[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"drug-refractory-epilepsy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:drug-refractory-epilepsy":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100593877","optimizing-therapy-in-epilepsy-using-seizure-forecasts-via-eeg-and-wearables-100593877",false,"NCT07012148","Optimizing Therapy in Epilepsy Using Seizure Forecasts Via EEG and Wearables","FORESITE (FOREcasting Seizures to Initiate ThErapy): Optimizing Management of Drug-Resistant Epilepsy Using Seizure Forecasts Via Subscalp EEG and Wearables","FORESITE","Inclusion Criteria:\n\nSubjects enrolled in this study must have epilepsy involving the temporal lobe and will have undergone video-EEG monitoring within the past 3 years, and will have met the following criteria:\n\n* Focal epilepsy, including complex partial, and secondarily generalized seizures, including:\n\n  * disabling seizure (i.e. involving loss of awareness, motor control, speech, or other essential functions) counts at least 2 per month on average over the preceding 3 months, established by verbal history or caregiver report.\n  * For 3 months prior to enrollment, subject's AED dosages have been stable (less than a 25% change in dosage) and subject has had at least two seizures per month, on average, with a seizure-free interval not to exceed 60 days. Seizures must be separated by a minimum of four hours not to be considered part of a cluster. A cluster, for the purpose of this criterion, shall be considered a single seizure.\n* With the exception of epilepsy, subject must be medically and neurologically stable.\n* Age 18 to 75.\n* Ability and willingness to provide informed consent and participate in the study protocol. Subject is able to interpret and to respond, in accordance with the study protocol, to the advisory indicators provided by the device.\n* Subject has seizures that are distinct, stereotypical events that can be reliably counted by the subject or caregiver, and have a distinct EEG pattern that can be recorded using subscalp EEG over the frontotemporal head region, established by video-EEG monitoring.\n* Subject can reasonably be expected to maintain a seizure diary alone or with the assistance of a competent individual.\n* Subject is able to complete regular office visits and telephone appointments in accordance with the study protocol requirements.\n* Subject's seizure focus, based upon clinical semiology, scalp EEG, intracranial electroencephalographic (iEEG) findings, and\u002For neuroimaging, demonstrate consistent involvement of the temporal lobe with their EEG seizure pattern.\n* Subject speaks and reads English.\n* Subject has no reason to anticipate requiring a magnetic resonance imaging (MRI) evaluation within the next two years.\n* Subject has EEG documentation of ictal events consistent with his or her predominant current seizure type.\n* Subject's anatomy will permit implantation of the UNEEG SubQ device in the opinion of the study's neurosurgeon.\n* Female subjects have a negative pregnancy test, have no plans to become pregnant, and use effective contraception during the study.\n\nExclusion Criteria:\n\n* For 3 months prior to enrollment, subject's AED dosages have not been stable (greater than 25% change in dosage), or subject has had more than 30 disabling seizures per month, on average, or more than 10 seizure days per month, on average.\n* Subject needs to have magnetic resonance imaging during the study period.\n* Subject has a substance abuse history (alcohol, prescription, or illicit medications) within the preceding two years.\n* Subject participated in another drug or device trial within the preceding 30 days.\n* Subject has been hospitalized for a psychiatric condition within the preceding two years or has had a history of psychosis within the preceding two years (excluding post-ictal psychosis).\n* Subject is implanted with pacemaker, implantable cardiac defibrillator, cardiac management product, brain stimulator, or other medical device that would interfere with the UNEEG device. This includes, but is not limited to, direct brain neurostimulators, spinal cord stimulators, and cochlear implants. Vagus nerve stimulators are not expected to interfere with the subscalp EEG device and will be permitted, as long as stimulation parameters can be reasonably expected to remain stable (25% or less change in amplitude) throughout the study.\n* Subject has experienced unprovoked status epilepticus.\n* Subject has had therapeutic surgery to treat epilepsy that may interfere with electrode placement in the judgement of the neurosurgeon.\n* Subject is on anticoagulants and is unable to discontinue them perisurgically, as required by the neurosurgeon or Investigator.\n* Subject has significant platelet dysfunction from medical conditions or medications (including, particularly, aspirin or sodium valproate). If platelet dysfunction is suspected, subject can be enrolled only if a hematologist, the Investigator, and the neurosurgeon judge it to be advisable. Blood tests to evaluate platelet and bleeding disorder issues will be obtained prior to enrollment.\n* Subject is otherwise ineligible for cranial surgery, or the Investigators identify other medical or psychosocial factors that would counter indicate participation in the study.\n* Subject is pregnant or intends to become pregnant during the study period.\n* Subject has a known diagnosis of psychogenic nonepileptic seizures (PNES)\n* Female subject is pregnant or plans to become pregnant.","ALL","18 Years","75 Years",{"count":21,"type":22},12,"ESTIMATED","INTERVENTIONAL",[25],"NA","The purpose of this study is to evaluate the safety and feasibility of using seizure forecasts based on subscalp EEG.",[28,29,30],"Focal Epilepsy","Generalized Seizure","Drug Refractory Epilepsy",[32,33,34,35],"complex partial seizure","UNEEG","seizure forecasting","Subscalp EEG","RECRUITING","2026-03-18",{"date":39,"type":40},"2026-03-19","ACTUAL",{"date":42,"type":40},"2026-01-20",{"date":44,"type":22},"2029-12",{"name":46,"class":47},"Mayo Clinic","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":48},"100538565","focused-ultrasound-for-drug-resistant-epilepsy-100538565","NCT06292494","Focused Ultrasound for Drug-resistant Epilepsy","Inclusion Criteria:\n\n* Patients aged 20 and above.\n* Localized refractory epilepsy (ineffective with maximum doses of two or more anti-seizure medications).\n* Seizure frequency records for at least one month prior to the trial.\n* Patients who have undergone a complete preoperative examination, including EEG, MRI, and positron emission tomography (PET).\n* Capable of undergoing high-resolution computed tomography (CT scan), and SDR (Skull Density Ratio) ≥ 0.3.\n* Must have a body type suitable for entry into the magnetic resonance imaging (MRI) machine and be able to tolerate MRI scans.\n* During the surgical procedure, communication with the physician and the expression of sensory perceptions are essential; general anesthesia is not required.\n* Must be able to voluntarily press the stop button.\n* Willing to undergo removal of hair from the treatment site.\n\nExclusion Criteria:\n\n* This product is not suitable for individuals with contraindications related to MRI, such as those with metallic implants, those unable to undergo MRI, severe claustrophobia, or those with adverse reactions to contrast agents.\n* Individuals with implants in the brain or skull, such as shunts, electrodes, hard brain membrane patches, or electrode plates, that cannot be avoided along the expected path of brain ultrasound.\n* Patients along the expected path of brain ultrasound who cannot avoid structures or sensitive tissues with energy absorption (e.g., previous brain shunt surgery sites, surgical metal clips, or any hard implants).\n* Patients with extensive scabbing along the expected path of brain ultrasound.\n* Patients who have used contrast agents (e.g., MRI, ultrasound) within the past 24 hours before treatment.\n* Patients with other high-risk brain disorders (e.g., intracranial aneurysm).\n* Patients with intraoperative or postoperative bleeding risk:\n\n  1. Those with a history of cerebrovascular disease (multiple strokes or strokes within the past six months) or a history of cerebral hemorrhage and stroke.\n  2. Those with abnormal bleeding, intracranial bleeding, coagulation disorders, or a history of bleeding or clotting disorders, either during or after surgery.\n* Patients taking or injecting anticoagulant medications such as aspirin, coumadin, heparin, novel oral anticoagulants (NOACs), etc., which may lead to prolonged bleeding. Medication should be discontinued for 3-7 days before treatment.\n* Patients with severe uncontrolled hypertension (systolic blood pressure \\> 180 mmHg after stable medication, diastolic blood pressure \\> 100 mmHg).\n* Patients unable to communicate with the physician during the treatment process.\n* Unstable cardiac conditions (heart rate \\> 180 beats\u002Fminute or \\\u003C 40 beats\u002Fminute; systolic blood pressure \\> 180 mmHg or \\\u003C 90 mmHg).\n* Substance abuse (use of illegal drugs or using medications in a manner not recommended by a physician or manufacturer) or alcohol addiction.\n* Patients who have taken medications affecting the central nervous system within the past six months (e.g., central nervous system stimulants, sympathomimetic agents).\n* Patients with psychological abnormalities (e.g., schizophrenia, severe depression, bipolar disorder).\n* Individuals with severe head surface injuries or potential allergies to materials in contact with the head (such as conductive gels, head silicone membranes)",{"count":56,"type":22},20,[25],"Focused ultrasound (FUS) has been shown to differentially lesion or modulate (excite and inhibit) brain circuit and neural activity across a broad range of acoustic stimulus parameters (intensity, duty cycle, pulse repetition frequency and pulse duration) for decades. From our previous study, FUS sonication may suppress the number of epileptic signal bursts observed in EEG recordings after the induction of acute epilepsy. The presence of the suppressive effect was found in terms of the number of epileptic EEG spikes from the analysis of the unfiltered and theta-band EEG activity, and further discontinue the seizure attacks. EEG activity has also been consistently reported to have a positive correlation with the level of epilepsy, and FUS-mediated reduction of epileptic EEG activity was most notably observed, no matter lesioning or modulating effects. The aims of this study are to demonstrate the safety and efficacy of FUS technology in epilepsy patients and to estimate the optimal parameters of focused ultrasound exposure that will be used in the case of epilepsy.",[60,61,30,62,63],"Focused Ultrasound","MR-guided FUS","Drug Resistant Epilepsy","Medication Resistant Epilepsy","2025-09-02",{"date":66,"type":40},"2025-09-09",{"date":68,"type":40},"2024-01-01",{"date":70,"type":22},"2027-12-31",{"name":72,"class":73},"Taipei Veterans General Hospital, Taiwan","OTHER_GOV"]