n\n* Implantable cardiac pacemaker or defibrillator;\n* Neurosurgical clips;\n* Cochlear implants;\n* Neural or peripheral stimulator;\n* Foreign orbital or brain metallic foreign bodies;\n* Endoprostheses implanted for less than 4 weeks and osteosynthesis materials placed for less than 6 weeks;\n* Claustrophobia.\n\nRelated to near infraRed spectroscopy\n\n\\- Hairs that do not allow proper near infraRed spectroscopy measurement upon ligh blockage",true,"ALL","18 Years","50 Years",{"count":184,"type":185},80,"ESTIMATED","INTERVENTIONAL",[188],"NA","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.\n\nCompared 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.\n\nThe 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.\n\nBesides 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.\n\nAs 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.",[191],"Hyperphagia",[193,194,195,196],"emotional overeating","functional near infraRed spectroscopy","neurofeedback","cognitive control","2026-09-22",{"date":199,"type":200},"2026-09-28","ACTUAL",{"date":202,"type":200},"2022-04-07",{"date":204,"type":185},"2028-06",{"name":5,"class":6},1]