View clinical trials related to Epilepsy.
Filter by:This is an open label, single arm, interventional, prospective first in human study, designed to evaluate the safety of the NAO.VNS SYSTEM.
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: - Changes in quality of life - Percent of newly reported side effects after the stimulation period - 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).
Over the past decade, the concept of the brain as a complex network has extremely influenced the way regarding how the latter is studied (Bartolomei et al., 2017). The structure of both structural and functional networks within the brain has been related to optimal brain functioning (Duma et al., 2022). This evolution of methods and approaches of investigation has directly impacted the study of epilepsy. An early conception of focal epilepsy was that it was related to the activity of the epileptogenic zone, which was identified as the generative element of seizures. However, what was previously considered focal was found to be network alterations at various levels, thus moving from the epileptogenic zone to the concept of the epileptogenic network. Alterations in both the structural and functional network, compared with a healthy control population, have been identified in various forms of epilepsy from focal to idiopathic generalized epilepsy (Lariviere et al., 2022, Zhang et al., 2009). Often the identification and removal of the epileptogenic network, turns out to be the elective therapy in drug-resistant focal epilepsies. The process of diagnosing and defining the epileptogenic network is still debated today. One of the most widely used methods is the implantation of intracranial electrodes for electroencephalographic recording of seizures (Bartolomei et al., 2017). This methodology carries with it several, albeit controlled, risks to the patient. New noninvasive approaches are being developed seeking to integrate information from structural neuroimaging and cortical electrical activity measured by high-density electroencephalography with external electrodes (Duma et al., 2021). These new approaches also include simulative approaches that exploit individualized information such as cortex geometry and patient-specific white matter connections (Courtiol et al. 2020). Thus, starting from a simple structural and diffusion MRI, which is done in routine clinical examinations, multiple localizing hypotheses of the epileptogenic network can be tested using simulative models and then compared with the real EEG signal as validation. Of great relevance is also to understand how the structural-functional connectome relates to cognitive function in patients with epilepsy, who have a high probability of presenting impaired functioning in one or more cognitive domains.
Background Epilepsy is a common neurological disorder. It affects 50 million people worldwide and has the highest incidence in pediatric age. According to the latest classification of the ILAE (International League against Epilepsy), epilepsies are divided into lesional (symptomatic) and non-lesional/genetic forms. Symptomatic causes of epilepsy may include scarring, tumors, strokes, and brain developmental disorders such as dysplasias. In approximately 30% of epilepsies a genetic cause of epilepsy can be hypothesized. Since the identification of the first epilepsy gene in 1995, over the next 25 years over 500 genes associated with epilepsy have been identified. The importance of many genes and many gene variants identified in many genes is not yet clear and the mutations identified in different genes require confirmation with functional studies and confirmation on larger series of patients. Furthermore, the genetic defect underlying many patients with epilepsy remains unknown to this day, despite a high level of gene sequencing effort. Molecular studies on these genes have demonstrated how pathogenic variants on these genes determine a protein dysfunction that can cause neuronal hyperexcitability and pathological synchronization of neuronal networks leading to epileptic seizures and brain dysfunction. A notable complication in the field of epilepsy genetics is represented by the fact that the concept of a gene/a disease is valid only in a few cases, as there is a high phenotypic and genotypic heterogeneity so that a gene can present different types of epilepsy even within the same family. This means that there is a complex multigenic and multifactorial genetic substrate for which the impact of a specific genetic variant is conditioned by variants of other genes. This concept is particularly valid for the most common epileptic forms such as idiopathic generalized epilepsies. The integration of genetic analysis with epileptological characterization in clinical practice is increasingly crucial in defining a clear molecular diagnosis in patients whose disease cause would otherwise remain unknown, and potentially allows avoiding other unnecessary diagnostic investigations. It is therefore expected that this will lead to optimizing clinical management and reducing overall costs over time. The genetic finding can constitute a useful biomarker for defining the outcome of the disease and for guiding clinical decisions such as the best choice of therapy. Despite the advantages, before starting the genetic testing process, patients and their family members should be informed about the ethical issues that may arise from genetic testing, the technical limitations, legal aspects and costs of genetic investigation. Aim of the study Characterization of patients with epilepsy recruited at the Hospital Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico in Milan (Italy) and analysis with exome NGS sequencing of patients with the highest probability of genetic diagnosis with exome (use of a probability score) Endpoints of study are the following: 1. Identification of the genetic cause of the forms of genetic epilepsies with the highest probability of molecular diagnosis with exome 2. Clinical-instrumental and epileptological characterization according to the ILAE classification of patients with epilepsy followed at the Fondazione IRCCS Ca' Granda Fondazione Ospedale Maggiore Policlinico 3. Correlation of clinical and instrumental parameters (in particular EEG and neuropsychological) of epilepsy recorded on the database with etiology, outcome and response to therapy
The purpose of the study is to investigate the long-term safety and tolerability of brivaracetam in study participants with childhood absence epilepsy or juvenile absence epilepsy.
This study aims to evaluate the efficacy of a ketogenic diet in treating pediatric intractable epilepsy and to explore its relationship with changes in inflammatory markers. The investigators plan to recruit 59 participants with intractable epilepsy, 39 of whom will receive a combination of ketogenic diet and conventional antiepileptic drugs, while 20 will receive only conventional drugs. The study will assess the impact of the ketogenic diet on epilepsy control and inflammatory markers, hoping to discover new treatment strategies.
This study wants to make it easier to find kids with a type of epilepsy called childhood absence epilepsy (CAE) who might have problems with ongoing seizures and thinking. Right now, doctors use tests that can be expensive and take a long time. Eysz is developing a system that looks at how kids move their eyes which might help find CAE more quickly and accurately. This study will compare Eysz with the usual tests to see if it can predict seizures and thinking problems in kids with CAE. The goal is to find these problems earlier and help kids do better in school and life.
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
Epileptic seizures in newborns (often called "neonatal convulsions") represent the most frequent neurological problem in newborns (1-3/1000 newborns). The type of seizure and their etiology is very varied and therefore the therapeutic protocol also requires adaptations with a personalization of the therapeutic approach according to the characteristics of the case according to principles of precision medicine in particular for forms of neonatal epilepsy compared to epileptic seizures acute symptomatic. In recent years it has been highlighted that the clinical characterization and instrumental characterization, in particular electroencephalographic, of epileptic seizures represents an important biomarker that allows the choice of therapy to be oriented appropriately. In the literature there is a lack of single-center studies that relate the type of crisis according to the new ILAE 2017 classification (Fisher 2017) and its proposal for neonatal adaptation (Pressler 2021) with the etiology, type of therapy and outcome neurological after a few years. The primary aim of the study is to evaluate the correlation between the type of seizure determined according to the ILAE classification (clinical variables), the EEG findings of the epileptic seizures and the specific etiology of the epileptic seizures. The secondary aim is to evaluate the correlation between seizure type and etiology with effective therapy, length of hospitalization and neurobehavioral development outcome. The study design is a retrospective observational on the population of neonates managed at our center in the last decade.
Vagus nerve stimulation (VNS) is an adjunctive treatment for refractory epilepsy. Although widely used, there is still a substantial number of patients with insufficient response. Light, and particularly blue light, can stimulate alertness, attention and cognition through modulation of anatomical targets which are common to the vagal afferent network. This project aims at understanding how exposure to blue enriched light may influence VNS effects in patients with refractory epilepsy by exploring the modulation of a series of biomarkers of VNS action. This could possibly lead to new therapeutic strategies to increase efficacy of VNS.