[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"drug-resistant-epilepsy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:drug-resistant-epilepsy":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,44,0,25,[9,42,80,107,130,156,180,210,221,252,281,307,330,356,379,426,450,474,494,517,542,569,586,612,635],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100054143","feasibility-study-of-the-iveacare-neuromodulation-system-for-the-treatment-of-drug-resistant-epilepsy-100054143",false,"NCT07640191","Feasibility Study of the iVEAcare Neuromodulation System for the Treatment of Drug-Resistant Epilepsy","iVEAcare-FS","Key Inclusion Criteria:\n\n* Age 4 to 75 years.\n* Focal (partial) onset seizures (with or without secondary generalization) or generalized seizures that are refractory to anti-seizure medications.\n* A minimum of 4 seizures per month averaged over the 90 days prior to enrollment.\n* Participant is diagnosed with Drug Resistant Epilepsy (DRE) - Failure to achieve seizure control with adequate trials of two or more tolerated anti-seizure medications.\n* Anti-seizure medications must be at a steady state for a minimum of 30 days and remain stable through the 6-month post-activation study visit. Rescue medications may still be used as necessary\n\nKey Exclusion Criteria:\n\n* Unsuitable for iVEAcare Neuromodulation System implant surgery.\n* Deteriorating neurologic or other deteriorating medical conditions.\n* Previous left vagotomy (left vagus nerve cut to treat another disorder).\n* A condition currently requiring diathermy treatment anywhere in their body (short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy).\n* Known vagal neuropathy, or other reasons that the left vagus nerve is not appropriate for implant.\n* Vocal cord paralysis.\n* Prior therapeutic brain surgery for epilepsy within 6 months prior to the baseline visit.\n* Currently implanted with an Implantable Cardiac Defibrillator (ICD), pacemaker, Deep Brain Stimulator (DBS), Responsive Neurostimulator (RNS), Spinal Cord Stimulator (SCS), Peripheral Nerve Stimulator (PNS), Sacral Nerve Stimulator (SNS), carotid baroreceptor stimulator, cochlear implant, or currently using external stimulation devices such as a Transcutaneous Electrical Nerve Stimulator (TENS). Note: Participants who currently have a commercially available VNS system for drug-resistant epilepsy and are eligible for a generator replacement (due to nearing end of life) can receive the iVEAcare Implantable Pulse Generator (IPG) alone if their existing lead has been confirmed to be functioning properly preoperatively and intraoperatively.\n* Pregnant or planning to be pregnant in the next 12 months. .\n* Any active malignant disease (not including skin cancer).\n* Any active infection in the vicinity of the implant site or any systemic infection.\n* Poorly controlled diabetes (Type I or Type II) determined by HbA1c \\>8% (or \\> 64 mmol\u002Fmol","ALL","4 Years","75 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"NA","The purpose of this study is to assess the safety and performance of the iVEAcare Neuromodulation System for the treatment of drug-resistant epilepsy.\n\nThe main questions it aims to answer are:\n\nWhat medical problems do participants have when being implanted with and using the iVEAcare system? Does the iVEAcare neurostimulator reduce seizure frequency and severity in patients with drug-resistant epilepsy? Does the iVEAcare neurostimulator improve quality of life in patients with drug-resistant epilepsy?\n\nAll participants will be implanted with an iVEAcare neurostimulator, and researchers will look at whether any medical problems are caused by the implant procedure or device, and how stimulation changes seizure frequency and severity and participant quality of life compared to when the participant enrolled.\n\nParticipants will:\n\nBe implanted with an iVEAcare device. Visit the clinic 1-month, 3-months, 6-months, 1-year, 18-months and then annually through 5 years where they will be asked to answer questionnaires about their seizures and quality of life.\n\nKeep a diary of the number of seizures they have each day.",[28],"Drug Resistant Epilepsy","NOT_YET_RECRUITING","2026-07-09",{"date":32,"type":33},"2026-07-13","ACTUAL",{"date":35,"type":22},"2026-06",{"date":37,"type":22},"2032-06",{"name":39,"class":40},"iVEAcare","INDUSTRY",1,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":54,"conditions":55,"keywords":63,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":41},"100645320","non-invasive-low-intensity-focused-ultrasound-stimulation-for-drug-resistant-epilepsy-100645320","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.","21 Years","65 Years",{"count":52,"type":22},40,[25],"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.",[56,57,58,59,60,61,62],"Drug-Resistant Epilepsy","Epilepsy","Epilepsy (Treatment Refractory)","Epilepsy Comorbidities","Epilepsy, Drug Resistant","Epilepsy, Generalized","Epilepsy, Focal",[64,56,57,65,66,67,68],"Seizures","Transcranial Ultrasound Stimulation","Focused ultrasound Stimulation","Electroencephalography (EEG)","Low Intensity Focused ultrasound (LIFU)","RECRUITING","2026-06-25",{"date":72,"type":33},"2026-07-02",{"date":74,"type":33},"2025-07-09",{"date":76,"type":22},"2027-06-01",{"name":78,"class":79},"University of California, San Francisco","OTHER",{"id":81,"slug":82,"hasResults":12,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":12,"sex":17,"minAge":88,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":23,"phases":91,"briefSummary":92,"conditions":93,"keywords":94,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":41},"100623645","biomarkers-of-response-to-seeg-thermocoagulation-100623645","NCT07399327","Biomarkers of Response to SEEG Thermocoagulation","Biomarkers of Response to SEEG Thermocoagulation in Patients With Refractory Focal Epilepsy","THALPO","Inclusion Criteria:\n\n* Patient, parents or legal representative who have given their written informed consent,\n* Adult or pediatric patient ≥ 12 years old suffering from drug-resistant focal epilepsy,\n* Standardized pre-surgical assessment including medical history, scalp video-EEG and 3T MRI,\n* Patients in whom a SEEG exploration for pre-surgical evaluation has been indicated,\n* Patient able to understand, speak and write in French,\n* Patient able to follow study's procedure,\n* Patient beneficiary or affiliated to a health insurance plan.\n\nExclusion Criteria:\n\n* Epilepsy surgery performed without the requirement of SEEG,\n* Contraindication to 3T or 7T brain MRI (patient with a cardiac pacemaker, metallic foreign bodies, non-removable implanted electronic medical devices, claustrophobia, inability to remain in supine position, patient havingwith Vagus Nerve Stimulation (VNS) or Deep Brain Sstimulation (DBS), intrauterine devices or tattoos in the imaging area less than 6 weeks old at the time of the 3T\u002F7T brain MRI),\n* Contraindication to gadolinium-based MRI contrast agent (history of allergic or anaphylactic reaction to gadolinium, hypersensitivity to gadoteric acid, meglumine, or any drug containing gadolinium, severe renal failure (glomerular filtration rate, GFR, below 30 ml\u002Fmin\u002F1.73 m2), patients on dialysis or with a history of kidney disease, such as renal transplantation, a single kidney, or renal malignancy),\n* Person protected by articles L1121-5, L1121-6 and L1121-8 of the Public Health Code (pregnant or breastfeeding woman, deprived of liberty by judicial decision, situations of social fragility, adults unable or unable to express their consent),\n* Patient in exclusion period of another study.","12 Years",{"count":90,"type":22},45,[25],"Drug-resistant focal epilepsy is a severe neurological disease that affects one-third of patients with epilepsy. Surgery is the only potentially curative treatment. Intracerebral exploration by stereo electroencephalography (SEEG) is an important step in the surgical pathway. It aims to establish the precise mapping of the epileptogenic network (EZN), including all the brain regions that generate seizures. At the end of SEEG, SEEG-guided radiofrequency thermocoagulation (SEEG RFTC) represents a therapeutic option that may be efficient as a palliative treatment in patients ineligible for resective surgery, or may lead, in some cases, to a definitive effect, avoiding open surgery. The safety and effectiveness of this approach have been established. However, the odds of remaining seizure-free after one year vary greatly between studies, ranging from 4% to 71%. This disparity in therapeutic responses could be linked to the absence of objective criteria for the selection of targets, but also to the existence of mechanisms of action outside of the direct lesional effect. A decrease in SEEG markers of epileptogenicity may predict thermocoagulation efficiency. However, no data are available regarding changes in alteration of the blood-brain barrier (BBB) connectivity, inflammation, or associated molecular changes and their relationship to prognosis.\n\nThis study aims to elucidate the mechanisms underlying the clinical effect of SEEG RFTC by studying the changes in electrophysiological (SEEG), structural (ultra-high field MRI), and biological (blood biomarkers of neuro-glio-vascular damage and inflammation, molecular adaptations) markers. They will be correlated with clinical outcome in a prospective cohort of patients with drug-resistant focal epilepsy. As advantages for clinical care, this study will allow selection of RFTC targets based on scientifically validated criteria, and elaboration of predictive scores for therapeutic response in each patient.\n\nThe primary objective is to study the predictive factors of response to SEEG RFTC, by correlating changes in BBB permeability with clinical response 3 months after RFTC, in a prospective cohort of patients with drug-resistant focal epilepsy.",[28],[95,96,97],"RFTC","Drug resistant epilepsy","SEEG","2026-06-23",{"date":100,"type":33},"2026-06-26",{"date":102,"type":33},"2026-06-19",{"date":104,"type":22},"2029-06-30",{"name":106,"class":79},"Assistance Publique Hopitaux De Marseille",{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":12,"sex":17,"minAge":115,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":23,"phases":118,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":41},"100352394","low-intensity-focused-ultrasound-epilepsy-a-pilot-trial-100352394","NCT03868293","Low Intensity Focused Ultrasound Epilepsy: A Pilot Trial","Low Intensity Focused Ultrasound Treatment for Epilepsy: A Pilot Trial","LIFUS","Inclusion Criteria:\n\n* Subjects at least eighteen (18) years of age\n* Subjects with drug-resistant temporal lobe epilepsy whose seizures involve altered awareness (ie failed at least two trials of antiepileptic drugs for seizures), as determined by one of the BWH epilepsy neurologists based on clinical seizure semiology and\u002For EEG findings.\n* Subjects who experience at least 1-2 seizures per month on average, are aware of or have reliable caregivers who are aware of when seizures occur and can reliably log seizure frequency\n* Subjects who have the cognitive ability to read and understand the consent form, describe any potential symptoms experienced during or after treatments.\n\nExclusion Criteria:\n\n* Subjects with a cognitive or psychiatric disorder that limits the ability to give informed consent or are unable to cooperate with testing\n* Subjects with dementia or other progressive degenerative disease, delirium or active psychosis\n* Subjects with ferromagnetic materials in the head\n* Subjects with severe cardiac disease, increased intracranial pressure, or a Transcutaneous Electrical Nerve Stimulation (TENS) unit\n* Subjects who have primary generalized epilepsy or non-epileptic seizures\n* Subjects who have experienced status epilepticus in the 3 months leading up to enrollment in the study\n* Subjects (females) who are pregnant, or are of childbearing potential and not willing to use reliable birth control during the treatment period.\n* Subjects who are unable to get a brain MRI for any reason (implanted metal in body, inability to lie still)\n* Subjects with current brain tumors or an intracranial vascular lesion\n* Subjects with severe, uncontrolled medical problems, such as diabetes mellitus, hypertension, pulmonary or airway disease, heart failure, coronary artery disease, or any other condition that poses a risk for the subject during participation.\n* Subjects with holes in the treatment area of the skull from trauma or prior surgery\n* Subjects with pacemakers, medication pumps, and other implanted electronic hardware. If a subject has a working Vagal Nerve Stimulator in place, the device will be turned off prior to each treatment session and then turned back on after each session.","18 Years",{"count":117,"type":22},10,[25],"The aim of the proposed pilot study is to investigate patient tolerability and efficacy of moderate term, repeated exposure of Pulsed Low-Intensity Focused Ultrasound (PLIFUS) in patients with drug-resistant temporal lobe epilepsy.",[28],"2026-06-17",{"date":123,"type":33},"2026-06-18",{"date":125,"type":33},"2019-02-07",{"date":127,"type":22},"2027-03-09",{"name":129,"class":79},"Brigham and Women's Hospital",{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":12,"sex":17,"minAge":137,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":23,"phases":140,"briefSummary":142,"conditions":143,"keywords":144,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":155},"100641515","phase-2-fluorescence-guided-focal-cortical-dysplasia-surgery-100641515","NCT07657975","Fluorescence Guided Focal Cortical Dysplasia Surgery","FLUOFOCODYS","Inclusion Criteria:\n\n* Patient with drug resistant epilepsy, related to a type II FCD visible on MRI\n* Patient with surgical indication validated by the epileptic multi-disciplinary staff meeting\n* First FCD surgery\n* Signed written informed consent before any study specific intervention\n* Patient affiliated to the national health system or benefiting from it\n\nExclusion Criteria:\n\n* Patients weighing over 75kg\n* Patients requiring general anaesthesia for MRI at investigator discretion\n* Contra indication to MRI : obesity, claustrophobia, metallic object\n* Hypersensitivity to the active substance or to porphyrins\n* Acute or chronic porphyria\n* For woman of childbearing potential: Pregnancy or breastfeeding or patients who is not willing to comply with the contraceptive requirements during the study period\n* Inability to follow the procedures of the study\n* Simultaneous enrolment to another study which could influence the results of the current study\n* Patient under legal protection or deprived of liberty","3 Years",{"count":139,"type":22},5,[141],"PHASE2","Epilepsy is one of the most common neurological disorders, with one of the highest morbidity rates of all diseases. Despite the development of new anticonvulsant drugs, around a third of patients suffer from drug-resistant epilepsy (RPE). The onset of RPE can be lengthy, prolonging the period during which affected patients live with seizures that have a negative impact on their quality of life. Epilepsy surgery can be a curative treatment, and can enable anticonvulsant medication to be discontinued, optimizing quality of life and cognitive development. In addition, as it has been shown that the prolonged duration of epilepsy prior to surgery has an impact on the occurrence of postoperative seizures, early surgery is increasingly being considered. Focal cortical dysplasia (FCD) is the leading cause of focal lesional epilepsy and is generally drug-resistant. Good postoperative seizure results after surgical resection are strongly linked to complete resection of the dysplastic tissue. Consequently, accurate localization and precise delineation of FCD lesions are crucial during surgery. Currently, the extent of surgical resection is based primarily on preoperative examination, as the macroscopic appearance of dysplastic tissue does not differ from normal cortex. The various intraoperative techniques available to improve the quality of excision (neuronavigation, ultrasound, intraoperative MRI and intraoperative guidance by fluorescence microscopy) all have their limitations. In this context, new intraoperative tools are needed to help the neurosurgeon delineate lesions during surgery. Intraoperative fluorescence spectroscopy is used for surgical guidance of gliomas and other brain pathologies, and has demonstrated its ability to characterize pathological tissues. DCFs exhibit metabolic differences that can also be detected by 5-amino-levulinic acid (5-ALA)-induced protoporphyrin IX (PpIX) fluorescence intraoperatively. Indeed, in some patients who underwent surgery after a diagnosis of glioma, fluorescence was observed even though histological analysis classified the excised tissue as DCF. What's more, glioma and DCF share a common feature: the mitochondria of affected cells are deficient in complex IV. Cytochrome c oxidase (CCO) is largely involved in mitochondrial complex IV, and NAD is a central metabolite involved in redox reactions within cells. Both metabolites (CCO and NAD) can be visualized intraoperatively by optical and fluorescence spectroscopy.\n\nFLUOFOCODYS is a prospective, non-comparative, single-center, human drug pilot clinical trial. 5 patients will be included.",[28],[57,145,146],"Focal Cortical Dysplasia","Intraoperative Fluorescence Spectroscopy","2026-06-15",{"date":123,"type":33},{"date":150,"type":22},"2026-09",{"date":152,"type":22},"2028-09",{"name":154,"class":79},"Hospices Civils de Lyon",2,{"id":157,"slug":158,"hasResults":12,"nctId":159,"briefTitle":160,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":12,"sex":17,"minAge":137,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":23,"phases":165,"briefSummary":166,"conditions":167,"keywords":168,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":41},"100520637","epileptogenic-network-visualisation-with-advanced-mri-100520637","NCT06059157","Epileptogenic Network Visualisation With Advanced MRI","EPIVAM","Inclusion Criteria:\n\n* Patient suffering from drug-resistant epilepsy\n* Patient already selected for SEEG implantation as part of their epileptic networks\n\nExclusion Criteria:\n\n* Patient excluded from SEEG (pregnant women, children too young for the procedure, patient unable to undergo the procedure)\n* Contra-indication for MRI",{"count":164,"type":22},80,[25],"The goal of this clinical trial is to improve non-invasive identification of epileptogenic networks in drug-resistant epileptic patient.\n\nThe investigators aim to compare epileptogenic network identification with stereo-EEG (used as glod standard) with the identification of the same network using advanced MRI (rs-fMRI, microstructural analysis of white matter, ...). The main goals are to:\n\n1. Compare the accuracy of network identification.\n2. Analyse the effect of the MRI sequences on candidates selection and target identification.\n\nParticipants will already have been selected for stereoEEG and will undergo a supplementary MRI (about 1h) with the additional MRI sequences. Follow-up MRI are scheduled for patient undergoing a second, therapeutic epileptic surgery.",[28],[169,170,171],"epilepsy","network","non-invasive investigation","2026-06-11",{"date":147,"type":33},{"date":175,"type":33},"2023-10-25",{"date":177,"type":22},"2029-10",{"name":179,"class":79},"Cliniques universitaires Saint-Luc- Université Catholique de Louvain",{"id":181,"slug":182,"hasResults":12,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":12,"sex":17,"minAge":188,"maxAge":189,"enrollmentInfo":190,"targetDuration":4,"studyType":23,"phases":192,"briefSummary":193,"conditions":194,"keywords":195,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":4},"100594768","phase-2-cannabinoids-for-drug-resistant-epilepsy-dre-in-adults-and-children-100594768","NCT07023744","CANnabinoids for Drug Resistant Epilepsy (DRE) in Adults and Children","A Triple-Blind, Placebo-Controlled, Randomized Clinical Trial of CANnabinoids for Drug Resistant Epilepsy in Adults and Children","CAN-DRE","Inclusion Criteria:\n\n1. Ages 24 months to 55 years old at the time of enrollment\n2. Diagnosed with DRE: not achieved seizure freedom, with adequate trials of 2 antiseizure medications 29\n3. Medical history of 4 + clinically recognizable seizures (any type with clusters counted as a single event) per month\n4. Have a negative pregnancy test at screening for patients who have experienced menarche\n5. Agree to abstain from driving and recreational cannabis use throughout the study\n\nExclusion Criteria:\n\n1. Diagnosis of psychogenic non-epileptic seizure\n2. Recent (\\\u003C30 days) change in anticonvulsant therapies including anticonvulsant medications, or settings on vagal nerve stimulator\n3. Ketogenic diet started within 6 months (participants stable on the ketogenic diet for more than 6 months are eligible to participate)\n4. Vagal nerve stimulator implanted and activated within 12 months\n5. Concomitant regular use of narcotics (except in emergencies and physician supervised)\n6. Initiation or dosage change of oral or injected steroids within 3 months\n7. Allergy or intolerance to compounds in trial preparations\n8. DRE secondary to progressive neurological disease\n9. Clinically significant cardiac, renal or hepatic disease (as assessed by site investigator); elevated liver enzymes (GGT and\u002For AST and\u002For ALT) or lipase \\>3 times upper limit, adjusted for age\n10. History of psychotic disorders\n11. Uncontrolled (in the perspective of the qualified investigator) medical conditions including substance use disorders\n12. History or concurrent cannabis use disorder\n13. Unwilling or unable to use highly effective methods of contraception throughout the study period and three months post-trial, where applicable","24 Months","55 Years",{"count":191,"type":22},90,[141],"Epilepsy is a neurological disorder affecting more than 50 million people globally, including more than 260,000 Canadians. Cannabidiol (CBD) reduces seizure frequency and improves quality of life for adults and children with Drug Resistant Epilepsy (DRE). Several uncontrolled, small, open label studies reported that CBD-enriched Cannabis Herbal Extract (CHE) resulted in a reduction of seizure frequency, but we lack critical information on efficacy, comparative effectiveness and dosing of CBD and ∆9-tetrahydrocannabinol (THC) in children and adults with DRE. CAN-DRE is an early phase, triple-blind, placebo-controlled, randomized clinical trial to answer the questions of if cannabinoids work to reduce seizures in children and adults (24 months to 55 years) with DRE and if CBD works better in an isolate or in a CBD-enriched Cannabis Herbal Extract. The primary outcome of CAN-DRE is reported monthly seizure count from baseline to maintenance phase.",[28],[196,197,198,199,200,201],"adult and children","cannabis","DRE","CBD-isolate","CBD-enriched Cannabis Herbal Extract (CHE)","cannabidiol","2026-06-09",{"date":172,"type":33},{"date":205,"type":22},"2026-07-27",{"date":207,"type":22},"2028-03-31",{"name":209,"class":79},"University of Manitoba",{"id":211,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":212,"targetDuration":4,"studyType":23,"phases":213,"briefSummary":26,"conditions":214,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":219,"leadSponsor":220,"locationsCount":4},"100643448",{"count":21,"type":22},[25],[28],"2026-06-08",{"date":217,"type":33},"2026-06-10",{"date":35,"type":22},{"date":37,"type":22},{"name":39,"class":40},{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":12,"sex":17,"minAge":115,"maxAge":229,"enrollmentInfo":230,"targetDuration":4,"studyType":23,"phases":232,"briefSummary":233,"conditions":234,"keywords":237,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":41},"100626388","overnight-ti-in-tle-100626388","NCT07434986","Overnight TI in TLE","Overnight Temporal Interference Stimulation of Bilateral Hippocampi to Reduce Epileptogenic Biomarkers and Improve Sleep in Temporal Lobe Epilepsy","TI-HPC-TLE","Inclusion Criteria:\n\n* Age 18 - 70 years\n* Diagnosis of focal drug-resistant temporal lobe epilepsy\n* Candidate for in-laboratory overnight monitoring with PSG and scalp EEG, with ability to comply with study procedures\n* Stable antiseizure medication regimen for at least 1 week prior to admission\n* Capacity to provide consent\n\nExclusion Criteria:\n\n* Generalized epilepsy syndromes or primary generalized seizures\n* Recent status epilepticus, seizure clusters requiring emergency intervention, or other features indicating unacceptable risk for monitored participation\n* Uncontrolled psychiatric illness (e.g., acute psychosis, severe untreated depression with high suicide risk)\n* Implanted electronic or metallic devices incompatible with TI (e.g., certain pacemakers, cochlear implants) as per device manual\n* Severe obstructive sleep apnea requiring immediate CPAP initiation and not yet treated\n* Dermatologic disease at electrode sites or known contact allergy to electrode materials\n* Pregnancy or breastfeeding\n* Concurrent enrollment in other interventional neuromodulation or pharmacological trials likely to confound EEG or sleep outcomes","70 Years",{"count":231,"type":22},20,[25],"The goal of this clinical trial is to gauge whether overnight, non-invasive temporal interference (TI) stimulation aimed at the hippocampus can reduce abnormal brain activity linked to seizures and improve sleep in adults with drug-resistant temporal lobe epilepsy. The main questions are:\n\nDoes overnight TI stimulation lower seizure-related EEG activity during sleep?\n\nDoes overnight TI stimulation improve sleep quality and sleep patterns measured overnight in the lab?\n\nResearchers will compare each participant's nights without stimulation to nights with active stimulation, and will also look at a night after stimulation ends to see whether any changes last.\n\nParticipants will:\n\nStay in-lab for six days for overnight sleep and EEG monitoring\n\nHave one night of monitoring without stimulation\n\nReceive TI stimulation during sleep for several nights\n\nHave another night of monitoring without stimulation after the stimulation nights\n\nComplete brief questionnaires and thinking\u002Fmemory tasks before and after the stimulation nights\n\nBe checked for side effects and comfort during the study and at follow-up",[235,28,236],"Temporal Lobe Epilepsy (TLE)","Sleep",[57,238,239,28,240,241,242,236],"Temporal Lobe","Epilepsy and Sleep","Temporal Interference","Stimulation","Hippocampus","2026-05-08",{"date":245,"type":33},"2026-05-12",{"date":247,"type":22},"2026-06-01",{"date":249,"type":22},"2026-10-30",{"name":251,"class":79},"Duke University",{"id":253,"slug":254,"hasResults":12,"nctId":255,"briefTitle":256,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":259,"sex":17,"minAge":115,"maxAge":260,"enrollmentInfo":261,"targetDuration":4,"studyType":23,"phases":262,"briefSummary":263,"conditions":264,"keywords":267,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":41},"100593968","a-pet-mri-study-of-serotoninergic-brainstem-pathway-in-patients-with-dravet-syndrome-100593968","NCT07013331","A PET-MRI Study of Serotoninergic Brainstem Pathway in Patients With Dravet Syndrome","DRAPETONINE","Patients with DS\n\n* Inclusion criteria\n\n  1. Adult patients (≥ 18 but \\\u003C 60 years)\n  2. Diagnosis of Dravet syndrome will be confirmed based on medical history, type of seizures, EEG data and results of genetic testing\n  3. No restriction related to the seizure frequency\n  4. Patient assent and patient (or patient's legal representative guardianship) who gave its written informed consent to participate to the study\n  5. For women of childbearing\n* Exclusion criteria\n\n  1. Subject in exclusion period of another study\n  2. MRI contra-indication (presence of metallic elements, claustrophobia, Patients unable to maintain a minimul level of immobility during the imaging acquisition)\n  3. Presence of Vagal Nerve Stimulation\n  4. Patients unable to maintain a minimul level of immobility during the imaging acquisition\n  5. Pregnant women, women in labor or breastfeeding women.\n  6. Severe renal failure (Glomerular filtration rate \\\u003C 30 ml\u002Fmin)\n  7. Hypersensitivity to \\[18F\\] MPPF\n  8. Persons deprived of their liberty by a judicial or administrative decision\n  9. Persons under psychiatric care\n  10. Persons not affiliated to a social security scheme or beneficiaries of a similar scheme\n\nPatients with drug-resistant focal epilepsy\n\n* Inclusion criteria\n\n  1. Adult patient (≥ 18 years)\n  2. Patient suffering from drug-resistant focal epilepsy according to ILAE classification\n  3. Patient in whom presurgical evaluation is considered\n  4. No restriction related to the seizure frequency\n  5. Patient who gave her\u002Fhis written informed consent to participate to the study\n  6. For women of childbearing potential, use highly effective contraception during study participation\n* Exclusion criteria\n\n  1. Subject in exclusion period of another study\n  2. MRI contra-indication (presence of metallic elements, claustrophobia)\n  3. Presence of Vagal Nerve Stimulation\n  4. Ongoing serotoninergic treatment, including selective serotonin reuptake inhibitor\n  5. Pregnant women, women in labor or breastfeeding women.\n  6. Severe renal failure (Glomerular filtration rate \\\u003C 30 ml\u002Fmin)\n  7. Hypersensitivity to \\[18F\\] MPPF\n  8. Persons deprived of their liberty by a judicial or administrative decision\n  9. Persons under psychiatric care\n  10. Persons admitted to a health or social institution for purposes other than research\n  11. Adults subject to a legal protection measure (guardianship, curatorship)\n  12. Persons not affiliated to a social security scheme or beneficiaries of a similar scheme\n\nHealthy controls\n\n* Inclusion criteria\n\n  1. Presence of the symptoms of anxiety and\u002For depression as defined by a score ≥ 11 at the French version of the Hospital Anxiety and Depression Scale (HADS)\n  2. Ongoing treatment with selective serotonin reuptake inhibitor\n  3. MRI contra-indication (presence of metallic elements, claustrophobia)\n  4. Pregnant women, women in labor or breastfeeding women.\n  5. Severe renal failure (Glomerular filtration rate \\\u003C 30 ml\u002Fmin)\n  6. Hypersensitivity to \\[18F\\] MPPF\n  7. Persons deprived of their liberty by a judicial or administrative decision\n  8. Persons under psychiatric care\n  9. Persons admitted to a health or social institution for purposes other than research\n  10. Adults subject to a legal protection measure (guardianship, curatorship)\n  11. Persons not affiliated to a social security scheme or beneficiaries of a similar scheme\n* Exclusion criteria\n\n  1. Presence of the symptoms of anxiety and\u002For depression as defined by a score ≥ 11 at the French version of the Hospital Anxiety and Depression Scale (HADS)\n  2. Ongoing treatment with selective serotonin reuptake inhibitor\n  3. MRI contra-indication (presence of metallic elements, claustrophobia)\n  4. Pregnant women, women in labor or breastfeeding women.\n  5. Severe renal failure (Glomerular filtration rate \\\u003C 30 ml\u002Fmin)\n  6. Hypersensitivity to \\[18F\\] MPPF\n  7. Persons deprived of their liberty by a judicial or administrative decision\n  8. Persons under psychiatric care\n  9. Persons admitted to a health or social institution for purposes other than research\n  10. Adults subject to a legal protection measure (guardianship, curatorship)\n  11. Persons not affiliated to a social security scheme or beneficiaries of a similar scheme",true,"60 Years",{"count":21,"type":22},[25],"Dravet Syndrome (DS) is a severe neurodevelopmental disease, which is predominantly caused by mutations of SCN1A, the gene coding for Nav1.1 voltage-gated sodium channels. DS is characterized by infancy onset, severe cognitive deficit and drug-resistant seizures, including several generalized convulsive seizures per day and frequent status epilepticus, often triggered by fever or hyperthermia. Among the causes of premature deaths in patients with epilepsy, sudden and unexpected death in epilepsy (SUDEP) represents a major cause. SUDEP is a non-traumatic and non-drowning death in patients with epilepsy, unrelated to a documented status epilepticus. The risk of SUDEP is particularly high in patients suffering from DS, reaching about 9\u002F1000-person-year, as compared to about 1\u002F1000-person-year in people with epilepsy including all disease types. The main clinical risk factor of SUDEP is the frequency of convulsive seizures. Beyond improving seizure control, which we showed to mitigate the SUDEP risk, more specific preventive treatment strategies are still lacking.\n\nExperimental and clinical data suggest that most SUDEP cases result from postictal brainstem dysfunction, including central respiratory arrest There is a body of evidence suggesting involvement of serotonin (5HT) dysfunction both in the pathogenesis of epilepsy in DS and in seizure-related respiratory dysfunction. Serotonin indeed plays a key role in the regulation of respiration. Population firing of serotoninergic neurons in the medullary raphe is significantly decreased during the ictal and post-ictal periods, in association with decreased breathing and heart rate during and after seizures. Most importantly, post-mortem data in patients, including DS, showed alteration of neuronal populations in the medulla in SUDEP cases with evidence for greater reduction in neuromodulatory neuropeptidergic and monoaminergic, including serotoninergic, systems.\n\nSUDEP in DS might therefore be the result of a seizure-induced fatal apnea in a patient who has developed epilepsy-related vulnerability to central respiratory dysfunction favored by 5HT dysfunction. However, several issues remain to be addressed to identify detailed mechanisms and effective therapies. Among them, a key issue is the exact relation between the alterations of the 5HT pathway observed in DS and epilepsy-related respiratory dysfunction\n\nIn the present study, the hypothesis is that adult patients with DS might demonstrate specific alterations of the 5HT pathway within the brainstem as assessed by PET imaging. The DRAPETOTINE study will thus focus on imaging 5HT brainstem pathway with PET and MRI in patients with DS to assess if abnormalities can be observed and through comparison with data collected in patients drug-resistant focal epilepsy whether these abnormalities are DS specficic or reflect the consequence on brainstem 5HT pathway of refractory seizures.\n\nThis study will involve 20 adult patients, including 10 adults with established diagnosis of Dravet Syndrome and 10 patients with drug-resistant focal epilepsy. Ten healthy adults will also be included. Participants will be recruited over a period of 18 months and the duration of participation for each participant will be 2 weeks to 8 weeks",[57,265,28,266],"Dravet Syndrome","Healthy Controls",[169,268,269,270,271,272,273],"Dravet syndrome","drug-resistant focal epilepsy","serotonin","PET-MRI","MPPF","SUDEP","2026-05-05",{"date":243,"type":33},{"date":277,"type":33},"2026-05-04",{"date":279,"type":22},"2028-01-04",{"name":154,"class":79},{"id":282,"slug":283,"hasResults":12,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":4,"eligibilityCriteria":287,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":288,"targetDuration":290,"studyType":291,"phases":4,"briefSummary":292,"conditions":293,"keywords":295,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":4},"100634943","post-market-real-world-evidence-registry-for-the-neuroone-onerf-ablation-system-for-epilepsy-100634943","NCT07546253","Post-Market Real-World Evidence Registry for the NeuroOne OneRF® Ablation System for Epilepsy","OneRF® Ablation System Post-Market Real-World Evidence Registry","Inclusion Criteria:\n\n1. Patients diagnosed with drug resistant epilepsy (DRE)\n2. Patients who have received or will receive EVO® sEEG-RF implants\n3. Patients who have undergone or may undergo an RF ablation procedure using the OneRF Ablation System.\n4. Patient, or legal guardian, understands study procedures and voluntarily signs informed consent in accordance with institutional policies. In the event that the patient is under the age of 18, the patient may also be required (per IRB) to sign an assent affirming their agreement to participate.\n\nExclusion Criteria:\n\n1\\. Any condition that, in the judgement of the clinician, would make the participant inappropriate for registry participation",{"count":289,"type":22},100,"1 Year","OBSERVATIONAL","This is a multi-site registry study that aims to collect real-world clinical outcomes and device performance of the OneRF Ablation System. The study focuses on patients with refractory epilepsy who undergo, or are being considered for, sEEG-guided RF ablation using the OneRF Ablation System, as part of routine seizure diagnosis and treatment.",[28,294],"Refractory Epilepsy",[296,297,169],"radiofrequency ablation","sEEG","2026-04-16",{"date":300,"type":33},"2026-04-22",{"date":302,"type":22},"2026-07",{"date":304,"type":22},"2028-07",{"name":306,"class":40},"NeuroOne Medical Technologies Corporation",{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":17,"minAge":137,"maxAge":314,"enrollmentInfo":315,"targetDuration":4,"studyType":23,"phases":317,"briefSummary":318,"conditions":319,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":41},"100593746","microbiota-gut-brain-axis-in-resistant-epilepsy-100593746","NCT07010445","MiCrobiota-gut-brain Axis in Resistant Epilepsy","CARE","Inclusion criteria:\n\n* 3-50 years old;\n* diagnosis of epilepsy at onset or DRE;\n* ensured participation of the patient or a caregiver;\n* willingness to sign the informed consent.\n\nExclusion criteria:\n\n* diagnosis of organic gastrointestinal disorders (e.g. chronic inflammatory bowel disease);\n* special diets;\n* use of antibiotics, corticoids or probiotics in the previous month.","50 Years",{"count":316,"type":22},120,[25],"Epilepsy is one of the most common neurological chronic conditions with a serious burden on patients, their caregivers, and society. Drug-resistant epilepsy (DRE) heightens this burden. New approaches are thus a priority. Studies in animal models and humans have shown the link between gut microbiota (GM) and the central nervous system in health, neurological conditions, and neurodevelopmental disorders. DRE has been linked to GM dysbiosis. Preliminary findings in children with DRE showed GM modifications when responding to a ketogenic diet. The mediator role of GM has not yet been studied in DRE patients undergoing surgery\u002Fvagal nerve stimulation.\n\nCARE's central hypothesis is that the GM and its metabolic profile could contribute to clinical outcomes following these different therapeutic procedures. Identifying microbial biomarkers will enable us to deepen the knowledge of the role of gut-brain axis in epilepsy and to tailor the intervention to each patient based on GM modulation.",[320,57,56],"Gut Microbiota","2026-04-06",{"date":323,"type":33},"2026-04-09",{"date":325,"type":33},"2024-08-16",{"date":327,"type":22},"2027-02",{"name":329,"class":79},"Niguarda Hospital",{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":17,"minAge":115,"maxAge":50,"enrollmentInfo":337,"targetDuration":4,"studyType":23,"phases":339,"briefSummary":340,"conditions":341,"keywords":344,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":349,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":41},"100553948","a-pilot-study-to-evaluate-the-efficacy-and-safety-of-navifus-system-neuromodulating-treatment-for-patients-with-drug-resistant-epilepsy-100553948","NCT06492720","A Pilot Study to Evaluate the Efficacy and Safety of NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy","A Pilot, Open-label, Two-arm, Parallel-group Randomized Trial Study to Evaluate the Efficacy and Safety of NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy","Inclusion Criteria:\n\n1. Male or female patients aged over than and equal to 18 years old.\n2. Patients with drug-resistant epilepsy (defined as at least 3 ASM failed) and 1-4 ASM at the time of study entry.\n3. Epileptogenic focus (or foci) is determined by comprehensive presurgical evaluation.\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. Willing and able to sign written informed consent and be able to comply with the study protocol during the study period.\n\nExclusion Criteria:\n\n1. Patients with concurrent active psychiatric or mood disorders that have been assessed to interfere with participation in the study.\n2. Presence of pacemaker, implantable cardioverter-defibrillator (ICD), permanent medication pumps, cochlear implants, or deep brain stimulation (DBS).\n3. The skull bone area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), wounds, or atrophy of the scalp.\n4. Image documented calcified lesion in the FUS exposure path.\n5. Abnormal coagulation profile:\n\n   1. Platelet (PLT) \\\u003C 100,000\u002FμL.\n   2. prothrombin time (PT) \\> 15 sec.\n   3. activated partial thromboplastin time (APTT) \\> 45 sec.\n   4. international normalized ratio (INR) \\> 1.5.\n   5. Patients requiring anticoagulant medications.\n6. Pregnant or breast-feeding women.\n7. Coexisting medical problems of sufficient severity to limit compliance with the study.\n8. Known sensitivity\u002Fallergy to Magnetic Resonance Imaging (MRI) contrast agents or any of its components; having metallic implants that are assessed as unsuitable for MRI examination.\n9. Use of any recreational drugs or history of drug addiction or known history of substance or alcohol abuse.\n10. Patients have received an investigational drug or an investigational device within 4 weeks prior to the study\n11. 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.\n12. Any ASM treatment change during the baseline (screening period).\n13. Vagus nerve stimulation (VNS) dosing changes within 2 months before baseline (screening period).\n14. Radiofrequency thermocoagulation (RFTC) within 2 months before baseline (screening period).\n15. Patient has an IQ \\\u003C 70, based on the Wechsler Abbreviated Scale of Intelligence (WASI-III or IV).\n16. Any other condition that, in the investigator's judgment, patient not applicable to participate this study.",{"count":338,"type":22},16,[25],"This will be a prospective, pilot, open-label, two-arm, parallel-group, randomized study to evaluate the efficacy and safety of low-intensity focused ultrasound (LIFU) neuromodulation using NaviFUS System in patients with drug-resistant epilepsy (DRE).",[28,57,342,343],"Epilepsy, Temporal Lobe","Seizures, Focal",[345,346,347,348],"NaviFUS System","Focused Ultrasound","Low-Intensity Focused Ultrasound","LIFU",{"date":323,"type":33},{"date":351,"type":33},"2024-09-01",{"date":353,"type":22},"2027-03-31",{"name":355,"class":40},"NaviFUS Corporation",{"id":357,"slug":358,"hasResults":12,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":12,"sex":17,"minAge":115,"maxAge":4,"enrollmentInfo":363,"targetDuration":4,"studyType":23,"phases":365,"briefSummary":367,"conditions":368,"keywords":371,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":372,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":378},"100545959","phase-1-a-safety-tolerability-and-preliminary-efficacy-of-low-intensity-focused-ultrasound-neuromodulation-in-patients-with-drug-resistant-epilepsy-100545959","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.",{"count":364,"type":22},8,[366,141],"PHASE1","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).",[28,57,343,369,370],"Seizure","Seizure Disorder",[345,346,347,348],{"date":323,"type":33},{"date":374,"type":33},"2024-09-13",{"date":376,"type":22},"2027-05-31",{"name":355,"class":40},3,{"id":380,"slug":381,"hasResults":12,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":385,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":17,"minAge":115,"maxAge":4,"enrollmentInfo":387,"targetDuration":4,"studyType":291,"phases":4,"briefSummary":389,"conditions":390,"keywords":414,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":425},"100571728","neurosurgical-outcome-network-100571728","NCT06724029","Neurosurgical Outcome Network","Neurosurgical Outcome Network Per la Predizione Dell'Outcome in Neurochirurgia","NEON","Inclusion Criteria:\n\n* Neuro-oncological pathology: supratentorial and subtentorial tumors, intra and extra axial tumors excluding the skull base (anterior, middle and posterior fossa; sellar and parasellar region)\n* Basicranial pathology: tumors originating from the anterior cranial fossa, middle cranial fossa and posterior cranial fossa, sellar region with or without supratentorial\u002Fparasellar development.\n* Vascular pathology: aneurysms, AVMs, cavernomas, other pathologies (Moyamoya disease, dural fistulas, nontraumatic hematomas)\n* Traumatic pathology: diffuse damage (nonvisible diffuse damage, diffuse damage, diffuse damage with edema, diffuse damage with shift) and focal damage (acute\u002Fsubacute\u002Fchronic subdural hematoma, extradural hematoma, subarachnoid hemorrhage, intraparenchymal hematoma, fractures); hydrocephalus. The inclusion criterion for chronic subdural hematoma is recent bleeding for TBI with CT finding of chronic subdural hematoma candidate for evacuation surgery.\n* Spinal pathology: degenerative cervical (anterior\u002Fposterior), myelopathic, and trauma pathology; instrumented, uninstrumented thoracolumbar pathology (disc pathology, canal pathology), and trauma pathology; oncologic spinal pathology.\n* Functional pathology: Parkinson's disease, spasticity, trigeminal neuralgia, craniofacial pain\u002Falgia, neuropathic pain, tremor, dystonias, obsessive compulsive disorder, drug-resistant epilepsies, depression. Normotensive hydrocephalus.\n* Peripheral nervous system pathology: peripheral nerve compression syndromes, peripheral nerve and plexus tumors, brachial plexus and peripheral nerve trauma (contusion and section)\n* Malformative pathology: Chiari malformation type 1 and craniostenoses including both those framed in malformative syndromes and those not framed in malformative syndromes (monosutural craniostenoses: trigonocephaly, plagiocephaly, scaphocephaly; multisutural craniostenoses). Malformative hydrocephalus.\n* For cognitive and psychological assessment: age 18 years or older; adequate understanding of Italian language; diagnosis of glioma, meningioma, vascular pathology, spinal pathology\n\nExclusion Criteria:\n\n* For cognitive and psychological assessment: patients with psychiatric diseases in history and\u002For taking psychotropic drugs; presence of overt cognitive decline (not due to the injury) in history; patients younger than 18 years old.",{"count":388,"type":22},4500,"The evaluation of neurosurgical outcomes varies from center to center, and the predictive factors that determine these outcomes are not fully known or shared. This study aims to assess outcomes and their predictors using measures agreed upon by the participating centers. Standardizing the evaluation of outcomes and predictors improves the quality of research, allows for data comparison, and facilitates a \"common language\" in routine clinical practice. Most importantly, it influences therapeutic decisions in various neurosurgical conditions. Clinically, the identified predictors can also be used during preoperative assessments to provide more precise guidance to patients undergoing surgery.",[391,392,393,394,395,396,397,398,399,400,401,402,403,404,405,406,407,408,409,410,411,412,413],"Aneurysms","Arteriovenous Malformations","Cavernomas","Skull Base Tumors","Moyamoya Disease","Dural Fistulas","Subdural Hematoma","Extradural Hematoma","Subarachnoid Hemorrhage","Hydrocephalus","Parkinson&Amp;#39;s Disease","Spasticity","Trigeminal Neuralgia","Craniofacial Pain","Neuropathic Pain","Tremor","Dystonias","Obsessive-compulsive Disorder","Drug-resistant Epilepsy","Depression","Normal Pressure Hydrocephalus","Tumors of Peripheral Nerves","Chiari Malformation Type 1",[415],"Neurosurgery Outcome Artificial Intelligence predictors","2026-03-25",{"date":418,"type":33},"2026-03-30",{"date":420,"type":33},"2022-12-05",{"date":422,"type":22},"2027-06",{"name":424,"class":79},"Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta",27,{"id":427,"slug":428,"hasResults":12,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":4,"eligibilityCriteria":432,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":433,"enrollmentInfo":434,"targetDuration":4,"studyType":23,"phases":435,"briefSummary":436,"conditions":437,"keywords":438,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":4},"100631169","mrgfus-for-childhood-epilepsy-100631169","NCT07497178","MRgFUS for Childhood Epilepsy","A Prospective Cohort Study of High Intensity Focused Ultrasound Ablation for Brain Lesions in Children With Drug Resistant Epilepsy","Inclusion Criteria:\n\n• Age 4 - 17 years at time of enrollment • A confirmed diagnosis of epileptogenic lesion refractory to medication therapy. • Diagnosis of intractable epilepsy with failure after trial of two anti-epileptic medications. • Able to fit into a standard MRI unit. • Subjects with benign (WHO grade I) centrally located intracranial tumors which require clinical intervention and are known to carry minimal hemorrhage risk. • Patients with a head circumference \\>52cm and can tolerate frame-based stereotaxy. • Subjects should be on a stable dose of all condition-related medications for 30 days prior to study entry as determine by medical records. • The epileptogenic lesions (HH or other) can be targeted by the Exablate device. The lesion and region of treatment must be apparent on MRI and CT such that image fusion can delineate and model targeting when registered to the Exablate device.\n\nExclusion Criteria:\n\n• Any contraindication to MRI scanning • Pregnancy • Evidence of ethanol or substance abuse • Significant cardiac, respiratory, renal, or endocrine conditions (including arrhythmias) that increase procedural risk • History of abnormal bleeding disorders or hemorrhage • Use of anticoagulant, antiplatelet, or hemorrhage-associated medications","17 Years",{"count":231,"type":22},[25],"The goal of this observational study is to learn if magnetic resonance imaging guided focused ultrasound (MRgFUS) can treat brain lesions causing epilepsy in children with drug resistant epilepsy. The main questions it aims to answer are:\n\nIs MRgFUS safe in children with drug-resistant epilepsy due to central brain lesions?\n\nDoes MRgFUS treatment reduce seizure frequency and severity and improve quality-of-life?\n\nResearchers will prospective assess outcomes following MRgFUS in children.\n\nParticipants undergoing MRgFUS will complete seizure diaries and questionnaires related to seizure severity and quality-of-life.",[28,57],[57,198,439,440],"MRI-guided focused ultrasound","MRgFUS","2026-03-23",{"date":443,"type":33},"2026-03-27",{"date":445,"type":22},"2026-03-01",{"date":447,"type":22},"2029-12-31",{"name":449,"class":79},"The Hospital for Sick Children",{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":4,"eligibilityCriteria":456,"healthyVolunteers":12,"sex":17,"minAge":115,"maxAge":4,"enrollmentInfo":457,"targetDuration":4,"studyType":23,"phases":459,"briefSummary":460,"conditions":461,"keywords":462,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":466,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":41},"100604128","infrared-photobiomodulation-in-humans-with-epilepsy-100604128","NCT07145489","Infrared Photobiomodulation in Humans With Epilepsy","An Open Label Pilot Study of Infrared Photobiomodulation in Humans With Epilepsy","Inclusion Criteria:\n\n* Drug resistant epilepsy\n* Age 18 or older\n* Average seizure rate of at least 2 seizures per month\n* Accurate seizure diary with at least 3 months recorded\n\nExclusion Criteria:\n\n* Implanted intracranial neurostimulation device (DBS or RNS)\n* Intracranial shunt\n* Skin photosensitivity\n* Cancer on scalp\n* Taking any medication that can cause photosensitivity",{"count":458,"type":22},13,[25],"Drug-resistant epilepsy represents roughly 40% of people with epilepsy. It is very challenging to stop seizures in this condition, and the treatment options are limited. This study aims to investigate a new treatment that involves using infra-red light. In animals, this treatment has shown promise as a possible way to reduce seizures, but it has not been tested in humans for this. The investigators are interested to know if it can reduce seizures, and how comfortable it is to be treated with this therapy.",[28],[169,463,464],"photobiomodulation","seizure","2026-02-03",{"date":467,"type":33},"2026-02-04",{"date":469,"type":33},"2025-11-25",{"date":471,"type":22},"2027-09-25",{"name":473,"class":79},"Beth Israel Deaconess Medical Center",{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":478,"acronym":479,"eligibilityCriteria":480,"healthyVolunteers":12,"sex":17,"minAge":115,"maxAge":260,"enrollmentInfo":481,"targetDuration":4,"studyType":23,"phases":482,"briefSummary":483,"conditions":484,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":487,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":493,"locationsCount":41},"100354362","meg-versus-eeg-hr-for-the-localization-of-the-epileptogenic-zone-as-part-of-the-pre-surgical-assessment-of-epilepsy-100354362","NCT03893916","MEG Versus EEG HR for the Localization of the Epileptogenic Zone as Part of the Pre-surgical Assessment of Epilepsy","EPIMEEG","Inclusion Criteria:\n\n* patients with partial epilepsy for at least 2 years and for whom are decided and planned: either i) a surgical procedure to resect the epileptogenic zone without prior intracranial EEG recording either ii) an intracranial EEG record needed before a possible cortectomy procedure\n* Routine scalp EEG revealing known paroxysmal interictal abnormalities (at least 5 points on a 20-minute plot performed less than 2 years before inclusion in the study)\n* Patient giving written consent\n\nExclusion Criteria:\n\n* patient aged over 60 or under 18\n* patients with contraindications to brain MRI and MEG\n* women of childbearing age for whom a urine pregnancy test performed during the first visit would detect a pregnancy",{"count":289,"type":22},[25],"Drug-resistant partial epilepsies are disabling diseases for which surgical treatment may be indicated. The determination of the area to be operated (or 'epileptogenic zone') is based on a bundle of clinical arguments and neuroimaging, having a direct impact on surgical success.\n\nEpileptic patients have electrical abnormalities that can be detected with surface electrophysiological examinations such as surface EEG or MagnetoEncephalography (MEG). The intracerebral source of these abnormalities can be localized in the brain using source modeling techniques from MEG signals or EEG signals if a sufficient number of electrodes is used (\\> 100, so-called high EEG technique Resolution = EEG HR). EEG HR and MEG are two infrequent state-of-the-art techniques.\n\nThe independent contribution of EEG HR and MEG for the localization of the epileptogenic zone has been shown in several studies. However, several modeling studies have shown that MEG and EEG HR have a different detection capacity and spatial resolution depending on the cortical generators studied. Modeling studies suggest that MEG has better localization accuracy than EEG for most cortical sources.\n\nNo direct comparison of the locating value of MEG and EEG HR for the localization of the epileptogenic zone has been performed to date in a large-scale clinical study.\n\nIn this prospective study, 100 patients with partial epilepsy who are candidates for epilepsy surgery, and for some of them with intracranial EEG recording, will benefit from two advanced electrophysiological examinations including magnetoencephalographic recording (MEG). ) interictal electrophysiological abnormalities and high-resolution EEG recording (128 electrodes) in addition to the usual examinations performed as part of the pre-surgical assessment, prior to cortectomy and \u002F or intracranial EEG recording.\n\nBased on recent work conducted in humans, we postulate:\n\n* that the MEG and the EEG HR make it possible to precisely determine the epileptogenic zone, by using two approaches of definition of the epileptogenic zone (zone operated in the cured patients, zone at the origin of the crises during the intracranial recordings), but that the MEG is a little more precise than the EEG HR for the determination of the epileptogenic zone (we will try to highlight a difference of about 10%)\n* that the quantitative study of the complementarity between EEG HR and MEG for modeling sources of epileptic spikes will show an added value in the use of both methods compared to the use of only one of the two methods\n* that it is possible to determine the epileptogenic zone by determining the MEG model zone having the highest centrality value (hub) within the intercritical network by studying networks using graph theory.",[409,485,57],"Candidates for Surgical Treatment","2026-01-13",{"date":488,"type":33},"2026-01-15",{"date":490,"type":33},"2019-10-25",{"date":492,"type":22},"2029-04-25",{"name":154,"class":79},{"id":495,"slug":496,"hasResults":12,"nctId":497,"briefTitle":498,"officialTitle":499,"acronym":500,"eligibilityCriteria":501,"healthyVolunteers":259,"sex":17,"minAge":115,"maxAge":115,"enrollmentInfo":502,"targetDuration":4,"studyType":23,"phases":504,"briefSummary":505,"conditions":506,"keywords":507,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":511,"startDateStruct":513,"completionDateStruct":514,"leadSponsor":516,"locationsCount":4},"100620364","evaluation-of-the-efficacy-of-neurofeedback-technique-based-on-eeg-desynchronization-in-epileptic-patients-100620364","NCT07356661","Evaluation of the Efficacy of Neurofeedback Technique Based on EEG Desynchronization in Epileptic Patients","Randomized Double-blind Placebo-controlled Study of the Evaluation of the Efficacy of Neurofeedback Technique Based on EEG Desynchronization in Pharmaco-resistant Epilepsy","EPIFEED","For patients :\n\nInclusion Criteria:\n\n* Male or female patient between 18 and 65 years old\n* Patient suffering from focal or multifocal drug-resistant epilepsy\n* Patient having a number of seizures: at least 3 \u002F month during the baseline\n* Patient's IQ, which in the investigator's opinion will enable questionnaires and neuropsychological assessments to be carried out;\n* Patient having stable medications for epilepsy 4 weeks before the baseline (except rescue treatment);\n* Patient able to understand, speak and write in French;\n* Patient willing to participate, and gave written consent to the study after receiving clear information\n* Patient beneficiary or affiliated to a health insurance plan\n\nExclusion Criteria:\n\n* \\- Difficulty reading or understanding the French language or inability to understand information about the study\n* Generalized epilepsy\n* Major visual impairment incompatible with the realization of neurofeedback, based on investigator's opinion.\n* Patient currently having psychogenic non-epileptic seizures\n* Any condition that makes the study subject, in the opinion of the investigator, unsuitable for the study including presence of any disease, abnormality, medical or physical condition that, in the opinion of the investigator, may adversely impact, compromise, interfere, limit, affect or reduce the safety of the subject, the integrity of the data ; Person protected by articles L1121-5, L1121-6 of Public Health Code (pregnant or breastfeeding woman, deprived of liberty by judicial decision, situations of social fragility, adults unable or unable to express their consent, person under judicial safeguard (article L1122-2)).\n\nFor healthy volunteers :\n\nInclusion criteria :\n\n* Male or female of over 18 years of age\n* IQ compatible with the realization of the study\n* Patient able to understand, speak and write in French;\n* Patient willing to participate, and gave written consent to the study after receiving clear information\n* Subject beneficiary or affiliated to a health insurance plan\n\nExclusion criteria :\n\n* Subject presenting any neurological or psychiatric illnesses.\n* Subject having major visual impairment incompatible with the realization of neurofeedback, based on investigator's opinion.",{"count":503,"type":22},22,[25],"A large proportion of patients (approximately 30%) with drug-resistant epilepsy are not eligible for surgical treatment. The alternatives that can be offered to reduce the frequency of seizures are neuromodulation (vagus nerve stimulation (VNS), deep brain stimulation (DBS), or transcranial direct current stimulation (tDCS)). Most of these alternatives require invasive procedures and therefore carry risks.\n\nNeurofeedback (NFB) is a potential adjunctive treatment that allows patients to self-modulate brain activity and thus reduce seizure frequency in a non-invasive manner.\n\nThis technique involves measuring neurophysiological activity using a technical interface to extract a parameter of interest, which is presented in real time to the participant, who has been trained and has learned how to modify it.\n\nNFB is of interest in various neurological and psychiatric diseases and can lead to improvement in mood disorders, which are frequently associated with epilepsy. Previous NFB methods in epilepsy aimed to modulate sensorimotor rhythms or slow cortical potentials. The investigators propose an innovative EEG-NFB paradigm based on real-time estimation of EEG functional connectivity (FC) measured on the scalp EEG (NFC-FC).\n\nThis paradigm was developed based on previous studies demonstrating increased functional brain connectivity during the interictal period and decreased synchrony induced by VNS and transcranial electrical stimulation as a possible anti-epileptic mechanism.\n\nThis study consists of a randomized, double-blind comparison between NFB-FC and sham-NFB (control). The effect of this functional connectivity-based NeuroFeedBack (NFB-FC) will be evaluated on the number of seizures before and after treatment, as well as on their severity and on criteria related to quality of life.\n\nIn this study, two healthy volunteers will be recruited in order to generate the sham sessions.",[57,28],[169,508,509],"neurofeedback","connectivity","2026-01-12",{"date":512,"type":33},"2026-01-21",{"date":445,"type":22},{"date":515,"type":22},"2029-10-31",{"name":106,"class":79},{"id":518,"slug":519,"hasResults":12,"nctId":520,"briefTitle":521,"officialTitle":522,"acronym":523,"eligibilityCriteria":524,"healthyVolunteers":12,"sex":17,"minAge":525,"maxAge":526,"enrollmentInfo":527,"targetDuration":4,"studyType":291,"phases":4,"briefSummary":529,"conditions":530,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":534,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":539,"locationsCount":41},"100306407","impact-of-epileptic-discharge-on-the-structural-connectivity-of-the-developing-brain-100306407","NCT03268824","Impact of Epileptic Discharge on the Structural Connectivity of the Developing Brain","Impact of Epileptic Discharge on the Structural Connectivity of the Developing Brain: Combination of Intracerebral Stereotactic Electroencephalography Recording and Diffusion Tensor Imaging in Children With Drug-resistant Focal Epilepsy","EPITRACT","Inclusion Criteria:\n\n\\- Drug resistant focal epilepsy\n\nInclusion Criteria for control patients:\n\n\\- without drug resistant focal epilepsy\n\nExclusion Criteria:\n\n* Severe mental retardation (IQ \\\u003C 50)\n* Lack of French-language skills\n* Contraindications to MRI\n* Bi-hemispherical epilepsy or affecting multiple lobes\n\nExclusion Criteria for control patients:\n\n* Severe mental retardation (IQ \\\u003C 50)\n* Lack of French-language skills\n* Contraindications to MRI\n* Congenital pathology altering cerebral connectivity\n* Parenchymal brain lesions\n* Unilateral or bilateral blindness\n* Unilateral or bilateral deafness\n* Autistic disorders","18 Months","16 Years",{"count":528,"type":22},82,"Focal epilepsy is associated with widespread alterations in structural brain connectivity, often present at the disease onset and related to learning disabilities. Whether ongoing seizure activity contributes to network pathology is a matter of debate. This study intends to measure the impact of seizures on structural connectivity on a local and on a global level. In children examined with intracerebral electrodes to evaluate whether a surgical cure can be proposed, we combine intracerebral stereotactic electroencephalography (EEG) recordings with diffusion weighted imaging of white matter fibers. On the local level, the study will quantify the number of deficient connections in the seizure onset zone. On a global level, the study will compare the white matter fibers of the left and right hemisphere to probe whether physiological language lateralization is preserved.",[531,532,28],"Epilepsies, Focal","Pediatrics","2025-12-30",{"date":535,"type":33},"2026-01-05",{"date":537,"type":33},"2017-12-19",{"date":302,"type":22},{"name":540,"class":541},"Fondation Ophtalmologique Adolphe de Rothschild","NETWORK",{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":548,"eligibilityCriteria":549,"healthyVolunteers":12,"sex":17,"minAge":550,"maxAge":4,"enrollmentInfo":551,"targetDuration":4,"studyType":23,"phases":553,"briefSummary":554,"conditions":555,"keywords":556,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":568},"100541829","efficacy-of-personnalized-transcranial-direct-current-electrical-stimulation-tdcs-in-drug-resistant-epileptic-100541829","NCT06334952","Efficacy of Personnalized Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epileptic","Model-based Multichannel Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epilepsy: A Cross-over Study of Efficacy","GALVANI GS-3","Inclusion Criteria:\n\n1. Patient, parents or legal representative who have given written informed consent;\n2. Age: ≥ 9 years;\n3. Patients with drug-resistant focal epilepsy with no evolutive brain lesion and no surgical indication or with a previous surgical failure, refusing surgery or with a planned surgery compatible with the total duration of this study;\n4. SEEG previously performed before inclusion with an adequate definition of the epileptogenic zone with all data required (pre-SEEG MRI, CT-scan or MRI with electrodes during SEEG and SEEG files) for personalization ;\n5. Patient having a pre-SEEG 3D-T1 MRI and CT-scan with electrodes during SEEG available; This MRI can be done specifically for this trial or might be reused from EPINOV or NEURO7T trial)\n6. For patients with VNS, experiencing no response or partial response, and for whom the stimulation parameters have been stable for at least 6 months\n7. A research MRI scan that is suitable for navigated brain stimulation (NBS) and generation of electrical fields including dMRI for tractography;\n8. Number of seizures ≥3\u002Fmonth during the baseline (before the first session of tDCS treatment);\n9. Patient having stable medications for epilepsy 4 weeks before the baseline (except rescue treatment);\n10. Patient's IQ, which in the investigator's opinion will enable questionnaires and neuropsychological assessments to be carried out;\n11. Patient able to understand, speak and write in French;\n12. Patient able to follow study's procedure;\n13. Patient beneficiary or affiliated to a health insurance plan.\n\nExclusion Criteria:\n\n1. Patients with seizures of generalized onset in the last 12 months;\n2. Patient with multifocal epileptogenic zones, bilateral epileptogenic zone, or poorly defined epileptogenic zone. The epileptogenic network should not be restricted to the orbito frontal cortex or cingulate cortex;\n3. Patients with psychogenic nonepileptic seizures;\n4. Patient presenting a contraindication to MRI 3T (patient having a pacemaker, metallic foreign bodies, non-removably implanted electronic medical devices, claustrophobia, inability to remain in supine position, vagus nerve stimulator even when switched off is a contraindication for MRI 3T. EPINOV or NEURO 7T trial patients, who have accepted for their data to be reused, can be included even while wearing a VNS device) ;\n5. Substance use abuse that may include alcohol , opioids (heroin, fentanyl) stimulants (Cocaine, methamphetamine) , hallucinogens (LSD, psilocybin (magic mushrooms), MDMA (Ecstasy))\n6. Patient presenting a serious intercurrent pathology and\u002For a progressive brain tumor\n7. Patient having damaged skin or scalp that may interfere with tDCS stimulation (e.g., eczema, lesion);\n8. Patient having any cranial metal implants such as shrapnel or surgical clips (excluding \\\u003C1 mm thick epicranial titanium skull plates and dental fillings) or medical devices (i.e. cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant)\n9. Patient having previous surgeries opening the skull leaving skull defects capable of allowing the insertion of a cylinder with a radius greater or equal to 5 mm;\n10. Any condition that makes the study subject, in the opinion of the investigator, unsuitable for the study including presence of any disease, abnormality, medical or physical condition that, in the opinion of the investigator, may adversely impact, compromise, interfere, limit, affect or reduce the safety of the subject, the integrity of the data ;\n11. Person protected by articles L1121-5, L1121-6 of Public Health Code (pregnant or breastfeeding woman, deprived of liberty by judicial decision, situations of social fragility, adults unable or unable to express their consent, person under judicial safeguard (article L1122-2)).","9 Years",{"count":552,"type":22},60,[25],"The goal of this clinical trial is to to obtain a significant decrease in seizure frequency in patients with refractory focal epilepsy after applying treatment of cathodal tDCS, compared to sham stimulation drug-resistant epileptic patient. The main questions it aims to answer are:\n\n* Changes in quality of life\n* Percent of newly reported side effects after the stimulation period\n* Scores in epilepsy severity. Participants will be randomized in a cross-over, and will receive 10 days of tDCS or Sham. Each day will allow 2 periods of 20 minutes stimulation separated by 20 minutes off (with 40 minutes of cathodal stimulation total).",[57,28],[169,557,558,559],"transcranial direct current stimulation","numerical models","quality of life","2025-12-13",{"date":562,"type":33},"2025-12-19",{"date":564,"type":33},"2024-12-18",{"date":566,"type":22},"2028-01-18",{"name":106,"class":79},7,{"id":570,"slug":571,"hasResults":12,"nctId":572,"briefTitle":573,"officialTitle":573,"acronym":4,"eligibilityCriteria":574,"healthyVolunteers":12,"sex":17,"minAge":290,"maxAge":115,"enrollmentInfo":575,"targetDuration":4,"studyType":291,"phases":4,"briefSummary":576,"conditions":577,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":578,"lastUpdatePostDateStruct":579,"startDateStruct":581,"completionDateStruct":582,"leadSponsor":584,"locationsCount":41},"100614094","outcomes-of-drug-resistant-epileptic-pediatric-patient-by-modified-atkins-diet-100614094","NCT07275125","Outcomes of Drug Resistant Epileptic Pediatric Patient by Modified Atkins Diet","Inclusion Criteria:\n\n* Children aged 1-18 years.\n* Diagnosed with drug-resistant epilepsy according to ILAE definition.\\[2\\]\n* On KD for at least 6 months.\n\nExclusion Criteria:\n\n* \\- Patients with contraindicated metabolic\u002Fgenetic conditions.\n* Non-compliance with KD .\n\nPatients on alternative dietary therapies (e.g., low glycemic diet)",{"count":52,"type":22},"To assess clinical outcomes in drug resistant epileptic pediatric patient by modified atkin diet with focusing on following points:\n\n1. Control of seizures(frequency , duration and numbers of hospital admissions) .\n2. Quality of life by pediatric quality of life inventory v4.\n3. Cognitive function by stanford binet intelligence scale 5th edition.\n4. Growth parameters ( weight, height will be combined to report BMI in kg\u002Fm\\^2).",[28],"2025-11-28",{"date":580,"type":33},"2025-12-10",{"date":533,"type":22},{"date":583,"type":22},"2026-06-30",{"name":585,"class":79},"Sohag University",{"id":587,"slug":588,"hasResults":12,"nctId":589,"briefTitle":590,"officialTitle":591,"acronym":4,"eligibilityCriteria":592,"healthyVolunteers":12,"sex":17,"minAge":115,"maxAge":4,"enrollmentInfo":593,"targetDuration":4,"studyType":23,"phases":595,"briefSummary":596,"conditions":597,"keywords":598,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":603,"lastUpdatePostDateStruct":604,"startDateStruct":606,"completionDateStruct":608,"leadSponsor":610,"locationsCount":41},"100510604","goals-for-epilepsy-clinic-visits-trial-100510604","NCT05928598","Goals for Epilepsy Clinic Visits Trial","Drug-Resistant Epilepsy (DRE) Goals for Epilepsy Clinical Visits mHealth Epilepsy Visit Planner Trial","Inclusion Criteria - Patient Participants:\n\n* Adults with drug-resistant epilepsy\n* Participants receiving care through the Epilepsy clinics at the University of Michigan\n\nExclusion Criteria - Patient Participants:\n\n* \\\u003C18 years old\n* Non-English speaking\n* Do not clearly have drug-resistant epilepsy\n* Moderate-to-severe cognitive impairment that precludes study questionnaire completion\n\nInclusion Criteria - Provider Participants:\n\n-University of Michigan epilepsy providers\n\nExclusion Criteria - Provider Participants:\n\n-Not University of Michigan epilepsy providers",{"count":594,"type":22},152,[25],"The purpose of this project is to conduct a trial to assess whether patients that receive a tablet-based waiting room priority communication tool (the \"Epilepsy Visit Planner\") have improved outcomes compared to patients that do not receive the tool.\n\nThe project's hypotheses are:\n\n* Patients that receive the Epilepsy Visit Planner will have improved patient-provider communication compared to the non-planner group.\n* Patients that receive the Epilepsy Visit Planner will have improved quality of life scores.\n* The Epilepsy Visit Planner will score highly on process measures of feasibility and acceptability, demonstrating suitability for future larger scale study.\n\nAdditionally, there is a related survey project that is not part of the clinical trial and will not be included in this registration information.",[28],[599,600,601,602],"Survey","Quality of life","Communication tool","Patient-provider communication","2025-10-15",{"date":605,"type":33},"2025-10-20",{"date":607,"type":33},"2023-09-27",{"date":609,"type":22},"2027-01-01",{"name":611,"class":79},"University of Michigan",{"id":613,"slug":614,"hasResults":12,"nctId":615,"briefTitle":616,"officialTitle":616,"acronym":4,"eligibilityCriteria":617,"healthyVolunteers":12,"sex":17,"minAge":115,"maxAge":4,"enrollmentInfo":618,"targetDuration":4,"studyType":23,"phases":619,"briefSummary":620,"conditions":621,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":625,"lastUpdatePostDateStruct":626,"startDateStruct":628,"completionDateStruct":630,"leadSponsor":632,"locationsCount":41},"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":231,"type":22},[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.",[346,622,623,28,624],"MR-guided FUS","Drug Refractory Epilepsy","Medication Resistant Epilepsy","2025-09-02",{"date":627,"type":33},"2025-09-09",{"date":629,"type":33},"2024-01-01",{"date":631,"type":22},"2027-12-31",{"name":633,"class":634},"Taipei Veterans General Hospital, Taiwan","OTHER_GOV",{"id":636,"slug":637,"hasResults":12,"nctId":638,"briefTitle":639,"officialTitle":640,"acronym":4,"eligibilityCriteria":641,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":115,"enrollmentInfo":642,"targetDuration":4,"studyType":291,"phases":4,"briefSummary":643,"conditions":644,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":648,"lastUpdatePostDateStruct":649,"startDateStruct":651,"completionDateStruct":653,"leadSponsor":655,"locationsCount":378},"100539854","effectiveness-and-impact-on-the-quality-of-life-of-ketogenic-diet-in-pediatric-patients-100539854","NCT06309251","Effectiveness and Impact on the Quality of Life of Ketogenic Diet in Pediatric Patients","Clinical and Nutritional Effectiveness and Impact on the Quality of Life of the Ketogenic Diet in Pediatric Patients With Neurological, Genetic or Metabolic Disorders: a Multicenter Prospective Observational Study","Inclusion Criteria:\n\n* Pediatric patients (aged \\\u003C 18 years) with drug-resistant epilepsy (fail to achieve (and maintain) seizure freedom with adequate trials of two or more antiseizure medications) or genetic, metabolic, neurological (congenital and acquired) diseases treated with ketogenic diet\n* Pediatric patients (aged \\\u003C 18 years) with metabolic, genetic or neurological (congenital and acquired) diseases (not necessarily associated with drug-resistant epilepsy) treated with ketogenic diet; this includes the new KD indications or the administration of KD in the ICU for status epilepticus.\n\nExclusion Criteria:\n\n* Patients affected by beta-oxidation cycle disorders, systemic primary carnitine deficiency, primary dyslipidemia, pyruvate carboxylase deficiency, porphyria, mitochondrial disease, defects in ketone body metabolism (ketogenesis or ketolysis), defect in gluconeogenesis.\n* Children with type 1 diabetes\n* Parents (or caregivers) unable to guarantee adherence to the",{"count":289,"type":22},"The goal of this observational study is to learn about the clinical and nutritional effectiveness of ketogenic diet (KD) in pediatric patients with genetic, neurological or metabolic conditions requiring KD.\n\nThe main question\\[s\\] it aims to answer are:\n\n* does KD support adequate growth?\n* does KD improve clinical symptoms?\n* how does KD impact quality of life? Participants will be followed up as per clinical practice",[28,645,646,647],"Autism Spectrum Disorder","Chronic Migraine","Brain Tumor, Pediatric","2025-08-26",{"date":650,"type":33},"2025-09-03",{"date":652,"type":33},"2022-03-01",{"date":654,"type":22},"2026-12-31",{"name":656,"class":40},"Danone Nutricia SpA Società Benefit"]