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Epilepsy clinical trials

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NCT ID: NCT03184597 Recruiting - Epilepsy Clinical Trials

HLA Screening in Reducing the Risk of Antiepileptic Drug-induced Cutaneous Adverse Reactions

Start date: August 1, 2017
Phase: N/A
Study type: Interventional

Cutaneous adverse drug reactions (cADRs) include mild maculopapular exanthema (MPE) and severe cutaneous reactions such as hypersensitivity syndrome, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN). cADRs are considered as a major public health issue because of their potentially life-threatening morbidity, especially severe cutaneous reactions. The incidence of SJS/TEN is estimated to vary from 1 in 1,000 to 10,000 drug exposures, and its mortality is as high as 35%. Antiepileptic drugs (AEDs), particularly those with aromatic ring structures such as carbamazepine (CBZ), oxcarbazepine (OXC), lamotrigine (LTG), phenobarbital (PB), and phenytoin (PHT), are among the most common causes of severe cutaneous reactions. The incidence of AED-induced SJS was estimated as 0.2% and all cases occurred in individuals receiving aromatic AEDs. Previous studies have validated that the human leukocyte antigen (HLA) allele HLA-B*15:02 is strongly associated with CBZ-induced SJS/TEN in southern Han Chinese and populations in southeast Asia. Our recent studies indicated that HLA-A*24:02 is a common genetic risk factor for CBZ-, LTG-, and PHT-induced SJS/TEN. It is also associated with MPE. Additionally, another four alleles, including HLA-B*15:01, HLA-B*15:11, HLA-A*02:01,and HLA-DRB1*01:01, were showed to be potential risk factors for aromatic AEDs-induced SJS/TEN. In 2007, the US Food and Drug Administration issued the safety alert that recommended HLA-B*15:02 screening for people with Asian ancestry before starting CBZ, and avoidance of the drug if the test is positive. Subsequent studies from Taiwan, Hong Kong and Thailand demonstrated that HLA-B*15:02 screening before commencing CBZ can significantly reduce the incidence of CBZ-induced SJS/TEN. However, the overall incidence of AEDs-induced SJS/TEN remained unchanged in Hong Kong, as PHT-induced SJS/TEN increased when CBZ-SJS/TEN decreased. Moreover, no study focuses on the incidences of AEDs-induced cADRs with and without HLA screening before commencing aromatic AEDs. Therefore, we are planning to conduct a multicenter prospective study to examine the reduction of AEDs-induced cADRs after the HLA screening prior to the beginning of aromatic AEDs administration.

NCT ID: NCT03163719 Recruiting - Lactate Clinical Trials

Impact of Early Lactate Dosage Compared to CK for Diagnosis of a Suspected Seizure

Start date: November 28, 2016
Phase: N/A
Study type: Observational

Defining the origin of a seizure remains a difficult diagnosis. The presence of witness is not systematic, the clinical examination can be little contributory, and the delay recommended by the FSN is often surpassed for the realization of Creatine kinase (4h). In the event of a suspected seizure, an initial blood test with Creatine kinase and Lactates is often done on admission of the patient in other words before the 4hours delay. It seems interesting to harmonize the practices, to limit the patient wait in the emergencies for a deferred dosage of CK at 4 hours from the seizure and to identify an early biological marker. Objectives: To evaluate the value of blood CK and Lactate dosage in emergency procedures in the diagnosis of generalized seizures.

NCT ID: NCT03094312 Recruiting - Epilepsy Clinical Trials

Evaluation of the Risk of Cognitive Deficit After Surgery of Epilepsy by Dynamic Spectral Imaging (ISD) of the Cognitive Functions in Patients Explored in StereoElectroEncephaloGraphy (SEEG)

ISD SEEG
Start date: June 23, 2017
Phase: N/A
Study type: Interventional

Epilepsy affects between 0.5 and 0.7% of the European population. Despite the availability of numerous drug treatments, one third of patients still have seizures, which are associated with significant cognitive and social complications and excess mortality. In these patients, surgical treatment to remove the epileptogenic zone (EZ), the region of the brain responsible for seizures, is the only approach that can allow control of the disease. However, before investigating this surgery, investigations have to answer two questions: (i) what is the location and extension of the EZ and (ii) what functional risks, both motor and cognitive, would represent the resection of this Cortical region? As it is a functional surgery, it is in fact inconceivable that the surgery will result in an over-handicap. For these reasons, all candidates for surgery benefit from a complete assessment including imaging examinations, a neuropsychological assessment and a long-term video-EEG recording to record seizures. Nevertheless, in some patients, this assessment does not give us a formal answer. In these subjects, it is then necessary to carry out a second step, consisting of an invasive exploration by implantation of intracerebral electrodes during a stereoencephalography (SEEG). Due to its temporal and spatial resolution, the SEEG allows, besides the precise determination of the EZ, to carry out a functional mapping of the cortical regions likely to be included in cortectomy. Conventionally, this mapping is carried out on the basis of the cortical electrical stimulations applied to the implanted electrodes. If this approach is very robust for exploring primary functions such as motor skills or language, it cannot be used to evaluate more complex cognitive tasks such as face recognition or attention Effective cognitive treatment on a daily basis. This has led to the development in recent years, in Lyon and Grenoble, of a complementary approach to cerebral stimulation: dynamic spectral imaging (ISD). Numerous experimental paradigms have demonstrated that the realization of a cognitive task associates with the generation within the cortical regions involved in its treatment of a particular cortical activity. This activity is characterized by oscillations of the cortical rhythm in high frequencies (> 30 Hz), called gamma activities. The ISD thus consists in mapping this gamma activity during various cognitive tasks, thus making it possible to study more widely the complexity of the cognitive functions. Correlations between gamma activity and cognitive tasks have so far been exclusively performed in the non-epileptic cortex explored at the periphery of the EA during SEEG. Nevertheless, the cortical oscillatory pattern study associated with a specific cognitive task within the EZ could better anticipate complex cognitive deficits that could be generated by the resection of a cortical region. The main objective of this project is to establish the predictive character of the gamma cortical oscillatory pattern associated with a specific cognitive task on the risk of occurrence of a cognitive disorder after surgery of epilepsy.

NCT ID: NCT03074279 Recruiting - Epilepsy Clinical Trials

Risk Factors of SUDEP

PRERIES
Start date: July 1, 2011
Phase: N/A
Study type: Observational

Numerous studies over the past decade have shown without any doubt that there is a higher mortality risk in patients with epilepsy than in the general population. The cause of death may be related to the cause of epilepsy, being directly related to a seizure (status epilepticus or sudden unexpected death in epilepsy; SUDEP), a consequence of seizures (accidents, etc), other associated pathologies (cancer, cardiovascular disease, ischemic heart disease, pneumonia, etc) or an associated disorder (depression or suicide). A SUDEP is defined as a sudden, non-traumatic, unexpected death in a patient with epilepsy, not necessarily in the presence of witnesses, that is not due to drowning, with or without evidence of a seizure, excluding documented status epilepticus and in which a post-mortem autopsy reveals no anatomical or toxicological cause of death. Little is known about SUDEP and its mechanisms and risk factors. This epidemiological study is based on the RSME. The Main objective of this study to identify risk factors of SUDEP, in particular night-time supervision and the risks associated with anti-epileptic drugs including compliance and drug interactions.

NCT ID: NCT03062514 Recruiting - Refractory Epilepsy Clinical Trials

Trial to Evaluate the Safety and Effectiveness of Vagus Nerve Stimulation for Children With Refractory Epilepsy

Start date: October 9, 2017
Phase: N/A
Study type: Interventional

Children with refractory epilepsy who are candidates for a treatment with vagus nerve stimulation will be prospectively randomized into 2 arms. Vagus nerve stimulation parameters are programmed and adjusted during outpatient clinic visits, within the normal clinical practice.

NCT ID: NCT03054961 Recruiting - Epilepsies, Partial Clinical Trials

Cerebral Oxygen Saturation and Cytochrome Oxidase REDOX State in Children With Epilepsy: A Pilot Study

Start date: February 10, 2017
Phase:
Study type: Observational

The purpose of this pilot study is to describe the relationship of regional cerebral oximetry and cytoximetry, measured using near-infrared spectroscopy, with seizure activity in the periictal period in children with epilepsy.

NCT ID: NCT03035513 Recruiting - Clinical trials for Cryptogenic Epilepsy

Diffusion Tensor Imaging in Epilepsy With Continuous Spikes and Waves During Sleep

POCS-DTI
Start date: January 2017
Phase: N/A
Study type: Observational

Continuous Spikes and Waves during Sleep (CSWS) is a rare paediatric epileptic encephalopathy. Even if the correlation between the severity of the epilepsy and the cognitive consequences is well established, the mechanisms involved in epileptic cognitive degradation are complex and poorly understood. In CSWS, there are many arguments for the implication of cortical and subcortical cerebral structures. Among them the thalamus seems to play a crucial role. In fact it is strongly implicated in the sleep and this function is determining for learning. Moreover, it is part of the propagation pathway of generalized forms of epilepsy like absences in animal studies. Unfortunately there is no animal model for CSWS to confirm this theory. In human studies, few cases are caused by thalamic injuries but most of the time conventional MRI is normal. Despite few literature on CSWS, some studies reported abnormal functional connectivity especially in the thalamus. The investigators hypothesize that the first utilisation of diffusion tensor imaging (DTI) and tractography will be useful in CSWS to confirm the implication of a cortico-thalamo-cortical network showing an abnormal structural connectivity. The investigators will try to determinate if a particular thalamic nucleus is concerned and demonstrate a link between the disease severity (duration and cognitive consequences) and the importance of structural abnormalities. Using resting state functional MRI (fMRI), the investigators will also try to investigate the default mode network. Its implication was also suggested in the literature.

NCT ID: NCT03031028 Recruiting - Refractory Epilepsy Clinical Trials

Effect of Outpatient Classic Ketogenic Diet in Epileptic Children and Adolescent.

Start date: July 2016
Phase: Phase 2
Study type: Interventional

This study will consider the effectiveness of the ketogenic diet (high-fat, low-carbohydrate, and moderate protein) in treating epilepsy. Investigators enroll a group of eligible epileptic children and adolescent who have been referred from epilepsy center to our clinic and prescribe them ketogenic diet.

NCT ID: NCT02954107 Recruiting - Absence Epilepsy Clinical Trials

Longitudinal Early Epilepsy Study

LEES
Start date: September 2016
Phase:
Study type: Observational [Patient Registry]

This longitudinal study will focus on the cognitive and brain development of children with absence epilepsy. In addition, the investigators aim to identify prognostic factors for cognitive deterioration and/or poor seizure control in these children.

NCT ID: NCT02899832 Recruiting - Epilepsy Clinical Trials

A Study of Hemodynamic Changes Using Near Infra-red Spectrometry (NIRS) in Infantile Epilepsy Spasms

SPASMES-NIRS
Start date: February 21, 2013
Phase:
Study type: Observational

This study will included 20 children presenting with epilepsy with spasms. It aims to offer these children, non invasively and without supplementary examinations, a recording of local and cerebral hemodynamic changes concomitant with an electroencephalographic recording during epileptic episodes. This will be carried out by combining optical imaging using near infra-red spectroscopy (NIRS) with electroencephalography (EEG), in a simultaneous high-resolution (HR) recording. This study is among those based on multimodal analyses of epilepsy, combining methods of analysis of electrical activity (electrical imaging) and hemodynamics (optical imaging). Surface electroencephalography (EEG) is a precious tool enabling the study of neuronal dysfunction from a functional point view. It is used in the routine follow-up of children with epilepsy. Optical imaging is a promising medical imaging technique. It uses light in the spectral regions of near infra-red as a source of radiation. It is quantitative, rapid, non invasive, and inoffensive which could easily be used at the child's bedside or in a clinical setting and can provide metabolic information about cerebral function. This study is multidisciplinary, which calls upon the skills of neurophysiologists, biophysicists, and clinicians