[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645320":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":41,"responsibleParty":57,"collaborators":59,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":39,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":39,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":88,"overallStatus":43,"whyStopped":39,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Target optimization using LIFU","ACTIVE_COMPARATOR","Participants in this single experimental group will undergo a series of LIFU sessions to determine optimal clinical response. Each participant will receive active LIFU stimulation of up to three personalized brain targets. The study utilizes a within-subject, sham-controlled design where participants receive both active LIFU and sham (placebo) stimulation across different sessions to compare physiological and clinical responses.",[13],"Device: Target optimization using LIFU",{"label":15,"type":10,"description":16,"interventionNames":17},"Serial LIFU stimulation","If an optimal target is identified, patients will undergo serial stimulation of the optimal target.",[18],"Device: Serial LIFU stimulation",[20,26],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","LIFU will be administered using the ATTN201 wearable device by Attune Neurosciences Inc. Positioning is guided by an offline MRI scan, enabling non-invasive targeting of the LIFU beams directly to deep brain structures. Targeting will be determined based on the epileptogenic network.",[9],[25],"Low Intensity Focused Ultrasound (LIFU)",{"type":21,"name":15,"description":27,"armGroupLabels":28,"otherNames":29},"Serial LIFU will again be administered using the ATTN201 wearable device by Attune Neurosciences Inc. Serial stimulation target selection will be based on the initial target optimization outcome, including the assessment of physiology and clinical treatment response.",[15],[25],[31],{"name":32,"affiliation":5,"role":33},"Joline M Fan, MD, MS","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Study Coordinator","CONTACT","4155087069",null,"lifu.research@ucsf.edu",[42],{"facility":5,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","San Francisco","California","94107","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-122.41942,37.77493,{"lat":53,"lon":52},[56],{"name":32,"role":33,"phone":39,"phoneExt":39,"email":39},{"type":58,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR",[60],{"name":61,"class":62},"Attune Neurosciences Inc","INDUSTRY","100645320","non-invasive-low-intensity-focused-ultrasound-stimulation-for-drug-resistant-epilepsy-100645320",false,"NCT07680842","Non-Invasive Low Intensity Focused Ultrasound Stimulation for Drug-Resistant Epilepsy","Pilot Study of Non-Invasive Low Intensity Focused Ultrasound as an Adjunctive Treatment for Drug-Resistant Epilepsy","Inclusion Criteria\n\n* Male or female between 21 and 65 years of age at screening\n* Clinical diagnosis of drug-resistant epilepsy with on average, 4 or more seizures per month.\n* Able to provide informed consent (or assent when applicable) by the subject or subject's legal representative.\n* Be willing to undergo a brain MRI.\n* Be able and willing to wear a headband during the treatment duration.\n* Be able to complete scheduled visits and daily seizure logs.\n\nExclusion Criteria\n\n* Has a craniotomy or pathologic intracranial lesion (e.g. vascular malformations) in the trajectory of the focused ultrasound beam.\n* Pregnant, breastfeeding, is attempting pregnancy, or unwilling to practice birth control during participation in the study.\n* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.\n* Has any unstable medical or psychiatric disease.\n* Any contraindications for completing a brain MRI scan.\n* Has evidence of any other clinically relevant neurological disorder at the time of screening, including Alzheimer's disease, frontotemporal dementia, Huntington's disease, amyotrophic lateral sclerosis, and multiple sclerosis.","ALL","21 Years","65 Years",{"count":74,"type":75},40,"ESTIMATED","INTERVENTIONAL",[78],"NA","The goal of this study is to investigate the effects of a non-invasive, low intensity focused ultrasound (LIFU) stimulation on seizure frequency and the epileptogenic network in drug-resistant epilepsy. LIFU uses focused sound waves to modulate deep brain regions and to enable changes in brain network activity. Encephalography (EEG) and behavioral tasks will also be used to study how LIFU affects brain activity.",[81,82,83,84,85,86,87],"Drug-Resistant Epilepsy","Epilepsy","Epilepsy (Treatment Refractory)","Epilepsy Comorbidities","Epilepsy, Drug Resistant","Epilepsy, Generalized","Epilepsy, Focal",[89,81,82,90,91,92,93],"Seizures","Transcranial Ultrasound Stimulation","Focused ultrasound Stimulation","Electroencephalography (EEG)","Low Intensity Focused ultrasound (LIFU)","2026-06-25",{"date":96,"type":97},"2026-07-02","ACTUAL",{"date":99,"type":97},"2025-07-09",{"date":101,"type":75},"2027-06-01",{"name":5,"class":6},1]