[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"infantile-spasm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:infantile-spasm":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,73,100],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100638796","ibis---investigating-reliability-of-bis-and-sedline-monitoring-in-children-with-developmental-and-epileptic-encephalopathies-dee-100638796",false,"NCT07585643","IBIS - Investigating Reliability of BIS and SEDLINE Monitoring in Children With Developmental and Epileptic Encephalopathies (DEE).","IBIS","Inclusion Criteria:\n\n* Children (\\\u003C16 years old) with a confirmed diagnosis of early onset EE or DEE due to any cause (prior to age 2 years).\n\nExclusion Criteria:\n\n* Language barriers impeding data collection\n* Department for Child Protection and Family Support is involved in the care of the child.","ALL","0 Years","15 Years",{"count":20,"type":21},40,"ESTIMATED","OBSERVATIONAL","When children have surgery, anaesthetists carefully monitor the depth of anaesthesia by using sensors on the forehead that measure brain activity, also known as processed electroencephalogram (pEEG). These monitors are routinely used in paediatric anaesthesia; however, investigators do not know if they work accurately in babies and young children with seizure disorders or on anti-seizure medications.\n\nChildren with developmental and epileptic encephalopathies may need anaesthesia for tests or procedures. It is important that their treating doctors understand whether these monitors truly reflect how awake or asleep the children are. This study aims to compare a child's electrical brain activity using two commonly used devices in paediatric anaesthesia with the conventional 21-lead EEG patterns in children with seizure disorders. The results of this research may help improve the safety and perioperative care of children with seizure disorders who require general anaesthesia in the future.",[25,26,27,28],"Epileptic Encephalopathy","Early Infantile Epileptic Encephalopathy","Infantile Spasm","Developmental and Epileptic Encephalopathies",[30,31,32,33],"epileptic encepthalopathy","anaesthesia","PILOT STUDY","MULTICENTRE","NOT_YET_RECRUITING","2026-05-27",{"date":37,"type":38},"2026-05-29","ACTUAL",{"date":40,"type":21},"2026-05-20",{"date":42,"type":21},"2029-06-20",{"name":44,"class":45},"Telethon Kids Institute","OTHER",2,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":46},"100384727","phase-2-treatment-of-refractory-infantile-spasms-with-fenfluramine-100384727","NCT04289467","Treatment of Refractory Infantile Spasms With Fenfluramine","A Phase II Study of Fenfluramine for Treatment of Refractory Infantile Spasms","Inclusion Criteria:\n\n* Children ages 12 to 36 months, inclusive\n* Clinical diagnosis of infantile spasms\n* Continued epileptic spasms despite adequate treatment with ACTH and vigabatrin.\n\nExclusion Criteria:\n\n* Significant preexisting cardiovascular disease\n* Exposure to any cannabinoid product within 14 days of screening\n* Initiation or dose-titration of any second-line treatment for infantile spasms in the 14 days prior to screening.\n* Implantation of a vagal nerve simulator within 14 days of screening\n* Initiation and maintenance of the ketogenic diet within 3 months of screening","12 Months","36 Months",{"count":57,"type":21},10,"INTERVENTIONAL",[60],"PHASE2","This is a phase II clinical trial in which children with refractory infantile spasms (also called epileptic spasms or West syndrome) will be treated with fenfluramine, to evaluate efficacy, safety, and tolerability. Patients with infantile spasms that have not responded to treatment with vigabatrin and ACTH we will be invited to participate. Study participants will undergo baseline video-EEG, receive treatment with fenfluramine for 21 days, and then undergo repeat video-EEG to determine effectiveness. Patients with favorable response will have the opportunity to continue treatment for up to 6 months.",[27],"RECRUITING","2026-04-13",{"date":66,"type":38},"2026-04-15",{"date":68,"type":38},"2023-06-16",{"date":70,"type":21},"2026-12-31",{"name":72,"class":45},"Children's Hospital of Orange County",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":83,"conditions":84,"keywords":85,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":99},"100536546","characterization-by-automated-system-on-infantile-spasmes-100536546","NCT06266234","Characterization by Automated System on Infantile Spasmes","REASSESS","Inclusion Criteria:\n\n* Patients who presented with spasm and had a video EEG recording in one of the participating centers\n* Social security affiliation\n* Legal tutor autorisation.\n\nExclusion Criteria:\n\n\\-","3 Years",{"count":82,"type":21},5000,"Infantile spasms are defined by the occurrence of epileptic episodes characterized by the appearance of very specific motor seizures, made up of rapid, repeated contractions in flexion or extension known as spasms. This syndrome is of high concern as it will lead to mental retardation if it is not early identified and treated. Most often, spasms are characterized by sudden contractions of the body in flexion. More rarely, spasms occur in extension: the neck and legs suddenly tense, and the arms move upwards or sideways. Spasms may be accompanied by eye revulsion. They are brief, lasting 0.5 to 2 seconds each. At the start of the attack, they may be isolated, but then may occur in series lasting up to several tens of minutes.\n\nBecause of its nature and duration, infantile spasm is often difficult to identify and is often confused with benign motor manifestations in children, such as hiccups or muscular jerks. This difficulty often leads to delays in diagnosis. Indeed, patients are often seen at the stage when cognitive regression has set in.\n\nThe gold standard for diagnosing infantile spasms is to capture them on video-EEG to confirm the ictal correlate of the seizure. Although multiple variations are known, the ictal correlation is often a diffuse slow wave of high amplitude with subsequent electrodecrement. Yet continuous video electroencephalogram is an expensive and time-consuming resource often unavailable in developing countries and in many parts of the developed world. Furthermore, in an appropriate clinical scenario, continuous video-EEG may be unnecessary. For example, a home video examination with typical spasms combined with a definitively epileptic ambulatory EEG may certainly be adequate for the diagnosis of infantile spasms\n\nAs part of Mr. Diop's thesis, the study team have developed a system for analyzing videos acquired in 2 dimensions from a simple smartphone or webcam and highlighting the existence of spasms in a child. The principle is to use computer vision and computer learning model to identify the spasms from these videos. The first prototype of this system achieved a positive predictive value of 77%, which is very good considering the small sample used (\\\u003C 100) but quite insufficient to obtain a diagnostic prediction for medical use, for which we hope for sensitivity and specificity of around 95%.\n\nThe aim is to achieve a sensitivity and specificity of over 95% so that we can offer this detection system to healthcare professionals and parents of children who do not have rapid access to diagnosis. The aim is to develop a system enabling broad screening at the population level so that identified children can be more rapidly directed towards the healthcare system and appropriate treatment for their disease.\n\nTo achieve this goal, we need access to a standardized reference database that currently exists in the various pediatric electrophysiology laboratories of the Assistance Publique - Hôpitaux de Paris and the Île-de-France region. we propose using the films stored in these laboratories to teach the computer to recognize spasms that have already been formally identified by electrophysiologists and by ictal concordance.",[27],[86,87,88,89],"infantile Spasm","epilepsy","neurology","neurological disease","2025-02-10",{"date":92,"type":38},"2025-02-11",{"date":94,"type":38},"2024-02-01",{"date":96,"type":21},"2026-01",{"name":98,"class":45},"Assistance Publique - Hôpitaux de Paris",1,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":58,"phases":111,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":99},"100385700","vigabatrin-with-high-dose-prednisolone-combination-therapy-vs-vigabatrin-alone-for-infantile-spasm-100385700","NCT04302116","Vigabatrin With High Dose Prednisolone Combination Therapy vs Vigabatrin Alone for Infantile Spasm","Efficacy of Vigabatrin With High Dose Prednisolone Combination Therapy Versus Vigabatrin Alone for Infantile Spasm: a Randomized Trial","Inclusion Criteria:\n\n* Age at 2-14 months at date of enrollment\n* Clinical diagnosis of infantile spasm assessed by pediatric neurologist and hypsarrhythmic pattern or variants interpreted by pediatric epileptologist\n* Thai nationality\n\nExclusion Criteria:\n\n* Previous treatment (within the last 28 days) with vigabatrin or corticosteroid\n* Previous diagnosis of epileptic encephalopathy e.g. early infantile epileptic encephalopathy and early myoclonic epileptic encephalopathy\n* Has a clinical suspicious or diagnosis of tuberous sclerosis complex characterized by one of these; known affected parent, previously diagnosed cardiac rhabdomyoma, hypomelanotic macules, forehead fibrous plaque, shagreen patch, retinal phakoma, or known polycystic kidneys\n* A contraindication to vigabatrin or corticosteroid such as recent varicella or herpes zoster infection, gastrointestinal hemorrhage etc.\n* Thai language ability of the parents or guardians is that they may not understand what is being requested of them.\n* Predictable lack of availability of follow up","2 Months","14 Months",{"count":110,"type":21},250,[112],"NA","Infantile spasms (IS) are seizures associated with a severe infantile epileptic encephalopathy. Both cessation of spasms and electrographic response are necessary for the best neurodevelopmental outcomes. Adrenocorticotrophic hormone (ACTH), or prednisolone, or vigabatrin are considered the first-line treatment individually. However, ACTH expense and availability are the barriers in developing countries including Thailand. Vigabatrin, therefore, is the first recommended by Epilepsy Society of Thailand due to ACTH unavailability. Recently, combined steroid treatments (either ACTH or high dose prednisolone) with vigabatrin are superior in cessation of spasms compared to steroid treatment alone. Thus, this study is aimed to compare the efficacy of vigabatrin with high dose prednisolone combination therapy and vigabatrin alone.",[27,115],"West Syndrome",[27,117,118,119,115],"Vigabatrin","Prednisolone","Treatment","2021-08-24",{"date":122,"type":38},"2021-08-25",{"date":124,"type":38},"2020-05-18",{"date":126,"type":21},"2026-12",{"name":128,"class":129},"Kullasate Sakpichaisakul","OTHER_GOV"]