Active clinical trials for "Drug Resistant Epilepsy"

This is a study looking at the effects of transcranial magnetic stimulation (TMS), a form of non-invasive brain stimulation (NIBS), on the human brain as recorded by intracranial electroencephalography in neurosurgical patients. NIBS will be applied in a targeted manner and brain responses will be recorded.

record fast ripples with novel intracranial electrodes with micro-tetrodes to improve the identification of epileptogenic zone (EZ) and investigate the neuronal circuits underlying brain dynamics associated with epilepsy

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.

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

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.

Ketogenic dietary therapies (KDTs) are well-established, safe, non-pharmacologic treatments used for children and adults with drug-resistant epilepsy and other neurological disorders. Ketone bodies levels undergo a significant inter-individual and intra-individual variability and can be affected by several factors. This evidence suggests the need for personalized monitoring for diet optimization, especially at the beginning of the treatment but during whole follow-up. Possible variations in glycemia and ketone bodies' blood level according to different phases of menstrual cycle have not been systematically assessed yet, but this time window deserves special attention because of hormonal and metabolic related changes. We present the methodological protocol for a longitudinal, multicentric study aimed at searching for subtle changes in ketone bodies blood level during menstrual cycle in epileptic female patients undergoing a stable ketogenic diet. The study will be divided into two phases. The first one will be purely observational, aiming at the assessment of ketonemia during menstrual cycle. Whether this finding will be confirmed, a second phase of ketogenic diet therapy adjustment will be scheduled.

This study consist of define anatomo-functional reorganization (plasticity) profiles for the mentioned cognitive functions, before surgery (chronic plasticity induced by the epileptogenic zone) in patients with drug-resistant epilepsy. For that, patients will have 2 MRI examinations, one before surgery and the second, between 3 and 8 months after surgery.

The exact function of the anterior cingulate cortex (ACC) is one of the largest riddles in cognitive neuroscience and a major challenge in mental health research. ACC dysfunction contributes to a broad spectrum of neurological and psychiatric disorders, such as depression, ADHD, Parkinson's disease, OCD and many others, but nobody knows what it actually does. Recently a new theory has been developed about ACC function; the HRL-ACC (Hierarchical Reinforcement Learning Theory of ACC). This theory proposes that the ACC selects and motivates high-level tasks based on the principles of hierarchical reinforcement learning. The ACC associates values with tasks, selects the correct tasks and applies control over other neural networks (such as the dorsolateral prefrontal cortex and basal ganglia), which execute the tasks. The values of these tasks are attributed based on "reward prediction error signals", which are sent from the midbrain dopamine system to the ACC. These signals can be recorded using scalp-EEG as an "event-related brain potential" (ERP), which is called the "reward positivity". Until this day, the exact origin of the reward positivity is not yet known. Studies have delivered strong indirect evidence that the reward positivity is generated in the ACC. However, there is an important lack of direct evidence to support this hypothesis. The goal of this study is to provide direct evidence that the reward positivity is generated in the ACC by letting a group of patients with refractory epilepsy perform the virtual T-maze task (which is known to elicit reward positivity) and simultaneously recording intracranial video-EEG.

Resting-state functional MRI (r-fMRI) has emerged in recent years to analyze resting networks. It allows, without active participation of the patients, to identify and analyze the different functional brain networks. The analysis of r-fMRI can be done thanks to the graph theory, which is based on the based on the calculation of quantifiable parameters applied to the functional network studied, making it possible to assess its effectiveness. To the knowledge of the investigators, no study has used graph theory applied to r-fMRI data in order to obtain parameters useful for the useful parameters for the individual prognosis of children who have to be operation for drug-resistant lesional epilepsy.

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. Epileptic 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. The 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. No 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. In 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 / or intracranial EEG recording. Based on recent work conducted in humans, we postulate: 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%) 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 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.