[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100461756":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":30,"responsibleParty":172,"collaborators":20,"id":174,"slug":175,"hasResults":176,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":20,"eligibilityCriteria":180,"healthyVolunteers":176,"sex":181,"minAge":182,"maxAge":183,"enrollmentInfo":184,"targetDuration":20,"studyType":187,"phases":188,"briefSummary":190,"conditions":191,"keywords":195,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":212},{"fullName":5,"class":6},"CereGate Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"PD Patients treated with CereGate Software","EXPERIMENTAL","This singular arm contains participants diagnosed with Parkinson's Disease (PD) and previously implanted with a subthalamic nucleus deep brain stimulation (STN-DBS) System. Participants will use the CereGate software for 60(+\u002F-8) days on demand.",[13],"Device: CereGate Software; BSN cDBS Programmer; BSN Burst Programmer",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","CereGate Software; BSN cDBS Programmer; BSN Burst Programmer","CereGate's objective is to, with a single DBS system implanted in the standard STN location for PD:\n\n(i) deliver conventional tonic DBS stimulation of STN-to mitigate dopamine-responsive symptoms; and concurrently (ii) deliver bursting DBS-induced \"cueing\" stimulation-to mitigate FOG.\n\nThe sole function of CereGate Software is to guide the clinician through a systematic investigation of the stimulation parameter space to thereby configure \u002F tune CereGate Therapy for each participant. CereGate Software proposes parameters for the clinician to evaluate and assists in documenting the response. It does not send commands to, nor control the output of, the DBS System.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Kathleen Kmiecik","STUDY_CHAIR",[26],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","330-241-9098","kathleen@ceregate.com",[31,52,68,93,113,132,153],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Kaiser Permanente, KPNC Comprehensive Movement Disorders Program","RECRUITING","Redwood City","California","94063","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-122.23635,37.48522,{"lat":43,"lon":42},[46,50],{"name":47,"role":27,"phone":48,"phoneExt":20,"email":49},"Elena Call, MD","650-464-6321","elena.call@kp.org",{"name":47,"role":51,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"facility":53,"status":33,"city":54,"state":55,"zip":56,"country":37,"countryCode":38,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"University of Colorado Anschutz Medical Campus","Aurora","Colorado","80045",{"type":40,"coordinates":58},[59,60],-104.83192,39.72943,{"lat":60,"lon":59},[63,67],{"name":64,"role":27,"phone":65,"phoneExt":20,"email":66},"Drew Kern, MD","303-724-4172","drew.kern@cuanschutz.edu",{"name":64,"role":51,"phone":20,"phoneExt":20,"email":20},{"facility":69,"status":33,"city":70,"state":71,"zip":72,"country":37,"countryCode":38,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"University of Miami","Miami","Florida","33136",{"type":40,"coordinates":74},[75,76],-80.19366,25.77427,{"lat":76,"lon":75},[79,83,87,88,91],{"name":80,"role":27,"phone":81,"phoneExt":20,"email":82},"Ihtsham Haq, MD","305-243-6732","ihaq@med.miami.edu",{"name":84,"role":27,"phone":85,"phoneExt":20,"email":86},"Lissette Perez","305-243-2172","lperez4@miami.edu",{"name":80,"role":51,"phone":20,"phoneExt":20,"email":20},{"name":89,"role":90,"phone":20,"phoneExt":20,"email":20},"Corneliu Luca, MD","SUB_INVESTIGATOR",{"name":92,"role":90,"phone":20,"phoneExt":20,"email":20},"Taylor Peabody, MD",{"facility":94,"status":33,"city":95,"state":96,"zip":97,"country":37,"countryCode":38,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Northwestern University","Chicago","Illinois","60611",{"type":40,"coordinates":99},[100,101],-87.65005,41.85003,{"lat":101,"lon":100},[104,108,109,111],{"name":105,"role":27,"phone":106,"phoneExt":20,"email":107},"Neil Shetty, MD","312-695-7950","Neil.shetty@nm.org",{"name":105,"role":51,"phone":20,"phoneExt":20,"email":20},{"name":110,"role":90,"phone":20,"phoneExt":20,"email":20},"Joshua Rosenow, MD",{"name":112,"role":90,"phone":20,"phoneExt":20,"email":20},"Jessica Karl, PhD, PA-C",{"facility":114,"status":33,"city":115,"state":116,"zip":117,"country":37,"countryCode":38,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Wake Forest University","Winston-Salem","North Carolina","27157",{"type":40,"coordinates":119},[120,121],-80.24422,36.09986,{"lat":121,"lon":120},[124,128,130],{"name":125,"role":27,"phone":126,"phoneExt":20,"email":127},"Tonya Woosley, CRC","336-716-9520","twoosley@wakehealth.edu",{"name":129,"role":51,"phone":20,"phoneExt":20,"email":20},"Deepal Shah-Zamora, MD",{"name":131,"role":90,"phone":20,"phoneExt":20,"email":20},"Ha Green, PA",{"facility":133,"status":33,"city":134,"state":135,"zip":136,"country":37,"countryCode":38,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"Vanderbilt University Medical Center","Nashville","Tennessee","37232",{"type":40,"coordinates":138},[139,140],-86.78444,36.16589,{"lat":140,"lon":139},[143,147,151],{"name":144,"role":27,"phone":145,"phoneExt":20,"email":146},"Travis J Hassell, M.D.","615-936-2025","travis.j.hassell@vumc.org",{"name":148,"role":27,"phone":149,"phoneExt":20,"email":150},"Jackie Harris, RMA, CTRC III","615-936-3833","jacqueline.c.harris@vumc.org",{"name":152,"role":51,"phone":20,"phoneExt":20,"email":20},"Travis J Harris, M.D.",{"facility":154,"status":33,"city":155,"state":156,"zip":157,"country":37,"countryCode":38,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"University of Washington","Seattle","Washington","98195",{"type":40,"coordinates":159},[160,161],-122.33207,47.60621,{"lat":161,"lon":160},[164,168,170],{"name":165,"role":27,"phone":166,"phoneExt":20,"email":167},"Sarah Simon","206-221-2132","ssimon3@uw.edu",{"name":169,"role":51,"phone":20,"phoneExt":20,"email":20},"Yi-Han (Anny) Lin, MD",{"name":171,"role":90,"phone":20,"phoneExt":20,"email":20},"John Sanderson, MD",{"type":173,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100461756","use-of-ceregate-therapy-for-freezing-of-gait-in-pd-100461756",false,"NCT05292794","Use of CereGate Therapy for Freezing of Gait in PD","A Multi-Center, Controlled Study to Evaluate Use of CereGate Therapy to Reduce Freezing of Gait in Participants Diagnosed With Parkinson's Disease","Inclusion Criteria:\n\n1. Participant has an implanted STN-DBS system with Boston Scientific Gevia™ or Genus™ R16 IPG connected to any brand lead or extension that have been approved by the FDA to be used with Gevia or Genus IPGs.\n2. Participant is receiving treatment with carbidopa\u002Flevodopa, and\u002For with a dopamine agonist at the optimal doses as determined by a movement disorders neurologist.\n3. DBS optimized with documented improvement in motor signs (UPDRSIII) from DBS\n\nExclusion Criteria:\n\n1. Participant is unable to understand the study requirements and the treatment procedures, or unwilling \u002F unable to provide written informed consent before any study-specific tests or procedures are performed.\n2. Participant is unwilling or unable to comply with visit schedule and study related procedures.\n3. Participant's medication regimen has not been stable for at least 28 days prior to CG initiation.\n4. Participant's DBS stimulation settings have not been stable for at least 28 days prior to CG initiation.\n5. Participant is less than 21 years of age or older than 80 years of age.\n6. Participant is a female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception as determined by the study investigator.\n7. Participant has a terminal illness with life expectancy of \\\u003C 1 year.\n8. Participant has history of recurrent or unprovoked seizures.\n9. Participant currently diagnosed with drug or alcohol abuse, per DSM-5 criteria.\n10. Participant is in a very advanced stage of Parkinson's disease defined as: (i) Stage 5 as classified by the Hoehn and Yahr scale on medication and DBS (non-ambulatory) or (ii) participant requires an assistive device to perform the TBC OFF-meds \u002FON-DBS at the time of enrollment.\n11. Participant has a condition that makes walking difficult or could interfere with the study procedures or confound the evaluation of the study data, including musculoskeletal issues, peripheral neuropathies, hip\u002Fknee prostheses, or any visual or anatomical abnormality that affects their walking.\n12. Participant has disabling dyskinesias.\n13. Participant has a history of suicide attempt or current active suicidal ideation as determined by a positive response to Items 2-5 of suicide ideation sub-scale of the Columbia Suicide Severity Rating Scale (CSSRS).\n14. Participant, at the time of enrollment, fails the subthalamic nucleus (STN) stimulation challenge test (subject must perceive distinct bilateral sensations).\n15. Participant has less than 8% arrhythmicity as measured in the Turning and Barrier Course Figures of 8 (TBC-F8) pre-CG therapy (ON Medications\u002FON DBS \u002FOFF CG).","ALL","21 Years","80 Years",{"count":185,"type":186},41,"ESTIMATED","INTERVENTIONAL",[189],"NA","A Multi-Center, Controlled Study to Evaluate Use of CereGate Therapy to Reduce Freezing of Gait in Participants Diagnosed with Parkinson's Disease.",[192,193,194],"Parkinson Disease","Freezing of Gait","Deep Brain Stimulation",[192,196,193,197,198,199,200,201,202],"Parkinson's Disease","Freezing of Gait Symptoms in Parkinson Disease","Gait Disorders","Gait Disorders, Neurologic","Gait Disorder, Sensorimotor","Motor Disorder","Gait Impairment","2026-05-25",{"date":205,"type":206},"2026-05-28","ACTUAL",{"date":208,"type":206},"2022-04-18",{"date":210,"type":186},"2027-07",{"name":5,"class":6},7]