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Clinical Neurophysiology : Official... Jul 2024This systematic review aimed to evaluate if event-related potentials (ERPs) can be a relevant tool for cognitive dysfunction diagnosis in Multiple Sclerosis (MS). (Review)
Review
OBJECTIVE
This systematic review aimed to evaluate if event-related potentials (ERPs) can be a relevant tool for cognitive dysfunction diagnosis in Multiple Sclerosis (MS).
METHODS
Four databases were consulted (PubMed, Embase, Scielo, and Web of Science). The included studies should include adults with clear MS diagnoses, independently of having cognitive complaints, and all should have been submitted to ERPs (P300, N400 or mismatch negativity (MMN)). The main outcomes evaluated were ERPs' amplitude and/or latency.
RESULTS
425 studies were obtained initially from all databases, with 26 studies fulfilling the eligibility criteria. P300 was the most used ERP (25 studies), showing a reduced amplitude or an increased latency in 84% of those. N400 was evaluated in one study, showing also abnormal results. MMN was addressed in two studies with inconsistent findings. Some studies further suggest that ERPs may show earlier abnormal results compared with neuropsychological tests.
CONCLUSIONS
Most MS patient groups revealed ERP abnormalities, suggesting that these neurophysiological tests may be a relevant and appropriate diagnostic aid method for cognitive impairment in MS.
SIGNIFICANCE
The use of ERPs in MS patients seems able to demonstrate cognitive impairment and its use should be considered as part of the regular patient evaluation.
Topics: Humans; Multiple Sclerosis; Evoked Potentials; Cognitive Dysfunction; Electroencephalography
PubMed: 38759513
DOI: 10.1016/j.clinph.2024.04.024 -
Multiple Sclerosis and Related Disorders Jul 2024Multiple sclerosis (MS) is a disabling neurological disease that causes cognitive impairment and mental problems that occur in all MS phenotypes but are most common in... (Meta-Analysis)
Meta-Analysis
Effects of virtual reality-based rehabilitation on cognitive function and mood in multiple sclerosis: A systematic review and meta-analysis of randomized controlled trials.
BACKGROUND
Multiple sclerosis (MS) is a disabling neurological disease that causes cognitive impairment and mental problems that occur in all MS phenotypes but are most common in patients with secondary progressive MS. Various degrees of cognitive impairment and mental health concerns are common among patients with MS (PwMS). Virtual reality (VR)-based rehabilitation is an innovative approach aimed at enhancing cognitive function and mood in PwMS. This study aims to perform a meta-analysis to assess the effects of VR-based rehabilitation on cognitive function and mood in PwMS.
METHODS
Using PubMed, Embase, the Cochrane Library, Web of Science, and the Physiotherapy Evidence Database (PEDro), a thorough database search was performed to identify randomized controlled trials (RCTs) examining the effects of VR on PwMS. Trials published until October 31, 2023, that satisfied our predetermined inclusion and exclusion criteria were included. Data were extracted, literature was examined, and the methodological quality of the included trials was assessed. StataSE version 16 was used for the meta-analysis.
RESULTS
Our meta-analysis included 461 patients from 10 RCTs.
PRIMARY OUTCOMES
The Montreal Cognitive Assessment (MoCA) (weighted mean difference [WMD]=1.93, 95 % confidence interval [CI]=0.51-3.36, P = 0.008, I² = 75.4 %) the Spatial Recall Test (SPART) (WMD=3.57, 95 % CI=1.65-5.50, P < 0.001, I² = 0 %), immediate recall (standard mean difference [SMD]=0.37, 95 % CI=0.10-0.64, P = 0.007, I² = 0 %) and delayed recall ([SMD]=0.30, 95 % CI=0.06-0.54, P = 0.013, I² = 35.4 %) showed improvements in comparison to the control group in terms of global cognitive function immediate recall, delayed recall, and visuospatial abilities.
SECONDARY OUTCOMES
Compared to the control group, anxiety improved (standard mean difference [SMD]=0.36, 95 % CI=0.10-0.62, P = 0.007, I² = 43.1 %). However, there were no significant differences in processing speed, attention, working memory or depression.
CONCLUSIONS
This systematic review provides valuable evidence for improving cognitive function and mood in PwMS through VR-based rehabilitation. In the future, VR-based rehabilitation may be a potential method to treat cognitive function and emotional symptoms of MS.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO; identifier: CRD42023474467.
Topics: Humans; Affect; Cognition; Cognitive Dysfunction; Multiple Sclerosis; Neurological Rehabilitation; Randomized Controlled Trials as Topic; Virtual Reality; Virtual Reality Exposure Therapy
PubMed: 38735202
DOI: 10.1016/j.msard.2024.105643 -
Neurologia I Neurochirurgia Polska 2024Multiple sclerosis (MS) is a central nervous system (CNS) disease associated with inflammation, demyelination, and neurodegeneration. It affects more than 2 million...
INTRODUCTION
Multiple sclerosis (MS) is a central nervous system (CNS) disease associated with inflammation, demyelination, and neurodegeneration. It affects more than 2 million people globally, and usually occurs in young adults, three-quarters of whom are women. Importantly, accurate diagnosis and treatment are essential, as this disease can lead to the rapid development of disability. The choroid plexus (CP) is a structure widely known as the main cerebrospinal fluid source. However, it is also involved in immune cell trafficking to the cerebrospinal fluid, which is increased in different neurological disorders, particularly those associated with neuroinflammation. As MS is generally thought to be caused by an autoimmune process, it has been suggested that the choroid plexus may play a significant role in its pathogenesis, manifesting via changes in imaging characteristics.
MATERIAL AND METHODS
Although research regarding this topic has been very limited, the results of the available studies appear promising. To further investigate this subject, we performed a systematic literature review according to the PRISMA 2020 guidelines. The PubMed and Embase databases were searched for relevant articles, and after thorough analysis, 16 studies were included in our review.
RESULTS
CP volume was significantly increased in MS patients compared to healthy individuals. Furthermore, some studies found that CP enlargement occurs even before a definite diagnosis. Moreover, a few articles reported correlations between CP volume and brain atrophy, or even disease severity.
CONCLUSIONS
Our findings show that CP imaging has the potential to become a novel and valuable tool in multiple sclerosis management.
Topics: Humans; Multiple Sclerosis; Choroid Plexus; Magnetic Resonance Imaging; Female; Neuroimaging; Adult
PubMed: 38721672
DOI: 10.5603/pjnns.98706 -
Pharmacoepidemiology and Drug Safety May 2024Randomized controlled trials are considered the gold standard in regulatory decision making, as observational studies are known to have important methodological... (Review)
Review
BACKGROUND
Randomized controlled trials are considered the gold standard in regulatory decision making, as observational studies are known to have important methodological limitations. However, real-world evidence may be helpful in specific situations. This review investigates how the effect estimates obtained from randomized controlled trials compare to those obtained from observational studies, using drug therapy for relapsing-remitting multiple sclerosis as an example.
STUDY DESIGN AND SETTING
A systematic review of randomized controlled trials and observational studies was conducted. The primary outcome was the annualized relapse rate. Using (network) meta-analysis together with posterior predictive distributions, the drug-specific rate ratios from the network of randomized controlled trials were compared with those from the network of observational studies.
RESULTS
Effect estimates from 26 observational studies showed greater magnitudes and were less precise compared to estimates obtained from 21 randomized controlled trials. Twenty of the 28 treatment comparisons between designs had similar rate ratios. Seven inconsistencies in observed rate ratios could be attributed to two specific disease-modifying therapies.
CONCLUSION
In this case study, estimates from observational studies predominantly agreed with estimates from randomized controlled trials given their posterior predictive distributions. Multiple observational studies together may therefore supplement additional pivotal randomized controlled trials in relapsing-remitting multiple sclerosis, for instance facilitating the extrapolation of trial results to the broader patient population.
Topics: Humans; Multiple Sclerosis, Relapsing-Remitting; Randomized Controlled Trials as Topic; Observational Studies as Topic; Treatment Outcome; Research Design
PubMed: 38720409
DOI: 10.1002/pds.5810 -
Clinical and Translational Science May 2024No systematic review of trial designs in patients with relapsing multiple sclerosis (RMS) was reported. This systematic review was conducted on the trial designs and... (Review)
Review
No systematic review of trial designs in patients with relapsing multiple sclerosis (RMS) was reported. This systematic review was conducted on the trial designs and primary end points (PEs) of phase II and III trials intended to modify the natural course of the disease in patients with RMS. The purpose of the study is to explore trends/topics and discussion points in clinical trial design and PE, comparing them to regulatory guidelines and expert recommendations. Three trial registration systems, ClinicalTrials.gov, the EU Clinical Trials Register, and the Japan Registry of Clinical Trials, were used and 60 trials were evaluated. The dominant clinical trial design was a randomized controlled parallel-arms trial and other details were as follows: in adult phase III confirmatory trials (n = 32), active-controlled double-blind trial (DBT) (53%) and active-controlled open-label assessor-masking trial (16%); in adult phase II dose-finding trials (n = 9), placebo- and active-controlled DBT (44%), placebo-controlled DBT (22%), and placebo-controlled add-on DBT (22%); and in pediatric phase III confirmatory trials (n = 8), active-controlled DBT (38%) and active-controlled open-label non-masking trial (25%). The most common PEs were as follows: in adult confirmatory trials, annual relapse rate (ARR) (56%) and no evidence of disease activity-3 (NEDA-3) (13%); in adult dose-finding trials, the cumulative number of T1 gadolinium-enhancing lesions (56%), combined unique active lesions (22%), and overall disability response score (22%); and in pediatric confirmatory trials, ARR (38%) and time to first relapse (25%). It was suggested that some parts of the regulatory guidelines and expert recommendations need to be revised.
Topics: Humans; Clinical Trials, Phase III as Topic; Clinical Trials, Phase II as Topic; Adult; Multiple Sclerosis, Relapsing-Remitting; Child; Research Design; Endpoint Determination; Randomized Controlled Trials as Topic
PubMed: 38708586
DOI: 10.1111/cts.13794 -
Midwifery Jul 2024Little is known regarding the impact of multiple sclerosis (MS) on maternal and neonatal outcomes. Consequently, this systematic review and meta-analysis aimed to study... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
Little is known regarding the impact of multiple sclerosis (MS) on maternal and neonatal outcomes. Consequently, this systematic review and meta-analysis aimed to study the impacts of MS on maternal and neonatal outcomes in pregnant women with a history of MS.
METHODS
This review was designed in line with the PRISMA guidelines. Two researchers conducted independent reviews of the literature without time restrictions until January 2023 using international databases, including PubMed, Web of Science, CINAHL Plus, Embase, Scopus, Science Direct, and Google Scholar. A random-effect meta-analysis, using the db metan command in Stata 17.2, was used to calculate the pooled measure of association.
RESULTS
The meta-analysis identified 15 studies involving 33,174,541 pregnant women (32,191 with MS and 33,142,350 as controls). The findings indicate that women with a history of MS are at an increased risk of cesarean delivery (OR=1.28, 95% Confidence Intervals [CI]: 1.14-1.45, p-value: 0.042). Also, these women are at higher risk of neonatal outcomes, such as preterm birth (OR= 1.39, 95% CI: 1.08-1.78, p-value: 0.02), congenital malformations (OR=1.32, 95%CI: 1.16-1.50, p-value: 0.031), Apgar score <7 (OR=2.13, 95% CI: 1.19-3.79, p-value: 0.03), and small for gestational age (OR=1.27, 95% CI: 1.08-1.51, p-value: 0.040).
CONCLUSION
Pregnant women with MS have a greater chance of adverse pregnancy results than pregnant women without MS. Consequently, pregnant women with MS should create detailed before and after pregnancy plans, in consultation with their doctors, spouses, families, and friends, regarding the necessary care and supplements. Future studies applying a prospective cohort design that control for potential confounders are needed to further validate the findings.
Topics: Humans; Pregnancy; Female; Multiple Sclerosis; Pregnancy Outcome; Infant, Newborn; Pregnant Women; Pregnancy Complications; Adult
PubMed: 38703425
DOI: 10.1016/j.midw.2024.104004 -
Frontiers in Immunology 2024The objective of this study is to evaluate the risk of secondary autoimmune diseases in multiple sclerosis (MS) patients treated with alemtuzumab (ALZ) through a... (Meta-Analysis)
Meta-Analysis
BACKGROUND AND PURPOSE
The objective of this study is to evaluate the risk of secondary autoimmune diseases in multiple sclerosis (MS) patients treated with alemtuzumab (ALZ) through a meta-analysis.
METHODS
PubMed, Web of Science, OVID, EMBASE, and Cochrane central register of controlled trials were searched. Information and data were screened and extracted by 2 researchers. The obtained data were analyzed using the R software meta package. Quality assessment was conducted using the Newcastle-Ottawa Scale (NOS). The causes of heterogeneity were analyzed using subgroup analysis and sensitivity analysis. Publication bias was evaluated using funnel plots and Egger's test.
RESULTS
The search retrieved a total of 3530 papers from the databases. After screening, a total of 37 studies were included in the meta-analysis. The analysis results indicate that the pooled incidence rate of overall secondary autoimmune events (SAEs) in the included studies was 0.2824 [0.2348, 0.3300] (I²=94%, p<0.01). The overall incidence of autoimmune thyroid events (ATE) was 0.2257 [0.1810, 0.2703] (I²=94%, p<0.01). Among them, the rate of serious autoimmune thyroid events (SATE) was 0.0541 [0.0396, 0.0687] (I²=0%, p=0.44). The incidence rates of different thyroid events were as follows: Graves' disease (GD), 0.2266 [0.1632, 0.2900] (I²=83%, p<0.01); Hashimoto thyroiditis (HT), 0.0844 [0.0000, 0.2262] (I²=81%, p=0.02); Hashimoto thyroiditis with hypothyroidism (HTwH), 0.0499 [0.0058, 0.0940] (I²=37%, p=0.21); fluctuating thyroid dysfunction (FTD), 0.0219 [0.0015, 0.0424] (I²=0%, p=0.40); transient thyroiditis (TT), 0.0178 [0.0062, 0.0295] (I²=0%, p=0.94). The overall incidence of hematological events was 0.0431 [0.0274, 0.0621] (I²=70%, p<0.01). The incidence rates from high to low were as follows: lymphopenia, 0.0367 [0.0000, 0.0776] (I²=81%, p=0.02); Idiopathic thrombocytopenic purpura (ITP), 0.0258 [0.0199, 0.0323] (I²=25%, p=0.15); Hemolytic anemia (HA), 0.0177 [0.0081, 0.0391] (I²=29%, p=0.23); pancytopenia, 0.0136 [0.0000, 0.0314] (I²=0%, p=0.67); Neutropenia, 0.0081 [0.0000, 0.0183] (I²=0%, p=0.42). After excluding thyroid and hematological diseases, the combined incidence of other related SAEs was 0.0061 [0.0014, 0.0109] (I²=50%, p=0.02). The incidence of each disease ranked from highest to lowest as: skin psoriasis (SP), 0.0430 [0.0000, 0.0929] (I²=0%, p=0.57); alopecia areata (AA), 0.0159 [0.0024, 0.0372] (I²=19%, p=0.29); vitiligo, 0.0134 [0.0044, 0.0223] (I²=0%, p=0.81); inflammatory atrichia (IA), 0.0103 [0.0000, 0.0232] (I²=0%, p=0.43); chronic urticaria (CU), 0.0107 [0.0000, 0.0233] (I²=0%, p=0.60); and nephropathy, 0.0051 [0.0000, 0.0263] (I²=62%, p=0.02).
CONCLUSION
The occurrence of secondary autoimmune diseases in patients with MS treated with ALZ is noteworthy, particularly in the form of thyroid events and hematological events. Clinicians should monitor the overall condition of patients promptly for early management and avoid delayed diagnosis and treatment.
SYSTEMATIC REVIEW REGISTRATION
inplasy.com/inplasy-2024-4-0048/, identifier INPLASY202440048.
Topics: Humans; Alemtuzumab; Multiple Sclerosis; Autoimmune Diseases; Incidence; Hashimoto Disease
PubMed: 38690271
DOI: 10.3389/fimmu.2024.1343971 -
The Primary Care Companion For CNS... Apr 2024Current therapies for multiple sclerosis (MS) often have limited efficacy and side effects, necessitating alternative approaches. Noninvasive brain stimulation (NIBS),...
Current therapies for multiple sclerosis (MS) often have limited efficacy and side effects, necessitating alternative approaches. Noninvasive brain stimulation (NIBS), such as transcranial direct current stimulation and transcranial magnetic stimulation (TMS), offers potential solutions. Among NIBS techniques, theta burst stimulation (TBS) is notable for its ability to modulate cortical activity. The objective of this systematic review is to assess the impact of TBS on MS symptoms. The study conducted rigorous systematic searches in PubMed, Google Scholar, and Scopus databases up to June 2023, using specific Medical Subject Headings terms related to NIBS and MS, such as TMS and TBS, in conjunction with terms like MS or demyelinating disease. Additionally, the bibliographic references of included studies, book chapters, and original articles were manually reviewed. The study selection process involved a 2-tiered screening mechanism, beginning with an evaluation of titles and abstracts, followed by a full-text review of selected articles. Inclusion criteria incorporated randomized controlled trials (RCTs) focusing on TBS with MS patients. Exclusion criteria included non-qualitative, non-MS, and non-TBS studies. Risk of bias assessment was conducted using the 2008 Cochrane Risk of Bias 2 Scale for RCTs. Data extraction was conducted by thoroughly reviewing each research article and systematically recording the relevant information using a standardized data extraction form, ensuring consistency and accuracy throughout the process. In a systematic review encompassing 5 randomized controlled trials involving 117 individuals with relapsing-remitting or secondary progressive MS across Italy, France, and Russia, various forms of TBS were applied. These interventions ranged from intermittent TBS (iTBS) to continuous intermittent TBS (c-iTBS) that demonstrated favorable outcomes. Notably, TBS interventions led to significant reductions in spasticity, fatigue, and pain, with c-iTBS combined with vestibular rehabilitation showing additional improvements in vestibular-ocular reflexes, gait, and balance. While specific protocols varied among the studies, collectively, the results suggest promise for TBS approaches in alleviating MS-related symptoms. The findings of this review suggest that TBS may hold promise in addressing specific MS symptoms, notably fatigue and spasticity. Future research should include a more diverse participant pool to explore TBS effects across different MS subtypes and aim for larger sample sizes to enhance statistical power and result reliability. .
Topics: Humans; Multiple Sclerosis; Transcranial Magnetic Stimulation; Theta Rhythm
PubMed: 38684013
DOI: 10.4088/PCC.23r03645 -
Multiple Sclerosis and Related Disorders Jul 2024Although many people with MS (pwMS) modify their diet after diagnosis, there is still no consensus on dietary recommendations for pwMS. A number of observational studies...
BACKGROUND
Although many people with MS (pwMS) modify their diet after diagnosis, there is still no consensus on dietary recommendations for pwMS. A number of observational studies have explored associations of diet and MS progression, but no studies have systematically reviewed the evidence. This systematic review aimed to provide an objective synthesis of the evidence for associations between diet and MS progression, including symptoms and clinical outcomes from observational studies.
METHODS
We performed a systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Electronic database searches were performed for studies completed up to 26 July 2023 using PubMed (Medline), Web of Science, CINAHL, Embase (Ovid), and Scopus, followed by citation and reference list checking. We included studies using diet quality scores or dietary indices. Studies assessing individual foods, nutrients, or dietary supplements were excluded. We used the Newcastle-Ottawa Scale to assess the risk of bias of included studies.
RESULTS
Thirty-two studies met the inclusion criteria. Of these, 20 were cross-sectional and 12 prospective. The most frequent outcomes assessed were disability (n = 19), quality of life (n = 12), fatigue (n = 12), depression (n = 9), relapse (n = 8), anxiety (n = 3), and magnetic resonance imaging (MRI) outcomes (n = 4). Based on prospective studies, this review suggests that diet might be associated with quality of life and disability. There were also potential effects of higher diet quality scores on improved fatigue, disability, depression, anxiety, and MRI outcomes but more evidence is needed from prospective studies.
CONCLUSIONS
Observational studies show some evidence for an association between diet and MS symptoms, particularly quality of life and disability. However, the impact of diet on other MS outcomes remains inconclusive. Ultimately, our findings suggest more evidence is needed from prospective studies and well-designed tailored intervention studies to confirm associations.
Topics: Humans; Diet; Disease Progression; Multiple Sclerosis; Observational Studies as Topic
PubMed: 38678968
DOI: 10.1016/j.msard.2024.105636 -
Frontiers in Public Health 2024A growing body of studies have examined the effect of exercise in people with multiple sclerosis (MS), while findings of available studies were conflicting. This... (Meta-Analysis)
Meta-Analysis
BACKGROUND
A growing body of studies have examined the effect of exercise in people with multiple sclerosis (MS), while findings of available studies were conflicting. This meta-analysis aimed to explore the effects of exercise on balance, walking ability, walking endurance, fatigue, and quality of life in people with MS.
METHODS
We searched PubMed, Web of Science, Scopus, and Cochrane databases, through March 1, 2024. Inclusion criteria were: (1) RCTs; (2) included an intervention and control group; (3) had people with MS as study subjects; (4) had balance, walking ability, walking endurance, fatigue, or quality of life as the outcome measures. Exclusion criteria were: (1) non-English publications; (2) animal model publications; (3) review articles; and (4) conference articles. A meta-analysis was conducted to calculate weighted mean difference (WMD) and 95% confidence interval (CI). Cochrane risk assessment tool and Physiotherapy Evidence Database (PEDro) scale were used to evaluate the methodological quality of the included studies.
RESULTS
Forty studies with a total of 56 exercise groups ( = 1,300) and 40 control groups ( = 827) were eligible for meta-analysis. Exercise significantly improved BBS (WMD, 3.77; 95% CI, 3.01 to 4.53, < 0.00001), TUG (WMD, -1.33; 95% CI, -1.57 to -1.08, < 0.00001), MSWS-12 (WMD, -2.57; 95% CI, -3.99 to -1.15, = 0.0004), 6MWT (WMD, 25.56; 95% CI, 16.34 to 34.79, < 0.00001), fatigue (WMD, -4.34; 95% CI, -5.83 to -2.84, < 0.00001), and MSQOL-54 in people with MS (WMD, 11.80; 95% CI, 5.70 to 17.90, = 0.0002) in people with MS. Subgroup analyses showed that aerobic exercise, resistance exercise, and multicomponent training were all effective in improving fatigue in people with MS, with resistance exercise being the most effective intervention type. In addition, a younger age was associated with a larger improvement in fatigue. Furthermore, aerobic exercise and multicomponent training were all effective in improving quality of life in people with MS, with aerobic exercise being the most effective intervention type.
CONCLUSION
Exercise had beneficial effects in improving balance, walking ability, walking endurance, fatigue, and quality of life in people with MS. Resistance exercise and aerobic exercise are the most effective interventions for improving fatigue and quality of life in people with MS, respectively. The effect of exercise on improving fatigue was associated with the age of the participants, with the younger age of the participants, the greater the improvement in fatigue.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=371056, identifier: CRD42022371056.
Topics: Humans; Multiple Sclerosis; Quality of Life; Fatigue; Exercise Therapy; Walking; Exercise; Postural Balance
PubMed: 38660348
DOI: 10.3389/fpubh.2024.1387658