Florin I. Floricel, Paula E. Reichel, Najla Dickson, Sofia Fleyshman, Christoph Reichel, Jan-Peer Elshoff
Objective
The objective of this study is to evaluate possible long-term effects of treatment with brivaracetam (BRV) on body weight in children with epilepsy.
Method
Post hoc analysis of data from patients (aged 1 month to <17 years) with ≥6 months of BRV treatment in a long-term, open-label trial (N01266 [NCT01364597]). Outcomes included body weight and body mass index (BMI) over time (z-score growth curves), and treatment-emergent adverse events (TEAEs). Previous/ongoing medical conditions that may affect body weight (gastrointestinal and metabolic/nutritional disorders); concomitant antiseizure medications (ASMs) were also evaluated.
Results
Two hundred nine patients (mean [standard deviation] age 7.9 [4.6] years) were analyzed. Most (154 [73.7%]) had focal-onset seizures. At study initiation, median (range) BRV dose was 1.0 (0.4–7.5) mg/kg/day. Overall, 189 (90.4%) patients had a previous or ongoing medical condition (gastrointestinal disorders: 43 [20.6%]; metabolism/nutritional disorders: 26 [12.4%]). Most patients followed z-score curves for body weight and BMI during BRV treatment, although there were outliers in both directions. Incidences of appetite/weight-change TEAEs were low. Twenty-three (11.0%) patients had a TEAE of decreased appetite and 14 (6.7%) had a TEAE of weight decreased.
Significance
Long-term adjunctive BRV was well tolerated in growing children with no indication of detrimental effects on body weight.
Plain Language Summary
Brivaracetam is an antiseizure medication (ASM) used to treat seizures in people with epilepsy. Some ASMs can lead to changes in people's appetite and weight. Knowing the effect a drug has on appetite and weight is particularly important in children. We looked at 209 children with epilepsy taking brivaracetam and studied changes in their body weight and body mass index over time. The number of reported side effects related to appetite or weight change was low. There was no apparent long-term effect on their body weight, even when taking their medical history and use of other ASMs into account.
{"title":"Treatment with brivaracetam has no apparent long-term effects on body weight in pediatric patients with epilepsy","authors":"Florin I. Floricel, Paula E. Reichel, Najla Dickson, Sofia Fleyshman, Christoph Reichel, Jan-Peer Elshoff","doi":"10.1002/epi4.13045","DOIUrl":"10.1002/epi4.13045","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>The objective of this study is to evaluate possible long-term effects of treatment with brivaracetam (BRV) on body weight in children with epilepsy.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Method</h3>\u0000 \u0000 <p>Post hoc analysis of data from patients (aged 1 month to <17 years) with ≥6 months of BRV treatment in a long-term, open-label trial (N01266 [NCT01364597]). Outcomes included body weight and body mass index (BMI) over time (<i>z</i>-score growth curves), and treatment-emergent adverse events (TEAEs). Previous/ongoing medical conditions that may affect body weight (gastrointestinal and metabolic/nutritional disorders); concomitant antiseizure medications (ASMs) were also evaluated.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Two hundred nine patients (mean [standard deviation] age 7.9 [4.6] years) were analyzed. Most (154 [73.7%]) had focal-onset seizures. At study initiation, median (range) BRV dose was 1.0 (0.4–7.5) mg/kg/day. Overall, 189 (90.4%) patients had a previous or ongoing medical condition (gastrointestinal disorders: 43 [20.6%]; metabolism/nutritional disorders: 26 [12.4%]). Most patients followed <i>z</i>-score curves for body weight and BMI during BRV treatment, although there were outliers in both directions. Incidences of appetite/weight-change TEAEs were low. Twenty-three (11.0%) patients had a TEAE of decreased appetite and 14 (6.7%) had a TEAE of weight decreased.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Significance</h3>\u0000 \u0000 <p>Long-term adjunctive BRV was well tolerated in growing children with no indication of detrimental effects on body weight.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Plain Language Summary</h3>\u0000 \u0000 <p>Brivaracetam is an antiseizure medication (ASM) used to treat seizures in people with epilepsy. Some ASMs can lead to changes in people's appetite and weight. Knowing the effect a drug has on appetite and weight is particularly important in children. We looked at 209 children with epilepsy taking brivaracetam and studied changes in their body weight and body mass index over time. The number of reported side effects related to appetite or weight change was low. There was no apparent long-term effect on their body weight, even when taking their medical history and use of other ASMs into account.</p>\u0000 </section>\u0000 </div>","PeriodicalId":12038,"journal":{"name":"Epilepsia Open","volume":"9 6","pages":"2230-2240"},"PeriodicalIF":2.8,"publicationDate":"2024-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11633704/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142361332","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
<p>As the incoming Editor-in-Chief of <i>Epilepsia Open</i>, I am honored to step into this role at a time of significant growth and innovation in epilepsy research. I am excited to lead this distinguished journal, building upon the solid foundation established by my esteemed predecessors. The opportunity to guide <i>Epilepsia Open</i> forward in its mission to disseminate high-quality research is both a privilege and a responsibility that I embrace wholeheartedly.</p><p><i>Epilepsia Open</i> was launched in 2016 as the official open-access journal of the International League Against Epilepsy (ILAE). Over the years, it has rapidly established itself as a reputable platform for rigorous basic, translational, and clinical research in epilepsy. The journal's commitment to transparency and inclusivity in publishing has allowed it to stand out, accepting not only groundbreaking studies but also high-quality research that reports negative, confirmatory, or preliminary findings - studies that are essential for the robust development of our field.</p><p>As I assume the role of Editor-in-Chief, I would like to express my deepest gratitude to the outgoing Editor-in-Chief, Professor Aristea Galanopoulou, and Deputy Editor, Professor Dong Zhou. Their leadership has been instrumental in shaping the journal's current trajectory. Under their leadership, <i>Epilepsia Open</i> has seen a steady increase in submissions, readership, and citations, reflecting the journal's growing influence in the epilepsy research community.</p><p>Moreover, I am eager to embrace the opportunities presented by emerging technologies and interdisciplinary research. The field of epilepsy research is evolving rapidly, with new methodologies and big data approaches offering unprecedented insights. I also aim to collaborate with data science and machine learning experts to analyze citation trends and suggest strategies to increase the journal's impact. These advanced analytical tools will not only help us understand the shifting landscape of research influence but also guide us in curating content that resonates with the needs of the epilepsy community.</p><p><i>Epilepsia Open</i> is uniquely positioned to serve as a forum for these advancements, and I encourage submissions that push the boundaries of current knowledge and practice. By fostering collaboration across disciplines and leveraging the power of artificial intelligence, we can drive the field of epilepsy research forward, ensuring that our journal remains at the cutting edge of scientific discovery.</p><p>In this rapidly evolving landscape of medical research, where technology and innovation are reshaping how we approach epilepsy care, <i>Epilepsia Open</i> will continue to be at the forefront. We will actively seek out research that not only advances our understanding of epilepsy but also translates into better clinical outcomes for patients around the world. Our goal is to ensure that every article we publish contributes meani
作为即将上任的《Epilepsia Open》主编，我很荣幸能在癫痫研究取得重大发展和创新之际担任这一职务。我很高兴能在我尊敬的前辈们打下的坚实基础上领导这份杰出的期刊。有机会指导 Epilepsia Open 履行其传播高质量研究成果的使命，既是我的荣幸，也是我全心全意接受的责任。Epilepsia Open 于 2016 年创刊，是国际抗癫痫联盟（ILAE）的官方开放获取期刊。多年来，它已迅速成为癫痫领域严谨的基础、转化和临床研究的知名平台。该杂志致力于提高出版的透明度和包容性，这使其能够脱颖而出，不仅接受开创性研究，还接受报告负面、证实性或初步发现的高质量研究--这些研究对我们领域的蓬勃发展至关重要。在我就任主编之际，我想对即将离任的主编Aristea Galanopoulou教授和副主编周东教授表示最深切的感谢。他们的领导对杂志目前的发展轨迹起到了重要作用。在他们的领导下，《Epilepsia Open》的投稿量、读者人数和引用次数都在稳步增长，这反映出该期刊在癫痫研究界的影响力日益增强。癫痫研究领域发展迅速，新方法和大数据方法提供了前所未有的洞察力。我还希望与数据科学和机器学习专家合作，分析引文趋势，提出提高期刊影响力的策略。这些先进的分析工具不仅能帮助我们了解研究影响力的变化情况，还能指导我们策划与癫痫社区的需求产生共鸣的内容。Epilepsia Open 具有独特的优势，可以作为这些进步的论坛，我鼓励那些突破当前知识和实践界限的投稿。通过促进跨学科合作和利用人工智能的力量，我们可以推动癫痫研究领域向前发展，确保我们的期刊始终站在科学发现的最前沿。在医学研究迅速发展的今天，技术和创新正在重塑我们的癫痫护理方式，Epilepsia Open 将继续站在最前沿。我们将积极寻求不仅能促进我们对癫痫的理解，而且能为全世界患者带来更好临床疗效的研究。我们的目标是确保我们发表的每一篇文章都能为癫痫研究和护理领域的持续对话做出有意义的贡献。我热衷于与我们敬业的团队合作，包括新任命的副主编Piero Perucca教授、副主编、编委会成员和同行评审员。通过与 ILAE 和 Wiley 员工的密切合作，我们将努力保持该杂志的卓越声誉，同时探索新的途径，使我们的内容更容易为全球不同的读者所获取，更有吸引力。我邀请你们所有人--作者、审稿人、读者和研究人员--加入我们这个激动人心的新篇章。你们一如既往的支持和贡献使 Epilepsia Open 成为一个蓬勃发展、充满活力的癫痫研究论坛。
{"title":"Embracing a new chapter at Epilepsia Open: A message from the incoming Editor-in-Chief","authors":"Merab Kokia","doi":"10.1002/epi4.13048","DOIUrl":"10.1002/epi4.13048","url":null,"abstract":"<p>As the incoming Editor-in-Chief of <i>Epilepsia Open</i>, I am honored to step into this role at a time of significant growth and innovation in epilepsy research. I am excited to lead this distinguished journal, building upon the solid foundation established by my esteemed predecessors. The opportunity to guide <i>Epilepsia Open</i> forward in its mission to disseminate high-quality research is both a privilege and a responsibility that I embrace wholeheartedly.</p><p><i>Epilepsia Open</i> was launched in 2016 as the official open-access journal of the International League Against Epilepsy (ILAE). Over the years, it has rapidly established itself as a reputable platform for rigorous basic, translational, and clinical research in epilepsy. The journal's commitment to transparency and inclusivity in publishing has allowed it to stand out, accepting not only groundbreaking studies but also high-quality research that reports negative, confirmatory, or preliminary findings - studies that are essential for the robust development of our field.</p><p>As I assume the role of Editor-in-Chief, I would like to express my deepest gratitude to the outgoing Editor-in-Chief, Professor Aristea Galanopoulou, and Deputy Editor, Professor Dong Zhou. Their leadership has been instrumental in shaping the journal's current trajectory. Under their leadership, <i>Epilepsia Open</i> has seen a steady increase in submissions, readership, and citations, reflecting the journal's growing influence in the epilepsy research community.</p><p>Moreover, I am eager to embrace the opportunities presented by emerging technologies and interdisciplinary research. The field of epilepsy research is evolving rapidly, with new methodologies and big data approaches offering unprecedented insights. I also aim to collaborate with data science and machine learning experts to analyze citation trends and suggest strategies to increase the journal's impact. These advanced analytical tools will not only help us understand the shifting landscape of research influence but also guide us in curating content that resonates with the needs of the epilepsy community.</p><p><i>Epilepsia Open</i> is uniquely positioned to serve as a forum for these advancements, and I encourage submissions that push the boundaries of current knowledge and practice. By fostering collaboration across disciplines and leveraging the power of artificial intelligence, we can drive the field of epilepsy research forward, ensuring that our journal remains at the cutting edge of scientific discovery.</p><p>In this rapidly evolving landscape of medical research, where technology and innovation are reshaping how we approach epilepsy care, <i>Epilepsia Open</i> will continue to be at the forefront. We will actively seek out research that not only advances our understanding of epilepsy but also translates into better clinical outcomes for patients around the world. Our goal is to ensure that every article we publish contributes meani","PeriodicalId":12038,"journal":{"name":"Epilepsia Open","volume":"9 5","pages":"1630-1631"},"PeriodicalIF":2.8,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11450645/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142364883","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lluïsa Guillem, Guillermo Hernández-Pérez, Damaris Berbel, Ivan Pelegrín, Mercè Falip, Carmen Cabellos
Objective
Our aim was to assess seizure development as a complication of pneumococcal meningitis and its possible prevention with antiseizure medication prophylaxis.
Methods
Antiseizure medication (ASM) prophylaxis has been practiced for a long time at our center. We assessed all cases of community-acquired pneumococcal meningitis admitted from January 2010 to April 2021 recorded in our prospective database and conducted further retrospective studies.
Results
Of the 86 cases recorded, 21 (24.4%) developed acute symptomatic seizures, more than half of which (11/21; 52.4%) before admission. Seizure development increased the need for orotracheal intubation and intensive care unit admission, while also lengthening hospital stays and suggesting more risk of death and disability at discharge [adjusted odds ratio (aOR), 3.13; 95% confidence interval (CI): 1–9.8]. Of the 74 patients eligible for ASM prophylaxis, 64 received it and 10 did not. ASM prophylaxis seemed effective in preventing seizure development, as only six seizure events were recorded in 64 patients with ASM prophylaxis (9.4%) compared with four in the 10 patients without prophylaxis (40%). Its preventive capacity was especially notable when administered within 4 h of admission. Differences in mortality did not reach statistical significance. Adverse effects were rare.
Significance
Seizure development is a common complication in pneumococcal meningitis and is associated with increased risks of Intensive Care Unit admission, orotracheal intubation, and longer hospital stays. ASM prophylaxis may be effective in blocking seizure development in patients with preventable seizures and may be associated with better prognosis. Further studies are now warranted.
Plain Language Summary
Infection of the meninges (the covering of the brain) due to the common bacteria S pneumoniae, used to be a fatal disease before the introduction of antibiotics and corticoids. Thanks to these drugs, more people survive this disease but, due to the frequent complications, they may have several sequelae. Seizures are a common complication. Our study suggests that they might be prevented by using antiseizure drugs which may reduce both severity and hospital stay.
{"title":"Seizure prophylaxis in pneumococcal meningitis, cohort study","authors":"Lluïsa Guillem, Guillermo Hernández-Pérez, Damaris Berbel, Ivan Pelegrín, Mercè Falip, Carmen Cabellos","doi":"10.1002/epi4.13054","DOIUrl":"10.1002/epi4.13054","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>Our aim was to assess seizure development as a complication of pneumococcal meningitis and its possible prevention with antiseizure medication prophylaxis.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Antiseizure medication (ASM) prophylaxis has been practiced for a long time at our center. We assessed all cases of community-acquired pneumococcal meningitis admitted from January 2010 to April 2021 recorded in our prospective database and conducted further retrospective studies.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Of the 86 cases recorded, 21 (24.4%) developed acute symptomatic seizures, more than half of which (11/21; 52.4%) before admission. Seizure development increased the need for orotracheal intubation and intensive care unit admission, while also lengthening hospital stays and suggesting more risk of death and disability at discharge [adjusted odds ratio (aOR), 3.13; 95% confidence interval (CI): 1–9.8]. Of the 74 patients eligible for ASM prophylaxis, 64 received it and 10 did not. ASM prophylaxis seemed effective in preventing seizure development, as only six seizure events were recorded in 64 patients with ASM prophylaxis (9.4%) compared with four in the 10 patients without prophylaxis (40%). Its preventive capacity was especially notable when administered within 4 h of admission. Differences in mortality did not reach statistical significance. Adverse effects were rare.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Significance</h3>\u0000 \u0000 <p>Seizure development is a common complication in pneumococcal meningitis and is associated with increased risks of Intensive Care Unit admission, orotracheal intubation, and longer hospital stays. ASM prophylaxis may be effective in blocking seizure development in patients with preventable seizures and may be associated with better prognosis. Further studies are now warranted.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Plain Language Summary</h3>\u0000 \u0000 <p>Infection of the meninges (the covering of the brain) due to the common bacteria <i>S pneumoniae</i>, used to be a fatal disease before the introduction of antibiotics and corticoids. Thanks to these drugs, more people survive this disease but, due to the frequent complications, they may have several sequelae. Seizures are a common complication. Our study suggests that they might be prevented by using antiseizure drugs which may reduce both severity and hospital stay.</p>\u0000 </section>\u0000 </div>","PeriodicalId":12038,"journal":{"name":"Epilepsia Open","volume":"9 6","pages":"2319-2330"},"PeriodicalIF":2.8,"publicationDate":"2024-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11633693/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142344237","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Yang Hu, Duo Lin, Dongmei Wu, Yuqing Zhang, Gongbo Li
Objective
Numerous observational studies have found a relationship between systemic lupus erythematosus (SLE) and epilepsy; however, their causal relationship remains unclear. This study aimed to investigate the causal role of SLE in epilepsy or any of its subtypes using a two-sample Mendelian randomization (MR) analysis.
Methods
Single nucleotide polymorphisms (SNPs) linked to SLE were utilized as instrumental variables in MR analysis to assess their causal impact on epilepsy. The primary MR findings were derived using the inverse variance weighted (IVW) method, which was further supported by the weighted median and MR-Egger regression techniques. Additionally, sensitivity analyses, including Cochran's Q test and pleiotropy tests, were conducted to evaluate the influence of these SNPs on epilepsy, particularly looking for signs of horizontal pleiotropy and heterogeneity.
Results
We selected 43 SNPs that reached genome-wide significance from genome-wide association studies (GWASs) on SLE to serve as instrumental variables in this study. The IVW method showed no evidence to support a causal association between SLE and epilepsy (all epilepsy: odds ratio (OR) = 1.006, 95% confidence interval (CI) = 0.994–1.018; focal epilepsy: OR = 1.006, 95% CI = 0.994–1.019; generalized epilepsy: OR = 1.015, 95% CI = 0.996–1.035). Other MR complementary methods revealed consistent results. Furthermore, there was no evidence indicating heterogeneity or horizontal pleiotropy.
Significance
The findings of MR analysis did not support a genetically predicted causal relationship between SLE and epilepsy, but emphasized the need for further research on shared pathophysiological mechanisms, particularly the role of immune system abnormalities and potential influences such as chronic inflammation and therapeutic interventions.
Plain Language Summary
The etiology of epilepsy is complex and diverse, including immune factors. Through a Mendelian randomization analysis, we did not find evidence of a genetic causal relationship between systemic lupus erythematosus and epilepsy. However, this does not invalidate epidemiological evidence, and further exploration is needed to investigate factors influencing the relationship between the two.
{"title":"Systemic lupus erythematosus and epilepsy: A Mendelian randomization study","authors":"Yang Hu, Duo Lin, Dongmei Wu, Yuqing Zhang, Gongbo Li","doi":"10.1002/epi4.13058","DOIUrl":"10.1002/epi4.13058","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>Numerous observational studies have found a relationship between systemic lupus erythematosus (SLE) and epilepsy; however, their causal relationship remains unclear. This study aimed to investigate the causal role of SLE in epilepsy or any of its subtypes using a two-sample Mendelian randomization (MR) analysis.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Single nucleotide polymorphisms (SNPs) linked to SLE were utilized as instrumental variables in MR analysis to assess their causal impact on epilepsy. The primary MR findings were derived using the inverse variance weighted (IVW) method, which was further supported by the weighted median and MR-Egger regression techniques. Additionally, sensitivity analyses, including Cochran's Q test and pleiotropy tests, were conducted to evaluate the influence of these SNPs on epilepsy, particularly looking for signs of horizontal pleiotropy and heterogeneity.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>We selected 43 SNPs that reached genome-wide significance from genome-wide association studies (GWASs) on SLE to serve as instrumental variables in this study. The IVW method showed no evidence to support a causal association between SLE and epilepsy (all epilepsy: odds ratio (OR) = 1.006, 95% confidence interval (CI) = 0.994–1.018; focal epilepsy: OR = 1.006, 95% CI = 0.994–1.019; generalized epilepsy: OR = 1.015, 95% CI = 0.996–1.035). Other MR complementary methods revealed consistent results. Furthermore, there was no evidence indicating heterogeneity or horizontal pleiotropy.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Significance</h3>\u0000 \u0000 <p>The findings of MR analysis did not support a genetically predicted causal relationship between SLE and epilepsy, but emphasized the need for further research on shared pathophysiological mechanisms, particularly the role of immune system abnormalities and potential influences such as chronic inflammation and therapeutic interventions.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Plain Language Summary</h3>\u0000 \u0000 <p>The etiology of epilepsy is complex and diverse, including immune factors. Through a Mendelian randomization analysis, we did not find evidence of a genetic causal relationship between systemic lupus erythematosus and epilepsy. However, this does not invalidate epidemiological evidence, and further exploration is needed to investigate factors influencing the relationship between the two.</p>\u0000 </section>\u0000 </div>","PeriodicalId":12038,"journal":{"name":"Epilepsia Open","volume":"9 6","pages":"2274-2282"},"PeriodicalIF":2.8,"publicationDate":"2024-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11633673/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142344238","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
João Ferreira, Ricardo Peixoto, Lígia Lopes, Sándor Beniczky, Philippe Ryvlin, Carlos Conde, João Claro
<div> <section> <h3> Objective</h3> <p>This systematic review aims to describe the involvement of persons with epilepsy (PWE), healthcare professionals (HP) and caregivers (CG) in the design and development of medical devices is epilepsy.</p> </section> <section> <h3> Methods</h3> <p>A systematic review was conducted, adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Eligibility criteria included peer-reviewed research focusing on medical devices for epilepsy management, involving users (PWE, CG, and HP) during the MDD process. Searches were performed on PubMed, Web of Science, and Scopus, and a total of 55 relevant articles were identified and reviewed.</p> </section> <section> <h3> Results</h3> <p>From 1999 to 2023, there was a gradual increase in the number of publications related to user involvement in epilepsy medical device development (MDD), highlighting the growing interest in this field. The medical devices involved in these studies encompassed a range of seizure detection tools, healthcare information systems, vagus nerve stimulation (VNS) and electroencephalogram (EEG) technologies reflecting the emphasis on seizure detection, prediction, and prevention. PWE and CG were the primary users involved, underscoring the importance of their perspectives. Surveys, usability testing, interviews, and focus groups were the methods used for capturing user perspectives. User involvement occurs in four out of the five stages of MDD, with production being the exception.</p> </section> <section> <h3> Significance</h3> <p>User involvement in the MDD process for epilepsy management is an emerging area of interest holding a significant promise for improving device quality and patient outcomes. This review highlights the need for broader and more effective user involvement, as it currently lags in the development of commercially available medical devices for epilepsy management. Future research should explore the benefits and barriers of user involvement to enhance medical device technologies for epilepsy.</p> </section> <section> <h3> Plain Language Summary</h3> <p>This review covers studies that have involved users in the development process of medical devices for epilepsy. The studies reported here have focused on getting input from people with epilepsy, their caregivers, and healthcare providers. These devices include tools for detecting seizures, stimulating nerves, and tracking brain activity. Most
{"title":"User involvement in the design and development of medical devices in epilepsy: A systematic review","authors":"João Ferreira, Ricardo Peixoto, Lígia Lopes, Sándor Beniczky, Philippe Ryvlin, Carlos Conde, João Claro","doi":"10.1002/epi4.13038","DOIUrl":"10.1002/epi4.13038","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>This systematic review aims to describe the involvement of persons with epilepsy (PWE), healthcare professionals (HP) and caregivers (CG) in the design and development of medical devices is epilepsy.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>A systematic review was conducted, adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Eligibility criteria included peer-reviewed research focusing on medical devices for epilepsy management, involving users (PWE, CG, and HP) during the MDD process. Searches were performed on PubMed, Web of Science, and Scopus, and a total of 55 relevant articles were identified and reviewed.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>From 1999 to 2023, there was a gradual increase in the number of publications related to user involvement in epilepsy medical device development (MDD), highlighting the growing interest in this field. The medical devices involved in these studies encompassed a range of seizure detection tools, healthcare information systems, vagus nerve stimulation (VNS) and electroencephalogram (EEG) technologies reflecting the emphasis on seizure detection, prediction, and prevention. PWE and CG were the primary users involved, underscoring the importance of their perspectives. Surveys, usability testing, interviews, and focus groups were the methods used for capturing user perspectives. User involvement occurs in four out of the five stages of MDD, with production being the exception.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Significance</h3>\u0000 \u0000 <p>User involvement in the MDD process for epilepsy management is an emerging area of interest holding a significant promise for improving device quality and patient outcomes. This review highlights the need for broader and more effective user involvement, as it currently lags in the development of commercially available medical devices for epilepsy management. Future research should explore the benefits and barriers of user involvement to enhance medical device technologies for epilepsy.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Plain Language Summary</h3>\u0000 \u0000 <p>This review covers studies that have involved users in the development process of medical devices for epilepsy. The studies reported here have focused on getting input from people with epilepsy, their caregivers, and healthcare providers. These devices include tools for detecting seizures, stimulating nerves, and tracking brain activity. Most","PeriodicalId":12038,"journal":{"name":"Epilepsia Open","volume":"9 6","pages":"2087-2100"},"PeriodicalIF":2.8,"publicationDate":"2024-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11633715/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142344239","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Wei Li, Junxia Chen, Yingjie Qin, Sisi Jiang, Xiuli Li, Heng Zhang, Cheng Luo, Qiyong Gong, Dong Zhou, Dongmei An
<div> <section> <h3> Objective</h3> <p>Dystonic posturing (DP) is a common semiology in temporal lobe epilepsy (TLE). We aimed to explore cerebellar gradient alterations in functional connectivity in TLE patients with and without DP.</p> </section> <section> <h3> Methods</h3> <p>Resting-state functional MRI data were obtained in 60 TLE patients and 32 matched healthy controls. Patients were further divided into two groups: TLE with DP (TLE + DP, 31 patients) and TLE without DP (TLP-DP, 29 patients). We explored functional gradient alterations in the cerebellum based on cerebellar–cerebral functional connectivity and combined with independent component analysis to evaluate cerebellar–cerebral functional integration and reveal the contribution of the motor components to the gradient.</p> </section> <section> <h3> Results</h3> <p>There were no obvious differences in clinical features and postoperative seizure outcomes between TLE + DP and TLE-DP patients. Patients and controls all showed a clear unimodal-to-transmodal gradient transition in the cerebellum, while TLE patients demonstrated an extended principal gradient in functional connectivity compared to healthy controls, which was more limited in TLE + DP patients. Gradient alterations were more widespread in TLE-DP patients, involving bilateral cerebellum, while gradient alterations in TLE + DP patients were limited in the cerebellum ipsilateral to the seizure focus. In addition, more cerebellar motor components contributed to the gradient alterations in TLE + DP patients, mainly in ipsilateral cerebellum.</p> </section> <section> <h3> Significance</h3> <p>Extended cerebellar principal gradients in functional connectivity revealed excessive functional segregation between unimodal and transmodal systems in TLE. The functional connectivity gradients were more limited in TLE + DP patients. Functional connectivity in TLE patients with dystonic posturing involved more contribution of cerebellar motor function to ipsilateral cerebellar gradient.</p> </section> <section> <h3> Plain Language Summary</h3> <p>Dystonic posturing contralateral to epileptic focus is a common symptom in temporal lobe epilepsy, and the cerebellum may be involved in its generation. In this study, we found cerebellar gradients alterations in functional connectivity in temporal lobe epilepsy patients with and without contralateral dystonic posturing. In particular, we found that TLE patients with dystonic posturing may have more li
{"title":"Limited cerebellar gradient extension in temporal lobe epilepsy with dystonic posturing","authors":"Wei Li, Junxia Chen, Yingjie Qin, Sisi Jiang, Xiuli Li, Heng Zhang, Cheng Luo, Qiyong Gong, Dong Zhou, Dongmei An","doi":"10.1002/epi4.13056","DOIUrl":"10.1002/epi4.13056","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>Dystonic posturing (DP) is a common semiology in temporal lobe epilepsy (TLE). We aimed to explore cerebellar gradient alterations in functional connectivity in TLE patients with and without DP.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Resting-state functional MRI data were obtained in 60 TLE patients and 32 matched healthy controls. Patients were further divided into two groups: TLE with DP (TLE + DP, 31 patients) and TLE without DP (TLP-DP, 29 patients). We explored functional gradient alterations in the cerebellum based on cerebellar–cerebral functional connectivity and combined with independent component analysis to evaluate cerebellar–cerebral functional integration and reveal the contribution of the motor components to the gradient.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>There were no obvious differences in clinical features and postoperative seizure outcomes between TLE + DP and TLE-DP patients. Patients and controls all showed a clear unimodal-to-transmodal gradient transition in the cerebellum, while TLE patients demonstrated an extended principal gradient in functional connectivity compared to healthy controls, which was more limited in TLE + DP patients. Gradient alterations were more widespread in TLE-DP patients, involving bilateral cerebellum, while gradient alterations in TLE + DP patients were limited in the cerebellum ipsilateral to the seizure focus. In addition, more cerebellar motor components contributed to the gradient alterations in TLE + DP patients, mainly in ipsilateral cerebellum.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Significance</h3>\u0000 \u0000 <p>Extended cerebellar principal gradients in functional connectivity revealed excessive functional segregation between unimodal and transmodal systems in TLE. The functional connectivity gradients were more limited in TLE + DP patients. Functional connectivity in TLE patients with dystonic posturing involved more contribution of cerebellar motor function to ipsilateral cerebellar gradient.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Plain Language Summary</h3>\u0000 \u0000 <p>Dystonic posturing contralateral to epileptic focus is a common symptom in temporal lobe epilepsy, and the cerebellum may be involved in its generation. In this study, we found cerebellar gradients alterations in functional connectivity in temporal lobe epilepsy patients with and without contralateral dystonic posturing. In particular, we found that TLE patients with dystonic posturing may have more li","PeriodicalId":12038,"journal":{"name":"Epilepsia Open","volume":"9 6","pages":"2251-2262"},"PeriodicalIF":2.8,"publicationDate":"2024-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11633717/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142344236","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Takayuki Iwayama, Kimihito Mizuno, Esra Yildiz, Kheng-Seang Lim, Soon Ming Yi, Yee Joe Lynn, Ching Woon Hin, Jason Chia Zhi Jean, Si-Lei Fong, Yu Xuen, Ong Zhi Qian, Izumi Kuramochi
<div> <section> <h3> Objective</h3> <p>Epilepsy is a neurological disorder characterized by recurrent seizures, exhibiting variance in prevalence and treatment availability across diverse geopolitical contexts and cultural milieus. The stigma associated with epilepsy is a significant global issue affecting the quality of life (QOL) of people with epilepsy (PWE). This study aims to examine the relationship between self-stigma and depressive symptoms in PWE, with a particular emphasis on understanding the manifestations of these across different cultural contexts. We aim to enhance the provision of customized care to diverse cultural settings, fostering the adoption of healthier lifestyles for PWE.</p> </section> <section> <h3> Methods</h3> <p>We recruited PWE who received treatment at specialized medical facilities for epilepsy in Japan, Malaysia (Chinese, Malay), and Turkey from February to October 2023. The Epilepsy Self-Stigma Scales (ESSS), Neurological Disorders Depression Inventory for Epilepsy (NDDI-E), and Generalized Anxiety Disorder 7 (GAD-7) in local languages were used to assess self-stigma, depressive symptoms, and anxiety.</p> </section> <section> <h3> Results</h3> <p>The ESSS total scores were significantly higher among the Turkish and Japanese cohorts (<i>F</i> [3, 406] = 6.57, <i>p</i> < 0.001, <i>η</i><sup>2</sup> = 0.05). In addition, the self-stigma observed moderate positive correlations for depressive symptoms (rs = 0.41–0.50, <i>P</i>s < 0.001) and anxiety (rs = 0.42–0.44, <i>P</i>s < 0.001). The ANCOVA findings suggested that the notable variations in self-stigma, as found in the one-way ANOVA conducted across four cultures, were reduced when taking into consideration depressed symptoms. Our finding highlights the potential influence of mental health factors over cultural factors concerning self-stigma.</p> </section> <section> <h3> Significance</h3> <p>The manifestation of self-stigmatization within epilepsy exhibits distinctions across diverse cultural cohorts, regardless of the demographic and clinical variation, yet demonstrates a significant correlation with psychological factors. In subsequent research endeavors, we should comprehensively investigate these subtle differences, their potential impact on patient care, and the development of supportive approaches.</p> </section> <section> <h3> Plain Language Summary</h3> <p>This cross-cultural study reveals significant variations in self-stigma among people with ep
{"title":"A multicultural comparative study of self-stigma in epilepsy: Differences across four cultures","authors":"Takayuki Iwayama, Kimihito Mizuno, Esra Yildiz, Kheng-Seang Lim, Soon Ming Yi, Yee Joe Lynn, Ching Woon Hin, Jason Chia Zhi Jean, Si-Lei Fong, Yu Xuen, Ong Zhi Qian, Izumi Kuramochi","doi":"10.1002/epi4.13051","DOIUrl":"10.1002/epi4.13051","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>Epilepsy is a neurological disorder characterized by recurrent seizures, exhibiting variance in prevalence and treatment availability across diverse geopolitical contexts and cultural milieus. The stigma associated with epilepsy is a significant global issue affecting the quality of life (QOL) of people with epilepsy (PWE). This study aims to examine the relationship between self-stigma and depressive symptoms in PWE, with a particular emphasis on understanding the manifestations of these across different cultural contexts. We aim to enhance the provision of customized care to diverse cultural settings, fostering the adoption of healthier lifestyles for PWE.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We recruited PWE who received treatment at specialized medical facilities for epilepsy in Japan, Malaysia (Chinese, Malay), and Turkey from February to October 2023. The Epilepsy Self-Stigma Scales (ESSS), Neurological Disorders Depression Inventory for Epilepsy (NDDI-E), and Generalized Anxiety Disorder 7 (GAD-7) in local languages were used to assess self-stigma, depressive symptoms, and anxiety.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The ESSS total scores were significantly higher among the Turkish and Japanese cohorts (<i>F</i> [3, 406] = 6.57, <i>p</i> < 0.001, <i>η</i><sup>2</sup> = 0.05). In addition, the self-stigma observed moderate positive correlations for depressive symptoms (rs = 0.41–0.50, <i>P</i>s < 0.001) and anxiety (rs = 0.42–0.44, <i>P</i>s < 0.001). The ANCOVA findings suggested that the notable variations in self-stigma, as found in the one-way ANOVA conducted across four cultures, were reduced when taking into consideration depressed symptoms. Our finding highlights the potential influence of mental health factors over cultural factors concerning self-stigma.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Significance</h3>\u0000 \u0000 <p>The manifestation of self-stigmatization within epilepsy exhibits distinctions across diverse cultural cohorts, regardless of the demographic and clinical variation, yet demonstrates a significant correlation with psychological factors. In subsequent research endeavors, we should comprehensively investigate these subtle differences, their potential impact on patient care, and the development of supportive approaches.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Plain Language Summary</h3>\u0000 \u0000 <p>This cross-cultural study reveals significant variations in self-stigma among people with ep","PeriodicalId":12038,"journal":{"name":"Epilepsia Open","volume":"9 6","pages":"2283-2293"},"PeriodicalIF":2.8,"publicationDate":"2024-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11633698/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142344220","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Epilepsy is a common chronic neurological disorder in pediatrics. Depression is an often underdetected comorbidity in childhood epilepsy. This study aimed to adapt the Neurological Disorders Depression Inventory-Epilepsy for Youth (NDDI-E-Y) to the Indonesian language and population, as well as to validate the Indonesian version of NDDI-E-Y (NDDI-E-Y[ID]).
Methods
This three-stage study comprised instrument translation, cultural verification, and content validity testing (first stage), pilot testing (second stage), followed by concurrent validity and reliability testing (third stage) of the NDDI-E-Y(ID). Validation was done against the Centre for Epidemiologic Studies Depression Scale – Revised (CESD-R). Content validity, assessed by six experts, was quantified using the content validity index for items (I-CVI) and scale (S-CVI). Participants were adolescents aged 12–17 years diagnosed with any type of epilepsy who completed both instruments. Concurrent validity was evaluated using Spearman's correlation and reliability was measured using Cronbach's alpha.
Results
The first stage produced a culturally appropriate NDDI-E-Y(ID). Thirty healthy adolescents and 10 adolescents with epilepsy participated in the second stage. In the third stage, another group of 30 adolescents with epilepsy took part. We obtained I-CVI and S-CVI values averaging 1. The NDDI-E-Y(ID) showed a positive and significant correlation with CESD-R (Spearman's rho = 0.671, p < 0.001). A Cronbach's alpha of 0.928 reflected a high internal consistency.
Significance
Based on the results, the NDDI-E-Y(ID) was found to be a valid and reliable screening instrument for detecting depression in youth with epilepsy.
Plain Language Summary
Depression is an under-recognized problem in youth with epilepsy. Currently available depression screening tools are in English, making it less suitable for detection purposes in Indonesia. This study developed and validated the Indonesian version of the NDDI-E-Y, a depression screening tool for youth with epilepsy.
{"title":"Evaluating depression in Indonesian adolescents with epilepsy: Comprehensive validation and reliability assessment of the neurological disorders depression inventory-epilepsy for youth Indonesian version (NDDI-E-Y[ID])","authors":"Setyo Handryastuti, Tjhin Wiguna, Novie Amelia Chozie, Bernie Endyarni Medise, Wahyuni Indawati, Cut Nurul Hafifah, Widdy Winarta","doi":"10.1002/epi4.13052","DOIUrl":"10.1002/epi4.13052","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objectives</h3>\u0000 \u0000 <p>Epilepsy is a common chronic neurological disorder in pediatrics. Depression is an often underdetected comorbidity in childhood epilepsy. This study aimed to adapt the Neurological Disorders Depression Inventory-Epilepsy for Youth (NDDI-E-Y) to the Indonesian language and population, as well as to validate the Indonesian version of NDDI-E-Y (NDDI-E-Y[ID]).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>This three-stage study comprised instrument translation, cultural verification, and content validity testing (first stage), pilot testing (second stage), followed by concurrent validity and reliability testing (third stage) of the NDDI-E-Y(ID). Validation was done against the Centre for Epidemiologic Studies Depression Scale – Revised (CESD-R). Content validity, assessed by six experts, was quantified using the content validity index for items (I-CVI) and scale (S-CVI). Participants were adolescents aged 12–17 years diagnosed with any type of epilepsy who completed both instruments. Concurrent validity was evaluated using Spearman's correlation and reliability was measured using Cronbach's alpha.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The first stage produced a culturally appropriate NDDI-E-Y(ID). Thirty healthy adolescents and 10 adolescents with epilepsy participated in the second stage. In the third stage, another group of 30 adolescents with epilepsy took part. We obtained I-CVI and S-CVI values averaging 1. The NDDI-E-Y(ID) showed a positive and significant correlation with CESD-R (Spearman's rho = 0.671, <i>p</i> < 0.001). A Cronbach's alpha of 0.928 reflected a high internal consistency.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Significance</h3>\u0000 \u0000 <p>Based on the results, the NDDI-E-Y(ID) was found to be a valid and reliable screening instrument for detecting depression in youth with epilepsy.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Plain Language Summary</h3>\u0000 \u0000 <p>Depression is an under-recognized problem in youth with epilepsy. Currently available depression screening tools are in English, making it less suitable for detection purposes in Indonesia. This study developed and validated the Indonesian version of the NDDI-E-Y, a depression screening tool for youth with epilepsy.</p>\u0000 </section>\u0000 </div>","PeriodicalId":12038,"journal":{"name":"Epilepsia Open","volume":"9 6","pages":"2342-2352"},"PeriodicalIF":2.8,"publicationDate":"2024-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11633709/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142344235","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Hao Yu, Chang Liu, Yu Sun, Yao Wang, Qingzhu Liu, Taoyun Ji, Shuang Wang, Xiaoyan Liu, Yuwu Jiang, Ye Wu, Lixin Cai
<div> <section> <h3> Objective</h3> <p>To assess seizure outcomes, prognostic factors, and developmental changes in children undergoing total posterior quadrant disconnection (PQD) for drug-resistant epilepsy (DRE).</p> </section> <section> <h3> Methods</h3> <p>We conducted a retrospective analysis of the clinical data of children with DRE who underwent total PQD surgery. The study focused on Engel's classification for seizure outcomes, exploring correlation of preoperative data and surgical effectiveness, and predictors of seizure prognosis. It involved a comparative analysis of developmental levels pre- and 3 months postoperatively using Griffiths Mental Development Scales-China (GMDS-C), and the correlation between clinical characteristics and GMDS-C results.</p> </section> <section> <h3> Results</h3> <p>Out of 61 pediatric patients, 70.5% showed no seizure recurrence postoperatively. In the univariate analysis, interictal electroencephalogram (EEG), magnetic resonance imaging (MRI), fluorodeoxyglucose positron emission tomography (FDG-PET), and acute postoperative seizure (APOS) were significantly related to surgical prognosis. In multivariate analysis, interictal EEG and APOS were identified as predictors of seizure prognosis. Survival analysis indicated significant associations between MRI, interictal EEG, FDG-PET, APOS and postoperative seizure occurrence. Preoperative GMDS-C levels were significantly correlated with epilepsy duration, seizure frequency, interictal EEG, and FDG-PET. GMDS-C scores improved postoperatively, while developmental quotients remained stable.</p> </section> <section> <h3> Significance</h3> <p>For patients with structural abnormalities in the entire posterior quadrant, thorough preoperative assessment and timely total PQD surgery can effectively control seizures without causing neurological development deterioration. APOS and interictal EEG abnormalities beyond the posterior quadrant are predictors for seizure prognosis but should not be deemed contraindications for surgery.</p> </section> <section> <h3> Plain Language Summary</h3> <p>Due to lack of analysis on pediatric total PQD cases, 61 pediatric patients who underwent total PQD surgery were retrospectively enrolled. Seizure and development results were collected and analyzed as dependent variables. The study found that 70.5% of patients were seizure-free and showed development improvement, with no deaths or severe complications reported. Prognosis predictors inc
{"title":"Total posterior quadrant disconnection for drug-resistant epilepsy in children","authors":"Hao Yu, Chang Liu, Yu Sun, Yao Wang, Qingzhu Liu, Taoyun Ji, Shuang Wang, Xiaoyan Liu, Yuwu Jiang, Ye Wu, Lixin Cai","doi":"10.1002/epi4.13044","DOIUrl":"10.1002/epi4.13044","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>To assess seizure outcomes, prognostic factors, and developmental changes in children undergoing total posterior quadrant disconnection (PQD) for drug-resistant epilepsy (DRE).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We conducted a retrospective analysis of the clinical data of children with DRE who underwent total PQD surgery. The study focused on Engel's classification for seizure outcomes, exploring correlation of preoperative data and surgical effectiveness, and predictors of seizure prognosis. It involved a comparative analysis of developmental levels pre- and 3 months postoperatively using Griffiths Mental Development Scales-China (GMDS-C), and the correlation between clinical characteristics and GMDS-C results.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Out of 61 pediatric patients, 70.5% showed no seizure recurrence postoperatively. In the univariate analysis, interictal electroencephalogram (EEG), magnetic resonance imaging (MRI), fluorodeoxyglucose positron emission tomography (FDG-PET), and acute postoperative seizure (APOS) were significantly related to surgical prognosis. In multivariate analysis, interictal EEG and APOS were identified as predictors of seizure prognosis. Survival analysis indicated significant associations between MRI, interictal EEG, FDG-PET, APOS and postoperative seizure occurrence. Preoperative GMDS-C levels were significantly correlated with epilepsy duration, seizure frequency, interictal EEG, and FDG-PET. GMDS-C scores improved postoperatively, while developmental quotients remained stable.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Significance</h3>\u0000 \u0000 <p>For patients with structural abnormalities in the entire posterior quadrant, thorough preoperative assessment and timely total PQD surgery can effectively control seizures without causing neurological development deterioration. APOS and interictal EEG abnormalities beyond the posterior quadrant are predictors for seizure prognosis but should not be deemed contraindications for surgery.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Plain Language Summary</h3>\u0000 \u0000 <p>Due to lack of analysis on pediatric total PQD cases, 61 pediatric patients who underwent total PQD surgery were retrospectively enrolled. Seizure and development results were collected and analyzed as dependent variables. The study found that 70.5% of patients were seizure-free and showed development improvement, with no deaths or severe complications reported. Prognosis predictors inc","PeriodicalId":12038,"journal":{"name":"Epilepsia Open","volume":"9 6","pages":"2198-2208"},"PeriodicalIF":2.8,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11633695/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142282567","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Cenobamate (CNB), a recently approved antiseizure medication by the European Medicines Agency (EMA), serves as an adjunctive therapy for focal-onset seizures in adult patients unresponsive to at least two other treatments. Administered in polytherapy, CNB can potentially interact with co-administered drugs in epilepsy patients, necessitating dose adjustments and the need for effective therapeutic drug monitoring (TDM).
Methods
In this study, we introduce a novel LC–MS/MS method for precise CNB quantification using Volumetric Absorptive Microsampling (VAMS), following validation according to ICH guidelines M10. VAMS samples are efficiently extracted with 200 μL of methanol, with chromatographic separation achieved using an Acquity UPLC HSS PFP column. The method's efficacy was confirmed through its application to real samples from adult CNB-treated patients.
Results
Our results demonstrate that the method exhibits linearity within the range of 0.05–30 mg/L, with intra- and inter-run precision ranging from 1% to 8% and accuracy from 1% to 10% based on 30 μL of sample. Furthermore, CNB stability in VAMS is confirmed for up to 15 days at 25°C and −20°C. Importantly, no significant difference was observed between CNB concentrations in VAMS samples and those in plasma obtained from venous blood.
Significance
This VAMS-based LC–MS/MS method presents a robust alternative for TDM in CNB-treated patients. Future investigations should explore CNB concentrations in capillary blood and assess their correlation with plasma levels to further enhance its clinical utility.
Plain Language Summary
Cenobamate is an antiepileptic drug and used for treatment of focal-onset seizures in adult patients (≥18 age). TDM can prevent drug interactions and minimize drug toxicity. The aim of this work is to evaluate volumetric absorptive microsampling (VAMS) from capillary blood as an alternative strategy for TDM in patients treated with the newly antiepileptic drug. Our method is suitable for TDM, and this study suggests that VAMS allows monitoring of cenobamate concentration and can offer valuable support for personalized therapy in refractory epilepsy.
{"title":"A VAMS-based LC–MS/MS method for precise cenobamate quantification in epilepsy (patients)","authors":"Federica Pigliasco, Alessia Cafaro, Sebastiano Barco, Margherita Biondi, Manuela Stella, Francesca Mattioli, Antonella Riva, Ugo de Grazia, Linda Molteni, Elisa Micalizzi, Flavio Villani, Pasquale Striano, Roberto Bandettini, Giuliana Cangemi","doi":"10.1002/epi4.12927","DOIUrl":"10.1002/epi4.12927","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>Cenobamate (CNB), a recently approved antiseizure medication by the European Medicines Agency (EMA), serves as an adjunctive therapy for focal-onset seizures in adult patients unresponsive to at least two other treatments. Administered in polytherapy, CNB can potentially interact with co-administered drugs in epilepsy patients, necessitating dose adjustments and the need for effective therapeutic drug monitoring (TDM).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>In this study, we introduce a novel LC–MS/MS method for precise CNB quantification using Volumetric Absorptive Microsampling (VAMS), following validation according to ICH guidelines M10. VAMS samples are efficiently extracted with 200 μL of methanol, with chromatographic separation achieved using an Acquity UPLC HSS PFP column. The method's efficacy was confirmed through its application to real samples from adult CNB-treated patients.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Our results demonstrate that the method exhibits linearity within the range of 0.05–30 mg/L, with intra- and inter-run precision ranging from 1% to 8% and accuracy from 1% to 10% based on 30 μL of sample. Furthermore, CNB stability in VAMS is confirmed for up to 15 days at 25°C and −20°C. Importantly, no significant difference was observed between CNB concentrations in VAMS samples and those in plasma obtained from venous blood.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Significance</h3>\u0000 \u0000 <p>This VAMS-based LC–MS/MS method presents a robust alternative for TDM in CNB-treated patients. Future investigations should explore CNB concentrations in capillary blood and assess their correlation with plasma levels to further enhance its clinical utility.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Plain Language Summary</h3>\u0000 \u0000 <p>Cenobamate is an antiepileptic drug and used for treatment of focal-onset seizures in adult patients (≥18 age). TDM can prevent drug interactions and minimize drug toxicity. The aim of this work is to evaluate volumetric absorptive microsampling (VAMS) from capillary blood as an alternative strategy for TDM in patients treated with the newly antiepileptic drug. Our method is suitable for TDM, and this study suggests that VAMS allows monitoring of cenobamate concentration and can offer valuable support for personalized therapy in refractory epilepsy.</p>\u0000 </section>\u0000 </div>","PeriodicalId":12038,"journal":{"name":"Epilepsia Open","volume":"9 6","pages":"2144-2153"},"PeriodicalIF":2.8,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11633685/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142282562","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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