[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563031":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":64,"collaborators":66,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":26,"enrollmentInfo":78,"targetDuration":26,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"To determine the most effective stimulation parameters for DRTT LIFU neuromodulation.","EXPERIMENTAL","Investigators will record wrist accelerometer signals while participants maintain standardized postures that maximally elicit their tremor before, during, and after delivering LIFU stimulation.",[13,14],"Device: Focused Ultrasound Neuromodulation - Sham Control","Device: Focused ultrasound neuromodulation",{"label":16,"type":17,"description":18,"interventionNames":19},"Defocusing lens","SHAM_COMPARATOR","This arm will be exactly the same as that of the active arm with the exception that a defocusing lens will be fitted to the ultrasound device which will cause the ultrasound energy to be dispersed rather than directed at the target structure.",[13],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Focused Ultrasound Neuromodulation - Sham Control","Each ultrasound stimulation protocol will last for 60 seconds, consisting of 4 pulse trains of 5 seconds duration separated by 10 second intervals without stimulation. Across successive stimulation protocols (up to 25\u002Fpatient) investigators will systematically vary pulse repetition frequency, duty cycle, and acoustic intensity to determine how these parameters contribute to the behavioral effect (transient tremor reduction). Parameters will be shuffled to control for group-level carry over effects. A defocusing lens will be in place during the session to test the difference between focused and unfoucused ultrasound while controlling for non-specific auditory and somatosensory confounds.",[16,9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Focused ultrasound neuromodulation","Each ultrasound stimulation protocol will last for 60 seconds, consisting of 4 pulse trains of 5 seconds duration separated by 10 second intervals without stimulation. Across successive stimulation protocols (up to 25\u002Fpatient) investigators will systematically vary pulse repetition frequency, duty cycle, and acoustic intensity to determine how these parameters contribute to the behavioral effect (transient tremor reduction) in each patient. Parameters will be shuffled to control for group-level carry over effects and will include sham (unfocused or off-target stimulation) conditions to control for non-specific auditory confounds.",[9],[32],{"name":33,"affiliation":5,"role":34},"Leo Sugrue, MD, PhD","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Leo P. Sugrue, MD, PhD","CONTACT","415-353-9056","leo.sugrue@ucsf.edu",{"name":42,"role":38,"phone":26,"phoneExt":26,"email":43},"Tommaso Di Ianni, PhD","tommaso.diianni@ucsf.edu",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Pritzker Building, UCSF","RECRUITING","San Francisco","California","94107","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-122.41942,37.77493,{"lat":57,"lon":56},[60,62],{"name":61,"role":38,"phone":26,"phoneExt":26,"email":40},"Leo P. Sugrue, MD PhD",{"name":63,"role":38,"phone":26,"phoneExt":26,"email":43},"Tommaso Di Ianni, MD",{"type":65,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[67],{"name":68,"class":6},"Focused Ultrasound Foundation","100563031","ultrasound-neuromodulation-in-essential-tremor-100563031",false,"NCT06610877","Ultrasound Neuromodulation in Essential Tremor","UNMET","Inclusion Criteria:\n\n* Patients with medically refractory tremor scheduled to undergo MR-guided high-intensity focused ultrasound (HIFU) thalamotomy to treat their tremor at UCSF.\n\nExclusion Criteria:\n\n* Due to the logistical complexity of performing MRI in patients with MR-conditional pacemakers (need for device and patient monitoring), patients with pacemakers will be excluded from enrollment. All other patients undergoing HIFU thalamotomy for tremor will be eligible for enrollment.","ALL","18 Years",{"count":79,"type":80},60,"ESTIMATED","INTERVENTIONAL",[83],"NA","This study is being done to test whether low-intensity focused ultrasound (LIFU) (low energy sound waves) cause temporary changes in brain activity and behavior when directed at particular parts of the brain. By targeting LIFU to the parts of the brain thought to be responsible for essential tremor (ET), and measuring any associated improvement in tremor, the investigators hope to show that LIFU can be a useful tool for studying the brain circuits responsible for tremor and other brain disorders.",[86,87],"Essential Tremor","Neuromodulation",[86,87,89,90],"Focused Ultrasound","brain functional connectivity","2026-03-04",{"date":93,"type":94},"2026-03-06","ACTUAL",{"date":96,"type":94},"2024-10-01",{"date":98,"type":80},"2027-03",{"name":5,"class":6},1]