[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Newronika\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100584625","investigating-adaptive-deep-brain-stimulation-in-parkinsons-disease-management-100584625",false,"NCT06891781","Investigating Adaptive Deep Brain Stimulation in Parkinson's Disease Management","A Prospective, Multi-center, Randomized, Double-blind, Cross Over, Clinical Trial to Compare the Safety and Effectiveness of Adaptive Versus Conventional Stimulation in Levodopa- Responsive Parkinson's Disease Treated With Bilateral Deep Brain Stimulation of the Subthalamic Nucleus","ADVENT","INCLUSION CRITERIA\n\nSubjects who meet all of the following criteria may be given consideration for inclusion in this clinical trial:\n\n1. Is willing and capable of signing informed consent\n2. Is ≥18 years old\n3. Has been diagnosed with levodopa-responsive idiopathic Parkinson's disease\n4. Has a Hoehn and Yahr (H\\&Y) scale stage of II or III when OFF medication at screening\n5. Exhibits motor fluctuations and PD-related symptoms that are not adequately controlled with medication, including motor complications of recent onset (\\>4 months duration)\n6. Has been referred for bilateral STN DBS in accordance with local practice\n7. Must be a good surgical candidate for placement of a deep brain stimulator as judged by the DBS surgical team\n8. Montreal Cognitive Assessment (MoCA) score of ≥ 26 at the Baseline\u002FScreening visit (when in \"MedsON\" state)\n9. UPDRS-III improvement by ≥30% with the levodopa challenge test as measured at approximately 90 minutes following administration of the challenge dose\n10. ≥4 hours per day (waking hours) with poor motor symptoms control (time \"OFF\" plus time \"ON\" with dyskinesia) despite optimal medical therapy, as assessed by the 3-day diary (at preop baseline)\n11. Subject successfully completed a test diary reaching a sufficient level of agreement (\\>75%) with study personnel responses and is willing and capable of completing a 3-day diary at each of the time points required per the protocol\n12. If female, subjects who are not currently pregnant as determined by negative serum pregnancy test, breastfeeding, or who are post-menopausal, surgically sterile or willing to use birth control for the duration of the study (acceptable forms of birth control are: hormone therapies (oral, injected, transdermal or implanted), IUD or other barrier methods (e.g., condom, diaphragm, cervical cap, spermicide\u002Fgel) or partner is surgically sterile\n13. Subject maintained a constant anti-PD medication treatment (best medical management, as duly documented) for at least 2 weeks prior to Baseline assessments\n14. Subject is willing and able to attend all study-required visits, complete the study procedures and attend appropriate follow up visits\n\nEXCLUSION CRITERIA\n\nThe subject must not meet any of the following exclusion criteria:\n\n1. Has contraindications for DBS surgery, including any intracranial abnormality (e.g., generalized atrophy, vascular malformation, hydrocephalus, hematoma, cavernous or venous angioma, tumor or metastases, midline shift, etc.) or metallic implant (e.g., aneurysm clip, cochlear implant, etc.) or other clinically significant space-occupying lesion which in the opinion of the surgeon would impact the ability to target and place the leads or IPG\n2. Is not on a stable dose of levodopa anti-Parkinson's disease medication for at least 2 weeks prior to Screening\u002FBaseline assessments\n3. Has any current major psychiatric disorder(s), such as Major Depressive Disorder, Bipolar I or II disorder, Schizophrenia, Schizoaffective Disorder, Delusional Disorder, Brief Psychotic Disorder, Obsessive-Compulsive Disorder, or any other current psychiatric condition that in the opinion of the investigator would confound the assessment of study endpoints, prevent proper data collection and\u002For compromise the subject's ability to participate, based on the psychiatric\u002Fpsychological assessment at screening.\n\n   (It is permitted if a subject has a diagnosis of Major Depressive Disorder with symptoms that currently are well-controlled and managed by a stable regimen of antidepressants for a minimum of 4 weeks prior to the screening visit). Includes current moderate or severe alcohol and\u002For substance use disorder based on the psychiatric\u002Fpsychological assessment at screening.\n4. A history of suicide attempt within 3 years of the screening visit or current active suicidal ideation as determined by a psychiatric\u002Fpsychological evaluation\n5. Any medical condition, such as cognitive impairment, dementia, seizures, congestive heart failure, unstable angina, uncontrolled diabetes, renal failure requiring dialysis, or any other severe medical condition that could interfere with study procedures, confound the assessment of study endpoints, prevent proper data collection, or that, in the opinion of the investigator, would compromise the subject's ability to participate\n6. Confirmation of diagnosis of a terminal illness associated with survival \\\u003C12 months\n7. Needs repeated MRI scans\n8. Requires diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT)\n9. Has an electrical or electromagnetic implant (e.g., cochlear prosthesis, pacemaker, neurostimulator, etc.) or plans to obtain, an active implanted medical device (AIMD) and\u002For an implanted medication pump (e.g., DUOPA™ infusion pump) and\u002For is treated with a portable infusion pump for any indication\n10. Is on anticoagulant therapy which cannot be paused for \\>5 days before surgery\n11. A history of cranial surgery including ablation procedure or any other previous neurosurgical procedure for the treatment of PD symptoms on either side of the brain\n12. Is currently participating in another clinical study (excluding any sub-study of the present trial). The sponsor will not grant waivers or protocol exceptions to any inclusion or exclusion criteria. Safety of subjects is the utmost concern and will be prioritized at every stage throughout this protocol.","ALL","18 Years",{"count":20,"type":21},104,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this prospective, multi-center, randomized, double-blind, crossover clinical trial is to evaluate the effectiveness and safety of adaptive DBS (aDBS) and conventional DBS (cDBS) delivered through the AlphaDBS system, in levodopa-responsive Parkinson's disease subjects. Data from previous studies conducted in Europe indicate that the use of the AlphaDBS system is safe and effective in both aDBS and cDBS modes. However, such studies suggest that aDBS may lead to more ON-time without troublesome dyskinesias in some patients. The study is designed to first demonstrate safety of effectiveness of cDBS, then to directly compare effectiveness of aDBS relative to cDBS. Subjects enrolled in the study will undergo multiple visits to assess the improvement of PD symptoms and will be randomized to Mode 1 for three months, followed by Mode 2. At the end of Mode 2, subjects will select their preferred mode, which will be maintained for 3 additional months. Subjects will complete patient diaries at different time points to evaluate their symptoms throughout the day.",[27],"Parkinson Disease, Idiopathic",[29,30,31,32,33,34],"Deep Brain Stimulation","Parkinson Disease","adaptive Deep Brain Stimulation","aDBS","conventional Deep Brain Stimulation","cDBS","NOT_YET_RECRUITING","2026-04-02",{"date":38,"type":39},"2026-04-08","ACTUAL",{"date":41,"type":21},"2026-08",{"date":43,"type":21},"2029-08",{"name":45,"class":46},"Newronika","INDUSTRY",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100414816","safety-and-efficacy-of-adaptive-deep-brain-stimulation-100414816","NCT04681534","Safety and Efficacy of Adaptive Deep Brain Stimulation","A Double-blind Crossover Study to Evaluate the Safety and Efficacy of Adaptive Deep Brain Stimulation Delivered Through AlphaDBS System in Patients With Parkinson's Disease","IPG Replacement Patients:\n\nInclusion Criteria\n\n1. Diagnosis of idiopathic PD;\n2. Subject is bilaterally treated with DBS in the STN using a Medtronic Activa PC or Activa RC IPG (mono-channnel or dual channel);\n3. DBS implant for at least 3 years and in need of battery replacement within 12 months after consent;\n4. Patients must be able to understand and sign the informed consent document.\n\nExclusion criteria\n\n1. Patients with severe cognitive decline, as resulting from MoCA assessment (MoCA score \\\u003C 10);\n2. Patients with major psychiatric issues or any other condition that, based on the physician opinion, could interfere with the study conduct (e.g. severe depression, psychosis, etc.);\n3. Patients with any medical conditions potentially interfering with DBS battery replacement surgery (e.g. severe hypertension, active cancer, intake of drugs interfering with the coagulation etc.);\n4. Need to replace or reposition the leads during the IPG replacement procedure;\n5. Patients with \\> 10 recurrent falls experienced in the 3 months prior to consent;\n6. Patients that cannot tolerate an interruption of DBS stimulation for at least 30 min;\n7. Patients taking less than one levodopa dose per day;\n8. Patients without suitable LFPs recordings or with significant artifacts;\n9. Pregnant or breastfeeding women.\n\nDe Novo DBS Patients:\n\nInclusion Criteria\n\n1. Patient is ≥ 18 years old;\n2. Patient has been diagnosed with levodopa-responsive idiopathic Parkinson's disease for ≥ 5 years;\n3. The disease stage is II, III or IV according to the Hoehn and Yahr scale\n4. Patient has history of improvement of PD-related symptoms as a direct result of levodopa intake;\n5. Patient has been selected for bilateral STN or GPi DBS, independently from this study, in accordance with local standard of care DBS screening;\n6. Patient has been selected to receive Medtronic leads model 3389 or 37086 or Abbott directional leads model number 6170 or 6172 or 6371, independently from this study, in accordance with local standard of care for DBS;\n7. Patient has DBS-leads circuit integrity assessed and confirmed by impedance testing, before IPG implantation;\n8. MoCA score \\> 26 in best medical condition;\n9. BDI-II score \\\u003C 17 in best medical condition;\n10. UPDRS-III improvement by ≥ 33% with levodopa challenge test (at approximately 90 min from the intake of the usual morning levodopa dose plus 30%);\n11. Patient is able to understand the study requirements and the treatment procedures and has provided written informed consent to participate;\n12. Patient has a responsible caregiver who will help completing the 3-day diary, provide feedback on activities of daily living (ADL), and ensure the patient complies with visit schedule;\n13. Patient is on stable PD-medication for one month prior surgery;\n14. Patient is willing and able to attend all study-required visits, complete the study procedures and attend appropriate follow up visits.\n\nExclusion Criteria\n\n1. Patient has contraindications for DBS surgery, including any intracranial abnormality (e.g., generalized atrophy, vascular malformation, hydrocephalus, hematoma, cavernous or venous angioma, tumor or metastases, midline shift, etc.) or metallic implant (e.g., aneurysm clip, cochlear implant, etc.);\n2. Patient has a history of suicide attempt or current active suicidal ideation as determined by a positive response to Item 2-5 of suicide ideation sub-scale of the Columbia Suicide Severity Rating Scale (C-SSRS);\n3. Patient has dementia, major depression, seizures, congestive heart failure, uncontrolled diabetes, dialysis, substance use disorders as described in DSM-V, or any other severe medical condition;\n4. Patient has any medical condition that could interfere with study procedures, confound the assessment of study endpoints, or prevent a proper data collection;\n5. Patient had confirmation of diagnosis of a terminal illness associated with survival \\\u003C 12 months;\n6. Patient needs repeated MRI scans;\n7. Patient requires diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT);\n8. Patient carries an electrical or electromagnetic implant (e.g., cochlear prosthesis, pacemaker, neurostimulator, etc.);\n9. Patient has, or plans to obtain, an implanted electrical stimulation medical device and\u002For an implanted medication pump (e.g., DUOPATM infusion pump) and\u002For is treated with a portable infusion pump;\n10. Patient is on anticoagulant therapy which cannot be paused for \\> 5 days before IPG implant surgery;\n11. Patient with a history of cranial surgery including ablation procedure or any other previous neurosurgical procedure for the treatment of PD symptoms on either side of the brain;\n12. Patient is currently participating in another clinical study (excluding any sub-study of the present study);\n13. Patient is a female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception;\n14. Patients without suitable LFPs recordings or with significant artifacts.",{"count":55,"type":21},15,[24],"The aim of this study is to assess the safety and the potential efficacy of personalized Local Field Potential (LFP)-based adaptive Deep Brain Stimulation (aDBS), using the implantable pulse generator (IPG) of the \"AlphaDBS\" System, in Parkinson's Disease patients, chronically implanted in subthalamic nucleus (STN) for DBS.",[30],"RECRUITING","2024-07-08",{"date":62,"type":39},"2024-07-09",{"date":64,"type":39},"2021-01-26",{"date":66,"type":21},"2025-12-30",{"name":45,"class":46},8,""]