Active clinical trials for "Epilepsy"

EudraCT: 2018-003887-29 Objective:To evaluate the safety and efficacy of: MGCND00EP1 from MGC PHARMACEUTICALS d.o.o. Study Design: Randomized, double blind, placebo controlled parallel grouped study Sample Size: 103 subjects Study Population: Children from 1 year to 18 years of age Comparator Product :Placebo solution, oral IMP Product : MGCND00EP1 (each ml of solution containing 100 mg of cannabidiol and 5 mg of (-)-trans-Δ9- tetrahydrocannabinol as active substance) from MGC PHARMACEUTICALS D.O.O. According to dosing scheme up to 25 mg/kg BW per day or maximum daily dose 800 mg (whichever smaller) for 6 weeks titration and 6 weeks of treatment, oral administration

The objectives of this research are to understand how the brain can keep information in mind ("working memory"), and use this information to guide behavior. The two experiments that fall under this study will collect brain signals from epilepsy patients who are having surgery as part of their treatment. More specifically, these signals will be studied from the time while the patient is performing two cognitive tasks.The endpoints are publication of the results from each of the proposed experiments in peer-reviewed journals.

Age related focal epilepsies in children encompasses, according to the ILAE criteria, benign epilepsy with centro temporal spikes (BECTS), atypical benign partial epilepsy (ABPE) and epileptic encephalopathy with continuous spike and waves during sleep (ECSWS). These non structural epilepsies are associated with interictal sleep spike and waves activated by sleep. Moreover, high prevalence of learning disorders occur in children with age related epilepsies. A correlation is suspected between learning disorders and sleep activation of spike and waves. The investigators suppose that learning dysfunction is linked to loss of information during sleep of epileptic children, unlike for control patients. As sleep allows memory consolidation of words learned during wakefulness, an epileptic activity during sleep may disrupt this consolidation, leading to a loss of information. Hypothesis: the investigators hypothesize a disruption of memory consolidation after one night in children affected with ABPE and ECSWS (severe group) compared to memory consolidation in children affected with BECTS (benign group), and control group. Primary purpose: To demonstrate that the deficit of delayed recall in 15 word learning test after one night is higher for the "severe group", compared to the "benign group" and the control group. Secondary purposes: to study the evolution over time of memory consolidation to evaluate the correlation of the deficit of delayed recall with executive dysfunction, clinical factors of epilepsy, neurophysiological factors of epilepsy, and sleep architecture

Doose syndrome is a rare epileptic syndrome that can lead to learning difficulties and a poor quality of life. The goal of this study is to evaluate the evolution of epilepsy and its consequences on cognitive development and learning issues in children with Doose syndrome.

The human brain presents outstanding challenges to science and medicine. Brain function and structure span broad spatial scales (from single neurons to brain-wide networks) as well as temporal scales (from milliseconds to years). Currently, none of the tools available for studying the brain can fully capture its structure and function across these diverse scales - "the neuroimaging puzzle". This poses crucial limitations to understanding how the brain works, and how it is affected by numerous diseases. The central goal of this project is to expand currently available tools for non-invasive human brain imaging, to bridge critical gaps in the neuroimaging puzzle. New methodologies will be developed, focused on ultra-high field magnetic resonance imaging (UHF MRI) and its combination with electroencephalography (EEG). New contrast mechanisms and technological advances enabled by UHF MRI and EEG will be explored to allow unprecedented views into the microstructure of brain regions like the thalamus, and to capture the activity of large-scale neuronal networks in the brain with high sensitivity, temporal and spatial specificity. These advances will be directly applied to address open questions in the diagnosis and treatment of essential tremor, and psychosis. In general, improved brain imaging techniques are critical for a deeper understanding of how the brain works, and to detect and characterize diseases more effectively, thereby improving clinical management and leading to a healthier population. The non-invasive characterization and treatment of neurodegenerative diseases like tremor is particularly relevant to aging modern societies.

We aim to determine the clinical utility of 'dynamic tractography': a novel method for visualizing electrical neural transfers that incorporates the underlying white matter tracts and supporting linguistic processing. We will also determine how well objective electrophysiology biomarkers will improve the prediction of language outcomes following epilepsy surgery. This project will ultimately optimize understanding of how the human brain develops its language network dynamics.

Cenobamate is a newly-FDA and EMA approved drug used to treat -focal-onset seizures in adult patients. The aim of the current study is to analyse retrospectively the overall effectiveness and tolerability of cenobamate from real-world data collected in patients who partecipated in the Early Access Program (EAP) and were treated with cenobamate as adjunctive ASM.

This is a phase I/IIa clinical trial investigating the safety of a lentiviral epilepsy gene therapy using an engineered potassium channel in patients with refractory epilepsy.

The overarching goal of this exploratory research is to understand the dynamic and flexible nature of speech processing in the human supratemporal plane. The temporal lobe has long been established as a region of interest in the speech perception and processing literature because it contains the auditory cortex. More recently, research has localized the supratemporal plane as an area that exhibits response specificity to acoustic properties of complex auditory signals like speech. The supratemporal plane, comprised of Heschl's gyrus, the planum polare, and the planum temporale, is capable of the rapid spectrotemporal analysis required to map acoustic information to linguistic representation. Neural activity in this area, however, is rarely studied directly because it is difficult to access with non-invasive measures like scalp electroencephalography (EEG). Capitalizing on the unique opportunity to access these areas via routine clinical stereoelectroencephalography (sEEG) in a patient population, this study seeks to understand how cortical responses reflect the diagnosticity of two acoustic-phonetic dimensions of interest and how responses rapidly and flexibly adapt to changes in listening demands. Examining how neural response to voice onset time (VOT) and fundamental frequency (F0) modulates as a function of perceptual weight carried in signaling phoneme categories, and identifying how changes in listening context shift perceptual weight, will provide invaluable data that indicates how speech processing flexibly adapts to short-term acoustic patterns.

The PRECISION-study offers a non-invasive, curative intervention for drug-resistant localised epilepsy patients who are not eligible for surgery. The intervention will consist of a single LINAC based SRT treatment and is given by the radiation-oncologist after detailed localisation of the epileptogenic zone with the neurologist, radiologist and neurosurgeon. This intervention will make curative-intent treatment possible where this could otherwise not be given and is a non-invasive and non-competitive alternative to epilepsy surgery. It is expected that the health costs for this curative treatment will not exceed standard treatment, such as lifelong medication and neuromodulation.