[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100473439":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":28,"locations":35,"responsibleParty":60,"collaborators":64,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":10,"enrollmentInfo":84,"targetDuration":10,"studyType":87,"phases":10,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Fundacao Champalimaud","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"DBS-induced Mania Cohort",null,"Patients diagnosed with Parkinson's Disease (PD) who were submitted to deep brain stimulation (DBS) surgery irrespective of its target and who developed a manic episode or mixed affective state diagnosed after surgery and associated to DBS modulation, i.e., after switching on the device or changing modulation parameters.",[13],"Other: No Intervention \u002F Exposure",{"label":15,"type":10,"description":16,"interventionNames":17},"DBS Control Cohort","Patients diagnosed with PD who were submitted to DBS surgery irrespective of its target and who did not develop DBS-induced mania.",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"No Intervention \u002F Exposure","No intervention \u002F exposure since this is an observational study",[15,9],[24],{"name":25,"affiliation":26,"role":27},"Albino J. Oliveira-Maia, MD, MPH, PhD","Champalimaud Foundation","PRINCIPAL_INVESTIGATOR",[29],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},"Sofia Marques","CONTACT","+351 210 480 048","4153","sofia.marques@research.fchampalimaud.org",[36],{"facility":26,"status":37,"city":38,"state":10,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","Lisbon","1400-038","Portugal","PT",{"type":43,"coordinates":44},"Point",[45,46],-9.1498,38.72509,{"lat":46,"lon":45},[49,50,51,54,56,58],{"name":30,"role":31,"phone":10,"phoneExt":10,"email":34},{"name":25,"role":27,"phone":10,"phoneExt":10,"email":10},{"name":52,"role":53,"phone":10,"phoneExt":10,"email":10},"Gonçalo Cotovio, MD","SUB_INVESTIGATOR",{"name":55,"role":53,"phone":10,"phoneExt":10,"email":10},"Francisco Viana",{"name":57,"role":53,"phone":10,"phoneExt":10,"email":10},"Sara Penedos, MD",{"name":59,"role":53,"phone":10,"phoneExt":10,"email":10},"J. Bernardo Barahona-Correa, MD, PhD",{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Albino Maia","Director of Neuropsychiatry Unit, Champalimaud Foundation",[65,68,70,72],{"name":66,"class":67},"Centro Hospitalar Lisboa Ocidental","OTHER_GOV",{"name":69,"class":6},"Centro Hospitalar De São João, E.P.E.",{"name":71,"class":6},"Unidade Local de Saúde de Coimbra, EPE",{"name":73,"class":6},"Centro Hospitalar de Lisboa Central","100473439","deep-brain-stimulation-induced-mania-in-parkinsons-disease-100473439",false,"NCT05444907","Deep Brain Stimulation-Induced Mania in Parkinson's Disease","Understanding Deep Brain Stimulation-induced Mania: Finding Potential Predictors to Optimize Treatment","BPD_DBS","DBS-induced mania cohort:\n\nInclusion Criteria:\n\n* Age≥18-years-old;\n* Patients diagnosed with PD who were submitted to DBS surgery irrespective of its target;\n* Manic episode or mixed affective state diagnosed after surgery and associated to DBS modulation, i.e., after switching on the device or changing modulation parameters.\n\nExclusion Criteria:\n\n* Patients diagnosed with bipolar disorder, or manic episode, or mixed affective state before the age of 18\n* Patients diagnosed with bipolar disorder, or manic episode, or mixed affective state, before DBS surgery.\n\nDBS Control Cohort:\n\nA control cohort will also be collected. These patients will also meet the aforementioned inclusion and exclusion criteria with the exception of not having presented a manic episode or mixed affective state diagnosed after surgery and associated to DBS modulation.","ALL","18 Years",{"count":85,"type":86},100,"ESTIMATED","OBSERVATIONAL","Parkinson's Disease (PD) is a common and debilitating neurodegenerative disease. While medication can alleviate its symptoms, not all patients will adequately respond to medical therapy. For these cases, deep brain stimulation (DBS) has been used to improve symptoms and quality of life. Nevertheless, this approach is, in some cases, associated with incapacitating neuropsychiatric side-effects, including mood disturbances, such as DBS-induced mania. While this condition has important functional short- and long-term consequences for quality of life and prognosis, its pathophysiology is still poorly understood. In this project the investigators propose to conduct a retrospective and naturalistic study in PD patients in whom DBS stimulation resulted in mania or mixed state episode, to clarify if specific sociodemographic and clinical predictors, namely stimulation parameters and target locations, might be associated to the occurrence of this neuropsychiatric adverse event. Additionally, the investigators aim to clarify if the occurrence of DBS-induced mania results from the impact of specific stimulation parameters and\u002For target locations in functional connectivity networks. To explore this question, the investigators will use different neuroimaging analysis methods termed lesion topography analysis and lesion network mapping, in order to compute maps of the stimulated regions topography and the functional networks that are associated with DBS-mania, respectively. The data that will be analyzed in this project, including neuroimages, will be obtained retrospectively, by different Movement Disorders and Functional Surgery Groups in the context of Deep Brain Stimulation, and that has been collected according to their usual clinical practice.",[90,91],"Mania","Parkinson Disease",[93,94,90],"Parkinson's Disease","Deep Brain Stimulation","2025-02-24",{"date":97,"type":98},"2025-02-26","ACTUAL",{"date":100,"type":98},"2021-05-25",{"date":102,"type":86},"2025-12-31",{"name":62,"class":6},1]