[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656987":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":21,"studyPopulation":13,"armGroups":22,"interventions":29,"overallOfficials":34,"centralContacts":38,"locations":44,"responsibleParty":61,"collaborators":13,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":13,"enrollmentInfo":72,"targetDuration":13,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":13,"overallStatus":46,"whyStopped":13,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"University of Minnesota","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Gait Test","Subjects walk for one minute each on a treadmill set to match their individual overground walking speed. A forceplate measures the center of pressure trajectory from which integral software detects time and location of heel-strike and toe-off events. These events, and the treadmill speed, are used to compute step lengths.","This will be repeated approximately 30 times throughout the study visit (Day 1) on various DBS settings to reach putatively optimal DBS settings.",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"NA","SINGLE_GROUP","BASIC_SCIENCE",{"masking":19,"maskingDescription":20,"whoMasked":13},"NONE","Participants will not be told what their DBS stimulation settings are during testing (single blind)","Patients will undergo on-label DBS for the treatment of Parkinson's disease, at stimulator settings different from their usual settings, but within the FDA-approved range for this indication, based on the output of the Bayesian optimization algorithm. Test settings will be evaluated by a brief period of walking on a treadmill which captures measurements of step length. The resulting step length will be provided to the algorithm to inform the next recommended test setting. This will be repeated approximately 30 times to reach putatively optimal DBS settings.",[23],{"label":24,"type":25,"description":26,"interventionNames":27},"All participants","EXPERIMENTAL","All participants will be allocated to this group for DBS stimulation within FDA-approved limits and labeling for symptoms of PD.",[28],"Other: Deep Brain Stimulation",[30],{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":13},"Deep Brain Stimulation","DBS within FDA-approved limits and labeling for symptoms of PD",[24],[35],{"name":36,"affiliation":5,"role":37},"Scott Cooper, MD, PhD","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":13,"email":43},"Johanna Caskey, BA","CONTACT","763-353-9470","caske039@umn.edu",[45],{"facility":5,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Minneapolis","Minnesota","55455","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-93.26384,44.97997,{"lat":56,"lon":55},[59,60],{"name":40,"role":41,"phone":42,"phoneExt":13,"email":43},{"name":36,"role":37,"phone":13,"phoneExt":13,"email":13},{"type":62,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100656987","early-phase-1-bayesian-optimization-of-dbs-for-gait-100656987",false,"NCT07835308","Bayesian Optimization of DBS for Gait","BOG DBS","Inclusion Criteria:\n\n* Diagnosis of Parkinson's Disease\n* DBS in STN or GP (bilateral or unilateral)\n* At least 3 months after lead implantation\n\nExclusion Criteria:\n\n* Inability to walk in the off-med, off-stimulation condition (even with safety harness)\n* Gait impaired significantly by a condition other than PD, as determined by the PI\n* Breaks or shorts in active contacts\n* IPG battery nearing end of life (in patients with primary-cell IPGs)\n* Females who are nursing or pregnant\n* Diminished capacity to consent (concluded via UBACC)","ALL","18 Years",{"count":73,"type":74},15,"ESTIMATED","INTERVENTIONAL",[77],"EARLY_PHASE1","This project aims to establish the feasibility of Bayesian optimization for tuning deep brain stimulation (DBS) to treat gait symptoms in Parkinson's disease (PD) patients. Our primary question is: Can Bayesian optimization of DBS achieve reproducible results within a feasible number of gait measurements? PD patients will be enrolled who have DBS of the subthalamic nucleus (STN) or globus pallidus (GP) in whom at least 3 months have passed since activation of their neurostimulators, for stabilization of clinical stimulator settings. We will apply Bayesian optimization to derive DBS settings which maximally lengthen step length relative to the OFF DBS state.",[80],"Parkinson Disease (PD)","2026-09-25",{"date":83,"type":84},"2026-09-28","ACTUAL",{"date":86,"type":74},"2026-12",{"date":88,"type":74},"2033-03",{"name":5,"class":6},1]