[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576488":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":44,"responsibleParty":64,"collaborators":66,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":11,"enrollmentInfo":81,"targetDuration":11,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":94,"overallStatus":47,"whyStopped":11,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Association de Recherche Bibliographique pour les Neurosciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active tDCS","ACTIVE_COMPARATOR",null,[13],"Device: active-tDCS",{"label":15,"type":16,"description":11,"interventionNames":17},"Sham tDCS","SHAM_COMPARATOR",[18],"Device: Sham-tDCS",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DEVICE","active-tDCS","2mA stimulation (anode on the left dorsolateral prefrontal cortex, cathode on the right fronto-orbital).\n\n10 sessions of 20 minutes each, spread over 2 consecutive weeks (5 days with stimulation, 2 days without stimulation, 5 days with stimulation).",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Sham-tDCS","No intensity applied (anode on the left dorsolateral prefrontal cortex, cathode on the right fronto-orbital).\n\n10 sessions of 20 minutes each, spread over 2 consecutive weeks (5 days with stimulation, 2 days without stimulation, 5 days with stimulation).",[15],[30],{"name":31,"affiliation":32,"role":33},"Sandrine LOUCHART de la CHAPELLE, MD, PhD","Memory Clinic and Gerontologic center, Princess Grace Hospital (MONACO)","PRINCIPAL_INVESTIGATOR",[35,41],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Kevin POLET, PhD","CONTACT","99995599","00377","kevin.polet@chpg.mc",{"name":42,"role":37,"phone":38,"phoneExt":39,"email":43},"Solange HESSE","solange.hesse@chpg.mc",[45],{"facility":46,"status":47,"city":48,"state":11,"zip":49,"country":48,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Clinical Research Unit-Memory Clinic \u002F Centre de Gérontologie Clinique Rainier III \u002F Princess Grace Hospital","RECRUITING","Monaco","98000","MC",{"type":52,"coordinates":53},"Point",[54,55],7.42145,43.73718,{"lat":55,"lon":54},[58,60,62],{"name":42,"role":37,"phone":59,"phoneExt":11,"email":43},"+377 99995599",{"name":61,"role":37,"phone":11,"phoneExt":11,"email":40},"Kevin POLET",{"name":63,"role":33,"phone":11,"phoneExt":11,"email":11},"Sandrine LOUCHART DE LA CHAPELLE, MD-PHD",{"type":65,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[67,69],{"name":68,"class":6},"Centre Hospitalier Princesse Grace",{"name":70,"class":71},"Association des Aidants et Malades à Corps de Lewy (A2MCL)","UNKNOWN","100576488","tdcs-effect-on-psychotic-symptoms-in-dementia-with-lewy-bodies-dlb-and-impacts-on-caregiver-burden-100576488",false,"NCT06785948","tDCS Effect on Psychotic Symptoms in Dementia With Lewy Bodies (DLB), and Impacts on Caregiver Burden","MCL-tDCS","Inclusion Criteria:\n\n* Male or Female, aged over 60,\n* Diagnosed with a neurodegenerative pathology of the DLB type, at a moderate stage, according to the McKeith and al. (2017) criteria\n* No change in antiparkinsonian or psychotropic medications, or cholinesterase inhibitors, for a period of one month prior to inclusion,\n* Mini Mental State Examination (MMSE) \\> 15,\n* Composite score called \"psychotic factor\" (corresponding to the sum of the psychotic-type symptoms sub-scores from the NPI \\[12\\]) greater than 0,\n* Presence of a family caregiver,\n* Sufficient written and oral expression in French,\n* Written informed consent signed by the patient and his\u002Fher family caregiver\n\nExclusion Criteria:\n\n* History of alcoholism, drug addiction or neurological diseases such as brain trauma, epilepsy, encephalitis, intracranial normal-pressure hydrocephalus, etc. which may lead to cognitive impairment,\n* Concomitant major psychiatric illness,\n* Significant physical illness or comorbidities\n* History of moderate to severe visual impairment secondary to glaucoma, cataract or macular degeneration,\n* Patient under guardianship or curators","ALL","60 Years",{"count":82,"type":83},30,"ESTIMATED","INTERVENTIONAL",[86],"NA","The goal of this pilot prospective study is to evaluate the effect of tDCS on psychotic-like symptoms in patients with Lewy Body Dementia (LBD). The main questions it aims to answer are:\n\n* What is the effect of tDCS on neuropsychiatric symptoms, especially psychotic-like symptoms?\n* What is the impact of tDCS on caregiver burden?\n\nResearchers will compare active tDCS (2mA stimulation, anode on the left dorsolateral prefrontal cortex, cathode on the right fronto-orbital) to Sham tDCS (placebo stimulation, no intensity applied) to see if there is an effect on reducing psychotic-like symptoms and on caregiver burden.\n\nParticipants will:\n\n* Undergo a stimulation phase consisting of 10 tDCS sessions of 20 minutes each, spread over 2 consecutive weeks (5 days with stimulation, 2 days without stimulation, 5 days with stimulation).\n* perform assessments at T0 (inclusion), T1 (at the end of the stimulation phase), and T2 (follow-up at 8 weeks post stimulation).",[89,90,91,92,93],"Lewy Body Dementia","Lewy Body Dementia With Behavioral Disturbance","Burden, Caregiver","Lewy Body Disease","Dementia With Lewy Bodies",[95,96,97,98],"Transcranial Direct-Current Stimulation (t-DCS)","Brain stimulation","Psychotic symptoms","Caregiver burden","2025-09-30",{"date":101,"type":102},"2025-10-01","ACTUAL",{"date":104,"type":102},"2025-01-10",{"date":106,"type":83},"2026-11",{"name":5,"class":6},1]