Neurology and Therapy最新文献

{"title":"Efgartigimod in Patients with Generalized Myasthenia Gravis Refractory or Intolerant to IVIg.","authors":"Flora D'Amico, Sofia Campo, Nicasio Rini, Claudia Vinciguerra, Liliana Bevilacqua, Carmen Erra, Paolo Barone, Francesco Tuccillo, Francesco Habetswallner, Filippo Brighina, Vincenzo Di Stefano","doi":"10.1007/s40120-026-00923-1","DOIUrl":"10.1007/s40120-026-00923-1","url":null,"abstract":"<p><strong>Introduction: </strong>Generalized myasthenia gravis (gMG) is a rare chronic autoimmune disorder of the neuromuscular junction caused by pathogenic autoantibodies directed against a postsynaptic target. The therapeutic landscape of gMG has recently expanded with the introduction of FcRn inhibitors. This study aimed to assess the real-world effectiveness and safety of efgartigimod (EFG) in AChR-positive gMG patients who failed or were intolerant to intravenous immunoglobulin (IVIg).</p><p><strong>Methods: </strong>EFG was administered as four consecutive weekly intravenous infusions at 10 mg/kg. Treatment efficacy was evaluated using the Myasthenia Gravis Activity of Daily Living (MG-ADL) and Myasthenia Gravis quantitative (QMG) scales at baseline and after 4 weeks. Incidence of adverse events and prednisone use were collected at each time point.</p><p><strong>Results: </strong>Thirteen patients (6 women and 7 men, mean age 52.9 years) received EFG following IVIg therapy. After one treatment cycle, both MG-ADL and QMG scores showed significant clinical improvement. MG-ADL responder rate (MG-ADL reduction > 2) was 84.6% while 69.2% on QMG (QMG reduction > 3). Minimal symptom expression was reached in one patient, accompanied by a mean reduction in daily prednisone dose of 6.9 mg.</p><p><strong>Conclusion: </strong>In this real-world cohort, efgartigimod demonstrated a rapid and meaningful clinical benefit with a favorable tolerability profile in patients with AChR-positive gMG after IVIg failure or intolerance. These findings support the potential role of EFG as an effective therapeutic option in this difficult-to-treat population.</p>","PeriodicalId":19216,"journal":{"name":"Neurology and Therapy","volume":" ","pages":"1293-1302"},"PeriodicalIF":4.7,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13172185/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147593635","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}

{"title":"From Environment to Symptoms: Mapping Premorbid Risk Factors onto Clinical Features of ALS in a Patient-Reported Database in China.","authors":"Xinyu Li, Qianrui Chen, Dongsheng Fan, Lu Chen","doi":"10.1007/s40120-026-00912-4","DOIUrl":"10.1007/s40120-026-00912-4","url":null,"abstract":"<p><strong>Introduction: </strong>Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease with multifactorial causes, including genetic and environmental factors. This study aimed to identify environmental and lifestyle factors influencing the progression of ALS by leveraging the first and largest patient-reported ALS database in China (the AskHelpU ALS Patient Platform), addressing a critical gap in regional research.</p><p><strong>Methods: </strong>Data from 1421 patients with ALS, including detailed information on occupational exposure, lifestyle habits, dietary patterns, and medical history, were collected from the AskHelpU platform. Statistical analyses were conducted to identify associations between these factors and clinical characteristics. The associations between pre-onset factors and disease progression were analyzed using multicariable generalized linear models, adjusting for multiple comaparisons with the Bonferroni correction.</p><p><strong>Results: </strong>Employment in the agriculture industry (p < 0.001) was associated with rapid ALS progression, whereas employment in the leasing and business services industry (p = 0.01) and education industry (p = 0.033) slowed ALS progression. Other key pre-onset prognostic factors were cigarette smoking (p = 0.043) and pre-existing hypertension (p = 0.036).</p><p><strong>Conclusion: </strong>By utilizing the patient-reported ALS database, this study comprehensively examined the effects of environmental, occupational, and lifestyle factors on ALS progression. These findings provide novel insights into the regional variations in ALS etiology, emphasizing the multifactorial nature of the disease.</p>","PeriodicalId":19216,"journal":{"name":"Neurology and Therapy","volume":" ","pages":"1207-1219"},"PeriodicalIF":4.7,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13172245/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147458862","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}

{"title":"Artificial Intelligence and Machine Learning in Pediatric Epilepsy: A Systematic Review.","authors":"Emilia Malik, Michał Wizner, Julia I Karpierz, Zuzanna Pająk, Monika Roszkowska, Marcin Rojek, Justyna Paprocka","doi":"10.1007/s40120-026-00924-0","DOIUrl":"10.1007/s40120-026-00924-0","url":null,"abstract":"<p><strong>Introduction: </strong>To evaluate the progress of artificial intelligence (AI)-based tools in interpreting clinical data, to compare the existing models, to identify the most proficient models and to determine the limitations of current models and existing research.</p><p><strong>Methods: </strong>Three databases were searched to identify studies in any language that met the eligibility criteria. At least three independent reviewers screened and evaluated each record.</p><p><strong>Results: </strong>Convolutional neural networks emerged as the predominant deep learning architecture, whereas support vector machines were the most frequently used classical machine learning approach. AI-driven seizure detection showed diagnostic performance approaching that of experienced specialists. Reported applications include the detection of specific epilepsy syndromes, identification of electrical status epilepticus during sleep (ESES) and spike-wave index, continuous electroencephalography (EEG) surveillance, neonatal monitoring, and wearable seizure detection technologies.</p><p><strong>Conclusion: </strong>AI models achieved diagnostic accuracy exceeding 90% in distinguishing normal EEG recordings from abnormal ones, with automated seizure detection representing the most widespread case of clinical use. Despite encouraging results, the reliability of these systems is constrained by limited cohort sizes (typically < 100 patients). Future efforts should focus on large-scale, multicenter validation to enable clinical implementation.</p><p><strong>Protocol registration: </strong>INPLASY database, https://doi.org/10.37766/inplasy2025.10.0020 .</p>","PeriodicalId":19216,"journal":{"name":"Neurology and Therapy","volume":" ","pages":"975-1008"},"PeriodicalIF":4.7,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13172172/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147662874","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}

{"title":"Divergent Immunological and Neurotrophic Responses to CD20 Depletion in Relapsing and Progressive Multiple Sclerosis.","authors":"Gudrun M Körner, Thiemo M Möllenkamp, Konstantin F Jendretzky, Julian R Kretschmer, Anna Christina Saparilla Pietschmann, Janna M Siemer, Jarle von Hörsten, Franz F Konen, Philipp Schwenkenbecher, Martin W Hümmert, Franziska Bachhuber, Hayrettin Tumani, Roland Jacobs, Thomas Skripuletz, Stefan Gingele","doi":"10.1007/s40120-026-00908-0","DOIUrl":"10.1007/s40120-026-00908-0","url":null,"abstract":"<p><strong>Introduction: </strong>Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system with distinct subtypes, relapsing MS (RMS) and primary progressive MS (PPMS), which differ in clinical course and underlying immunopathology. Cytokines are pleiotropic mediators of inflammatory and regenerative processes and are considered important contributors to the pathophysiology of MS. Ocrelizumab, a CD20-targeting monoclonal antibody, is approved for the treatment of patients with RMS and PPMS, yet its effects on circulating cytokines and neurotrophic factors remain incompletely understood.</p><p><strong>Methods: </strong>In this prospective observational study, 84 patients with MS (57 RMS, 27 PPMS) were analyzed regarding demographic data, disease activity and serum cytokine profiles before and 6 months after the start of ocrelizumab therapy.</p><p><strong>Results: </strong>Baseline analyses revealed distinct cytokine signatures between patients with RMS and PPMS, with higher levels of several proinflammatory cytokines and chemokines in patients with RMS. Following ocrelizumab treatment, divergent cytokine profiles between patients with RMS and PPMS were partially attenuated, with significant modulation of Th1-associated chemokines and an increase in brain-derived neurotrophic factor (BDNF) observed in patients with RMS. In contrast, cytokine signatures in patients with PPMS remained largely unaffected by ocrelizumab treatment. Patients with RMS with disease activity during the first 6 months of ocrelizumab treatment showed a significant increase in different chemokines compared to baseline compared with patients without disease activity or those with PPMS.</p><p><strong>Conclusions: </strong>Our findings support divergent immunological mechanisms in RMS and PPMS, with a stronger cytokine-driven pathology and more pronounced immunomodulatory effects of ocrelizumab on the cytokine profile in patients with RMS.</p>","PeriodicalId":19216,"journal":{"name":"Neurology and Therapy","volume":" ","pages":"1121-1135"},"PeriodicalIF":4.7,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13172096/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147390654","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}

{"title":"Prognostic Value of the Day 5-7 Neurological Examination in Anterior Circulation Ischemic Stroke: A Post Hoc Analysis of the MARVEL Trial.","authors":"Xuanyu Chen, Lingyu Zhang, Gaoming Li, Xu Xu, Jinfu Ma, Haoxuan Zhu, Xiaolei Shi, Shihai Yang, Zhixi Wang, Mingyang Chen, Yihui Yang, Yuhan Fan, Binghan Wang, Guojian Liu, Linyu Li, Zhenxuan Tian, Boyu Chen, Chawen Ding, Dahong Yang, Wenzhe Sun, Lilan Wang, Shitao Fan, Chengsong Yue, Nizhen Yu, Jie Yang, Zhuang Li, Wenjie Zi, Kunxin Lin","doi":"10.1007/s40120-026-00918-y","DOIUrl":"10.1007/s40120-026-00918-y","url":null,"abstract":"<p><strong>Introduction: </strong>Early prediction of long-term recovery after endovascular thrombectomy (EVT) is essential for guiding care but is often confounded by the instability of acute neurological assessments. We aimed to evaluate the prognostic value of the National Institutes of Health Stroke Scale (NIHSS) measured at day 5-7 or earlier if discharged (D5-7/discharge) compared with baseline NIHSS and change-based metrics for predicting 90-day functional outcomes.</p><p><strong>Methods: </strong>We performed a post hoc analysis of the MARVEL trial, a multicenter randomized clinical trial involving adult patients with acute ischemic stroke due to anterior circulation large-vessel occlusion. The prognostic performance of baseline NIHSS, D5-7/discharge NIHSS, absolute change (ΔNIHSS), and percentage change was evaluated. The primary outcome was favorable outcome, defined as a modified Rankin Scale (mRS) score of 0-2 at 90 days. Discriminative performance was assessed using the area under the receiver operating characteristic curve (AUC), net reclassification improvement (NRI), and integrated discrimination improvement (IDI).</p><p><strong>Results: </strong>Among 1650 included patients, the D5-7/discharge NIHSS showed the highest discriminative ability among the evaluated NIHSS-based measures for predicting favorable outcome (AUC 0.897; 95% confidence interval [CI] 0.881-0.912), exceeding percentage change (AUC 0.891), ΔNIHSS (AUC 0.866), and baseline NIHSS (AUC 0.650) (all p < 0.001). A pragmatic, restricted cubic spline-informed threshold of D5-7/discharge NIHSS ≤ 5 yielded a sensitivity of 64.7% and specificity of 93.3% for 90-day favorable outcome. Adding D5-7/discharge to a model containing traditional covariates significantly improved predictive accuracy (AUC increased from 0.782 to 0.910; NRI 0.437; p < 0.001). Percentage change in NIHSS offered better discrimination than absolute change.</p><p><strong>Conclusion: </strong>The NIHSS assessed at D5-7/discharge showed higher discriminative performance for 90-day functional outcomes than baseline and change-based measures in this post hoc analysis. A threshold of ≤ 5 provided high specificity and may aid bedside counseling and discharge planning, although external validation is warranted.</p><p><strong>Trial registration: </strong>ChiCTR.org.cn Identifier, ChiCTR2100051729.</p>","PeriodicalId":19216,"journal":{"name":"Neurology and Therapy","volume":" ","pages":"1233-1247"},"PeriodicalIF":4.7,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13172080/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147574895","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}

{"title":"Dissecting Motor Domain Responses to Vibration Therapy in Parkinson's Disease: A Systematic Review and Meta-Regression Protocol.","authors":"Se-Ra Park, Jeong-Woo Seo, Kahye Kim, Jin Mi Chun, Ji-Woo Seok, Jung-Dae Kim","doi":"10.1007/s40120-026-00922-2","DOIUrl":"10.1007/s40120-026-00922-2","url":null,"abstract":"<p><strong>Background: </strong>Motor impairments in Parkinson's disease (PD), including gait dysfunction, postural instability, and freezing of gait, are often inadequately managed by pharmacological therapy alone, particularly in advanced stages. Vibration therapy (VT) has been proposed as a non-pharmacological adjunct to improve motor performance through sensorimotor modulation. However, existing evidence remains inconsistent, and previous systematic reviews have reported substantial heterogeneity, limiting clinical interpretability.</p><p><strong>Objective: </strong>This protocol outlines a systematic review and meta-regression analysis designed to evaluate the effects of VT on motor function in individuals with PD, with a specific focus on domain-specific outcomes and parameter-dependent response patterns.</p><p><strong>Methods: </strong>The review will include randomized and non-randomized controlled trials investigating mechanical VT in adults with PD. Motor outcomes will be categorized into four predefined domains: (1) global motor function, (2) gait quality and freezing, (3) functional mobility, and (4) dynamic balance. A comprehensive literature search will be conducted across major electronic databases. Quantitative synthesis will be performed using random-effects meta-analysis. Subgroup analyses and meta-regression will be applied to examine whether vibration characteristics, such as frequency, amplitude, modality, and total dose, explain variability in effect sizes across studies. Risk of bias will be assessed using RoB 2 and ROBINS-I, and the certainty of evidence will be evaluated using the GRADE approach.</p><p><strong>Discussion: </strong>By integrating multidimensional motor outcome categorization with parameter-sensitive analyses, this review aims to clarify whether VT effects in PD are domain-specific and dependent on stimulation characteristics. The findings are expected to provide a more mechanistically interpretable synthesis of the existing evidence and to inform the design of future clinical trials evaluating VT in PD rehabilitation.</p><p><strong>Systematic review registration: </strong>PROSPERO CRD420251124906.</p>","PeriodicalId":19216,"journal":{"name":"Neurology and Therapy","volume":" ","pages":"951-963"},"PeriodicalIF":4.7,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13172173/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147513547","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}

{"title":"Ultra-Long-Term Real-World Outcomes of Lower Extremity Nerve Decompression for Painful Diabetic Peripheral Neuropathy: A Retrospective Cohort Study.","authors":"Chenlong Liao, Shuo Li, Wenxiang Zhong, Yayuan Tian, Wenchuan Zhang","doi":"10.1007/s40120-026-00913-3","DOIUrl":"10.1007/s40120-026-00913-3","url":null,"abstract":"<p><strong>Introduction: </strong>Lower extremity nerve decompression (LEND) for painful diabetic peripheral neuropathy (PDPN) remains controversial, and evidence regarding its long-term effectiveness in real-world clinical practice is limited.</p><p><strong>Methods: </strong>This retrospective real-world cohort study included patients with PDPN treated with LEND or medical therapy alone between 2008 and 2011. Ultra-long-term outcomes were assessed after > 10 years of follow-up. Pain intensity was evaluated using the visual analogue scale (VAS). Composite pain burden and functional impact were assessed with the Brief Pain Inventory for Diabetic Peripheral Neuropathy (BPI-DPN). Psychological symptoms were measured using the Hospital Anxiety and Depression Scale (HADS), and analgesic medication burden was quantified by the Medication Quantification Scale III (MQS-III). Exploratory prognostic factor and subgroup analyses based on pain distribution were performed.</p><p><strong>Results: </strong>Seventy-six patients in the LEND group and 31 patients in the medical group were available for ultra-long-term analysis. Compared with medical management, LEND was associated with greater long-term pain relief (mean VAS change - 5.63 ± 2.16 vs - 1.03 ± 1.92; p < 0.001) and higher responder rates (≥ 50% pain reduction: 65.8% vs 9.7%; p < 0.001). Significant long-term improvements were also observed in BPI-DPN pain severity and pain interference (both p < 0.001), anxiety and depression symptoms (both p < 0.001), and medication burden (MQS-III p < 0.001). Within the LEND cohort, younger age at surgery and lower body mass index were independently associated with greater long-term pain improvement. Both focal and diffuse pain subgroups demonstrated significant improvements in pain and functional outcomes after surgery, with no meaningful differences at ultra-long-term follow-up. Diabetic foot ulcer events occurred less frequently after LEND (0% vs 32.3%; p < 0.001).</p><p><strong>Conclusions: </strong>LEND demonstrated long-term efficacy in alleviating pain and concurrently improving the pain-related interference and psychological status of patients with PDPN. A Graphical Abstract is available for this article.</p><p><strong>Trial registration: </strong>This study was retrospectively registrated in Chinese Clinical Trial Registry chictr.org. cn (ChiCTR2500099348), https://www.chictr.org.cn/bin/project/edit?pid=266042 .</p>","PeriodicalId":19216,"journal":{"name":"Neurology and Therapy","volume":" ","pages":"1155-1175"},"PeriodicalIF":4.7,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13172183/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147444304","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}

{"title":"Efficacy of Ublituximab in People with Highly Active Relapsing Multiple Sclerosis.","authors":"Hans-Peter Hartung, Derrick Robertson, Lawrence Steinman, Douglas L Arnold, Peiqing Qian, Sibyl Wray, Edward Fox, Christopher A Garner, Yihuan Xu, Koby Mok, Anne Gocke, Bruce A C Cree, Enrique Alvarez","doi":"10.1007/s40120-026-00904-4","DOIUrl":"10.1007/s40120-026-00904-4","url":null,"abstract":"<p><strong>Introduction: </strong>People with highly active multiple sclerosis benefit from early treatment with highly efficacious disease-modifying therapies. Here we present data on the efficacy of ublituximab versus teriflunomide in a subgroup of participants with highly active disease at baseline.</p><p><strong>Methods: </strong>Pooled post hoc analyses of the phase 3 ULTIMATE I (N = 549) and II (N = 545) studies evaluated efficacy measures at weeks 12 and 96 in participants with highly active disease, defined as ≥ 2 relapses in the year prior and ≥ 1 gadolinium-enhancing (Gd+) T1 lesion at baseline.</p><p><strong>Results: </strong>In the highly active disease population, the unadjusted annualized relapse rates (ARR) at week 96 were 0.145 and 0.496 for the ublituximab (n = 88) and teriflunomide (n = 80) groups, respectively (70.8% relative reduction, P < 0.001). The number (least squares means) of gadolinium-enhancing T1 lesions per scan for ublituximab versus teriflunomide was 0.114 versus 0.683 at week 12 (83.3% relative reduction) and 0.038 versus 0.875 at week 96 (95.6% relative reduction; both P < 0.001). Corresponding values for new/enlarging T2 lesions (ublituximab versus teriflunomide) were 1.754 versus 4.127 at week 12 (57.5% relative reduction) and 0.568 versus 6.367 at week 96 (91.1% relative reduction, both P < 0.001). No evidence of disease activity-3 (NEDA-3) rates with ublituximab versus teriflunomide were 29.5% versus 10.1% (P = 0.001) at week 12 and 77.9% versus 16.4% (P < 0.001) at week 96 (weeks 24-96, re-baselined).</p><p><strong>Conclusion: </strong>Ublituximab was associated with significant treatment benefits across multiple efficacy measures versus teriflunomide in participants with highly active disease at baseline.</p><p><strong>Trial registration: </strong>Clinical trial registry: ULTIMATE I and II ClinicalTrials.gov numbers, NCT03277261 (registration date September 7, 2017) and NCT03277248 (registration date September 7, 2017).</p>","PeriodicalId":19216,"journal":{"name":"Neurology and Therapy","volume":" ","pages":"1081-1097"},"PeriodicalIF":4.7,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13172083/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147365523","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}

{"title":"Transcutaneous Auricular Vagal Nerve Stimulation Against Fatigue Syndrome in Patients with Long COVID: Results of the Randomized, Placebo-Controlled Clinical Pilot Trial COVIVA.","authors":"Mortimer Gierthmuehlen, Kirsten Schmieder, Niklas Thon, Petra Christine Gierthmuehlen","doi":"10.1007/s40120-026-00928-w","DOIUrl":"10.1007/s40120-026-00928-w","url":null,"abstract":"<p><strong>Introduction: </strong>Fatigue is the most prevalent symptom in \"long COVID\", affecting 6-7% of patients after COVID-19 infection. Its pathophysiology remains unclear, with viral persistence, immune dysregulation, and mitochondrial dysfunction among proposed mechanisms. Transcutaneous auricular vagus nerve stimulation (taVNS), a non-invasive neuromodulatory approach, has been suggested as a potential treatment.</p><p><strong>Methods: </strong>We conducted a randomized, sham-controlled, single-blinded pilot study to evaluate adherence and clinical effects of taVNS in long COVID-related fatigue. Forty-five patients were randomized 1:1:1 to sham stimulation, sub-threshold taVNS, or above-threshold taVNS for 4 weeks using the Conformité Européenne (CE)-certified tVNS-L device (25 Hz, 250 µs, 4 h/day). The primary co-endpoints were fatigue severity (MFI-20) and adherence, defined as mean daily stimulation duration. Secondary endpoints included depressive symptoms (BDI-II), health-related quality of life (SF-36), and post-COVID symptom burden (PCS).</p><p><strong>Results: </strong>Of 45 enrolled patients (mean age 42.4 years; 73% female), 4 (8.9%) dropped out early. Mean stimulation time was 236 min/day, fulfilling the adherence criterion in > 80% of participants. Adverse events were mild, including skin irritation (6.7%) and vertigo (6.7%). Across all groups, questionnaire scores improved over time; however, no statistically significant differences were observed between the sham and active stimulation groups. Baseline fatigue and quality-of-life scores were markedly impaired compared with normative data.</p><p><strong>Conclusion: </strong>taVNS was safe, feasible, and associated with high adherence in long COVID-related fatigue, but showed no superiority over sham stimulation. Larger multicenter trials with more homogeneous populations and objective biomarkers are required to determine whether taVNS confers therapeutic benefit in this condition.</p><p><strong>Trial registration: </strong>The trial was approved by the ethics committee (23/7798) and registered at the German Clinical Trials Register, identifier DRKS00031974.</p>","PeriodicalId":19216,"journal":{"name":"Neurology and Therapy","volume":" ","pages":"1327-1343"},"PeriodicalIF":4.7,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13172187/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147593619","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}

{"title":"Practical Guidance for Initiation and Management of Patients on Once-Nightly Sodium Oxybate for Narcolepsy Treatment: Modified Delphi Panel Consensus Recommendations.","authors":"Monique Mulvany, Ellen Wermter, Maggie Lavender, Heidy Merius, Cecile Martin, Amber Burns, Jamie Simmons","doi":"10.1007/s40120-026-00919-x","DOIUrl":"10.1007/s40120-026-00919-x","url":null,"abstract":"<p><strong>Introduction: </strong>Despite its strong recommendation for treatment of excessive daytime sleepiness (EDS), cataplexy, and disease severity associated with narcolepsy by the American Academy of Sleep Medicine, sodium oxybate (SXB) remains underutilized. Once-nightly SXB (ON-SXB) is an extended-release formulation of SXB approved for treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy. ON-SXB has only been commercially available since 2023; thus, additional practical clinical recommendations may be helpful.</p><p><strong>Methods: </strong>Seven advanced practice providers (APPs) who practice sleep medicine were invited to participate in a modified Delphi panel to develop practical recommendations for the management and initiation of ON-SXB in patients with narcolepsy. Panelists addressed six themes: managing expectations and patient education, dosing and titration, discontinuation and adherence, transitioning from twice-nightly oxybates (TN-OXB), polypharmacy, and sodium. Panelists first answered open-ended questions, then met virtually to discuss responses and seek consensus. Topics not reaching consensus were fielded to the panelists via iterative rounds of questionnaires and virtual meetings.</p><p><strong>Results: </strong>Panelists recommended that clinicians set expectations for treatment, side effects, and frequent communication with oxybate-naive patients. Indicators of medication discontinuation (e.g., missed follow-up appointments, late/missed refills, patients needing \"coaching\" to continue medication) were identified. For patients switching from TN-OXB, questions were proposed to determine effects of the second nightly dose on the patient and family/partner. After determining readiness to modify concomitant narcolepsy treatments, stimulants were recommended as the first medication to adjust. Consensus was achieved that discussions about sodium should be relevant to the patient's existing cardiovascular risk and occur in the context of the benefits of consolidated sleep.</p><p><strong>Conclusion: </strong>APPs have a unique and pragmatic experience in treating people with narcolepsy. Delphi consensus recommendations drawn from their experience may inform the approach to ON-SXB use in narcolepsy and help clinicians optimize patient care.</p>","PeriodicalId":19216,"journal":{"name":"Neurology and Therapy","volume":" ","pages":"1249-1267"},"PeriodicalIF":4.7,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13172060/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147574937","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}