[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659078":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":45,"studyPopulation":38,"armGroups":46,"interventions":64,"overallOfficials":78,"centralContacts":86,"locations":91,"responsibleParty":108,"collaborators":38,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":112,"sex":118,"minAge":119,"maxAge":120,"enrollmentInfo":121,"targetDuration":38,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":138,"whyStopped":38,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},{"fullName":5,"class":6},"Fundacao Champalimaud","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":28},[9],{"measure":10,"description":11,"timeFrame":12},"Post-Stimulation Target-to-Network Resting-State fMRI Functional Connectivity","Resting-state fMRI functional connectivity between the individualized prefrontal stimulation target and the lesion-defined restrictive-eating network, quantified using the target-to-network connectivity index. The measure is assessed after each iTBS, cTBS, and sham session and compared within participants across the three stimulation conditions.","Within approximately 30 minutes after each stimulation session at crossover Visits 2, 3, and 4 (Weeks 2, 4, and 6; visits separated by at least 1 week)",[14,18,21,24],{"measure":15,"description":16,"timeFrame":17},"GNAT Inhibitory-Control Performance (d-prime) After Stimulation","Inhibitory-control performance assessed using the Go\u002FNo-Go Association Task (GNAT) with food and non-food stimuli. The pre-specified outcome metric is d-prime, assessed following each stimulation condition and compared within participants across iTBS, cTBS, and sham.","During post-stimulation task-based fMRI at crossover Visits 2, 3, and 4, within approximately 30 minutes after stimulation",{"measure":19,"description":20,"timeFrame":17},"Body Discrepancy Index After Stimulation","Body-image evaluation assessed using a 7-silhouette body-image task adapted for scanner administration. The primary metric is the body discrepancy index, based on the difference between perceived and ideal body silhouettes, and is compared within participants across iTBS, cTBS, and sham conditions.",{"measure":22,"description":23,"timeFrame":17},"Post-Stimulation Task-Based fMRI BOLD Signal in the Lesion-Defined Network","Blood-oxygen-level-dependent (BOLD) signal measured in pre-specified regions of interest within the lesion-defined restrictive-eating network during the GNAT and body-image task paradigms. BOLD responses are compared within participants across iTBS, cTBS, and sham conditions.",{"measure":25,"description":26,"timeFrame":27},"Eating Disorder Psychopathology Assessed With the EDE-Q","Eating-disorder psychopathology assessed using the Eating Disorder Examination Questionnaire (EDE-Q), version 6.0. The pre-specified metric is the EDE-Q total score. Higher scores indicate greater eating-disorder psychopathology. The EDE-Q is administered before stimulation at each crossover visit.","Pre-stimulation at crossover Visits 2, 3, and 4 (approximately Weeks 2, 4, and 6; visits separated by at least 1 week)",[29],{"measure":30,"description":31,"timeFrame":32},"Incidence and Nature of Adverse Events and Device-Related Safety Events","Incidence and nature of adverse events (AEs), serious adverse events (SAEs), serious adverse device effects (SADEs), and device deficiencies. Pre-specified TMS-specific safety events include seizure, syncope, severe headache, and severe mood change. Events will be summarized descriptively by stimulation condition.","From enrollment at Visit 1 through completion of Visit 4 (approximately 4-7 weeks per participant)",{"allocation":34,"interventionModel":35,"interventionModelDescription":36,"primaryPurpose":37,"observationalModel":38,"timePerspective":38,"maskingInfo":39},"RANDOMIZED","CROSSOVER","Each participant receives all three stimulation conditions (iTBS, cTBS, and sham) in randomized order across three separate crossover stimulation visits, with a washout interval of at least one week between visits. Each participant therefore serves as their own control.","BASIC_SCIENCE",null,{"masking":40,"maskingDescription":41,"whoMasked":42},"DOUBLE","Participants and outcome assessors are masked to stimulation condition. The TMS operator is not masked and records the assigned stimulation condition in a restricted stimulation log that is not accessible to blinded outcome assessors. Unblinding is permitted only when required for a safety-related emergency.",[43,44],"PARTICIPANT","OUTCOMES_ASSESSOR","RestrEAT is a mechanistic, proof-of-concept investigation designed to evaluate a personalized, circuit-guided targeting strategy for prefrontal theta-burst stimulation (TBS) in anorexia nervosa.\n\nThe targeting framework is based on a lesion-defined restrictive-eating network derived from brain lesions associated with restrictive eating and anorexia-nervosa-like psychopathology. For each participant, individualized electric-field modelling using SimNIBS is combined with functional connectivity derived from the participant's baseline fMRI data. Candidate TMS-accessible prefrontal sites are evaluated, and the stimulation site is selected according to the similarity between its individual functional connectivity profile and the lesion-defined network. The individualized target is subsequently implemented using neuronavigation.\n\nThe study is intended to generate mechanistic target-engagement data rather than establish the therapeutic efficacy of TMS for anorexia nervosa. The within-subject crossover design was selected because the effects of a single TBS session are expected to be acute and transient, allowing comparison of stimulation conditions within the same participant while reducing variability related to inter-individual differences in functional connectivity and cognitive performance.\n\nThe results are intended to evaluate the feasibility and biological validity of the personalized targeting approach, characterize effect-size estimates, and inform the design of a subsequent adequately powered therapeutic clinical trial if supported by the findings.",[47,53,58],{"label":48,"type":49,"description":50,"interventionNames":51},"Intermittent Theta-Burst Stimulation (iTBS)","EXPERIMENTAL","Participants receive one session of personalized prefrontal intermittent theta-burst stimulation (iTBS) during one of the three randomized crossover stimulation visits. Each participant receives this condition once, with a washout interval of at least one week between stimulation visits.",[52],"Device: Intermittent theta-burst stimulation (iTBS)",{"label":54,"type":49,"description":55,"interventionNames":56},"Continuous Theta-Burst Stimulation (cTBS)","Participants receive one session of personalized prefrontal continuous theta-burst stimulation (cTBS) during one of the three randomized crossover stimulation visits. Each participant receives this condition once, with a washout interval of at least one week between stimulation visits.",[57],"Device: Continuous theta-burst stimulation (cTBS)",{"label":59,"type":60,"description":61,"interventionNames":62},"Sham Theta-Burst Stimulation","SHAM_COMPARATOR","Participants receive one session of sham theta-burst stimulation during one of the three randomized crossover stimulation visits. Each participant receives this condition once, with a washout interval of at least one week between stimulation visits.",[63],"Device: Sham theta-burst stimulation",[65,70,74],{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":38},"DEVICE","Intermittent theta-burst stimulation (iTBS)","A single session of neuronavigated intermittent theta-burst stimulation (iTBS) is delivered using a MagVenture MagPro X100 with MagOption and the appropriate active coil (Cool-B65 or Cool-D-B80) selected according to the individualized target. Stimulation is delivered at 80% of the individual resting motor threshold (RMT) to a personalized prefrontal site defined using lesion network mapping and SimNIBS. Bursts are delivered at 5 Hz, with 3 pulses at 50 Hz per burst, in an intermittent pattern of 2 seconds ON and 8 seconds OFF, for a total of 600 pulses over approximately 190 seconds.",[48],{"type":66,"name":71,"description":72,"armGroupLabels":73,"otherNames":38},"Continuous theta-burst stimulation (cTBS)","A single session of neuronavigated continuous theta-burst stimulation (cTBS) is delivered using a MagVenture MagPro X100 with MagOption and the appropriate active coil (Cool-B65 or Cool-D-B80) selected according to the individualized target. Stimulation is delivered at 80% of the individual resting motor threshold (RMT) to a personalized prefrontal site defined using lesion network mapping and SimNIBS. Bursts are delivered at 5 Hz, with 3 pulses at 50 Hz per burst, continuously without interruption, for a total of 600 pulses over approximately 40 seconds.",[54],{"type":66,"name":75,"description":76,"armGroupLabels":77,"otherNames":38},"Sham theta-burst stimulation","A single session of sham theta-burst stimulation is delivered using the MagVenture MagPro X100 with MagOption and a shielded sham coil at the individualized prefrontal target. Coil positioning, neuronavigation display, and auditory and somatosensory characteristics are matched as closely as possible to the active conditions. The programmed sham protocol uses 5-Hz bursts with 3 pulses at 50 Hz per burst, an intermittent pattern of 5 seconds ON and 10 seconds OFF, 600 pulses, a session duration of 110 seconds, and an intensity setting of 80% of the individual RMT.",[59],[79,83],{"name":80,"affiliation":81,"role":82},"Gonçalo Cotovio, MD, PhD","Champalimaud Foundation","PRINCIPAL_INVESTIGATOR",{"name":84,"affiliation":81,"role":85},"Albino J. Oliveira-Maia, MD, MPH, PhD","STUDY_DIRECTOR",[87],{"name":80,"role":88,"phone":89,"phoneExt":38,"email":90},"CONTACT","+351 210 480 200","goncalo.cotovio@neuro.fchampalimaud.org",[92],{"facility":81,"status":38,"city":93,"state":94,"zip":95,"country":96,"countryCode":97,"cosmosGeoPoint":98,"geoPoint":103,"contacts":104},"Lisbon","Lisbon District","1400-038","Portugal","PT",{"type":99,"coordinates":100},"Point",[101,102],-9.1498,38.72509,{"lat":102,"lon":101},[105,106,107],{"name":80,"role":88,"phone":89,"phoneExt":38,"email":90},{"name":80,"role":82,"phone":38,"phoneExt":38,"email":38},{"name":84,"role":82,"phone":38,"phoneExt":38,"email":38},{"type":109,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100659078","circuit-guided-neuromodulation-for-anorexia-nervosa-100659078",false,"NCT07860320","Circuit-Guided Neuromodulation for Anorexia Nervosa","Re-tuning Restrictive Eating Circuits: From Lesion Network Mapping to Personalized Neuromodulation Targets","RestrEAT","Inclusion Criteria:\n\n* Age between 18 and 65 years, inclusive.\n* Established diagnosis of anorexia nervosa according to DSM-5 criteria, confirmed by the Structured Clinical Interview for DSM-5 (SCID-5) at Visit 1.\n* Capacity to provide written informed consent, as assessed by the investigator at Visit 1.\n* Fluency in European Portuguese sufficient to complete the study assessments.\n\nExclusion Criteria:\n\n* Current manic or psychotic episode.\n* Major or minor neurocognitive disorder.\n* Neurodevelopmental disorder, including attention-deficit\u002Fhyperactivity disorder (ADHD) or autism spectrum disorder (ASD).\n* Any medical or psychiatric condition requiring immediate hospitalization at the time of enrollment. Psychiatry day hospital care does not constitute an exclusion criterion.\n* History of a structural lesion of the central nervous system.\n* Presence of electrical or metallic implants incompatible with TMS or MRI, including cochlear implants, deep brain stimulators, vagus nerve stimulators, cardiac pacemakers, implantable cardioverter-defibrillators, intracardiac lines, or aneurysm clips or coils, in accordance with the manufacturer's contraindications.\n* Personal history of epilepsy or unexplained loss of consciousness.\n* Any contraindication to TMS or MRI.\n* Pregnancy or breastfeeding at the time of enrollment.\n* For participants of childbearing potential, lack of use of an effective method of contraception throughout the study period.","ALL","18 Years","65 Years",{"count":122,"type":123},30,"ESTIMATED","INTERVENTIONAL",[126],"NA","The goal of this clinical trial is to find out whether personalized, non-invasive brain stimulation can temporarily change communication within brain networks related to restrictive eating in adults with anorexia nervosa.\n\nThe main questions this study aims to answer are:\n\n* Does personalized transcranial magnetic stimulation (TMS) change functional connectivity within a brain network related to restrictive eating compared with sham stimulation?\n* Do different types of TMS affect measures related to inhibitory control, body image, eating-disorder symptoms, mood, and anxiety, and are they safe and well tolerated?\n\nParticipants will:\n\n* Attend four study visits, separated by at least one week.\n* Complete clinical and psychological assessments and undergo brain magnetic resonance imaging (MRI).\n* Receive three stimulation conditions in random order at separate visits: intermittent theta-burst stimulation (iTBS), continuous theta-burst stimulation (cTBS), and sham stimulation.\n* Complete brain MRI scans and research tasks so that the effects of the three stimulation conditions can be compared.\n\nResearchers will compare the effects of iTBS and cTBS with sham stimulation on brain connectivity and other study measures.\n\nThis is an exploratory proof-of-concept study designed to test whether personalized brain stimulation can engage the targeted brain circuit. It is not designed to determine whether TMS is an effective treatment for anorexia nervosa, and direct clinical benefit to participants is not expected.",[129],"Anorexia Nervosa",[131,132,133,134,135,136,137],"Eating Disorders","Restrictive Eating","Brain Mapping","Personalized Neuromodulation","Functional Connectivity","Lesion Network Mapping","Transcranial Magnetic Stimulation","NOT_YET_RECRUITING","2026-10-01",{"date":141,"type":142},"2026-10-06","ACTUAL",{"date":144,"type":123},"2026-09",{"date":146,"type":123},"2027-12",{"name":5,"class":6},1]