Tele-patient-reported Outcomes (telePRO) in Clinical Practice
EpilepsyThe aim of this study is to compare quality of care and patient experiences in two outpatients follow-up activities: 1) Standard telePRO (fixed interval telePRO follow-up) and 2) Open Access telePRO (patient-initiated telePRO follow-up)
Safety of Antiepileptic Withdrawal in Long Term Video-EEG Monitoring
EpilepsySAVE is a stratified cluster-randomised controlled, parallel group, open-label trial, with Epileptic Monitoring Unit (EMU) as the units of randomisation and patients as the unit of analysis. The focus of research is the management of AntiEpileptic Drugs (AEDs) withdrawal during long term Video EEG (VEEG) monitoring in patients with drug resistant seizures. This non-standardised medical practice, which aims at promoting the occurrence of seizures during the time limit of the monitoring period, exposes patients to significant risks which should be minimised by harmonisation of practice and a standardised protocol of AEDs withdrawal. SAVE will assess the impact of a standardised protocol of AEDs withdrawal during long-term VEEG monitoring on the frequency of seizure-related serious adverse events occurring during these monitorings and on the ability to obtain VEEG recording of seizures within appropriate time limits. 10 of the 22 EMUs will be randomised to the group where the standardised protocol of AEDs withdrawal will be used systematically, while the other ten EMUs will continue their current non-standardised practice of AEDs withdrawal, and will serve as a control group. The setting of the study will include a 6 months evaluation phase, prior to randomisation, during which the organisational characteristics, baseline EMUs' activity, current management of AEDs withdrawal, and rate of Serious Adverse Events (SAEs) of each participating center will be evaluated. The standardised study protocol of AEDs withdrawal has been defined on the basis of a systematic review of all relevant publications in the field.
Efficacy, Tolerability and Adherence of the Modified Atkins Diet on Drug-resistant Epilepsy
EpilepsyDrug ResistantThe Atkins Diet Modified (ADM) is the best alternative treatment for drug-resistant epilepsy, There is a high prevalence worldwide , especially in Latin American countries, including Mexico. Low income earners, many of which do not have a social security, must meet the high costs by Antiepileptic Drugs (AEDS), which in addition should be used in conjunction or combination therapy, because monotherapy is insufficient . The diet adkins makes some changes in the traditional food habits by others that are accessible and not necessarily expensive, whose mechanism allows for better control of the seizures.
Evaluation of a Web-based Virtual Nursing Epilepsy Self-Management Intervention
EpilepsyThe purpose of this pilot randomized controlled trial is to evaluate a web-based virtual nursing intervention (ÉPI-TAVIE) in terms of 1) acceptability and feasibility, and; 2) preliminary efficacy.
Open Label Safety and Efficacy Study of Levetiracetam in Korean Patients With Epilepsy
EpilepsyPartialA Korean open-label, community-based trial assessing the efficacy and safety of levetiracetam as adjunctive therapy in partial epilepsy. Similarity with a similar study conducted in Caucasian epileptic subjects will be assessed.
Pharmacokinetics and Tolerability of Sulthiame
EpilepsyThis preliminary pilot exploration aims at specifying the pharmacokinetic parameters of sulthiame, formulated as an immediate release tablet, thus helping to design proper clinical trials for the future assessment of new paediatric formulations currently under development. The clinical tolerability to single doses of sulthiame will also be closely monitored to orient future trials.
Improving Patient Communication About SUDEP
SUDEPEpilepsyChildren with generalized tonic-clonic seizures (GTCS) have about a 1 in 4500 of succumbing to sudden unexpected death in epilepsy (SUDEP). For that reason, the American Academy of Neurology recommends that clinicians caring for these children make their families aware of this small but important risk and provide appropriate supportive follow-up resources. Moreover, existing evidence suggests that children with poorly controlled GTCS have a strikingly increased odds of SUDEP, 3-24 fold, raising the importance of improving seizure control. Clinicians caring for these patients have multiple issues to address in the typical visit. The investigators propose to use information technology to help providers assure that addressing SUDEP is incorporated into their routine care. The investigators have developed the Child Health Improvement through Computer Automation system (CHICA), a computer based clinical decision support system for pediatric care. CHICA captures patient reported data in the waiting room and prioritizes clinical advice to the physician through the electronic health record (EHR). CHICA is used in five primary care clinics in the Eskenazi health system where it supports general pediatric care. The goal of this project is to test the effectiveness of a SUDEP module in this setting where CHICA is already in use - with a future goal of developing a full suite of CHICA modules for child neurologists.
Evaluation of the Efficiency of Mobile Application for Parents of Children With Epilepsy
ChildEpilepsy3 moreIntroduction: support to family and child related to epilepsy, controls or when they come for urgent reasons. Solutions must be found to ensure its continuity. this support. The widespread use of the Internet today, e-health and health education is increasing day by day. Objective: The investigators research is planned to develop a mobile Epilepsy Training Program. Parents with children diagnosed with epilepsy and assessing its effectiveness. Material and Method: The research is a randomized controlled experimental study. An application was made to the Eskişehir Osmangazi University Clinical Research Ethics Committee and the ethics committee permission was obtained with the decision of 13.02.2020 dated 80558721-050.99-E.20230 and 2019-66 decision. Only volunteer participants will be included in the research. Its population study 3-6 years old children diagnosed with epilepsy Eskişehir City Hospital Child Neurology Outpatient Clinic between 01 September 2020 and 31 September 2021. The sample of the research will consist of parents who meet the inclusion criteria. research between these dates. Parents meeting research sample selection criteria The application was randomized as a control group according to the Parent Epilepsy Information Scale. Application group; will use the mobile application the investigators prepared for the parent. Control group will consist of parents who follow the hospital's treatment protocol. The investigators study Completed with a total of 60 parents, 30 of whom are determined by power analysis group. Statistical analysis will be done with SPSS package program. Keywords: Child, Epilepsy, Parent Education, Mobile Application, Child Nurse
PF-06372865 in Subjects With Photosensitive Epilepsy
Reflex EpilepsyPhotosensitivePF-06372865 in subjects with photosensitive epilepsy
TAK-935 Multiple Rising Dose Study in Healthy Participants
EpilepsyThe purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of multiple rising doses of TAK-935 in healthy participants.