[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100471287":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":43,"responsibleParty":59,"collaborators":63,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":41,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":103,"overallStatus":45,"whyStopped":41,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Beijing Tiantan Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"STN-DBS","EXPERIMENTAL","The patients in this group will be treated with STN-DBS.",[13],"Device: STN-DBS",{"label":15,"type":16,"description":17,"interventionNames":18},"GPi-DBS","ACTIVE_COMPARATOR","The patients in this group will be treated with GPi-DBS.",[19],"Device: GPi-DBS",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","The patients will be treated with deep brain electrode placement of STN target under local and general anesthesia. Switching the system on: the stimulator will be switched on 3 weeks after surgery to allow time for the brain edema and \"stun effect\" to wear off. Postoperative medication: The subject taking medication in the past will continue the medication. If the subject with no medication before, will be required not to take medication related to dystonia.",[9],[26],"subthalamic necleus-deep brain stimulation",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"The patients will be treated with deep brain electrode implantation of GPi target under local and general anesthesia. Except that the surgical target was GPi, the operation process, stimulator switch-on time, and postoperative medication were the same as those in the STN-DBS group.",[15],[31],"globus pallidus internus-deep brain stimulation",[33],{"name":34,"affiliation":5,"role":35},"Jianguo Zhang, MD, PhD","STUDY_CHAIR",[37],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Yutong Bai, MD, PhD","CONTACT","13611420134",null,"baiyutong88@qq.com",[44],{"facility":5,"status":45,"city":46,"state":41,"zip":41,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Beijing","China","CN",{"type":50,"coordinates":51},"Point",[52,53],116.39723,39.9075,{"lat":53,"lon":52},[56],{"name":34,"role":39,"phone":57,"phoneExt":41,"email":58},"+86-13601294613","zjguo73@126.com",{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"PRINCIPAL_INVESTIGATOR","Jianguo Zhang","Director of Department of Functional Neurosurgery",[64,66,68,70,72,75,77,79],{"name":65,"class":6},"Peking Union Medical College Hospital",{"name":67,"class":6},"Peking University People's Hospital",{"name":69,"class":6},"Civil Aviation General Hospital",{"name":71,"class":6},"Chinese PLA General Hospital",{"name":73,"class":74},"Beijing Pins Medical Co., Ltd","INDUSTRY",{"name":76,"class":6},"Shandong University of Traditional Chinese Medicine",{"name":78,"class":6},"Qilu Hospital of Shandong University",{"name":80,"class":81},"Beijing Fengtai Hospital","UNKNOWN","100471287","deep-brain-stimulation-for-idiopathic-craniofacial-dystonia-gpi-or-stn-100471287",false,"NCT05416905","Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: GPi or STN","Multicenter Evaluation of Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: Globus Pallidus intErnus or Subthalamic Nucleus","MEIGES","Inclusion Criteria:\n\n1. Adult subject (male or female, 18-75 years);\n2. Diagnosed with idiopathic craniofacial dystonia for more than 1 year, including at least one of the eye and oromandibular region. Cervical dystonia may be present;\n3. Treated with oral drugs or botulinum toxin injections, but with no satisfactory curative effect;\n4. Normal cognitive function with MMSE score ≥ 24;\n5. Informed consent signed.\n\nExclusion Criteria:\n\n1. Only cervical dystonia, or combined with dystonia in other parts of the body other than the cervical region;\n2. Diagnosed with other neuropsychiatric diseases(Alzheimer's disease, amyotrophic lateral sclerosis, Parkinson's disease, etc.);\n3. History of brain surgery;\n4. Severe depression with HRSD score ≥ 35;\n5. Contraindications to neurosurgery(cerebral infarction, hydrocephalus, cerebral atrophy, sequelae of cerebrovascular disease, etc);\n6. Contraindications to CT or MRI scanning(claustrophobia, etc);\n7. pregnant or breastfeeding female, or has positive pregnancy test prior to randomization;\n8. Contraindications to general anesthesia (severe arrhythmia, severe anemia, abnormal liver and kidney function, etc.);\n9. Expected lifetime \\\u003C 12 months;\n10. Currently receiving an investigational drug or device;\n11. Other circumstances that the investigator considers unsuitable to participate in this study or that may pose a significant risk to the patient (inability to understand or comply with research procedures and follow-up, etc.).","ALL","18 Years","75 Years",{"count":94,"type":95},110,"ESTIMATED","INTERVENTIONAL",[98],"NA","MEIGES is a prospective, multicenter, randomized controlled clinical trial with the primary hypothesis that, STN-DBS is non-inferior to GPi-DBS for motor symptoms improvements at 365 days postoperatively in patients with idiopathic craniofacial dystonia.",[101,102],"Craniofacial Dystonia","Deep Brain Stimulation",[101,102,104,105],"Globus pallidus internus","Subthalamic nucleus","2025-04-17",{"date":108,"type":109},"2025-04-22","ACTUAL",{"date":111,"type":109},"2022-06-22",{"date":113,"type":95},"2025-05-30",{"name":5,"class":6},1]