Article
Clinical Neurology
V Lepore, C. Bosetti, C. Santucci, P. Iaffaldano, M. Trojano, P. Mosconi
Summary: This study compared the use of fixed baseline and roving EDSS reference scores in detecting disability-worsening events in RRMS patients, and found that roving EDSS reference scores were more sensitive in detecting worsening events unrelated to relapse.
EUROPEAN JOURNAL OF NEUROLOGY
(2021)
Article
Medicine, General & Internal
Ana Jerkovic, Sanda Pavelin, Josko Soda, Igor Vujovic, Maja Rogic Vidakovic
Summary: The present study investigated disability severity in people with multiple sclerosis (pwMS) in Croatia in 2021 using an electronic, unsupervised patient-reported Expanded Disability Status Scale (ePR-EDSS). The results showed significant differences in disability severity among patients of different ages, genders, and immunomodulatory drug use. There were also significant differences in disability symptoms among different types of multiple sclerosis. The study also found that the application of ePR-EDSS was a reliable tool for assessing disability status in pwMS.
JOURNAL OF CLINICAL MEDICINE
(2022)
Article
Clinical Neurology
Yi Chao Foong, Daniel Merlo, Melissa Gresle, Chao Zhu, Katherine Buzzard, Jeannette Lechner-Scott, Michael Barnett, Bruce Taylor, Tomas Kalincik, Trevor Kilpatrick, David Darby, Pamela Dobay, Johan van Beek, Robert Hyde, Helmut Butzkueven, Anneke van Der Walt
Summary: This study investigated the psychometric properties and longitudinal performance of the PDDS scale in patients with multiple sclerosis (MS). The findings showed that PDDS had greater correlation with patient-reported outcomes (PROs) and less correlation with other MS-related outcome measures compared to the EDSS. Furthermore, PDDS had little correlation with EDSS longitudinally.
EUROPEAN JOURNAL OF NEUROLOGY
(2023)
Article
Clinical Neurology
Andrew R. Romeo, William M. Rowles, Erica S. Schleimer, Patrick Barba, Wan-Yu Hsu, Refujia Gomez, Adam Santaniello, Chao Zhao, Jennifer R. Pearce, J. B. Jones, Bruce C. Cree, Stephen L. Hauser, Jeffrey M. Gelfand, Walter F. Stewart, Douglas S. Goodin, Riley M. Bove
Summary: The study found that the developed ePR-EDSS can effectively capture MS-related disability and has a high degree of agreement with traditional EDSS evaluations. It can also facilitate broader patient participation in research.
MULTIPLE SCLEROSIS JOURNAL
(2021)
Article
Biology
S. Mungan, I. Guzel, B. C. Demirdogen
Summary: This study aimed to assess the relationship between dietary antioxidant capacity and the Expanded Disability Status Scale (EDSS) scores in multiple sclerosis (MS) patients. The results showed significant correlations between levels of vitamins A, D, E, C, and retinol and the EDSS scores. The study findings suggest that evaluating antioxidant levels may be helpful in determining the severity of MS and the success of treatment.
BRAZILIAN JOURNAL OF MEDICAL AND BIOLOGICAL RESEARCH
(2023)
Article
Clinical Neurology
Tobia Zanotto, Jacob J. Sosnoff, Edward Ofori, Daniel Golan, Myassar Zarif, Barbara Bumstead, Marijean Buhse, Olivia Kaczmarek, Jeffrey Wilken, Lisa Muratori, Thomas J. Covey, Mark Gudesblatt
Summary: This study aimed to quantify the variability of spatiotemporal gait measures within homologous EDSS categories. The results showed that there was a correlation between gait measures and EDSS scores, and the variability of gait measures increased with the increase in EDSS categories. Therefore, more comprehensive objective metrics are needed to accurately evaluate disability in pwMS, in addition to the EDSS.
MULTIPLE SCLEROSIS AND RELATED DISORDERS
(2022)
Article
Clinical Neurology
Martina Petruzzo, Antonio Reia, Giorgia T. Maniscalco, Fabrizio Luiso, Roberta Lanzillo, Cinzia Valeria Russo, Antonio Carotenuto, Lia Allegorico, Raffaele Palladino, Vincenzo Brescia Morra, Marcello Moccia
Summary: The study found an association between cardiovascular risk factors and the prognosis of multiple sclerosis (MS). An increase in the Framingham risk score was associated with higher risks of MS relapses, disability, and treatment escalation. Early identification and management of cardiovascular comorbidities should be considered in MS management.
EUROPEAN JOURNAL OF NEUROLOGY
(2021)
Article
Clinical Neurology
Ian-Christopher Tanoh, Elisabeth Maillart, Pierre Labauge, Mikael Cohen, Adil Maarouf, Sandra Vukusic, Cecile Donze, Philippe Gallien, Jerome De Seze, Bertrand Bourre, Thibault Moreau, Celine Louapre, Morgane Vallee, Severine Bieuvelet, Lissandra Klaeyle, Anne-Laure Argoud, Saad Zinai, Ayman Tourbah
Summary: The software medical device MSCopilot has shown high specificity, sensitivity, and reliability in self-assessment of Multiple Sclerosis patients, with significant correlations to the Expanded Disability Status Scale (EDSS) and the ability to distinguish patients with different EDSS levels. The device was found to be able to capture nuances in different stages of MS that traditional tests like MSFC could not.
MULTIPLE SCLEROSIS AND RELATED DISORDERS
(2021)
Article
Clinical Neurology
Antonio Barreiro-Gonzalez, Maria T. Sanz, Sara Carratala-Bosca, Francisco Perez-Miralles, Carmen Alcala, Joan Carreres-Polo, Enrique Espana-Gregori, Bonaventura Casanova
Summary: The study developed and validated an EDSS model using clinical, OCT, and MRI measures in MS patients. Results showed correlations between EDSS and patient's age, SC volume, and GCL, leading to a regression model predicting diverse EDSS scores. This study suggests that MS disability measured through EDSS is age-dependent and influenced by SC and GCL, warranting further research on paraclinical disability predictors.
EUROPEAN NEUROLOGY
(2022)
Article
Clinical Neurology
Fred D. Lublin, Dieter A. Haering, Habib Ganjgahi, Alex Ocampo, Farhad Hatami, Jelena Cuklina, Piet Aarden, Frank Dahlke, Douglas L. Arnold, Heinz Wiendl, Tanuja Chitnis, Thomas E. Nichols, Bernd C. Kieseier, Robert A. Bermel
Summary: Patients with multiple sclerosis can acquire disability through either relapse-associated worsening or progression independent of relapses. This study found that early progression begins in all phenotypes of the disease, becoming the primary driver of disability accumulation in the progressive phase. Treatments with disease-modifying therapies significantly delay disability accumulation, with the greatest impact seen in patients in the earliest stages of multiple sclerosis.
Article
Clinical Neurology
Ki Hoon Kim, Su-Hyun Kim, Na Young Park, Jae-Won Hyun, Ho Jin Kim
Summary: This study evaluated the efficacy and safety of natalizumab in Korean patients with active MS, showing high efficacy in reducing annual relapse rate and improving or stabilizing disability in the majority of patients. NEDA-3 was achieved in 92% and 82% of patients at 1 and 2 years after initiating natalizumab treatment, respectively. No serious adverse events leading to discontinuation of natalizumab were observed.
FRONTIERS IN NEUROLOGY
(2021)
Article
Immunology
Milad-Kazava Keshvari, Frederick van Someren, Saima Sheikh, Ian Galea
Summary: During natalizumab treatment for multiple sclerosis, risk factors for eosinophilia were identified, including baseline pre-treatment eosinophilia, medical conditions potentially associated with eosinophilia, and suboptimal compliance. Changes in eosinophil and lymphocyte counts were found to be weakly correlated, suggesting factors other than Very Late Antigen-4 (VLA-4) inhibition may drive eosinophilia.
JOURNAL OF NEUROIMMUNOLOGY
(2021)
Article
Clinical Neurology
Jose M. Serra Lopez-Matencio, Yaiza Perez Garcia, Virginia Meca-Lallana, Raquel Juarez-Sanchez, Angeles Ursa, Lorena Vega-Piris, Dora Pascual-Salcedo, Annick de Vries, Theo Rispens, Cecilia Munoz-Calleja
Summary: The main variables influencing the pharmacology of natalizumab are body mass index and dosing interval. The concentrations of natalizumab and/or RO vary widely among patients, emphasizing the importance of routinely measuring them for personalized treatment and avoiding over or underdosing.
FRONTIERS IN NEUROLOGY
(2021)
Article
Clinical Neurology
Michael Guger, Christian Enzinger, Fritz Leutmezer, Franziska Di Pauli, Joerg Kraus, Stefan Kalcher, Erich Kvas, Thomas Berger
Summary: The study evaluated the long-term effectiveness of natalizumab (NTZ) in treating multiple sclerosis and identified several demographic, clinical, and radiological predictors related to long-term disease activity. It found that NTZ treatment led to stable disease course in relapse activity and progression for over 7 years, with factors such as higher relapse rate before treatment initiation, higher disability, shorter disease duration, and the absence of Gadolinium-enhancing MRI lesions being associated with reduced relapse risk. Additionally, older age at NTZ start was identified as the only significant risk factor for disease progression over the long-term.
JOURNAL OF NEUROLOGY
(2021)
Article
Clinical Neurology
Undine Proschmann, Hernan Inojosa, Katja Akgun, Tjalf Ziemssen
Summary: The study found that a portion of RRMS and SPMS patients experienced disease activity recurrence after discontinuing Natalizumab treatment. Concentrations of free and cell-bound Natalizumab, as well as alpha 4-integrin receptor saturation, decreased over time while alpha 4-integrin expression increased. sNfL levels were associated with disease activity recurrence and could serve as an early predictive marker.
FRONTIERS IN NEUROLOGY
(2021)
Article
Clinical Neurology
Menglan Pang, Ling Zhu, Audrey Gabelle, Arie R. Gafson, Robert W. Platt, James E. Galvin, Pierre Krolak-Salmon, Ivana Rubino, Carl de Moor, Shibeshih Belachew, Changyu Shen
Summary: Using instrumental variable meta-analysis, this study provides statistically significant evidence of a likely causal relationship between reduction in brain amyloid beta (Aβ) plaque and slowing cognitive and functional decline in patients with Alzheimer's disease (AD).
ALZHEIMERS & DEMENTIA
(2023)
Article
Clinical Neurology
Alexandra Buehler, Marcel Wolbers, Fabian Model, Qing Wang, Shibeshih Belachew, Marianna Manfrini, Johannes Lorscheider, Ludwig Kappos, Jan Beyersmann
Summary: This study proposes a definition of recurrent disability progression events and compares the analysis of time-to-first-event and recurrent events. The results show that recurrent event analysis includes a larger number of progression events, leading to more accurate treatment effect estimates and increased statistical power.
MULTIPLE SCLEROSIS JOURNAL
(2023)
Letter
Clinical Neurology
Menglan Pang, Ling Zhu, Audrey Gabelle, Arie R. Gafson, Robert W. Platt, James E. Galvin, Pierre Krolak-Salmon, Ivana Rubino, Carl de Moor, Shibeshih Belachew, Changyu Shen
ALZHEIMERS & DEMENTIA
(2023)
Article
Neurosciences
Bastien Caba, Alexandre Cafaro, Aurelien Lombard, Douglas L. Arnold, Colm Elliott, Dawei Liu, Xiaotong Jiang, Arie Gafson, Elizabeth Fisher, Shibeshih Mitiku Belachew, Nikos Paragios
Summary: In this study, a novel machine learning approach is developed for the automatic detection of acute multiple sclerosis (MS) lesions using single-timepoint non-contrast T1- and T2-weighted brain MRI. By using image inpainting, the MRI input data is supplemented, and a multi-objective statistical ranking module and ensemble classifier are used for analysis, leading to the identification of a compact textural signature characterizing the lesion phenotype. Our method achieves a balanced accuracy in the range of 74.3-74.6% on fully external validation cohorts for the patch-level task of acute versus chronic MS lesion classification.
Article
Clinical Neurology
Jennifer S. S. Graves, Marco Ganzetti, Frank Dondelinger, Florian Lipsmeier, Shibeshih Belachew, Corrado Bernasconi, Xavier Montalban, Johan van Beek, Michael Baker, Christian Gossens, Michael Lindemann
Summary: The smartphone sensor-based Draw a Shape Test, a part of the Floodlight Proof-of-Concept app, was validated for remotely assessing upper extremity impairment in individuals with multiple sclerosis. The test showed correlation with disease burden measures and ability to differentiate between multiple sclerosis patients and healthy controls.
ANNALS OF CLINICAL AND TRANSLATIONAL NEUROLOGY
(2023)
Article
Clinical Neurology
Xiaotong Jiang, Changyu Shen, Charlotte E. Teunissen, Mark Wessels, Henrik Zetterberg, Gavin Giovannoni, Carol M. Singh, Bastien Caba, Colm Elliott, Elizabeth Fisher, Carl de Moor, Shibeshih Belachew, Arie R. Gafson
Summary: This study analyzed the association between serum glial fibrillary acidic protein (sGFAP) concentration and disability progression in patients with secondary-progressive multiple sclerosis (SPMS). The results showed that changes in sGFAP concentration were not associated with current disability progression and could not predict future disability progression in the absence of inflammatory activity.
MULTIPLE SCLEROSIS JOURNAL
(2023)
Article
Clinical Neurology
Colm Elliott, David A. Rudko, Douglas L. Arnold, Dumitru Fetco, Ahmed M. Elkady, David Araujo, Bing Zhu, Arie Gafson, Zhe Tian, Shibeshih Belachew, Daniel P. Bradley, Elizabeth Fisher
Summary: This study aimed to assess the lesion-level concordance between paramagnetic rim lesions (PRLs) and slowly expanding lesions (SELs) in chronic active lesions (CALs) of multiple sclerosis (MS), and to characterize changes in brain tissue integrity in CALs. The results showed that co-localization of PRLs and SELs was associated with rapid expansion and worsening of microstructural damage over time, and both SELs with and without co-localization with PRLs showed ongoing tissue damage. Therefore, the coexistence of PRLs and SELs is associated with severe accumulation of tissue damage.
MULTIPLE SCLEROSIS JOURNAL
(2023)
Review
Health Care Sciences & Services
Seya Colloud, Thomas Metcalfe, Scott Askin, Shibeshih Belachew, Johannes Ammann, Ernst Bos, Timothy Kilchenmann, Paul Strijbos, Damien Eggenspieler, Laurent Servais, Chloe Garay, Athanasios Konstantakopoulos, Armin Ritzhaupt, Thorsten Vetter, Claudia Vincenzi, Francesca Cerreta
Summary: Digital health technology tools (DHTTs) offer opportunities for innovation, patient care improvement, shortened clinical trials, and reduced risk in medicines development. This review presents four case studies highlighting the regulatory requirements and the need for increased collaboration between stakeholders. The complexity of interactions, combined with unique challenges related to DHTTs, is addressed. These case studies provide insight into the regulatory approach and propose potential solutions for sponsors.
NPJ DIGITAL MEDICINE
(2023)
Article
Clinical Neurology
Menglan Pang, Audrey Gabelle, Paramita Saha-Chaudhuri, Willem Huijbers, Arie Gafson, Paul M. Matthews, Lu Tian, Ivana Rubino, Richard Hughes, Carl de Moor, Shibeshih Belachew, Changyu Shen
Summary: This study provides a proof of concept for precision medicine in future research and drug development for Alzheimer's disease through individual treatment response analysis.
ALZHEIMERS & DEMENTIA
(2023)
Article
Clinical Neurology
Xiaotong Jiang, Changyu Shen, Bastien Caba, Douglas L. Arnold, Colm Elliott, Bing Zhu, Elizabeth Fisher, Shibeshih Belachew, Arie R. Gafson
Summary: This study explored the prognostic capability of SuStaIn subtyping in multiple sclerosis and its usefulness as a personalized predictor of treatment effects of natalizumab and dimethyl fumarate. The results showed that while SuStaIn subtypes correlated with disease severity and functional impairment at baseline, they were unable to predict disability progression and discriminate treatment response heterogeneity.
MULTIPLE SCLEROSIS AND RELATED DISORDERS
(2023)
Meeting Abstract
Clinical Neurology
M. Scaramozza, P. A. Chiesa, M. Deloire, L. Zajac, Z. Sun, M. Tang A. Juraver, E. Bartholome, A. Saubusse, J. Charre Morin, N. Campbell, J. van Beek, T. Guymard, A. Scotland, B. Brochet, S. Belachew, A. Ruet
MULTIPLE SCLEROSIS JOURNAL
(2022)
Meeting Abstract
Clinical Neurology
Q. Spinat, B. Caba, A. Gafson, D. Ioannidou, X. Jiang, A. Cafaro, D. P. Bradley, R. Perea, E. Fisher, D. L. Arnold, C. Elliott, N. Paragios, S. Belachew
MULTIPLE SCLEROSIS JOURNAL
(2022)
Meeting Abstract
Clinical Neurology
L. Zajac, P. A. Chiesa, M. Deloire, M. Scaramozza, Z. Sun, M. Tang, A. Juraver, E. Bartholome, A. Saubusse, J. Charre Morin, N. Campbell, J. van Beek, T. Guymard, A. Scotland, B. Brochet, S. Belachew, A. Ruet
MULTIPLE SCLEROSIS JOURNAL
(2022)
Meeting Abstract
Clinical Neurology
B. Caba, A. Gafson, D. Ioannidou, X. Jiang, A. Cafaro, D. P. Bradley, R. Perea, E. Fisher, D. L. Arnold, C. Elliott, N. Paragios, S. Belachew
MULTIPLE SCLEROSIS JOURNAL
(2022)
Meeting Abstract
Clinical Neurology
C. Santos Garcia, B. Caba, A. Gafson, D. Ioannidou, X. Jiang, A. Cafaro, D. P. Bradley, R. Perea, E. Fisher, D. L. Arnold, C. Elliott, N. Paragios, S. Belachew
MULTIPLE SCLEROSIS JOURNAL
(2022)