[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546826":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":30,"responsibleParty":48,"collaborators":50,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":20,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":20,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":32,"whyStopped":20,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Beijing Tiantan Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intraoperative and One month after the operation microelectrode stimulation of DBS","EXPERIMENTAL","By comparing the behavioral characteristics of the memory paradigm under microelectrode stimulation during DBS operation and the characteristics of the electrophysiological signals behind it, as well as the behavioral characteristics of the memory paradigm under electrical stimulation and the characteristics of brain network activity during DBS startup one month after surgery, we analyzed the regulatory effect of substantia nigra DBS on memory network",[13],"Device: microelectrode stimulation of DBS",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","microelectrode stimulation of DBS","Contact selection: According to the electrode position in the image (target reconstruction through CT scan), the electrode located in the substantia nigra is selected as the negative electrode, the contact near the upper part of the substantia nigra is selected as the positive electrode, and the bipolar stimulation mode is selected.\n\nStimulation parameters: The frequency was selected as 0\u002F10\u002F130Hz, the pulse width remained unchanged at 90μs, the side effects of patients were observed, and the voltage was slowly increased to 2.0V; The patient voltage was 0 during the spurious stimulation. The washout period was 1 hour",[9],null,[22],{"name":23,"affiliation":5,"role":24},"lin shi, M.D.","STUDY_CHAIR",[26],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","008615210466780","shilin2015@foxmail.com",[31],{"facility":5,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"RECRUITING","Beijing","Beijing Municipality","100071","China","CN",{"type":39,"coordinates":40},"Point",[41,42],116.39723,39.9075,{"lat":42,"lon":41},[45],{"name":46,"role":27,"phone":47,"phoneExt":20,"email":29},"Shi Lin","86 010 15210466780",{"type":49,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[51,53,55],{"name":52,"class":6},"Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China",{"name":54,"class":6},"Tsinghua University",{"name":56,"class":6},"Boston Children's Hospital","100546826","mechanism-and-application-of-dbs-in-the-treatment-of-pd-100546826",false,"NCT06400017","Mechanism and Application of DBS in the Treatment of PD","Mechanism and Application of Deep Brain Stimulation in the Treatment of Parkinson's Disease","Inclusion Criteria:\n\n* Voluntarily participate in the clinical study and sign the informed consent;\n* Age 50-70 years old, gender unlimited;\n* The clinical diagnosis is consistent with typical PD, and the medical history is less than 20 years;\n* Patients who intend to use 3.0T magnetic resonance compatible dual-channel DBS device (G106R or G106RS, Beijing Pinchi Company) for bilateral subthalamic nucleus DBS surgery to control PD symptoms;\n* MRI excluded patients with obvious structural changes;\n* The visual acuity and hearing of the subjects were basically normal, and the compliance was good, and they could complete the tasks listed in the experimental scheme in accordance with the standards.\n\nExclusion Criteria:\n\n* Serious mental, cognitive and psychological disorders, unable to sign informed consent or cooperate with the operation and various tasks;\n* There are contraindications for neurosurgery, such as hydrocephalus, cerebral atrophy, cerebrovascular sequelae, heart disease and other cardiovascular and cerebrovascular diseases;\n* There are concomitant diseases that seriously affect health, such as tumors, serious abnormalities of liver and kidney function (indexes more than 3 times normal);\n* There is intracranial space occupation, cerebrovascular disease, mental illness, other neurological diseases, claustrophobia, or there is an implant in the body, which affects the nuclear magnetic scan;\n* The results of the Mini-Mental State Scale (MMSE) \\\u003C24 or the Montreal Cognitive Assessment Scale (MoCA) \\\u003C18 in the preoperative assessment, or the results of other scales indicate the presence of severe dementia.","ALL","50 Years","70 Years",{"count":68,"type":69},60,"ESTIMATED","INTERVENTIONAL",[72],"NA","Project name: The mechanism and application of deep brain stimulation in the treatment of Parkinson's disease\n\nObjective:\n\nTo test the hypothesis that electrical stimulation of substantia nigra regulates cognitive dysfunction in Parkinson's disease and to reveal its electrophysiological mechanism.\n\nStudy design:\n\nThis study is a self-controlled prospective cohort study. By comparing the behavioral characteristics of the memory paradigm under microelectrode stimulation during DBS operation and the characteristics of the underlying electrophysiological signals, and the behavioral characteristics of the memory paradigm and the characteristics of brain network activity under electrical stimulation when DBS is turned on 1 month after surgery. The regulatory effect of substantia nigra DBS on memory network was analyzed.\n\nCases: 60\n\nCase selection:\n\nInclusion criteria:\n\n1)Voluntarily participate in the clinical study and sign the informed consent; 2) Age 50-70 years old, gender unlimited; 3) The clinical diagnosis is consistent with typical PD, and the medical history is less than 20 years; 4) Patients who intend to use 3.0T magnetic resonance compatible dual-channel DBS device (G106R or G106RS, Beijing Pinchi Company) for bilateral subthalamic nucleus DBS surgery to control PD symptoms; 5) MRI excluded patients with obvious structural changes; 6) The visual acuity and hearing of the subjects were basically normal, and the compliance was good, and they could complete the tasks listed in the experimental scheme in accordance with the standards.\n\nExclusion criteria:\n\n1)Serious mental, cognitive and psychological disorders, unable to sign informed consent or cooperate with the operation and various tasks; 2) There are contraindications for neurosurgery, such as hydrocephalus, cerebral atrophy, cerebrovascular sequelae, heart disease and other cardiovascular and cerebrovascular diseases; 3) There are concomitant diseases that seriously affect health, such as tumors, serious abnormalities of liver and kidney function (indexes more than 3 times normal); 4) There is intracranial space occupation, cerebrovascular disease, mental illness, other neurological diseases, claustrophobia, or there is an implant in the body, which affects the nuclear magnetic scan; 5) The results of the Mini-Mental State Scale (MMSE) \\\u003C24 or the Montreal Cognitive Assessment Scale (MoCA) \\\u003C18 in the preoperative assessment, or the results of other scales indicate the presence of severe dementia.\n\ntherapeutic schedule： This study did not change the patient's overall treatment regimen, and only electrical stimulation was tested during and after DBS surgery\n\nEfficacy evaluation:\n\nEffectiveness evaluation index (primary efficacy index and secondary efficacy index) : accuracy of memory paradigm, response speed Safety evaluation indicators: blood pressure, heart rate, dual frequency index, patient complaints and symptoms\n\nStatistical methods:\n\nThe group t test was used to compare the normal distribution between the measurement data groups. For measurement data with non-normal distribution, Wilcoxon rank sum test was used for comparison between groups.\n\nThe study period is January 1, 2024 - December 31, 2026.",[75],"Parkinson's Disease and Parkinsonism",[77,78],"Cognitive dysfunction","Electrical stimulation of substantia nigra","2025-05-27",{"date":81,"type":82},"2025-05-31","ACTUAL",{"date":84,"type":82},"2024-07-01",{"date":86,"type":69},"2026-12-31",{"name":5,"class":6},1]