[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621337":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":25,"locations":30,"responsibleParty":42,"collaborators":46,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":25,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":25,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":74,"overallStatus":90,"whyStopped":25,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Conventional DBS Programming (Monopolar Review)","ACTIVE_COMPARATOR","Participants in this arm will undergo DBS programming using the conventional clinical approach based on monopolar review.",[13],"Device: Conventional DBS Programming (Monopolar Review)",{"label":15,"type":16,"description":17,"interventionNames":18},"Objective-Guided DBS Programming (Imaging + Local Field Potentials)","EXPERIMENTAL","Participants in this arm will undergo DBS programming guided by objective markers. Selection of stimulation contacts will be informed by postoperative anatomical reconstruction of electrode location using Brainlab Elements™ and by beta-band local field potential (LFP) activity recorded with BrainSense™ from the implanted DBS system.",[19],"Device: Objective-Guided DBS Programming (Imaging and Local Field Potential-Based)",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","DBS programming performed using the conventional clinical monopolar review approach. Stimulation contacts and parameters are selected through systematic clinical testing based on clinician assessment of motor benefit and stimulation-related side effects, together with patient-reported symptoms. Programming does not incorporate postoperative electrode localization from neuroimaging or neurophysiological biomarkers. All participants are implanted with a CE-marked DBS system (Percept™ PC or RC with SenSight™ leads), and programming begins approximately 5 weeks after surgery following standard clinical practice.\n\nAt 3 months after initial programming, Adaptive DBS is activated in all patients.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Objective-Guided DBS Programming (Imaging and Local Field Potential-Based)","DBS programming guided by objective anatomical and neurophysiological markers. Stimulation contact selection is informed by postoperative electrode reconstruction using Brainlab Elements™ and by LFP activity recorded with BrainSense™ from the implanted DBS system. These objective data are integrated with standard clinical testing to guide programming decisions. All participants are implanted with the same CE-marked DBS system (Percept™ PC or RC with SenSight™ leads), and programming starts approximately 5 weeks after surgery, following the same schedule as the comparator arm.\n\nAt 3 months after initial programming, Adaptive DBS will be activated in all patients.",[15],[31],{"facility":32,"status":25,"city":33,"state":25,"zip":25,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":25},"Hospital de la Santa Creu i Sant Pau","Barcelona","Spain","ES",{"type":37,"coordinates":38},"Point",[39,40],2.15899,41.38879,{"lat":40,"lon":39},{"type":43,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Ignacio Aracil Bolanos","MD PhD",[47],{"name":48,"class":49},"Medtronic","INDUSTRY","100621337","comparing-biomarker-guided-dbs-programming-with-standard-clinical-monopolar-programming-100621337",false,"NCT07369310","Comparing Biomarker-Guided DBS Programming With Standard Clinical Monopolar Programming","Randomized Trial on DBS Programming Based on Biomarkers vs. Standard Monopolar Review","Inclusion Criteria:\n\n* Age between 30 and 70 years.\n* Confirmed diagnosis of idiopathic Parkinson's disease according to the MDS diagnostic criteria (Postuma et al., 2015).\n* Indication for deep brain stimulation surgery based on CAPSIT-PD criteria.\n\nExclusion Criteria:\n\n* Presence of severe surgical complications (e.g., intracranial hemorrhage, infection).\n* Postoperative adverse events requiring electrode repositioning.\n* Any other medical or neurological condition that could interfere with safe participation in the trial.","ALL","30 Years","70 Years",{"count":61,"type":62},20,"ESTIMATED","INTERVENTIONAL",[65],"NA","The goal of this clinical trial is to learn whether an objective, data-guided approach to programming deep brain stimulation (DBS) can improve motor outcomes in people with Parkinson's disease who undergo DBS surgery. The study includes adults aged 30 to 70 years with Parkinson's disease who are candidates for DBS.\n\nThe main questions it aims to answer are:\n\nDoes DBS programming based on objective markers (brain imaging and brain signals) reduce the amount of daily time patients spend in the OFF state more than conventional clinical programming?\n\nDoes this programming approach improve quality of life and motor symptoms compared with standard programming?\n\nResearchers will compare conventional DBS programming based on clinical monopolar review with DBS programming guided by electrode location on neuroimaging and beta brain signals recorded from the implanted device, to see if the objective approach leads to better motor control and less OFF time.\n\nParticipants will:\n\nUndergo DBS surgery using a clinically approved DBS system\n\nBe randomly assigned to one of two DBS programming strategies\n\nWear inertial sensors at home for several days at different time points to objectively measure motor symptoms\n\nAttend scheduled clinical visits for DBS programming and motor and non-motor assessments\n\nHave adaptive DBS activated after 3 months and continue follow-up until 6 months after programming begins",[68,69,70,71,72,73],"Parkinson's Disease","Parkinson","Parkinsons Disease (PD)","Motor Fluctuations","DBS","Deep Brain Stimulation",[68,73,75,76,77,78,79,80,81,82,83,84,85,71,86,87,88,89],"DBS Programming","Monopolar Review","Local Field Potentials","Beta Oscillations","BrainSense","Medtronic Percept","Neuroimaging-Guided Programming","Objective Programming","Adaptive Deep Brain Stimulatoin","Wearable Sensors","Inertial Sensors","OFF Time","Dyskinesia","Neuromodulation","Subthalamic Nucleus","NOT_YET_RECRUITING","2026-01-26",{"date":93,"type":94},"2026-01-27","ACTUAL",{"date":96,"type":62},"2026-03-01",{"date":98,"type":62},"2028-09-01",{"name":5,"class":6},1]