View clinical trials related to Epilepsies, Partial.
Filter by:This is a clinical research study for an investigational drug called RAP-219 in patients with Refractory Focal Epilepsy. This study is being conducted to determine if RAP-219 works and is safe in patients with Refractory Focal Epilepsy.
Patients were first observed for a 4-week baseline period, which required no medication adjustments and a seizure frequency of greater than or equal to 2 times per 4-week . After the baseline observation period, if the patients met the criteria for enrolment and there were no contraindications, zonisamide was added as an additional therapeutic drug.Clinical data were collected before the initiation of treatment, at 1 month, 3 months and 6 months after taking zonisamide respectively, with regular review of blood tests and urinary ultrasound, and imaging and electrophysiological examinations according to the clinical needs of the patient's actual condition.
The study aims to evaluate the effectiveness of long-term video EEG monitoring using 10-20 electrodes extended with intra-auricular electrodes in locating the seizure onset zone and interictal epileptiform discharges (IEDs) in patients with temporal lobe epilepsy (TLE) and nontemporal lobe epilepsy (non-TLE).
This study investigates the usefulness of high resolution electrical source imaging (HR-ESI) in the setting of presurgical evaluation of drug-resistant focal epilepsy in children. This method is based on an estimation of the intra-cerebral source that produces a signal recorded by scalp electrodes by solving the inverse problem, taking into account attenuation factors resulting from particular conductivity properties of the cerebral, peri-cerebral and cranial tissues. Electrical sources are then fused on structural magnetic resonance imaging (MRI). Scalp EEG recorded using 64 to 256 electrodes refers to as high resolution EEG (HR-EEG), leading to HR-ESI. Studies based on small population of children or on mixt population of children and adults showed that HR-ESI has accuracy values, i.e. percentage of true positives (electrical source localized in the brain area resected and success of surgery) and true negatives (electrical source localized outside the brain area resected and failure of surgery) among the total population, ranging from 50 to 80%. Discrepancies between studies could be explained by the limited number of patients included or by the mixture of pediatric and adult data. Another limitation of previously published studies is that the spatial pattern of dipole source distribution was not taken into account to determine prediction accuracy of ESI. Studies using magnetoencephalography (MEG) to perform magnetic source imaging (MSI) suggest that the spatial pattern of dipole source distribution needs to be considered, a spatially-restricted dipole distribution being associated with better post-surgical outcome when resected. To tackle these issues, the investigators aim to conduct the first large prospective multicentric study in children with focal epilepsy candidates to surgery to assess prediction accuracy of ESI based on the finding of tight clusters of dipoles. This is original as this pattern (tight versus loose cluster of dipoles) has been studied by several researchers using MEG but not using HR-EEG. The investigators make the hypothesis that HR-EEG will allow to identity good candidates for epilepsy surgery and thus to offer this underutilized treatment in more children with better post-surgical outcome. Among the secondary objectives, the investigators will address methodological issues related to the resolution of the inverse problem (methods using distributed sources models versus methods based on equivalent dipole estimation), the potential added value to model high-frequency oscillations (HFO), and the investigators will assess the cost-utility of the HR-ESI procedure.
This is a national monocentric (San Raffaele Hospital - OSR, Via Olgettina, 60, 20132 Milan, Italy) observational low-risk-intervention study, prospective and multiparametric (clinical, EEG, neuropsychological evaluations) study. Patients with a diagnosis of DRE and DSE will be screened to evaluate their eligibility. They will undergo clinical and cognitive assessments in addition to 32channel EEG at baseline (T0). DRE patients will also undergo clinical and cognitive assessments, and 32-channel EEG at 6 months (T1), and 12 months (T2). Patients newly diagnosed with focal cryptogenic epilepsy (NDE) will undergo clinical and cognitive assessments, and 32-channel EEG at baseline (T0), at 6 months (T1), and 12 months (T2). High-definition EEG will be performed to investigate patterns of cortical sources and functional connectivity alteration specific to DRE and DSE and to explore their prognostic value. Longitudinal EEGs will be acquired to explore the evolution of EEG patterns. Cognitive evaluation will be performed by an experienced neuropsychologist. At baseline, DRE, DSE, and NDE patients will undergo a screening and a comprehensive cognitive battery in order to define performance differences among groups. The DRE and NDE group only will perform the same neuropsychological assessment at month 6 and 12 for monitoring the potential progression of cognitive and/or behavioural disturbances in these patients.
The objective of this prospective interventional monocentric clinical investigation is to evaluate the feasibility and performance of the flexible high-density SOFT ECoG electrode grids, manufactured by Neurosoft Bioelectronics SA (test device; TD), in comparison to regular high-density electrode grids (ADTech, CE-marked) (control device; CD) routinely used at the investigation site during epilepsy surgery. Subjects will undergo ≥ 2 additional intracranial recordings pre- and post-resection with the TD next to the standard recordings with the CD during ECoG-tailored epilepsy surgery.
The purpose of this research is to use electrical neuromodulation on patients with focal epilepsy. The main objective is to assess safety and observe potential therapeutic effects.
Epilepsy is a disabling neurological disease that affects tens of millions of people worldwide. Despite therapeutic advances, about a third of these patients suffer from treatment-resistant forms of epilepsy and still experience regular seizures.All seizures can last and lead to status epilepticus, which is a major neurological emergency. Epilepsy can also be accompanied with cognitive or psychiatric comorbidities. Reliable seizures count is an essential indicator for estimating the care quality and for optimizing treatment. Several studies have highlighted the difficulty for patients to keep a reliable seizure diary due for example to memory loss or perception alterations during crisis. Whatever the reasons, it has been observed that at least 50% of seizures are on average missed by patients. Seizure detection has been widely developed in recent decades and are generally based on physiological signs monitoring associated with biomarkers search and coupled with detection algorithms. Multimodal approaches, i.e. combining several sensors at the same time, are considered the most promising. Mobile or wearable non invasive devices, allowing an objective seizures documentation in daily life activities, appear to be of major interest for patients and care givers, in detecting and anticipating seizures occurence. This single-arm exploratory, multicenter study aims at assessing whether the use of such a non-invasive, wearable device can be useful in a real life setting in detecting seizures occurence through multimodal analysis of various parameters (heart rate, respiratory and accelerometry).
This is a study which seeks to develop a novel therapeutic approach, Intersectional Short Pulse (ISP) stimulation for seizure termination. The device embodiment of ISP is a scalp EEG recording system which also delivers spatially precise electrical stimulation in short pulses to the targeted brain region. The study team has already collected safety and tolerability data in human subjects, demonstrated ISP efficacy in terminating seizures in rodents, and have tested the efficacy of this device to modulate normal human brain activity. Now this study proposes to test the device's efficacy in stopping seizures in a within-subject randomized, sham-controlled study design.
The main goal of this project is to study the mechanisms of epileptic activities using intracranial macro and micro electrodes in epileptic patients undergoing pre-surgical investigation. The recordings will also be used to study physiological mechanisms like sleep and different cognitive functions.