[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100405324":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":46,"responsibleParty":101,"collaborators":104,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":32,"eligibilityCriteria":113,"healthyVolunteers":109,"sex":114,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":32,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":48,"whyStopped":32,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"University of California, Los Angeles","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Low Intensity Focused Ultrasound","EXPERIMENTAL","Device: Low Intensity Focused Ultrasound Device\n\nLow Intensity Focused Ultrasound Pulsation (LIFUP) of amygdala (a key area for anxiety) will be performed during two sessions. The proposed experiment will involve behavioral (e.g. HAM-A) and paramedical (i.e., MRI\u002FfMRI) measurements just before and after each of the two LIFUP sessions (i.e., 5 non-consecutive minutes of stimulation in each session). The device does not produce a sound when operating and as such, the active group will well blinded.",[13],"Device: Active LIFUP Treatment",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham","SHAM_COMPARATOR","Sham Treatment consists of placing the device but not turning it on. The device does not produce a sound when operating and as such, the sham group will well blinded.",[19],"Device: Sham LIFUP Treatment",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Active LIFUP Treatment","8 LIFUP Treatments",[9],[27],"BX Pulsar 1002",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Sham LIFUP Treatment","8 sham LIFUP treatments",[15],null,[34],{"name":35,"affiliation":5,"role":36},"Margaret G Distler, MD,PhD","PRINCIPAL_INVESTIGATOR",[38,42],{"name":35,"role":39,"phone":40,"phoneExt":32,"email":41},"CONTACT","(310) 794-1553","mdistler@mednet.ucla.edu",{"name":43,"role":39,"phone":44,"phoneExt":32,"email":45},"Andrew Bishay, BS","4243719869","abishay@mednet.ucla.edu",[47,67,84],{"facility":5,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Los Angeles","California","90095","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-118.24368,34.05223,{"lat":58,"lon":57},[61,64,66],{"name":62,"role":39,"phone":63,"phoneExt":32,"email":41},"Margaret G Distler, MD, PhD","310-794-1553",{"name":65,"role":39,"phone":32,"phoneExt":32,"email":45},"Andrew Bishay",{"name":35,"role":36,"phone":32,"phoneExt":32,"email":32},{"facility":68,"status":48,"city":69,"state":70,"zip":71,"country":52,"countryCode":53,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Massachusetts General Hospital","Boston","Massachusetts","02129",{"type":55,"coordinates":73},[74,75],-71.05977,42.35843,{"lat":75,"lon":74},[78,82],{"name":79,"role":39,"phone":80,"phoneExt":32,"email":81},"Darin Dougherty","617-724-9247","ddougherty@mgb.org",{"name":83,"role":36,"phone":32,"phoneExt":32,"email":32},"Darin D Dougherty, MD",{"facility":85,"status":48,"city":86,"state":87,"zip":88,"country":52,"countryCode":53,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Medical University of South Carolina","Charleston","South Carolina","29425",{"type":55,"coordinates":90},[91,92],-79.93275,32.77632,{"lat":92,"lon":91},[95,99],{"name":96,"role":39,"phone":97,"phoneExt":32,"email":98},"Elisabeth Collins","843-638-7517","collieli@musc.edu",{"name":100,"role":36,"phone":32,"phoneExt":32,"email":32},"Mark S George, MD",{"type":36,"investigatorFullName":102,"investigatorTitle":103,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Margaret Distler, MD, PhD","Health Sciences Assistant Clinical Professor",[105,106],{"name":68,"class":6},{"name":85,"class":6},"100405324","low-intensity-focused-ultrasound-pulsation-lifup-for-the-treatment-of-generalized-anxiety-disorder-gad-100405324",false,"NCT04557891","Low-Intensity Focused Ultrasound Pulsation (LIFUP) for the Treatment of Generalized Anxiety Disorder (GAD)","Feasibility of Low-Intensity Focused Ultrasound Pulsation (LIFUP) for the Treatment of Generalized Anxiety Disorder (GAD)","Inclusion Criteria:\n\n1. Male or female\n2. Age 18-65\n3. Normal or corrected-to normal vision and hearing\n4. Primary diagnosis of generalized anxiety disorder, moderate\u002Fsevere per DSM-5. (HAM-A\\>17) 4a) The duration of the illness must exceed one year.\n5. Must be medically stable as determined by investigator\n6. Patient must have attempted and failed treatment with at least 2 SSRI and 1 augmentation\n7. History of rTMS is permitted, but not required.\n\nExclusion Criteria:\n\n1. Diagnosis of primary DSM-5 anxiety disorder other than GAD 1a) Affective disorders such as unipolar or bipolar depression are permitted as long as GAD is primary\n2. Current use of any non-prescribed psychoactive medications or drugs (aside from medications for treatment of GAD)\n3. Contraindication to enter the MRI environment\n4. Pregnancy (or suspected\u002Fpossible pregnancy or plan to become pregnant in the short-term)\n5. Inability to adhere to treatment schedule\n6. Initiation of new anxiolytic treatment at the time of study randomization","ALL","18 Years","65 Years",{"count":118,"type":119},48,"ESTIMATED","INTERVENTIONAL",[122],"NA","There are few treatment options available for patients once they have failed standard psychopharmacological therapy for generalized anxiety disorder. Existing brain stimulation methods such as rTMS fail to target deep brain structures associated with anxiety disorders; structures such as the amygdala. In this double-blind sham-controlled clinical trial, the investigators propose to establish baseline severity of anxiety in 48 patients, then deliver eight treatments over four sessions of focused ultrasound stimulation to the amygdala. Anxiety severity will be assessed using standard psychometric scales after each session, and at follow-ups.",[125],"Generalized Anxiety Disorder",[127],"focused ultrasound","2026-02-06",{"date":130,"type":131},"2026-02-10","ACTUAL",{"date":133,"type":131},"2021-07-26",{"date":135,"type":119},"2027-12",{"name":5,"class":6},3]