[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"epilepsy-treatment-refractory\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:epilepsy-treatment-refractory":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,53,82,104,127,148,174,202],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":34,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"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":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30,31,32,33],"Drug-Resistant Epilepsy","Epilepsy","Epilepsy (Treatment Refractory)","Epilepsy Comorbidities","Epilepsy, Drug Resistant","Epilepsy, Generalized","Epilepsy, Focal",[35,27,28,36,37,38,39],"Seizures","Transcranial Ultrasound Stimulation","Focused ultrasound Stimulation","Electroencephalography (EEG)","Low Intensity Focused ultrasound (LIFU)","RECRUITING","2026-06-25",{"date":43,"type":44},"2026-07-02","ACTUAL",{"date":46,"type":44},"2025-07-09",{"date":48,"type":21},"2027-06-01",{"name":50,"class":51},"University of California, San Francisco","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":66,"conditions":67,"keywords":68,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"100601426","diagnosing-epilepsy-to-effect-change-100601426","NCT07110337","Diagnosing Epilepsy To EffeCT Change","A Prospective Study to Evaluate the Use of the Minder Device to Aid in Developing a Treatment Plan After Inconclusive Prolonged EEG in Patients With Epilepsy","DETECT","Inclusion Criteria:\n\n* Diagnosis of focal and\u002For generalized epilepsy.\n* Drug-resistant\n* At least an average of 1 seizure within the past 3 months\n* Participant completed a multi-day EEG assessment that was inconclusive, and is unchanged since the last EEG monitoring.\n\nExclusion Criteria:\n\n* Epilepsy surgery within the past 6 months\n* Active Deep Brain Stimulation (DBS) or Responsive Neurostimulator System (RNS)\n* Participant needs treatments or assessments that are not indicated with the Minder System like Magnetic Resonance Imaging (MRI), Electro-Convulsive Therapy (ECT), lithrotripsy, and diathermy\n* Participant cannot have surgery to have the device implanted","18 Years","75 Years",{"count":64,"type":21},210,[24],"The purpose of this research is to address the challenges of diagnosing and long-term management of epilepsy in participants whose seizures are not well captured by standard electroencephalography (EEG) tests and who cannot use or are not able to use more standard monitoring techniques. This research will compare the Minder System to standard of care in providing reliable seizure data. The Minder System was granted De Novo classification by the U.S. Food and Drug Administration (FDA) and is not investigational.\n\nParticipants will consent to join the study and be implanted with the Minder device; or consent to join the study and continue with their Standard of Care (SOC) as a control group. Participants chose to be implanted with the Minder device will have the device implanted under their scalp. After implantation, participants will be randomly assigned to a group where their treating physician will have access to the EEG data collected by the Minder System or a group where their treating physician does not have access to the EEG data collected by the Minder System. Participants receiving the Minder System will not know which group they are in (blinded) until the study ends.\n\nAll participants will continue to be followed by their treating physician and undergo assessments and visits until enough information is available to determine a treatment plan or the 6-month follow-up visit.",[28,29],[69,70],"Minder System","Sub-scalp EEG monitoring device","2026-06-03",{"date":73,"type":44},"2026-06-04",{"date":75,"type":44},"2025-12-23",{"date":77,"type":21},"2027-06",{"name":79,"class":80},"Epiminder America, Inc.","INDUSTRY",18,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":61,"maxAge":62,"enrollmentInfo":90,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":92,"conditions":93,"keywords":94,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},"100601435","diagnosing-epilepsy-to-effect-change-long-term-follow-up-100601435","NCT07110454","Diagnosing Epilepsy To EffeCT Change Long-Term Follow-Up","A Prospective Long-Term Follow-Up Study to Evaluate the Use of the Minder Device to Aid in Treatment After Actionable Event Identification in Patients Diagnosed With Epilepsy.","DETECT LTFU","Inclusion Criteria:\n\n* Participant met all inclusion criteria, was enrolled in the DETECT study, and received the Minder device\n* Participant completed the DETECT study by receiving an actionable event or by completing the 6-month follow-up visit\n* Participant continues to have the Minder device implanted\n* Participant must continue to meet relevant DETECT study inclusion criteria\n\nExclusion Criteria:\n\n* Participant meets any relevant DETECT study exclusion criteria including needing treatments or assessments that are not indicated with the Minder System like Magnetic Resonance Imaging (MRI)",{"count":64,"type":21},"OBSERVATIONAL","The purpose of this research is to address the challenges of correctly monitoring, managing, and diagnosing epilepsy in participants whose seizures are not well captured by standard electroencephalography (EEG) tests and who cannot use or are not able to use more standard monitoring techniques. This research is being done to understand how the Minder System helps physicians make decisions about participant's epilepsy treatment after an actionable event. The Minder System was granted De Novo classification by the U.S. Food and Drug Administration (FDA) and is not investigational.\n\nParticipants that have completed the DETECT study and received the Minder System previously will consent to join this long-term follow-up observational study. The study will collect information about general wellbeing, use of healthcare services, and experience using the Minder data over time to support long-term epilepsy care.\n\nAll participants will continue to be followed by their treating physician and undergo assessments and visits every six (6) months until two (2) years after receiving the Minder device.",[28,29],[69,70],"2026-05-15",{"date":97,"type":44},"2026-05-18",{"date":99,"type":21},"2026-06",{"date":101,"type":21},"2029-01",{"name":79,"class":80},12,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":61,"maxAge":18,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":4},"100617311","cest-based-biomarkers-to-delineate-the-epileptogenic-zone-100617311","NCT07316972","CEST-based Biomarkers to Delineate the Epileptogenic Zone","CEST-BEST","Inclusion Criteria:\n\n* Patients with drug-resistant temporal lobe epilepsy (mesial or lateral)\n* Requiring a pre-surgical evaluation including long-term video EEG\n* At least 5 of them will be recruited after surface video EEG indicates the need for further exploration by SEEG\n* With or without a radiologically visible lesion\n\nExclusion Criteria:\n\n* Absolute or relative contraindication to MRI (metallic implants, including intrauterine devices other than the MIRENA® brand, claustrophobia, etc.)\n* Expected inability to remain still for 90 minutes in a 7T MRI\n* Diabetic individuals\n* Individuals under legal protection measures\n* Pregnant or breastfeeding women",{"count":112,"type":21},20,[24],"Epilepsy is a common neurological disorder with an incidence of 1%. Although many anti-seizure medications are available, about 30% of patients are resistant to drug treatments. Epilepsy surgery is an effective treatment for some of these patients. It involves removing the brain region responsible for generating seizures, called the epileptogenic zone (EZ).\n\nA pre-surgical evaluation is performed to locate and delineate the region where seizures originate (the seizure onset zone \\[SOZ\\]) and to confirm that this zone is unique and accessible for surgery-that is, that the potential benefits outweigh the risks of functional deficits resulting from its removal. The lesion itself is identified and characterized through post-operative histological examination and, in some cases, based on MRI criteria.\n\nDuring pre-surgical evaluation, in cases where no lesion is visible on MRI or when surface EEG suggests that a large or multiple epileptic networks may be involved, stereo-electroencephalography (SEEG) is the method of choice to delineate the area for resection. However, SEEG has limitations: it is invasive and records from a restricted brain volume.\n\nDespite advances in neuroimaging techniques, the localization of the epileptogenic zone and mapping of functional brain alterations still need improvement beyond what morphological MRI anomalies can reveal.\n\nBecause epileptic tissue is characterized by increased neuronal excitability and metabolic abnormalities, techniques that allow precise evaluation of these changes could deepen our understanding of the disease and provide new tools for epilepsy surgery. An alternative MRI approach based on metabolite quantification using chemical exchange saturation transfer (CEST) has been suggested to aid in localizing the epileptogenic zone in preliminary studies. However, limited availability of ultra-high-field MRI, low localization precision of the epileptogenic zone, and lack of systematic validation in patients have delayed its clinical use.\n\nThis study aims to explore a cohort of patients with temporal lobe epilepsy who are candidates for surgery using CEST MRI. We will quantify glutamate and glucose concentrations using glu-CEST and gluco-CEST, respectively, and correlate the results with the localization of the epileptogenic zone determined by pre-surgical evaluation, and where applicable, SEEG and post-operative outcomes.",[29],"NOT_YET_RECRUITING","2025-12-19",{"date":119,"type":44},"2026-01-05",{"date":121,"type":21},"2026-03",{"date":123,"type":21},"2029-03",{"name":125,"class":126},"Fondation Ophtalmologique Adolphe de Rothschild","NETWORK",{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":133,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":22,"phases":135,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":4},"100612100","phase-1-a-study-to-evaluate-the-safety-and-effectiveness-of-magnetic-resonance-guided-ultrasound-ablation-of-the-anterior-nucleus-of-thalamus-for-the-treatment-of-drug-resistant-epilepsy-100612100","NCT07249190","A Study to Evaluate the Safety and Effectiveness of Magnetic Resonance-Guided Ultrasound Ablation of the Anterior Nucleus of Thalamus for the Treatment of Drug-resistant Epilepsy.","Inclusion Criteria:\n\nMale or female aged no less than 20 years old; Capable of signing the informed consent form and able to attend all study visits; Diagnosed as drug-resistant epilepsy by an epilepsy specialist; The subject's epilepsy is ineffective to the adequate use of at least two antiepileptic drugs, one of which must be a first-line drug. Adequate drug use is defined as the therapeutic dose of each drug or the occurrence of side effects with the increase of drug dose; Capable of communicating during the operation; Wechsler Adult Intelligence Scale (WAIS) score ≥ 70; The average number of epileptic seizures is ≥ 3 per month within 3 months before enrollment. The drug dose remains stable within 3 months before enrollment; The anterior nucleus of thalamus is identifiable on MRI (structural T1 and T2 images); Willing and able to keep an epileptic seizure diary.\n\nExclusion Criteria:\n\nThe frequency of epileptic seizures is \\\u003C 3 times per month within 3 months before the subject is enrolled; The subject's Wechsler Adult Intelligence Scale (WAIS) score \\\u003C 70; The subject cannot maintain the drug dose within 3 months after receiving treatment; The subject has epilepsy caused by previous infection (such as herpes virus); The subject has idiopathic epilepsy (Lennox-Gastaut syndrome, drop attacks); The subject is pregnant or lactating;\n\nThe subject has the following manifestations of unstable cardiac function:\n\n1. Unstable angina pectoris under medication;\n2. Medical records of myocardial infarction within 6 months before entering the study;\n3. Congestive heart failure that is not effectively controlled or is deteriorating;\n4. History of arrhythmia with hemodynamic disturbance;\n5. Patients with implanted cardiac pacemakers;\n6. Severe hypertension (diastolic blood pressure still \\> 100 mmHg after drug control); The subject exhibits behaviors consistent with alcohol addiction or substance abuse; History of abnormal systemic or intracranial hemorrhage; History of coagulation dysfunction: PLT \\\u003C 100,000\u002Fμl, PT \\> 14 sec or PTT \\> 36 sec, and INR \\> 1.3; Use of anticoagulants (such as warfarin) or antiplatelet drugs (such as aspirin) within one week before surgery, or use of drugs that can increase the risk of bleeding (such as bevacizumab) within one month before focused ultrasound surgery; The subject has cerebrovascular diseases, including but not limited to: intracranial aneurysm, dural arteriovenous malformation (AVM), stroke, intracranial atherosclerotic disease, dural arteriovenous fistula (AVF), etc.; The subject has a brain tumor; The subject has severe abnormal brain structure; Previous corpus callosotomy, VNS, DBS, or stereotactic ablation; Implants in the skull or intracranial cavity; More than 30% of the head area through which the ultrasound irradiation path passes is covered by scars\u002Fscalp diseases (such as eczema) or scalp atrophy; The subject has a history of claustrophobia; The overall Skull Density Ratio (SDR) calculated by the subject during screening is less than 0.40 (±0.05); Unable to tolerate the long-term supine and stationary posture required during treatment (about 2-3 hours); Currently participating in another clinical research project; Unable to communicate with researchers and treatment staff; The subject is considered unsuitable for surgery or the study, which may include but is not limited to the following situations: the researcher deems that the subject has any medical, social, or psychological problems that may complicate the evaluation of the study process; The subject had suicidal thoughts within one month before enrollment; The subject has a clinically significant neurological disease other than epilepsy.","20 Years",{"count":112,"type":21},[136],"PHASE1","The study \"Safety and Efficacy Evaluation of MR-Guided Focused Ultrasound Anterior Thalamic Nucleus Ablation for Drug-Resistant Epilepsy\" from Chinese PLA General Hospital, is a single-center, prospective, single-arm study. It uses a MR-guided Focused Ultrasound Therapy System and plans to recruit 20 patients with drug-resistant epilepsy who are ≥20 years old, have a WAIS score ≥70, an average of ≥3 monthly epileptic seizures in the 3 months before enrollment, and are refractory to at least 2 antiepileptic drugs (including 1 first-line drug), excluding those with unstable cardiac function, brain tumors, previous brain surgery history, etc. Anterior thalamic nucleus ablation is performed via MRgFUS, with multiple follow-ups from 48 hours to 2 years postoperatively. Safety is evaluated by the incidence of adverse events within 2 years, efficacy by seizure frequency recorded in epilepsy diaries and the QOLIE-31 scale. Statistical analysis is conducted using toolkits, while risks such as MRI-induced claustrophobia and CT radiation are controlled. It adheres to GCP and the Declaration of Helsinki to ensure data authenticity and subjects' rights. The technology provider is responsible for the normal operation of the device and providing 20 sets of treatment consumables.",[29],"2025-11-18",{"date":141,"type":44},"2025-11-25",{"date":143,"type":21},"2025-12-01",{"date":145,"type":21},"2027-12-30",{"name":147,"class":51},"Chinese PLA General Hospital",{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":61,"maxAge":156,"enrollmentInfo":157,"targetDuration":4,"studyType":22,"phases":159,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":172,"locationsCount":52},"100582441","percutaneous-repair-for-drug---resistant-epilepsy-by-intervention-of-closing-the-patent-foramen-ovalepredict-pfo-trial-100582441","NCT06863350","Percutaneous Repair for Drug - Resistant Epilepsy by Intervention of Closing the Patent Foramen Ovale（PREDICT-PFO Trial）","Efficacy and Safety of Percutaneous Foramen Ovale Closure in Adult Patients with Drug-resistant Epilepsy and Patent Foramen Ovale: a Randomized Controlled Trial","PREDICT-PFO","Inclusion Criteria:\n\n1. Age between 18 and 60 years, with no gender restrictions;\n2. Diagnosis of epilepsy in accordance with the International League Against Epilepsy (ILAE) criteria (2014 edition);\n3. Drug-resistant epilepsy, defined as failure to achieve sustained seizure freedom despite appropriate selection and tolerability of at least two antiseizure medications (monotherapy or combination therapy) for a minimum of six months;\n4. Diagnosis of patent foramen ovale (PFO) meeting the criteria established by the American Society of Echocardiography (ASE) and the Society for Cardiovascular Angiography and Interventions (SCAI) (2015 edition), with right-to-left shunting (RLS) of grade II or higher upon Valsalva maneuver, as assessed by contrast-enhanced echocardiography;\n5. Stable antiseizure medication regimen for at least four weeks prior to screening, with willingness to maintain a stable regimen throughout the study period;\n6. At least one documented seizure episode during a six-week screening period (with a minimum of four weeks of effective seizure diary recordings) and a retrospective self-reported history of at least 12 seizures in the year preceding screening;\n7. Ability to independently or with caregiver assistance complete a seizure diary and comply with clinical data collection and required medical examinations;\n8. Willingness to undergo the investigational treatment and voluntary provision of written informed consent.\n\nExclusion Criteria:\n\n1. Patients diagnosed with epilepsy of a known etiology, including infectious, metabolic, immune, genetic, or structural causes;\n2. History of stroke or psychogenic nonepileptic seizures (PNES);\n3. History of epilepsy surgery or implantable neurostimulation therapy, or planned epilepsy surgery, neurostimulation therapy, ketogenic diet therapy, or other antiseizure interventions during the study period;\n4. Presence of structural cardiac abnormalities other than patent foramen ovale (PFO), such as moderate or severe valvular regurgitation or pulmonary hypertension;\n5. Presence of severe central nervous system (CNS) diseases, including acute cerebrovascular disease, intracranial tumors, intracranial infections, or progressive CNS disorders;\n6. Evidence of vascular puncture site infection or difficulty with puncture as assessed by transesophageal echocardiography combined with contrast-enhanced right heart echocardiography;\n7. Documented contraindications to antiplatelet therapy;\n8. Presence of severe psychiatric disorders, such as schizophrenia, bipolar disorder, or severe depression or anxiety;\n9. History of alcohol or other substance abuse;\n10. Severe dysfunction of vital organs (heart, lungs, liver, kidneys) deemed by the investigator to pose a risk to the participant or impair the participant's ability to complete the study;\n11. Pregnant or breastfeeding women, or women planning to conceive during the study period;\n12. Participation in another interventional clinical trial within three months prior to signing the informed consent form, current participation in another interventional trial, or plans to participate in another interventional trial during the study period; inability to comply with follow-up due to travel or relocation;\n13. Any other condition that the investigator determines makes the patient unsuitable for participation in this study.","60 Years",{"count":158,"type":21},180,[24],"Patent foramen ovale (PFO) is the most common cause of right-to-left shunt (RLS) in the adult heart, with a prevalence of approximately 25% in the general population. Extensive research has demonstrated an association between PFO and neurological conditions such as cryptogenic stroke, migraine, and sleep apnea syndrome, and it is even considered a potential root cause of these disorders. However, the mechanisms by which PFO contributes to neurological diseases remain unclear. In our preliminary clinical work, we have observed a strong correlation between PFO and epilepsy, and PFO closure has shown some efficacy in reducing seizure frequency. The aim of this study is to further investigate the efficacy and safety of PFO closure in patients with drug-resistant epilepsy.",[162],"Epilepsy (treatment Refractory)",[164,165],"patent foramen ovale","epielpsy","2025-03-09",{"date":168,"type":44},"2025-03-11",{"date":170,"type":21},"2025-02-28",{"date":48,"type":21},{"name":173,"class":51},"Sichuan University",{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":16,"minAge":182,"maxAge":18,"enrollmentInfo":183,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":185,"conditions":186,"keywords":188,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":201},"100504205","evaluation-of-the-epilepsy-related-quality-of-life-seizure-related-accidents-and-validation-of-the-mjn-seras-solution-in-the-normalised-patient-environment-with-real-world-data-100504205","NCT05845255","Evaluation of the Epilepsy-related Quality of Life, Seizure-related Accidents and Validation of the Mjn-SERAS Solution in the Normalised Patient Environment with Real-World Data","Clinical Study for the Validation of the Medical Device Mjn-SERAS for the Detection and Prediction of Epileptic Seizures in Individuals from 12 to 65 Years, Suffering from Drug-resistant Epilepsy During Their Day-to-day Activity, to Find Out the Impact of the Digital Solution in the Quality of Life in a Normalised Environment and Provide Valuable Information from Real-World Data.","SERAS_Home_RWD","Inclusion Criteria:\n\n* Age criterion:\n\n  o Patient must be 12 to 65 years of age inclusive, at the time of signing the informed consent.\n* Clinical criteria:\n\n  * Confirmed diagnosis of drug-resistant\\*1 epilepsy, with focal, generalized or focal -generalized seizures, according to international standards from ILAE 2017 classification\\*2 (link), who will be evaluated by a specialised epilepsy unit and who are expected to have seizures.\n  * The video-EEG records of patients must have epileptic seizures counted and recorded by specialised clinical personnel through accepted and contrasted gold-standard systems\\*3 or evaluated by a specialized epilepsy unit and expected to experience seizures with electroclinical manifestations If there are clear clinical epileptic seizures (e.g. motor seizures), patients could be involved even without v-EEG records, according to medical criteria.\n  * Patients with a clinical history and previous video-EEG records that allows certainty about the diagnosis and characteristics of the participant's epilepsy. If there are clear clinical epileptic seizures (e.g. motor seizures), patients could be involved even without v-EEG records, according to medical criteria.\n  * Precise semiological information on the patients included.\n  * Patients with both sides localisation will be accepted, and the wearable device will be placed in the side that is most evident the origin of the seizures, to be placed as near as possible to the focal point.\n  * Presence of more than 10 day seizures per year, from tonic, tonic-clonic, clonic or atonic seizures, and a minimum of 2 to 4 day seizures per month (preferably 4 per month\u002F 1 per week) during the last 3 months, reported by the patients\u002Fcaregivers or assessed by the neurologist through the patient history. The patient must have seizures during the day to record them, not just seizures at night.\n  * Patients included in ICD-10\\*4 and ICD-10-GM\\*5 classification as G40 with electroclinical manifestation of seizures.\n* G40.1 Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple focal seizures\n* G40.2 Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex focal seizures\n* G40.3 Generalized idiopathic epilepsy and epileptic syndromes\n* G40.6 Grand mal seizures, unspecified (with or without petit mal). According to medical criteria and electroclinical seizure manifestations (focal, focal-generalized or generalized onset seizure with a normal interictal EEG recording).\n* G40.8 Other epilepsies (Epilepsies and epileptic syndromes, undetermined whether focal or generalized). According to medical criteria and electroclinical seizure manifestations (focal, focal-generalized or generalized onset seizure with a normal interictal EEG recording).\n\n  o In case of epileptic syndromes not listed in the above or shows some of the syndromes mentioned in the exclusion criteria, patients could be included according to medical criteria defined by the clinician. These criteria must be accordingly justified by the clinician ( e.g., focal or generalized onset seizures without encephalopathy and with a normal interictal EEG recording).\n* Technological criteria:\n\n  * Ability to navigate in Android or iOS operating system. If mild or moderate disability, family members can assist with navigation if patient is unable. The smartphone must stays with the patient to record EEG, but seizures are registered by a family member.\n\nExclusion criteria\n\n* Presence of psychogenic seizures.\n\n  * If there is a coexistence of epileptic and non-epileptic seizures, it will be considered an exclusion criterion if the patient or family cannot differentiate between the two types of seizures.\n  * If the patient or family can always differentiate between the two types of seizures, the patient could be included in the study according to medical criteria (but only recording the epileptic seizures.)\n* Psychiatric, neurological, or systemic disorders that the researcher believes could affect the realisation and interpretation of the results.\n* Presence of more than 10 seizures per day on a habitual basis.\n* Presence of epilepsia partialis continua (G40.5\\*4\\*5)\n* Patients with legal representative\n* Pregnant women\n* Patients with only absence seizures (G40.A\\*4,G40.4\\*5)\n* Patients with only myoclonic seizures or epileptic spasms (G40.B\\*4,G40.4\\*5).\n* Patients included in ICD-10\\*4 and ICD-10-GM\\*5 classification and not included in the medical criteria for specific epileptic syndromes in inclusion criteria.\n\n  * G40.0 Localization-related (focal)(partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset\n  * G40.4 Other generalized epilepsy and epileptic syndromes. In case of specific epileptic syndromes, patients could be included according to medical criteria (e.g., focal or generalized onset seizures without encephalopathy and with a normal interictal EEG recording)\n  * G40.5 Epileptic seizures due to external causes\\*4 or Special epileptic syndromes\\*5\n  * G40.7 Petit mal, unspecified, without grand mal seizures\n  * G40.9 Epilepsy, unspecified\n* Participants in previous clinical trials with mjn-SERAS device.\n* In the case the patient presents an epileptic syndrome mentioned in the exclusion criteria, the patient if the clinician considers the subject meets medical criteria to be included, the patient can be enrolled in the study. These criteria must be accordingly justified by the clinician (e.g., focal or generalized onset seizures without encephalopathy and with a normal interictal EEG recording","12 Years",{"count":184,"type":21},130,"The study will be prospective, multicentre, postmarketing clinical study, with a controlled and randomized design, to perform the analysis of 130 subjects with a clinical diagnosis of epilepsy, patients whose clinical semiology of their epilepsy is considered to be of interest for the validation in the day-to-day life a medical device (mjn-SERAS), which has already been validated and certified in Europe with CE mark Class IIa.\n\nThis new validation will take place in the participant's normalised environment, in individuals between 12 and 65 years of age, of both sexes with a diagnosis of drug-resistant epilepsy to determine the impact in quality of life of the mjn-SERAS on the early detection of epileptic seizures and the generation of a pre-seizure alert with a time window of a minimum of 1 minute.",[187,162],"Quality of Life",[189,190,191],"Safety and Performance","Medical device","Quality of life","2024-10-09",{"date":194,"type":44},"2024-10-15",{"date":196,"type":44},"2023-05-01",{"date":198,"type":21},"2025-06-30",{"name":200,"class":80},"MJN Neuroserveis, S.L",6,{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":16,"minAge":209,"maxAge":210,"enrollmentInfo":211,"targetDuration":4,"studyType":22,"phases":213,"briefSummary":214,"conditions":215,"keywords":216,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":4},"100561690","thalamic-ventral-intermediate-electrical-stimulation-for-refractory-familial-cortical-myoclonus-with-epilepsy-100561690","NCT06593444","Thalamic Ventral Intermediate Electrical Stimulation for Refractory Familial Cortical Myoclonus with Epilepsy","The Efficacy and Safety of Thalamic Ventral Intermediate Electrical Stimulation for Refractory Familial Cortical Myoclonus with Epilepsy: a Prospective, Pilot Trial","Inclusion Criteria:\n\n* Aged 30-70, meeting the diagnostic criteria for Refractory Familial Cortical Myoclonus with Epilepsy (FCMTE), meaning that tremors and\u002For seizures have not significantly improved despite long-term, stable use of current treatment medications, regardless of gender.\n* Tremors and seizures severely impact the patients\\' work and quality of life.\n* Experiencing drug resistance or intolerable adverse reactions to medication.\n* After being adequately informed about the nature and risks of the study, willing to provide written informed consent before participating in any study-related procedures.\n* Willing to adhere to the relevant trial protocol and regulations, including attending follow-up visits and undergoing related examinations within the specified timeframe.\n\nExclusion Criteria:\n\n* Patients with FCMTE whose symptoms are essentially controlled after standardized medication and other treatments.\n* Presence of structural abnormalities in the VIM (ventral intermediate nucleus).\n* Presence of an implanted electrical stimulator (e.g., pacemaker, spinal cord stimulator, repetitive nerve stimulator) or metallic implants in the head (e.g., aneurysm clips, cochlear implants). Note: Vagus nerve stimulation (with stable parameters for at least 3 months) is not an exclusion criterion.\n* IQ \\< 55, severe cognitive impairment that prevents participation in the study.\n* Pregnant individuals or those planning to conceive within 2 years.\n* Presence of progressive neurological diseases such as brain tumors, arteriovenous malformations, or cavernous hemangiomas.\n* Presence of other serious neuropsychiatric disorders such as dementia, severe depression (hospitalized in a psychiatric facility within the past 5 years or any suicidal or self-harming tendencies), schizophrenia, or neurodegenerative diseases. Resolved postictal psychiatric or behavioral abnormalities are not an exclusion criterion.\n* Conditions that may increase the risk of seizures during or after surgery (e.g., coagulation disorders) or require long-term oral anticoagulants or antiplatelet drugs.\n* Other severe physical illnesses, psychiatric disorders, internal diseases, or severe liver or kidney dysfunction; participation in other clinical trials within the past three months.","30 Years","70 Years",{"count":212,"type":21},5,[24],"The primary objective of this research is to study the efficacy and safety of deep brain stimulation (DBS) of Thalamic Ventral Intermediate as adjunctive therapy for alleviating symptoms in refractory familial cortical myoclonus with epilepsy.",[162],[217,218,219],"Deep Brain Stimulation","Thalamic Ventral Intermediate","Refractory Familial Cortical Myoclonus with Epilepsy","2024-09-09",{"date":222,"type":44},"2024-09-19",{"date":224,"type":21},"2024-09-20",{"date":226,"type":21},"2025-09-20",{"name":228,"class":51},"Xuanwu Hospital, Beijing"]