[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07410598":3,"trial-entities:NCT07410598":112,"trial-summary:NCT07410598":115},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":25,"primary_purpose":13,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":52,"secondary_outcomes":57,"sex":66,"minimum_age":67,"maximum_age":68,"healthy_volunteers":14,"eligibility_criteria":69,"std_ages":79,"locations":82,"central_contacts":97,"overall_officials":99,"references":100,"see_also_links":111},"NCT07410598","IRB202501673","Safety and Tolerability of Patterned Stimulation for DBS in the Home Setting","RECRUITING","2028-03-01","2026-07","2026-07-06","2026-05-06","University of Florida","OTHER",false,"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.","This pilot study will investigate the safety, tolerability, and feasibility of three distinct patterned Deep Brain Stimulation (pDBS) paradigms delivered in a home setting using the Boston Scientific Chronos Research Engine. The three stimulation patterns under evaluation are:\n\n1. Biphasic DBS (bDBS)\n2. Nocturnal Theta Burst Stimulation (tDBS)\n3. Region-Specific Frequency Alternation (fDBS).\n\nSixty patients with Parkinson's Disease (PD), each with stable bilateral Subthalamic Nucleus (STN) and Globus Pallidus internus (GPi) DBS for at least six months, will be enrolled and assigned to one of the three parallel study arms. At the baseline visit, each participant will be programmed with two stimulation settings: one replicating their chronic best clinical setting, and a second incorporating the assigned patterned stimulation.\n\nFor participants in the bDBS arm, the second setting will mirror their clinical setting but use a biphasic waveform to ensure charge balancing. 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. 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.\n\nParticipants will be blinded to the identity of the two settings and will be able to switch between them using their patient programmer. The study will follow a randomized, blinded, two-period crossover design over a total duration of four weeks. During the first two weeks, participants will use one of the two programmed settings. At the end of this period, a telemedicine visit will be conducted to collect quality of life (QoL) questionnaires, related surveys, and a video-based modified MDS-UPDRS assessment. Participants will then switch to the alternate setting for the remaining two weeks. At the conclusion of the study, participants will return for an in-person research visit to complete the same assessments for the second setting. This design allows for within-subject comparison of conventional DBS and patterned DBS in a real-world, home-based environment, and will generate critical data to inform the design of a future large-scale trial.",[18,19],"Parkinson Disease","Deep Brain Stimulation",[21,22,23,24],"Parkinson disease","PD","DBS","deep brain stimulation","INTERVENTIONAL",[27],"NA",{"count":29,"type":30},60,"ESTIMATED",[32,38,44,48],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DEVICE","Biphasic deep brain stimulation","Deep brain stimulation using active recharge biphasic waveforms consisting of an equal anodic and cathodic pulse immediately delivered sequentially",[37],"Biphasic DBS (bDBS)",{"type":33,"name":39,"description":40,"armGroupLabels":41},"Conventional deep brain stimulation","Conventional deep brain stimulation programming that is currently FDA approved",[37,42,43],"Nocturnal Theta Burst Stimulation (tDBS)","Region-Specific Frequency Alternation (fDBS)",{"type":33,"name":45,"description":46,"armGroupLabels":47},"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",[42],{"type":33,"name":49,"description":50,"armGroupLabels":51},"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",[43],[53],{"measure":54,"description":55,"timeFrame":56},"Tolerability of patterned DBS","The primary endpoint of this study is the proportion of participants who are able to tolerate patterned DBS (pDBS) for the full two-week intervention period. Tolerability is defined as the ability to remain on the assigned pDBS setting without reverting to an alternative DBS configuration.","From enrollment to the end of novel waveform trial period at 2 weeks",[58,62],{"measure":59,"description":60,"timeFrame":61},"Change in motor symptom severity","A comparison of the modified MDS-UPDRS between conventional and patterned waveform based on a video assessment","From enrollment to the end of study period at 4 weeks",{"measure":63,"description":64,"timeFrame":65},"Change in quality of life","A comparison of quality of life metrics through the Parkinson's Disease Questionnaire (PDQ-39) between conventional and patterned DBS","From enrollment to the end of the study period at 4 weeks","ALL","18 Years","80 Years",{"inclusion":70,"exclusion":74,"raw_text":78},[71,72,73],"Bilateral STN or GPi DBS with Boston Scientific Vercise Genus DBS System","Diagnosis of Parkinson's disease as confirmed by a movement disorders fellowship trained neurologist","Chronic stable DBS therapy, defined as having DBS therapy for at least 6 months",[75,76,77],"History of previous neurosurgical intervention aside from DBS","Diagnosis of dementia (whether primary or related to Parkinson's disease)","A diagnosis of atypical parkinsonism or secondary parkinsonism at any time after DBS implantation","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",[80,81],"ADULT","OLDER_ADULT",[83],{"facility":12,"status":7,"city":84,"state":85,"zip":86,"country":87,"contacts":88,"geoPoint":94},"Gainesville","Florida","32608","United States",[89],{"name":90,"role":91,"phone":92,"email":93},"Joshua Wong, MD","CONTACT","352-294-5400","joshua.wong@neurology.ufl.edu",{"lat":95,"lon":96},29.65163,-82.32483,[98],{"name":90,"role":91,"phone":92,"email":93},[],[101,105,108],{"pmid":102,"type":103,"citation":104},"32357269","BACKGROUND","Horn MA, Gulberti A, Gulke E, Buhmann C, Gerloff C, Moll CKE, Hamel W, Volkmann J, Potter-Nerger M. A New Stimulation Mode for Deep Brain Stimulation in Parkinson's Disease: Theta Burst Stimulation. Mov Disord. 2020 Aug;35(8):1471-1475. doi: 10.1002\u002Fmds.28083. Epub 2020 May 1.",{"pmid":106,"type":103,"citation":107},"33981207","Wong JK, Hu W, Barmore R, Lopes J, Moore K, Legacy J, Tahafchi P, Jackson Z, Judy JW, Raike RS, Wang A, Tsuboi T, Okun MS, Almeida L. Safety and Tolerability of Burst-Cycling Deep Brain Stimulation for Freezing of Gait in Parkinson's Disease. Front Hum Neurosci. 2021 Apr 26;15:651168. doi: 10.3389\u002Ffnhum.2021.651168. eCollection 2021.",{"pmid":109,"type":103,"citation":110},"27000764","Akbar U, Raike RS, Hack N, Hess CW, Skinner J, Martinez-Ramirez D, DeJesus S, Okun MS. Randomized, Blinded Pilot Testing of Nonconventional Stimulation Patterns and Shapes in Parkinson's Disease and Essential Tremor: Evidence for Further Evaluating Narrow and Biphasic Pulses. Neuromodulation. 2016 Jun;19(4):343-56. doi: 10.1111\u002Fner.12397. Epub 2016 Mar 22.",[],{"nct_id":4,"conditions":113,"biomarkers":114},[18],[],{"nct_id":4,"found":116,"summary":117,"prompt_version":127},true,{"design":118,"status":119,"heading":120,"summary":121,"follow_up":122,"word_count":123,"commitments":124,"compensation":125,"drugs_mentioned":126},"This is an interventional pilot study with 60 participants, testing three different patterned stimulation approaches. Participants will be assigned to one of three groups.","completed","Patterned Deep Brain Stimulation for Parkinson's Disease in the Home Setting","This study is looking at the safety and how well people tolerate different types of patterned Deep Brain Stimulation (DBS) for Parkinson's disease, used at home. DBS is a treatment where a device sends electrical signals to specific areas of the brain. The study will test three new ways of delivering DBS: Biphasic DBS, Theta Burst DBS (which delivers stimulation in bursts at night), and Multi-frequency DBS (which uses different frequencies on different parts of the DBS lead). Researchers want to see if these new patterns are safe and tolerable for people with Parkinson's disease who already have stable bilateral DBS. The study plans to enroll 60 participants aged 18 to 80 who have had DBS for at least 6 months.","Tolerability is measured from enrollment to the end of the novel waveform trial period at 2 weeks.",121,"You would have a baseline visit where your DBS device is programmed with two settings. The primary endpoint for tolerability is measured at the end of a two-week novel waveform trial period.","Not stated in the trial record.",[],null]