[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567429":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":45,"centralContacts":49,"locations":55,"responsibleParty":74,"collaborators":78,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":90,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":53,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":104,"overallStatus":58,"whyStopped":53,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Universidad de Granada","OTHER",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Combined intervention","EXPERIMENTAL","Experimental: Active iTBS of the DLPFC combined with inhibitory control training. An experimental group will receive: i) an informative session; ii) 4 pre treatment sessions (one assessment session with questionnaires, one with fMRI and one with biological samples. Also, a counselling session on diet and on physical exercise); iii) participate in 2 weekly individual intervention sessions that consist of iTBS of the left DLPFC (10 min) followed immediately by inhibitory control training for 10 minutes; iv) 3 sessions of post treatment assessment (one with questionnaires, one with fMRI and one with biological samples); v) 2 follow-up assessment sessions (3 months after completing the intervention) to repeat questionnaires and biological samples",[13,14],"Device: iTBS of the left DLPFC","Behavioral: Inhibitory control training",{"label":16,"type":17,"description":18,"interventionNames":19},"Active iTBS","ACTIVE_COMPARATOR","Experimental: Active iTBS of the DLPFC only. An experimental group will receive: i) an informative session; ii) 4 pre treatment sessions (one assessment session with questionnaires, one with fMRI and one with biological samples. Also, a counselling session on diet and on physical exercise); iii) participate in 2 weekly individual intervention sessions that consist of iTBS of the left DLPFC that will last about 10 minutes each; iv) 3 sessions of post treatment assessment (one with questionnaires, one with fMRI and one with biological samples); v) 2 follow-up assessment sessions (3 months after completing the intervention) to repeat questionnaires and biological samples",[13],{"label":21,"type":22,"description":23,"interventionNames":24},"Sham iTBS","SHAM_COMPARATOR","Control: iTBS of the vertex (sham). The control group will receive: i) an informative session; ii) 4 pre treatment sessions (one assessment session with questionnaires, one with fMRI and one with biological samples. Also, a counselling session on diet and on physical exercise); iii) participate in 2 weekly individual intervention sessions that consist of iTBS of the vertex that will last about 10 minutes each; iv) 3 sessions of post treatment assessment (one with questionnaires, one with fMRI and one with biological samples); v) 2 follow-up assessment sessions (3 months after completing the intervention) to repeat questionnaires and biological samples",[25],"Device: iTBS of the vertex",[27,33,38],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DEVICE","iTBS of the left DLPFC","Participants will receive a 3 minutes active theta burst transcranial magnetic stimulation (iTBS) of the DLPFC of the left hemisphere while not performing any other task",[16,9],[16],{"type":28,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"iTBS of the vertex","Participants will receive a 3 minutes active theta burst transcranial magnetic stimulation (iTBS) of the vertex while not performing any other task",[21],[21],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"BEHAVIORAL","Inhibitory control training","Computerized cognitive training. Participants will perform the task of the FoodT app for 10 minutes during two weeks (taking advantage of time of maximum brain potentiation after the iTBS, Rossi et al., 2009). Images of food and non-food appear on the left, right or centre of the smart phone screen and participants must touch it (or not, depending on the cue) with their index finger as quickly as possible. Participants earn points for correct tap responses and lose points for incorrect tap responses. If the image has a green border around it, participants must tap the image and win 1 point. But if the image has a red border around it, participants must inhibit the tapping response, otherwise 1 point will be lost. Participants must respond as quickly and accurately as possible. Pictures of healthy and unhealthy foods are always paired with the Go and the No-Go signal, respectively. Non-food images are paired 50% of the time with the Go and the No-Go signal",[9],[44],"FoodT",[46],{"name":47,"affiliation":5,"role":48},"Raquel Vilar López, Ph.D.","PRINCIPAL_INVESTIGATOR",[50],{"name":47,"role":51,"phone":52,"phoneExt":53,"email":54},"CONTACT","+34699407282",null,"rvilar@ugr.es",[56],{"facility":57,"status":58,"city":59,"state":53,"zip":53,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Mind, Brain and Behavior Research Center at University of Granada (CIMCYCUGR)","RECRUITING","Granada","Spain","ES",{"type":63,"coordinates":64},"Point",[65,66],-3.60667,37.18817,{"lat":66,"lon":65},[69,70],{"name":47,"role":51,"phone":52,"phoneExt":53,"email":54},{"name":71,"role":51,"phone":72,"phoneExt":53,"email":73},"Alfonso Caracuel Romero, Ph.D.","+34615425843","acaracuel@ugr.es",{"type":75,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":53,"oldOrganization":53},"SPONSOR_INVESTIGATOR","Raquel Vilar López","Principal Investigator",[79],{"name":80,"class":81},"Government of Spain","UNKNOWN","100567429","inhibitory-control-training-and-itbs-for-excess-weight-behavioral-and-brain-changes-inhibe-100567429",false,"NCT06668077","Inhibitory Control Training and iTBS for Excess Weight: Behavioral and Brain Changes (InhibE).","Inhibitory Control Training and Theta Burst Transcranial Magnetic Stimulation (iTBS) for Treating People With Excess Weight: Behavioral and Brain Changes (InhibE).","InhibE","Inclusion Criteria:\n\n* BMI between 25 and 39.9\n* Age between 18 and 60 years\n* Proficiency in the Spanish language\n* Right lateral dominance to avoid differential effects due to cortical hemispheric specialization\n\nExclusion Criteria:\n\n* Traumatic, digestive, metabolic or systemic disorders that affect the central nervous system, autonomic or endocrine\n* Severe psychopathological disorders and suicidal ideation or treatment for depression\n* Eating disorders\n* Contraindication for performing fMRI (pregnancy, metal implants, etc.) or iTBS (tinnitus, dizziness, surgical interventions, diseases or drugs that affect the CNS, etc.)",true,"ALL","18 Years","60 Years",{"count":95,"type":96},141,"ESTIMATED","INTERVENTIONAL",[99],"NA","People with excess weight (EW) are characterized by high impulsivity, high levels of craving for high-calorie foods, deficits in inhibitory control, and maladaptive decision-making. These characteristics are related, at the brain level, to alterations in the activation of areas such as the dorsolateral prefrontal cortex (DLPFC) and its connectivity. The proposed intervention seeks to target these issues. Thus, the present study aims to characterize the effects of neuromodulation with intermittent theta burst transcranial magnetic stimulation (iTBS) of the DLPFC alone and in combination with inhibitory control training to produce brain, cognitive and behavioral changes, and modify altered biological parameters in people with EW. Participants will be randomly allocated to one of three groups: (1) a group that will receive active iTBS of the DLPFC combined with inhibitory control training with a food Go\u002FNo-go paradigm, (2) a group that will receive active iTBS of the DLPFC only, and (3) a control group that will receive sham iTBS. It is hypothesized that the combined intervention will obtain better results that the neuromodulation alone, and that both interventions, compared to sham iTBS, will achieve: (i) decreased body mass index, (ii) decreased craving, (iii) modified brain connectivity and activation both at rest and linked to task performance with food stimuli, (iv) improved anthropometric measures (waist circumference and waist-to-hip and waist-to-height ratios), (v) improved eating and exercise behaviors (decreased caloric intake and increased frequency and time of physical activity), (vi) improved emotional symptoms and emotional eating (depression, anxiety, emotional regulation, emotional eating, reward-related eating, non-homeostatic eating), (vii) improved cognitive abilities (motor and cognitive inhibition, delay of gratification, impulsivity, working memory, cognitive flexibility and decision making), (viii) changes in biological parameters associated to the interventions (plasma and microbiota), and (ix) advantages in cost-effectiveness and cost-utility based on economic evaluation analyses.",[102,103],"Overweight and Obesity","Inhibition, Psychological",[105,106,107,108,109],"excess weight","overweight","inhibitory control","cognitive training","iTBS","2025-02-11",{"date":112,"type":113},"2025-02-14","ACTUAL",{"date":115,"type":113},"2024-11-30",{"date":117,"type":96},"2026-12",{"name":76,"class":6},1]