[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07680842":3,"trial-entities:NCT07680842":116,"trial-summary:NCT07680842":119},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":26,"study_type":32,"primary_purpose":33,"phases":34,"enrollment_info":36,"interventions":39,"primary_outcomes":52,"secondary_outcomes":57,"sex":66,"minimum_age":67,"maximum_age":68,"healthy_volunteers":69,"eligibility_criteria":70,"std_ages":86,"locations":89,"central_contacts":102,"overall_officials":108,"references":110,"see_also_links":115},"NCT07680842","24-41317","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","RECRUITING","2027-06-01","2026-06","2026-07-02","2025-07-09","University of California, San Francisco","OTHER",true,"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.",null,[19,20,21,22,23,24,25],"Drug-Resistant Epilepsy","Epilepsy","Epilepsy (Treatment Refractory)","Epilepsy Comorbidities","Epilepsy, Drug Resistant","Epilepsy, Generalized","Epilepsy, Focal",[27,19,20,28,29,30,31],"Seizures","Transcranial Ultrasound Stimulation","Focused ultrasound Stimulation","Electroencephalography (EEG)","Low Intensity Focused ultrasound (LIFU)","INTERVENTIONAL","TREATMENT",[35],"NA",{"count":37,"type":38},40,"ESTIMATED",[40,47],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"DEVICE","Target optimization using LIFU","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.",[42],[46],"Low Intensity Focused Ultrasound (LIFU)",{"type":41,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"Serial LIFU stimulation","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.",[48],[46],[53],{"measure":54,"description":55,"timeFrame":56},"Seizure Frequency","Seizure counts will be obtained from a seizure diary kept by each participant.","Seizure counts will be obtained daily for at least 1 month prior to the first study visit, throughout the study which averages around 4 months, and monitored for up to 2 months after the final visit.",[58,62],{"measure":59,"description":60,"timeFrame":61},"LIFU induced network change based on fMRI and\u002For electrophysiology","Baseline and post-serial stimulation fMRI and scalp electroencephalogram (EEG) will be obtained and compared. To measure brain activity, individuals will undergo a 1-hour scalp EEG recording with sensors placed in a standard 10-20 montage array. Patients will be instructed to rest quietly and attempt sleep during this routine EEG. EEG outcome measures will include interictal epileptiform discharge frequency and spectral power changes in the delta to gamma frequency bands pre versus post stimulation.","Obtained at the baseline visit and the final day of serial stimulation, which averages around 4 months.",{"measure":63,"description":64,"timeFrame":65},"Cognitive battery","A cognitive battery will be performed before and following stimulation and will span elements of working memory, inhibition, and planning. The cognitive battery will constitute the N-back (working memory), flanker (inhibition), dimensional set-shifting (set-shifting), and visuospatial memory assessments (working spatial memory).","The cognitive battery will be performed at baseline visit, as well as at the beginning and end of routine study visits; the duration averages around a 4 month period.","ALL","21 Years","65 Years",false,{"inclusion":71,"exclusion":78,"raw_text":85},[72,73,74,75,76,77],"Male or female between 21 and 65 years of age at screening","Clinical diagnosis of drug-resistant epilepsy with on average, 4 or more seizures per month.","Able to provide informed consent (or assent when applicable) by the subject or subject's legal representative.","Be willing to undergo a brain MRI.","Be able and willing to wear a headband during the treatment duration.","Be able to complete scheduled visits and daily seizure logs.",[79,80,81,82,83,84],"Has a craniotomy or pathologic intracranial lesion (e.g. vascular malformations) in the trajectory of the focused ultrasound beam.","Pregnant, breastfeeding, is attempting pregnancy, or unwilling to practice birth control during participation in the study.","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.","Has any unstable medical or psychiatric disease.","Any contraindications for completing a brain MRI scan.","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.","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.",[87,88],"ADULT","OLDER_ADULT",[90],{"facility":13,"status":8,"city":91,"state":92,"zip":93,"country":94,"contacts":95,"geoPoint":99},"San Francisco","California","94107","United States",[96],{"name":97,"role":98},"Joline M Fan, MD, MS","PRINCIPAL_INVESTIGATOR",{"lat":100,"lon":101},37.77493,-122.41942,[103],{"name":104,"role":105,"phone":106,"email":107},"Study Coordinator","CONTACT","4155087069","lifu.research@ucsf.edu",[109],{"name":97,"affiliation":13,"role":98},[111],{"pmid":112,"type":113,"citation":114},"39173737","BACKGROUND","Fan JM, Woodworth K, Murphy KR, Hinkley L, Cohen JL, Yoshimura J, Choi I, Tremblay-McGaw AG, Mergenthaler J, Good CH, Pellionisz PA, Lee AM, Di Ianni T, Sugrue LP, Krystal AD. Thalamic transcranial ultrasound stimulation in treatment resistant depression. Brain Stimul. 2024 Sep-Oct;17(5):1001-1004. doi: 10.1016\u002Fj.brs.2024.08.006. Epub 2024 Aug 22. No abstract available.",[],{"nct_id":4,"conditions":117,"biomarkers":118},[19],[],{"nct_id":4,"found":15,"summary":120,"prompt_version":129},{"design":121,"status":122,"heading":6,"summary":123,"follow_up":124,"word_count":125,"commitments":126,"compensation":127,"drugs_mentioned":128},"This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 40 participants, but the phase of the study is not specified.","completed","This study is investigating a new way to treat drug-resistant epilepsy using a non-invasive (no surgery) device called ATTN201. This device delivers low intensity focused ultrasound (LIFU) to specific areas of the brain to help reduce seizures. Researchers want to see if LIFU can change brain activity and lower the number of seizures you experience. You might be able to join if you are between 21 and 65 years old, have drug-resistant epilepsy with at least four seizures per month, and are willing to have a brain MRI and wear a headband during treatment. The main goal is to see how LIFU affects your seizure frequency. The current status of this study is unclear, and it plans to enroll 40 participants.","Your seizure frequency will be monitored for up to 2 months after your final study visit.",121,"You would undergo a brain MRI and wear a headband during treatment. Seizure counts will be recorded daily for about 4 months during the study, and for up to 2 months afterward.","Not stated in the trial record.",[],"v2"]