[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624512":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":44,"locations":50,"responsibleParty":66,"collaborators":68,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":31,"eligibilityCriteria":77,"healthyVolunteers":74,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":31,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":52,"whyStopped":31,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"University of Florida","OTHER",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Biphasic DBS (bDBS)","EXPERIMENTAL","For participants in the bDBS arm, the second setting will mirror their clinical setting but use a biphasic waveform to ensure charge balancing.",[13,14],"Device: Biphasic deep brain stimulation","Device: Conventional deep brain stimulation",{"label":16,"type":10,"description":17,"interventionNames":18},"Nocturnal Theta Burst Stimulation (tDBS)","In the tDBS arm, the second setting will deliver theta burst stimulation-six bursts per second at the therapeutic frequency-during nighttime hours, using the internal IPG clock to align with the participant's typical sleep schedule",[14,19],"Device: Theta burst deep brain stimulation",{"label":21,"type":10,"description":22,"interventionNames":23},"Region-Specific Frequency Alternation (fDBS)","For those in the fDBS arm, the second setting will apply high-frequency stimulation to dorsal contacts (Levels 3 or 4) and low-frequency stimulation (30-60 Hz) to ventral contacts (Levels 1 or 2), while maintaining all other clinical parameters.",[14,24],"Device: Multi frequency deep brain stimulation",[26,32,36,40],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DEVICE","Biphasic deep brain stimulation","Deep brain stimulation using active recharge biphasic waveforms consisting of an equal anodic and cathodic pulse immediately delivered sequentially",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Conventional deep brain stimulation","Conventional deep brain stimulation programming that is currently FDA approved",[9,16,21],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Theta burst deep brain stimulation","Deep brain stimulation using a conventional waveform but timed such that in the evening hours (based on device clock) the device will adjust stimulation to bursts of conventional stimulation at 6 per second",[16],{"type":27,"name":41,"description":42,"armGroupLabels":43,"otherNames":31},"Multi frequency deep brain stimulation","Deep brain stimulation using conventional waveforms but simultaneously delivering high frequency stimulation on the dorsal contacts of the DBS lead and low frequency stimulation on the ventral contacts of the DBS lead",[21],[45],{"name":46,"role":47,"phone":48,"phoneExt":31,"email":49},"Joshua Wong, MD","CONTACT","352-294-5400","joshua.wong@neurology.ufl.edu",[51],{"facility":5,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"RECRUITING","Gainesville","Florida","32608","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-82.32483,29.65163,{"lat":62,"lon":61},[65],{"name":46,"role":47,"phone":48,"phoneExt":31,"email":49},{"type":67,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[69],{"name":70,"class":71},"Boston Scientific Corporation","INDUSTRY","100624512","safety-and-tolerability-of-patterned-stimulation-for-dbs-in-the-home-setting-100624512",false,"NCT07410598","Safety and Tolerability of Patterned Stimulation for DBS in the Home Setting","Inclusion Criteria:\n\n* Bilateral STN or GPi DBS with Boston Scientific Vercise Genus DBS System\n* Diagnosis of Parkinson's disease as confirmed by a movement disorders fellowship trained neurologist\n* Chronic stable DBS therapy, defined as having DBS therapy for at least 6 months\n\nExclusion Criteria:\n\n* History of previous neurosurgical intervention aside from DBS\n* Diagnosis of dementia (whether primary or related to Parkinson's disease)\n* A diagnosis of atypical parkinsonism or secondary parkinsonism at any time after DBS implantation","ALL","18 Years","80 Years",{"count":82,"type":83},60,"ESTIMATED","INTERVENTIONAL",[86],"NA","The primary objective of the proposed pilot study is to assess the safety and tolerability of active patterned Deep Brain Stimulation (pDBS) when administered in a home setting for patients with Parkinson's disease (PD) who have had stable bilateral Subthalamic Nucleus (STN) and Globus Pallidus internus (GPi) DBS.",[89,90],"Parkinson Disease","Deep Brain Stimulation",[92,93,94,95],"Parkinson disease","PD","DBS","deep brain stimulation","2026-05-05",{"date":98,"type":99},"2026-05-06","ACTUAL",{"date":98,"type":83},{"date":102,"type":83},"2028-03-01",{"name":5,"class":6},1]