[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621834":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":31,"responsibleParty":57,"collaborators":26,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":26,"enrollmentInfo":70,"targetDuration":26,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":26,"overallStatus":34,"whyStopped":26,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"IRCCS Centro San Giovanni di Dio Fatebenefratelli","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Real tACS","EXPERIMENTAL","10 sessions of Transcranial Alternating Current Stimulation (5 sessions\u002Fweek, 60 minutes\u002Fsession)",[13],"Device: Transcranial Alternating Current Stimulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham Comparator: Sham tACS","SHAM_COMPARATOR","10 sessions of sham Transcranial Alternating Current Stimulation (5 sessions\u002Fweek, 60 minutes\u002Fsession)",[19],"Device: Sham Transcranial Alternating Current Stimulation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Transcranial Alternating Current Stimulation","10 sessions (5 days\u002Fweek for 2 weeks), each consisting in the application of a tACS session (real at 3 mA) at the cortical level for a duration of 60 minutes each.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sham Transcranial Alternating Current Stimulation","10 sessions (5 days\u002Fweek for 2 weeks), each consisting in the application of a sham tACS session at the cortical level for a duration of 60 minutes each. The electrode placement will be identical to that used for real stimulation. However, the electrical current will be automatically interrupted approximately 5 seconds after the start of stimulation, making it impossible for the patient to distinguish between sham and real stimulation",[15],[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":36,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"IRCCS Istituto Centro San Giovanni Di Dio - Fatebenefratelli Brescia","RECRUITING","Brescia","Italy","25125","IT",{"type":40,"coordinates":41},"Point",[42,43],10.21472,45.53558,{"lat":43,"lon":42},[46,51,55],{"name":47,"role":48,"phone":49,"phoneExt":26,"email":50},"Barbara Borroni, MD","CONTACT","+39 03035358","bborroni@fatebenefratelli.eu",{"name":52,"role":48,"phone":53,"phoneExt":26,"email":54},"Monica Almici, MS","+39 03035360","sct.irccs@fatebenefratelli.eu",{"name":47,"role":56,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"type":56,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Prof. Barbara Borroni","Professor","100621834","transcranial-alternating-current-stimulation-in-lewy-body-dementia-100621834",false,"NCT07375771","Transcranial Alternating Current Stimulation in Lewy Body Dementia","Interventional Study to Evaluate the Effectiveness of Transcranial Alternating Current Stimulation (tACS) on Cognitive Performance in Patients With Lewy Body Dementia","TACSDLB2","Inclusion Criteria:\n\n* Male or female subjects aged over 18 at the time of signing the informed consent form;\n* Presence of a clinical diagnosis of Lewy body dementia according to clinical criteria (McKeith et al., 2017)\n\nExclusion Criteria:\n\n* Age younger than that stated in the inclusion criteria;\n* Incapacity to understand;\n* Contraindications for tACS and TMS: patients with cardiac pacemakers and metal implants that are not compatible with electric or magnetic fields, history of epilepsy, current pregnancy (Safety questionnaire)","ALL","18 Years",{"count":71,"type":72},40,"ESTIMATED","INTERVENTIONAL",[75],"NA","The aim of the study is to evaluate the safety, feasibility, clinical and biological efficacy, and predictors of efficacy of an intervention consisting of transcranial alternating current stimulation (tACS) in patients with Lewy Body Dementia (DLB).\n\nIn neurodegenerative diseases, like DLB, the process of neurodegeneration is accompanied by a significant alteration in oscillatory activity.\n\ntACS is a neurophysiological method of non-invasive modulation of the excitability of the central nervous system that uses a mild electrical current. Recent studies have demonstrated the safety and efficacy of this method in modulating the natural brain oscillation frequencies underlying multiple cognitive processes, such as verbal memory, perception, and working memory. Preliminary data show that single stimulation with occipital α-tACS results in a significant improvement in visuospatial abilities and executive functions in patients wih DLB.\n\nThe study is double blind, randomised and placebo-controlled, participants will be randomised into two groups: group 1, participants will receive real tACS for 2 weeks, from Wednesday to Tuesday (5 sessions\u002Fweek, lasting approximately 60 minutes each); and group 2, participants will receive placebo tACS for 2 weeks (5 sessions\u002Fweek, lasting approximately 60 minutes each).\n\nVisits will take place at the beginning of the study (T00), after 2 weeks (T02), and 12 weeks (T12, follow-up). During each visit, participants undergo the following procedures: (i) blood sampling, (ii) clinical and neuropsychological assessment, (iii) EEG, and (iv) TMS-EEG. The occurrence of adverse events will be monitored throughout the duration of the study. Specific biomarker analyses will be performed on the blood samples to study the pathophysiological mechanisms of the disease and the effect of the experimental intervention.",[78,23],"Lewy Body Dementia (LBD)","2026-01-21",{"date":81,"type":82},"2026-01-29","ACTUAL",{"date":84,"type":82},"2025-10-01",{"date":86,"type":72},"2030-09",{"name":5,"class":6},1]