Antiepileptogenesis after stroke-trials and tribulations: Methodological challenges and recruitment results of a Phase II study with eslicarbazepine acetate.

There is currently no evidence to support the use of antiseizure medications to prevent unprovoked seizures following stroke. Experimental animal models suggested a potential antiepileptogenic effect for eslicarbazepine acetate (ESL), and a Phase II, multicenter, randomized, double-blind, placebo-controlled study was designed to test this hypothesis and assess whether ESL treatment for 1 month can prevent unprovoked seizures following stroke. We outline the design and status of this antiepileptogenesis study, and discuss the challenges encountered in its execution to date. Patients at high risk of developing unprovoked seizures after acute intracerebral hemorrhage or acute ischemic stroke were randomized to receive ESL 800 mg/d or placebo, initiated within 120 hours after primary stroke occurrence. Treatment continued until Day 30, then tapered off. Patients could receive all necessary therapies for stroke treatment according to clinical practice guidelines and standard of care, and are being followed up for 18 months. The primary efficacy endpoint is the occurrence of a first unprovoked seizure within 6 months after randomization ("failure rate"). Secondary efficacy assessments include the occurrence of a first unprovoked seizure during 12 months after randomization and during the entire study; functional outcomes (Barthel Index original 10-item version; National Institutes of Health Stroke Scale); post-stroke depression (Patient Health Questionnaire-9; PHQ-9); and overall survival. Safety assessments include the evaluation of treatment-emergent adverse events; laboratory parameters; vital signs; electrocardiogram; suicidal ideation and behavior (PHQ-9 question 9). The protocol aimed to randomize approximately 200 patients (1:1), recruited from 21 sites in seven European countries and Israel. Despite the challenges encountered, particularly during the COVID-19 pandemic, the study progressed and included a remarkable number of patients, with 129 screened and 125 randomized. Recruitment was stopped after 30 months, the first patient entered in May 2019, and the study is ongoing and following up on patients according to the Clinical Trial Protocol.

Mobile Applications for Epilepsy: Where Are We? Where Should We Go? A Systematic Review

The development of mobile health for epilepsy has grown in the last years, bringing new applications (apps) to the market and improving already existing ones. In this systematic review, we analyse the scope of mobile apps for seizure detection and epilepsy self-management, with two research questions in mind: what are the characteristics of current solutions and do they meet users’ requirements? What should be considered when designing mobile health for epilepsy? We used PRISMA methodology to search within App Store and Google Play Store from February to April of 2021, reaching 55 potential apps. A more thorough analysis regarding particular features was performed on 26 of those apps. The content of these apps was evaluated in five categories, regarding if there was personalisable content;features related to medication management;what aspects of seizure log were present;what type of communication prevailed;and if there was any content related to seizure alarm or seizure action plans. Moreover, the 26 apps were evaluated through using MARS by six raters, including two neurologists. The analysis of MARS categories was performed for the top and bottom apps, to understand the core differences. Overall, the lowest MARS scores were related to engagement and information, which play a big part in long-term use, and previous studies raised the concern of assuring continuous use, especially in younger audiences. With that in mind, we identified conceptual improvement points, which were divided in three main topics: customisation, simplicity and healthcare connection. Moreover, we summarised some ideas to improve m-health apps catered around long-term adherence. We hope this work contributes to a better understanding of the current scope in mobile epilepsy management, endorsing healthcare professionals and developers to provide off-the-shelf solutions that engage patients and allows them to better manage their condition.

Sleep and Awakening Quality during COVID-19 Confinement: Complexity and Relevance for Health and Behavior.

OBJECTIVE: The aim of this study was to evaluate sleep and awakening quality (SQ and AQ) during COVID-19 in a large and diversified population in order to identify significant associations and risks in terms of demography, health and health-related behaviors, sleep variables, mental health, and attitudes. METHODS/RESULTS: Online surveys were used for data collection, received from 5479 individuals from the general population, sleep disorder patients, and COVID-involved (medical doctors (MDs) and nurses) and COVID-affected professionals (teachers, psychologists, and dentists). SQ and AQ were worse in adults, females, and high-education subjects. Feeling worse, having economic problems, depression, anxiety, irritability, and a high Calamity Experience Check List (CECL) score during COVID were significantly associated with poor SQ and AQ. Shorter sleep duration, increased latency, poor nutrition, low physical activity, increased mobile and social network use, more negative and less positive attitudes and behaviors were associated with poor AQ. CONCLUSIONS: The SQ logistic regression showed gender, morbidities, CECL, and awakenings as relevant, whereas, for AQ, relevant variables further included age and physical activity. Aiming to have a high stress compliance, each individual should sleep well, have important control of their mood, practice positive behaviors while dismissing negative behaviors and attitudes, practice exercise, have adequate nutrition, and beware of technologies and dependences.