Predictors of Drug Resistant Epilepsy Among Pediatric Patients
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Epilepsy, Seizure, Resistance. Базовые параметры: 1 год — 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Predictors of Anti-seizure Medication Resistance in Pediatric Epilepsy
Обзор
1. This study aims to determine the main predictors of drug resistance in pediatric epilepsy by examining clinical data, EEG abnormalities, and neuroimaging results, in order to support early identification of resistant cases and improve treatment strategies . 2. Early introduction of new lines of treatment in case of refractory epilepsy as : Ketogenic diet , Rituximab and solumedrol
Подробное описание
Epilepsy is among the most prevalent chronic neurological disorders in the pediatric population, affecting approximately 0.5-1% of children worldwide . It is characterized by recurrent, unprovoked seizures resulting from abnormal, excessive, or synchronous neuronal activity in the brain. Epilepsy in childhood represents a major public health concern, not only because of its relatively high incidence, but also due to its significant impact on neurodevelopment, cognitive functions, psychosocial well-being, and overall quality of life .
Despite the remarkable advances in pharmacological therapy, the cornerstone of epilepsy management remains antiseizure medications (ASMs). More than two-thirds of children with epilepsy achieve satisfactory seizure control with one or two appropriately chosen medications. However, a considerable proportion-estimated at 20-40%-develop drug-resistant epilepsy (DRE) . According to the International League Against Epilepsy (ILAE), DRE is defined as the failure to achieve sustained seizure freedom after adequate trials of at least two well-tolerated and appropriately selected ASMs, whether administered as monotherapy or in combination . Children with DRE are at a particularly high risk of poor neurocognitive outcomes, behavioral problems, injury, psychosocial difficulties, and even increased mortality .
Given the serious consequences of uncontrolled epilepsy, early identification of patients at risk for ASM resistance is of paramount importance. Predictors of drug resistance in pediatric epilepsy have been widely studied, although results vary across different populations and study designs. Factors frequently reported include early age at seizure onset, high initial seizure frequency, abnormal developmental history, specific electroencephalographic (EEG) abnormalities, structural brain lesions, identifiable genetic syndromes, and poor response to the first-line ASM . Recognition of these predictors can enable clinicians to stratify patients into risk categories, anticipate treatment challenges, and implement timely alternative interventions such as epilepsy surgery, ketogenic diet, or neuromodulation .
Moreover, exploring predictors of ASM resistance in children is not only clinically relevant, but also contributes to a better understanding of the pathophysiology of epilepsy and its heterogeneous nature. By delineating the factors that influence treatment outcomes, researchers and clinicians may be able to develop more targeted therapeutic strategies, improve prognostic counseling for families, and ultimately enhance the overall management of pediatric epilepsy .
Первичные конечные точки
- Predictors of Drug Resistance in Pediatric Epilepsy [Срок оценки: through 12 months of follow-up.]
Вторичные конечные точки (1)
- Assessed from the time of diagnosis of drug resistance up to 12 months following initiation of the alternative treatment. [Срок оценки: Assessed from the time of diagnosis of drug resistance up to 6 to 12 months following initiation of the alternative treatment.]
Критерии участия
Критерии включения
- Children aged 1-18 years with a confirmed diagnosis of epilepsy.
- Both males and females will be included.
Критерии исключения
- Children younger than 1 year or older than 18 years.
- Patients with acute symptomatic seizures (e.g., febrile seizures, metabolic or infectious causes) or pseudo refractory epilepsy (e .g. syncope or uncorrect ASMs)
- Patients controlled on antiseizure medications
- Refusal of parents or guardians to participate in the study
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Публикации
- Loscher W, Potschka H, Sisodiya SM, Vezzani A. Drug Resistance in Epilepsy: Clinical Impact, Potential Mechanisms, and New Innovative Treatment Options. Pharmacol Rev. 2020 Jul;72(3):606-638. doi: 10.1124/pr.120.019539. PMID 32540959
- Devinsky O, Vezzani A, O'Brien TJ, Jette N, Scheffer IE, de Curtis M, Perucca P. Epilepsy. Nat Rev Dis Primers. 2018 May 3;4:18024. doi: 10.1038/nrdp.2018.24. PMID 29722352
- Sillanpaa M, Schmidt D. Natural history of treated childhood-onset epilepsy: prospective, long-term population-based study. Brain. 2006 Mar;129(Pt 3):617-24. doi: 10.1093/brain/awh726. Epub 2006 Jan 9. PMID 16401617
- Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000 Feb 3;342(5):314-9. doi: 10.1056/NEJM200002033420503. PMID 10660394
- Aaberg KM, Gunnes N, Bakken IJ, Lund Soraas C, Berntsen A, Magnus P, Lossius MI, Stoltenberg C, Chin R, Suren P. Incidence and Prevalence of Childhood Epilepsy: A Nationwide Cohort Study. Pediatrics. 2017 May;139(5):e20163908. doi: 10.1542/peds.2016-3908. Epub 2017 Apr 5. PMID 28557750
- Russ SA, Larson K, Halfon N. A national profile of childhood epilepsy and seizure disorder. Pediatrics. 2012 Feb;129(2):256-64. doi: 10.1542/peds.2010-1371. Epub 2012 Jan 23. PMID 22271699
Идентификаторы
NCT: NCT07241754 · Drugs resistant epilepsy