[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632450":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":29,"locations":39,"responsibleParty":55,"collaborators":28,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":28,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":28,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":42,"whyStopped":28,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"First Affiliated Hospital of Fujian Medical University","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"10 Hz LIFU Group","EXPERIMENTAL","Low-Intensity Focused Ultrasound (LIFU), PRF 10 Hz",[13],"Device: Low-Intensity Focused Ultrasound Stimulation（LIFU）",{"label":15,"type":10,"description":16,"interventionNames":17},"50 Hz LIFU Group","Low-Intensity Focused Ultrasound (LIFU), PRF 50 Hz",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"100 Hz LIFU Group","Low-Intensity Focused Ultrasound (LIFU), PRF 100 Hz",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DEVICE","Low-Intensity Focused Ultrasound Stimulation（LIFU）","This is not a traditional three-arm parallel trial but a Stage I\u002FII dose-finding study using an adaptive design. Participants are dynamically assigned to three pulse repetition frequency levels (10 Hz, 50 Hz, 100 Hz) based on predefined rules, rather than fixed randomization.\n\nThe study adopts a two-stage utility-based Bayesian optimal interval (U-BOIN) design:\n\nStage I: Dose decisions are based solely on dose-limiting toxicity (DLT) incidence. Participants are enrolled in cohorts of three. Based on observed DLTs, the next cohort's dose is determined (escalate\u002Fstay\u002Fde-escalate).\n\nStage II: When any dose group reaches 6 participants or the highest dose is explored, safety and efficacy data are integrated to calculate a utility value. Subsequent cohorts are assigned to the dose group with the highest utility value.\n\nThe study stops when any dose group reaches 12 participants or total enrollment reaches 24. Not all three dose levels may be utilized. Allocation is not fixed a priori.",[9,19,15],null,[30,35],{"name":31,"role":32,"phone":33,"phoneExt":28,"email":34},"Xin-Yuan Chen","CONTACT","+86 15005065282","fychenxinyuan@fjmu.edu.cn",{"name":36,"role":32,"phone":37,"phoneExt":28,"email":38},"Li-Zhu Wu","+86 18459867658","1809225097@qq.com",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":28,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Department of Rehabilitation Medicine, The First Affiliated Hospital of Fujian Medical University","RECRUITING","Fuzhou","Fujian","China","CN",{"type":48,"coordinates":49},"Point",[50,51],119.30611,26.06139,{"lat":51,"lon":50},[54],{"name":31,"role":32,"phone":33,"phoneExt":28,"email":34},{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"PRINCIPAL_INVESTIGATOR","Xinyuan Chen","Attending Physician","100632450","optimizing-parameters-of-low-intensity-focused-ultrasound-for-pallidal-modulation-in-huntingtons-disease-100632450",false,"NCT07513844","Optimizing Parameters of Low-Intensity Focused Ultrasound for Pallidal Modulation in Huntington's Disease","Low-Intensity Focused Ultrasound Stimulation of the External Globus Pallidus in Huntington's Disease: A Phase I\u002FII Safety and Feasibility Trial","Inclusion Criteria:\n\n1. Aged 18 to 75 years (inclusive)\n2. Genetically confirmed Huntington's disease with HTT CAG repeat length of 40 or greater\n3. Unified Huntington's Disease Rating Scale Total Maximal Chorea score of 8 or higher on a scale of 0 to 28, with higher scores indicating more severe chorea\n4. Huntington's Disease Integrated Staging System stage 2 or 3\n5. Willing to participate and provide informed consent\n6. Have a reliable caregiver available\n7. No severe cognitive impairment that would preclude reliable reporting of adverse events or efficacy during treatment\n\nExclusion Criteria:\n\n1. History of self-injury, aggressive behavior, or unstable psychiatric disorders\n2. History of head injury or neurosurgical procedure\n3. Presence of intracranial implants, metallic foreign bodies, cochlear implants, or cardiac pacemakers\n4. Severe systemic disease, pregnancy, or breastfeeding\n5. Contraindications to magnetic resonance imaging, ultrasound, or anesthesia\n6. Prior treatment with electroconvulsive therapy, transcranial magnetic stimulation, transcranial direct current stimulation, transcranial alternating current stimulation, or other neuromodulation therapies within the past 3 years\n7. Severe brain atrophy with unclear external globus pallidus structure on MRI\n8. Concurrent participation in another interventional clinical trial\n9. Any other condition that, in the opinion of the investigator, would preclude participation","ALL","18 Years","75 Years",{"count":70,"type":71},24,"ESTIMATED","INTERVENTIONAL",[74],"NA","The purpose of this research study is to determine the optimal pulse repetition frequency of low-intensity focused ultrasound that is safe and effective in improving motor symptoms in patients with Huntington's disease.",[77],"Huntington Disease",[79,77,80,81],"low intensity focused ultrasound","brain stimulation","ultrasonic stimulation","2026-04-23",{"date":84,"type":85},"2026-04-29","ACTUAL",{"date":87,"type":85},"2026-04-20",{"date":89,"type":71},"2027-03-31",{"name":5,"class":6},1]