[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554381":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":32,"centralContacts":67,"locations":77,"responsibleParty":233,"collaborators":236,"id":249,"slug":250,"hasResults":251,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":31,"eligibilityCriteria":255,"healthyVolunteers":251,"sex":256,"minAge":257,"maxAge":258,"enrollmentInfo":259,"targetDuration":31,"studyType":262,"phases":263,"briefSummary":265,"conditions":266,"keywords":31,"overallStatus":80,"whyStopped":31,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":278},{"fullName":5,"class":6},"University of Kiel","OTHER",[8,14],{"label":9,"type":6,"description":10,"interventionNames":11},"DBS-group","Within indication and clinical routine:\n\nbilateral high frequency deep brain stimulation of the subthalamic nucleus combined with best medical treatment",[12,13],"Procedure: bilateral high frequency deep brainstimulation of the subthalamic nucleus combined with best medical treatment","Drug: best medical treatment (BMT): Adjustment of the dopaminergic medication and non-dopaminergic therapy customized for each patient according to the latest published Consensus Group Recommendations",{"label":15,"type":6,"description":16,"interventionNames":17},"BMT-group","Within indication and clinical routine:\n\nbest medical treatment",[13],[19,26],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","bilateral high frequency deep brainstimulation of the subthalamic nucleus combined with best medical treatment","according to widely accepted expert consensus paper",[9],[25],"best medical treatment for management of impulse control in Parkinson´s disease",{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","best medical treatment (BMT): Adjustment of the dopaminergic medication and non-dopaminergic therapy customized for each patient according to the latest published Consensus Group Recommendations","according to (Debove et al (2024), 'Management of Impulse Control and Related Disorders in Parkinson's Disease: An Expert Consensus, Mov Disord.",[15,9],null,[33,37,39,42,44,48,51,54,56,58,62,65],{"name":34,"affiliation":35,"role":36},"Ines Deboves, MD","University Hospital Bern, Inselspital, Department of Neurology","PRINCIPAL_INVESTIGATOR",{"name":38,"affiliation":35,"role":36},"Paul Krack, Prof.",{"name":40,"affiliation":41,"role":36},"Annabel van der Weide, MD","Amsterdam University Medical Center (UMC)",{"name":43,"affiliation":41,"role":36},"Rob MA De Bie, Prof.",{"name":45,"affiliation":46,"role":47},"Daniel Weintraub, Prof.","University of Pennsylvania, Section of Geriatric Psychiatry Philadelphia","STUDY_CHAIR",{"name":49,"affiliation":50,"role":47},"Jan Rusz, Prof.","Czech Technical University Prague, Electrical Engineering",{"name":52,"affiliation":53,"role":47},"Ann-Kristin Helmers, Prof.","University Hospital Kiel,UKSH, Campus Kiel, Department of Neurosurgery",{"name":55,"affiliation":35,"role":47},"Claudio Pollo, Prof.",{"name":57,"affiliation":41,"role":47},"Rick Schuurmann, Prof.",{"name":59,"affiliation":60,"role":61},"Jörn Rau","Philipps-University Marburg, Coordinating Center for Clinical (KKS)","STUDY_DIRECTOR",{"name":63,"affiliation":64,"role":61},"Carmen Schade-Brittinger","Philipps-University Marburg, Coordinating Center for Clinical Trials (KKS)",{"name":66,"affiliation":64,"role":61},"Kerstin Winterstein",[68,74],{"name":69,"role":70,"phone":71,"phoneExt":72,"email":73},"Steffen Paschen, MD","CONTACT","+49 (0)431 500","23819","steffen.paschen@uksh.de",{"name":75,"role":70,"phone":31,"phoneExt":31,"email":76},"Guenther Deuschl, Prof.","g.deuschl@neurologie.uni-kiel.de",[78,95,106,119,130,142,153,166,177,190,204,217],{"facility":79,"status":80,"city":81,"state":31,"zip":31,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"University Hospital Cologne","RECRUITING","Cologne","Germany","DE",{"type":85,"coordinates":86},"Point",[87,88],6.95,50.93333,{"lat":88,"lon":87},[91,93],{"name":92,"role":70,"phone":31,"phoneExt":31,"email":31},"Michael Barbe, MD",{"name":94,"role":70,"phone":31,"phoneExt":31,"email":31},"Veerle Visser-Vandewalle, Prof.",{"facility":96,"status":80,"city":97,"state":31,"zip":31,"country":82,"countryCode":83,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"University Hospital Carl Gustav Carus","Dresden",{"type":85,"coordinates":99},[100,101],13.73832,51.05089,{"lat":101,"lon":100},[104],{"name":105,"role":70,"phone":31,"phoneExt":31,"email":31},"Bjoern Falkenburger, Prof.",{"facility":107,"status":80,"city":108,"state":31,"zip":31,"country":82,"countryCode":83,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"University Hospital Duesseldorf","Düsseldorf",{"type":85,"coordinates":110},[111,112],6.77927,51.22319,{"lat":112,"lon":111},[115,117],{"name":116,"role":70,"phone":31,"phoneExt":31,"email":31},"Alfons Schnitzler, Prof.",{"name":118,"role":70,"phone":31,"phoneExt":31,"email":31},"Jan Vesper, Prof.",{"facility":120,"status":80,"city":121,"state":31,"zip":31,"country":82,"countryCode":83,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"University Medical Center Hamburg-Eppendorf","Hamburg",{"type":85,"coordinates":123},[124,125],9.99302,53.55073,{"lat":125,"lon":124},[128],{"name":129,"role":70,"phone":31,"phoneExt":31,"email":31},"Monika Poetter-Nerger, MD",{"facility":131,"status":80,"city":132,"state":31,"zip":31,"country":82,"countryCode":83,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"University Hospital Schleswig-Holstein (UKSH), Campus Kiel","Kiel",{"type":85,"coordinates":134},[135,136],10.13489,54.32133,{"lat":136,"lon":135},[139,140],{"name":69,"role":70,"phone":31,"phoneExt":31,"email":31},{"name":141,"role":70,"phone":31,"phoneExt":31,"email":31},"Guenter Deuschl, Prof.",{"facility":143,"status":80,"city":144,"state":31,"zip":31,"country":82,"countryCode":83,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"University Hospital of Giessen and Marburg (UKGM), Campus Marburg","Marburg",{"type":85,"coordinates":146},[147,148],8.77069,50.80904,{"lat":148,"lon":147},[151],{"name":152,"role":70,"phone":31,"phoneExt":31,"email":31},"David Pedrosa, MD",{"facility":154,"status":80,"city":155,"state":31,"zip":31,"country":82,"countryCode":83,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"Charité Campus Mitte","Mitte",{"type":85,"coordinates":157},[158,159],13.40489,52.52003,{"lat":159,"lon":158},[162,164],{"name":163,"role":70,"phone":31,"phoneExt":31,"email":31},"Patricia Krause, MD",{"name":165,"role":70,"phone":31,"phoneExt":31,"email":31},"Andrea Kühn, Prof.",{"facility":167,"status":80,"city":168,"state":31,"zip":31,"country":82,"countryCode":83,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"University Hospital Tuebingen","Tübingen",{"type":85,"coordinates":170},[171,172],9.05222,48.52266,{"lat":172,"lon":171},[175],{"name":176,"role":70,"phone":31,"phoneExt":31,"email":31},"Daniel Weiss, Prof.",{"facility":178,"status":80,"city":179,"state":31,"zip":31,"country":82,"countryCode":83,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"University Hospital Wuerzburg","Würzburg",{"type":85,"coordinates":181},[182,183],9.95121,49.79391,{"lat":183,"lon":182},[186,188],{"name":187,"role":70,"phone":31,"phoneExt":31,"email":31},"Philipp Carpetian, MD",{"name":189,"role":70,"phone":31,"phoneExt":31,"email":31},"Jens Volkmann, Prof.",{"facility":191,"status":80,"city":192,"state":31,"zip":31,"country":193,"countryCode":194,"cosmosGeoPoint":195,"geoPoint":199,"contacts":200},"Amsterdam University Medical Center","Amsterdam","Netherlands","NL",{"type":85,"coordinates":196},[197,198],4.88969,52.37403,{"lat":198,"lon":197},[201,202],{"name":43,"role":70,"phone":31,"phoneExt":31,"email":31},{"name":203,"role":70,"phone":31,"phoneExt":31,"email":31},"Annabel von der Weide, MD",{"facility":205,"status":80,"city":206,"state":31,"zip":31,"country":207,"countryCode":208,"cosmosGeoPoint":209,"geoPoint":213,"contacts":214},"University Hospital of Bern (Inselspital)","Bern","Switzerland","CH",{"type":85,"coordinates":210},[211,212],7.44744,46.94809,{"lat":212,"lon":211},[215,216],{"name":34,"role":70,"phone":31,"phoneExt":31,"email":31},{"name":38,"role":70,"phone":31,"phoneExt":31,"email":31},{"facility":218,"status":80,"city":219,"state":31,"zip":31,"country":207,"countryCode":208,"cosmosGeoPoint":220,"geoPoint":224,"contacts":225},"University Hospital Zuerich (USZ)","Zurich",{"type":85,"coordinates":221},[222,223],8.55,47.36667,{"lat":223,"lon":222},[226,228,230],{"name":227,"role":70,"phone":31,"phoneExt":31,"email":31},"Lennart Stieglitz, Prof.",{"name":229,"role":70,"phone":31,"phoneExt":31,"email":31},"Fabian Buechele, MD",{"name":231,"role":232,"phone":31,"phoneExt":31,"email":31},"Sujitha Mahendran, MD","SUB_INVESTIGATOR",{"type":36,"investigatorFullName":234,"investigatorTitle":235,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Steffen Paschen","Dr. med.",[237,239,241,243,245,247],{"name":238,"class":6},"Insel Gruppe AG, University Hospital Bern",{"name":240,"class":6},"Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)",{"name":242,"class":6},"Philipps University Marburg",{"name":244,"class":6},"University Hospital Schleswig-Holstein",{"name":246,"class":6},"Czech Technical University in Prague",{"name":248,"class":6},"University of Pennsylvania","100554381","bilateral-subthalamic-stimulation-in-pd-patients-with-impulse-control-disorders---stimpulsecontrol-100554381",false,"NCT06498349","Bilateral Subthalamic Stimulation in PD Patients With Impulse Control Disorders - STIMPulseControl","A Randomized Controlled Trial of Bilateral Subthalamic Stimulation in Patients With Parkinson's Disease and Impulse Control Disorders","Inclusion Criteria:\n\n1. Age at the time of enrollment: ≤ 70 years\n2. Diagnosis of PD according to MDS clinical diagnostic criteria\n3. Onset of first PD motor symptoms ≥ 4 years\n4. Moderate or severe impulse control disorder or related behavioral disorders according to Ardouin, with at least 1 score greater than or equal to 3 (or at least 2 scores greater than or equal to 2) on the Ardouin behaviour scale with the following items considered to reflect ICBDs or related behaviors: pathological gambling, hypersexuality, shopping, eating, hobbyism, punding and compulsive medication use\n5. MDS-UPDRS III improvement of ≥ 30% in the standardized levodopa test or classical Parkinsonian tremor at rest\n6. Adaptation of medical therapy has been attempted\n7. MoCA ≥ 24 in the meds on condition\n8. BDI-II score \\\u003C 20 in the meds on condition, or Patients with moderately severe depression with a BDI-II between 20 and 28 points, strict consideration must be made with the involvement of a psychiatrist. Patients must be willing and able to comply this.\n9. Patients able to understand the study requirements and the treatment procedures\n10. Written informed consent before any study-specific tests or procedures are performed\n\n    Exclusion Criteria:\n11. Surgical contraindications to undergo DBS operation\n12. Ongoing severe depression (BDI-II \\> 28)\n13. suicidal ideation (item 9 of BDI-II \\> 1)\n14. Dementia (MoCA \\\u003C 24) in the meds on condition\n15. Any prior movement disorder treatments that involved intracranial surgery\u002Fablation or intracranial device implantation\n16. Any other active implanted device that is likely to interfere with the implantation or functioning of the DBS system\n17. Simultaneous participation in another clinical trial targeting or potentially interfering with ICD\n18. Any history of recurrent seizures or haemorrhagic stroke\n19. Fertile women not using adequate contraceptive methods\n20. Any terminal illness with significantly reduced life expectancy which exclude DBS implantation according to standard clinical care\n21. A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception\n22. Any impairment that would limit subject's ability to participate in the study and perform study procedures\n23. Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints","ALL","18 Years","70 Years",{"count":260,"type":261},60,"ESTIMATED","INTERVENTIONAL",[264],"NA","The focus of the study is on patients Parkinson's disease showing as well behavioral disorders that can be described as pathological and are summarized under the term impulse control disorder (ICD). Changes in behavior and also pathological disorders are a common side effect of treatment for Parkinson's disease. The goal of this academic study is to compare the effect of surgical (deep brain stimulation, DBS) treatment combined with a coordinated and adapted best medical treatment (BMT) to be compared with the effect of optimized best medical treatment (BMT) alone. The stimulation arm (DBS+BMT) as well as the medication arm (BMT only) will be monitored according to clinical routine. Participants will have to agree to be randomly assigned to either deep brain stimulation in combination with the best medical treatment (DBS group) or the best medical treatment alone (BMT group). Participants will have to come regularly according to clinical routine to the clinic and complete various questionaires and scales for the study.",[267,268],"Parkinson Disease","Impulse Control Disorders","2025-12-30",{"date":271,"type":272},"2026-01-05","ACTUAL",{"date":274,"type":272},"2024-09-05",{"date":276,"type":261},"2028-07-15",{"name":5,"class":6},12]