[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"seizure-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:seizure-disorder":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,50,79,108],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100545959","phase-1-a-safety-tolerability-and-preliminary-efficacy-of-low-intensity-focused-ultrasound-neuromodulation-in-patients-with-drug-resistant-epilepsy-100545959",false,"NCT06388707","A Safety, Tolerability, and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Patients With Drug-resistant Epilepsy","A Prospective, Open-label, Single-arm, Multi-center, Pilot Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Patients With Drug-resistant Unilateral or Bilateral Temporal Lobe Epilepsy","Inclusion Criteria:\n\n1. Male or female patients ≥ 18 years of age at the time of enrollment.\n2. Patients with drug-resistant temporal lobe epilepsy (DR-TLE), defined as failure of adequate trials of two tolerated, appropriately chosen and used anti-epileptic drug schedules (whether as monotherapies or in combination).\n3. Focal-onset seizures with or without secondary generalization and no more than two known seizure onset zones (seizure foci), at least one which is in the mesial temporal lobe.\n4. At least 4 focal-onset seizures with objectively visible or significantly disabling manifestations in the 8-week baseline and at least one seizure per month in the baseline.\n5. MRI and EEG within the past 3 years. At least one prior EEG should demonstrate interictal or ictal focal epileptiform findings.\n6. Patients with the central of FUS exposure region are located at least 30 mm distance beneath the skull bone.\n7. Patients must be on a stable regimen of anti-epileptic drugs (AEDs) for at least 30 days at the time of enrollment, except for rescue benzodiazepines or occasional extra doses of ongoing medicines, as required.\n8. Females of childbearing potential must have a negative pregnancy test prior to the first treatment. Females of childbearing potential and male patients with a partner of childbearing potential must agree to follow acceptable method of contraception (as outlined below) from prior to the first study treatment to 3 months after the last study treatment. Standard acceptable methods include use of highly effective method of contraception, including: hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom, spermicide, vasectomy, intrauterine device, and abstinence from sex.\n9. Patients are able and willing to have their hair shaved in the region where the coupling membrane will touch (or if they prefer, whole head).\n10. Patients are able to complete all clinical trial-related questionnaires in English, including with the use of a suitable interpreter.\n11. Patients or their legal representatives are able to provide written informed consent for participation in the trial and comply with study requirements in the opinion of the Investigator during the study period.\n\nExclusion Criteria:\n\n1. Patients who have primary generalized epilepsy, mixed focal and generalized epilepsy, or any history of non-epileptic seizures.\n2. Patients who have experienced tonic-clonic status epilepticus in the 12 months before the time of enrollment in the study. Subjects with focal status epilepticus may be considered at the discretion of the Investigator.\n3. The only feasible sonication pathway to the seizure onset zones involves either:\n\n   1. Skull area is covered by previous surgical site(s), scars, scalp disorders (e.g., eczema, psoriasis), or scalp atrophy.\n   2. Clips or other metallic implanted objects in the skull or brain, except shunts.\n   3. A prior craniotomy site.\n4. Patients with a potentially acute or progressive neurologic disorder (e.g., brain tumor, multiple sclerosis, dementia, or intracranial vascular lesion).\n5. Implanted electronic device, for example, implanted cardioverter-defibrillator (ICD), cardiac pacemaker, permanent medication pumps, cochlear implants, responsive neurostimulator, deep brain stimulation (DBS), or other electronic devices implanted in the brain. If a patient has a working Vagus Nerve Stimulator (VNS) in place, the settings should remain stable throughout the trial and the device will be turned off prior to each sonication treatment and then turned back on afterward.\n6. Patients with severe depression, active suicidal ideation or behavior (as per the C-SSRS), active psychosis (excluding time-limited postictal psychosis), or psychiatric hospitalization in the year before time of enrollment.\n7. Patient has an IQ \\\u003C 70, based on the Wechsler Abbreviated Scale of Intelligence (WASI-II or other Wechsler IQ measure).\n8. Coexisting medical problems of sufficient severity to limit compliance with or interpretation of the study.\n9. Patients have received an investigational drug or an investigational device within 4 weeks prior to the first treatment.\n10. Radiofrequency thermocoagulation (RFTC) within 2 months before time of enrollment.\n11. Known history of substance or alcohol abuse within the past year, not counting marijuana.\n12. Pregnant or breast-feeding women.\n13. Any other condition that, in the Investigator's judgment, might affect study endpoints or might increase the risk to the patients or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.","ALL","18 Years",{"count":19,"type":20},8,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This will be a prospective, open-label, single-arm, multi-center, pilot study to evaluate the safety, tolerability, and preliminary efficacy of low-intensity focused ultrasound (LIFU) neuromodulation using NaviFUS System in patients with drug-resistant unilateral or bilateral temporal lobe epilepsy (DR-TLE).",[27,28,29,30,31],"Drug Resistant Epilepsy","Epilepsy","Seizures, Focal","Seizure","Seizure Disorder",[33,34,35,36],"NaviFUS System","Focused Ultrasound","Low-Intensity Focused Ultrasound","LIFU","RECRUITING","2026-04-06",{"date":40,"type":41},"2026-04-09","ACTUAL",{"date":43,"type":41},"2024-09-13",{"date":45,"type":20},"2027-05-31",{"name":47,"class":48},"NaviFUS Corporation","INDUSTRY",3,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100348895","etiology-and-treatment-of-neonatal-seizure-100348895","NCT03822741","Etiology and Treatment of Neonatal Seizure","Gene Profiling and Individualized Treatment of Neonatal Seizure in China","Inclusion Criteria:\n\n* severe seizures in neonates or generalized epilepsy or intractable epilepsy in infancy with generalized tonic-clonic seizures,\n* seizures onset before 1 year of age,\n* epileptic syndromes\u002Fepileptic-encephalopathies with unknown etiology.\n\nExclusion Criteria:\n\n* Patients were excluded if they had traumas, central nervous system infections, hypoxic-ischemic encephalopathy, vascular events, systemic infections, and diagnosed metabolic disorders, and pathogenic copy-number variants were identified using array-based comparative genomic hybridization (CGH).","12 Months",{"count":59,"type":20},2000,"OBSERVATIONAL","Genetic diagnosis for neonates suffering from epilepsy has important implications for treatment, prognosis, and development of precision medicine strategies. Investigator performed exome sequencing (ES) or targeted sequencing on neonates with seizure onset within the first month of life. Investigator subgrouped our patients based on the onset age of seizure into neonatal and before 1 year (1-12 months), to compare the clinical and genetic features and treatment strategies.",[63,31,64,65],"Seizures","Seizure Newborn","Seizure Generalized",[67],"seizure","2026-03-13",{"date":70,"type":41},"2026-03-16",{"date":72,"type":41},"2016-08-08",{"date":74,"type":20},"2026-12-30",{"name":76,"class":77},"Children's Hospital of Fudan University","OTHER",1,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":16,"minAge":17,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":21,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":78},"100303686","modulating-movement-intention-via-cortical-stimulation-100303686","NCT03233399","Modulating Movement Intention Via Cortical Stimulation","Modulating Movement Intention Via Cortical Stimulation in Healthy Subjects and Patients With Psychogenic Movement Disorders and Non-epileptic Seizures","Inclusion Criteria:\n\n(Healthy Controls)\n\n* Fluent in English\n\n(Patients with PMD or PNES):\n\n* Diagnosis of PMD\u002FPNES confirmed by a neurologist with expertise in movement disorders.\n* Per the treating neurologist, subject is unlikely to require treatment and\u002For dosage changes for 3-6 months following screening\n\nExclusion Criteria:\n\n* Any history of a significant neurological disorder, which may interfere with the interpretation of study data, as determined by the PI\n* Chronic or progressive medical condition\n* Any history of traumatic brain injury or significant head trauma\n* Currently meets criteria for substance abuse or dependence\n* History of any psychotic disorder or other psychiatric condition which may interfere with data interpretation\n* Pregnancy\n* Metal or devices in the head, including neurostimulators or metal foreign bodies\n* Any other implanted metal device, including pacemaker, spinal cord stimulator, VNS.\n* Any other ferromagnetic substance in the body that may increase study risk (including dental prosthetics, etc.).\n* Taking tricyclic antidepressant or antiepileptic medications or CNS active drugs under \"strong potential hazard\" list in Rossi et al., 2009\n* Current diagnosis of any inflammatory or autoimmune disorder within last 6 months\n\nPMD and PNES Patients\n\n* Any history of traumatic brain injury or significant head trauma\n* Diagnosis of organic seizure disorder, including febrile seizures and tonic-clonic seizures;\n* Neurological disorder other than PMD and PNES including stroke, fainting spells or syncope of unknown cause(s);\n* Major or unstable medical illness, especially any current diagnosis of inflammatory or autoimmune disorders within last 6 months\n* Metal or devices in the head, including neurostimulators or metal foreign bodies\n* Taking tricyclic antidepressant medications or CNS active drugs under \"strong potential hazard\" list in Rossi et al., 2009;\n* Diagnosis of dementia, or Montreal Cognitive Assessment (MoCA) ≤24;\n* Recurrent visual hallucinations, within the past 6 months;\n* History of significant uncontrollable movements of the head;\n* Any clinically significant abnormality on vital signs",true,"65 Years",{"count":89,"type":20},30,[91],"NA","The purpose of this protocol is to learn about movement intention and volition. To improve such knowledge, investigators will conduct sub-studies using multiple non-invasive methodologies. These results could provide preliminary data for subsequent studies evaluating local and global efficacy of plasticity-inducing treatments for PMD symptoms.",[63,31,94],"Psychogenic Movement Disorder",[96,97,98],"Electroencephalography","Magnetoencephalography","Transcranial Magnetic Stimulation","2025-11-25",{"date":101,"type":41},"2025-11-28",{"date":103,"type":41},"2017-07-20",{"date":105,"type":20},"2027-05",{"name":107,"class":77},"NYU Langone Health",{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":116,"targetDuration":118,"studyType":60,"phases":4,"briefSummary":119,"conditions":120,"keywords":123,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":142},"100536459","epilepsy-learning-healthcare-system-elhs-100536459","NCT06265103","Epilepsy Learning Healthcare System (ELHS)","Epilepsy Learning Healthcare System (ELHS) for Quality Care & Outcome Improvement","ELHS","Inclusion Criteria:\n\n* In order to be eligible to participate in this registry-based study, an individual must meet all of the following criteria:\n\n  * Patient is in an established care relationship with the ELHS site\n\nExclusion Criteria:\n\n* An individual who meets any of the following criteria will be excluded from participation in this registry-based research study:\n\n  * Patients who are not currently in nor expect to be in an established care relationship with the ELHS site (for example, patients who are being seen at the center for a second opinion only).\n  * Patients who do not, after diagnostic evaluation, meet criteria for a diagnosis of epilepsy will not be analyzed in epilepsy-specific population groups. However, these non-epilepsy patients will not be excluded from the registry.",{"count":117,"type":20},100000,"10 Years","The Epilepsy Learning Health System (ELHS) is a quality improvement and research network to improve outcomes for people with epilepsy. The ELHS is designed as a model of value-based chronic care for epilepsy as envisioned by the National Academies of Medicine Committee in their landmark reports \"The Learning Health System\" and \"Epilepsy Across the Spectrum: Promoting Health and Understanding\".\n\nThe ELHS network is a collaboration among clinicians, patients and researchers that promotes the use of data for multiple purposes including one-on-one clinical care, population management, quality improvement and research. The ELHS Registry includes data on children and adults with epilepsy collected during the process of standard epilepsy care. These data are used to create population health reports and to track changes in outcomes over time. ELHS teams use quality improvement methods, such as Plan-Do-Study-Act (PDSA) cycles, to continuously learn how to improve care.",[28,31,121,122],"Neurologic Disorder","Rare Diseases",[124,125,126,127,128,129,130,30,131,132],"Focal seizures","Generalized seizures","Brain conditions","Developmental disorders","Rare diseases","Chronic condition","Health disparity","Post-traumatic epilepsy (PTE)","Post-stroke epilepsy","2024-08-28",{"date":135,"type":41},"2024-08-30",{"date":137,"type":41},"2019-03-20",{"date":139,"type":20},"2099-02-14",{"name":141,"class":77},"Epilepsy Foundation of America",13]