Publications by authors named "Maria Giovanna Marrosu"

145 Publications

mutation alters immune system activation, inflammation, and risk of autoimmunity.

Mult Scler 2020 Oct 14:1352458520963937. Epub 2020 Oct 14.

Istituto di Ricerca Genetica e Biomedica (IRGB), Consiglio Nazionale delle Ricerche (CNR), Cittadella Universitaria di Monserrato, Monserrato, Italy.

Background: Defective alleles within the gene, encoding the pore-forming protein perforin, in combination with environmental factors, cause familial type 2 hemophagocytic lymphohistiocytosis (FHL2), a rare, severe autosomal recessive childhood disorder characterized by massive release of cytokines-cytokine storm.

Objective: The aim of this study was to determine the function of hypomorph g.72360387 G > A on multiple sclerosis (MS) and type 1 diabetes (T1D).

Methods: We cross-compare the association data for mutation derived from GWAS on adult MS and pediatric T1D in Sardinians. The novel association with T1D was replicated in metanalysis in 12,584 cases and 17,692 controls from Sardinia, the United Kingdom, and Scotland. To dissect this mutation function, we searched through the coincident association immunophenotypes in additional set of general population Sardinians.

Results: We report that , is associated with increase of lymphocyte levels, especially within the cytotoxic memory T-cells, at general population level with reduced interleukin 7 receptor expression on these cells. The minor allele increased risk of MS, in 2903 cases and 2880 controls from Sardinia  = 2.06 × 10, odds ratio OR = 1.29, replicating a previous finding, whereas it protects from T1D  = 1.04 × 10, OR = 0.82.

Conclusion: Our results indicate opposing contributions of the cytotoxic T-cell compartment to MS and T1D pathogenesis.
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http://dx.doi.org/10.1177/1352458520963937DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8044257PMC
October 2020

Multi-Platform Characterization of Cerebrospinal Fluid and Serum Metabolome of Patients Affected by Relapsing-Remitting and Primary Progressive Multiple Sclerosis.

J Clin Med 2020 Mar 21;9(3). Epub 2020 Mar 21.

Department of Biomedical Sciences, Clinical Metabolomics Unit, University of Cagliari, 09121 Cagliari, Italy.

Background: Multiple sclerosis (MS) is a chronic immunemediated disease of the central nervous system with a highly variable clinical presentation and disease progression. In this study, we investigate the metabolomics profile of patients affected by relapsing-remitting MS (RRMS)and primary progressive MS (PPMS), in order to find potential biomarkers to distinguish between the two forms.

Methods: Cerebrospinal Fluid CSF and blood samples of 34 patients (RRMS = 22, PPMS = 12) were collected. Nuclear magnetic resonance (H-NMR) and mass spectrometry (coupled with a gas chromatography and liquid chromatography) were used as analytical techniques. Subsequently, a multivariate statistical analysis was performed; the resulting significant variables underwent U-Mann-Whitney test and correction for multiple comparisons. Receiver Operating Characteristic ROC curves were built and the pathways analysis was conducted.

Results: The analysis of the serum and the CSF of the two classes, allowed the identification of several altered metabolites (lipids, biogenic amines, and amino acids). The pathways analysis indicated the following pathways were affected: Glutathione metabolism, nitrogen metabolism, glutamine-glutamate metabolism, arginine-ornithine metabolism, phenylalanine, tyrosine and tryptophan biosynthesis etc. Conclusion: The analysis allowed the identification of a set of metabolites able to classify RRMS and PPMS patients, each of whom express different patterns of metabolites in the two biofluids.
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http://dx.doi.org/10.3390/jcm9030863DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7141510PMC
March 2020

The impact of modifiable risk factors on lesion burden in patients with early multiple sclerosis.

Mult Scler Relat Disord 2019 Dec 9;39:101886. Epub 2019 Dec 9.

MS Centre, Department of Medical Sciences and Public Health, University of Cagliari, Italy.

Introduction: Some studies have indicated the importance of considering smoking, vitamin D deficiency and obesity as negative prognostic factors for clinical and MRI outcomes in multiple sclerosis (MS). This study aimed to evaluate the possible effects of these modifiable risk factors on brain MRI lesion burden of patients with early MS, also exploring the influence on initial clinical features.

Methods: MS patients were enrolled at diagnosis time and examined for smoking, body mass index (BMI), serum level of lipids and 25(OH) vitamin D. Brain MRIs' were acquired and lesion volume assessed by Jim software. Clinical data (disease course, disease duration, and EDSS score) were also collected.

Results: 64 patients were enrolled, of these 4 (6.2%) had a primary progressive course. Mean age was 39.8 ± 11.1 years and mean EDSS 1.5 ± 1.1. Forty (62.5%) patients were smokers and 40 (62.5%) were overweight (BMI>25). Insufficient levels of vitamin D (<20 ng/mL) were reported in 36 (56.2%) patients, while 24 (37.5%) patients had an altered lipid profile with total cholesterol >200 mg/dl and LDL >100 mg/dl. No association between early clinical features and modifiable risk factors were reported. Multiple regression analysis showed an association between lesion burden and smoking status (p 0.003), while no association was reported with BMI, altered lipid profile and vitamin D insufficiency.

Conclusions: Several risk factors may play a role in evolution of MS. Our results show that smoking status, probably due to chronic vascular and neurotoxic effects of the cigarette components, can affect the brain damage from the early stages of MS. No association was observed with the other explored modifiable risk factors, although an effect due to the small sample size cannot be excluded.
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http://dx.doi.org/10.1016/j.msard.2019.101886DOI Listing
December 2019

Assessing the Metabolomic Profile of Multiple Sclerosis Patients Treated with Interferon Beta 1a by H-NMR Spectroscopy.

Neurotherapeutics 2019 07;16(3):797-807

Multiple Sclerosis Centre, Department of Medical Sciences and Public Health, Binaghi Hospital, University of Cagliari, via Is Guadazzonis 2, 09126, Cagliari, Italy.

Metabolomic research has emerged as a promising approach to identify potential biomarkers in multiple sclerosis (MS). The aim of the present study was to determine the effect of interferon beta (IFN ß) on the metabolome of MS patients to explore possible biomarkers of disease activity and therapeutic response. Twenty-one MS patients starting IFN ß therapy (Rebif® 44 μg; s.c. 3 times per week) were enrolled. Blood samples were obtained at baseline and after 6, 12, and 24 months of IFN ß treatment and were analyzed by high-resolution nuclear magnetic resonance spectroscopy. Changes in metabolites were analyzed. After IFN ß exposure, patients  were divided into responders and nonresponders according to the "no evidence of disease activity" (NEDA-3) definition (absence of relapses, disability progression, and magnetic resonance imaging activity), and samples obtained at baseline were analyzed to evaluate the presence of metabolic differences predictive of IFN ß response. The results of the investigation demonstrated differential distribution of baseline samples compared to those obtained during IFN ß exposure, particularly after 24 months of treatment (RX = 0.812, RY = 0.797, Q = 0.613, p = 0.003). In addition, differences in the baseline metabolome between responder and nonresponder patients with respect to lactate, acetone, 3-OH-butyrate, tryptophan, citrate, lysine, and glucose levels were found (RX = 0.442, RY = 0.768, Q = 0.532, p = 0.01). In conclusion, a metabolomic approach appears to be a promising, noninvasive tool that could potentially contribute to predicting the efficacy of MS therapies.
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http://dx.doi.org/10.1007/s13311-019-00721-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6694336PMC
July 2019

Correction to: The Italian multiple sclerosis register.

Neurol Sci 2019 Apr;40(4):907

Italian Multiple Sclerosis Foundation, Via Operai 40, Genoa, Italy.

Unfortunately in the original publication, the affiliation of the author Maria Pia Amato was incorrect. The author inadvertently missed out to include her second affiliation.
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http://dx.doi.org/10.1007/s10072-019-03772-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6828204PMC
April 2019

The Italian multiple sclerosis register.

Neurol Sci 2019 Jan 13;40(1):155-165. Epub 2018 Nov 13.

Italian Multiple Sclerosis Foundation, Via Operai 40, Genoa, Italy.

The past decade has seen extraordinary increase in worldwide availability of and access to several large multiple sclerosis (MS) databases and registries. MS registries represent powerful tools to provide meaningful information on the burden, natural history, and long-term safety and effectiveness of treatments. Moreover, patients, physicians, industry, and policy makers have an active interest in real-world observational studies based on register data, as they have the potential to answer the questions that are most relevant to daily treatment decision-making. In 2014, the Italian MS Foundation, in collaboration with the Italian MS clinical centers, promoted and funded the creation of the Italian MS Register, a project in continuity with the existing Italian MS Database Network set up from 2001. Main objective of the Italian MS Register is to create an organized multicenter structure to collect data of all MS patients for better defining the disease epidemiology, improving quality of care, and promoting research projects in high-priority areas. The aim of this article is to present the current framework and network of the Italian MS register, including the methodology used to improve the quality of data collection and to facilitate the exchange of data and the collaboration among national and international groups.
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http://dx.doi.org/10.1007/s10072-018-3610-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6329744PMC
January 2019

Quantifying gait impairment in individuals affected by Charcot-Marie-Tooth disease: the usefulness of gait profile score and gait variable score.

Disabil Rehabil 2020 03 18;42(5):737-742. Epub 2018 Oct 18.

Centro Sclerosi Multipla, Department of Medical Science and Public Health, University of Cagliari, Cagliari, Italy.

Gait analysis is a reliable tool to characterise ambulation in Charcot-Marie-Tooth, the obtained are complex data makes its use scarce in clinical practice. The use of synthetic measures may enable the clinician to easily interpret gait kinematics in Charcot-Marie-Tooth. To test the usefulness of Gait Profile Score as a method to quantify and monitor kinematic gait alterations in Charcot-Marie-Tooth. A group of patients with Charcot-Marie-Tooth and a control group underwent Gait Analysis. Neurological impairment was evaluated by means of the Charcot Marie Tooth neuropathy score in his original form and in the Rasch Analysis revised form. Differences in Kinematics scores induced by the pathology were assessed using the Mann-Whitney U test. The relationship between gait parameters and Charcot Marie Tooth neuropathy score was assessed by means of the Spearman correlation. Twenty patients were enrolled. Mann-Whitney U test revealed a significant effect of the pathology on Gait Profile Score (p < 0.001). Charcot Marie Tooth neuropathy score was positively correlated with Gait Profile Score (Rho = 0.708, p = 0.001). Gait profile score can differentiate Charcot Marie Tooth from unaffected people and to quantify ambulation impairment, also identifying the joints more affected by the disease.Implications for rehabilitationPhysiotherapy and orthotics constitute the sole possible clinical approach for Charcot Marie Tooth, but the clinical scales are scarcely effective for assessing the rehabilitative outcome.Synthetic measures are able to summarize Charcot Marie tooth kinematics in a single score, and Gait Profile Score is able to differentiate patients with Charcot Marie tooth from healthy controls.Gait Profile Score is related to clinical disability as measured by the Charcot Marie tooth neuropathy score.
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http://dx.doi.org/10.1080/09638288.2018.1506946DOI Listing
March 2020

A multicentric pharmacovigilance study: collection and analysis of adverse drug reactions in relapsing-remitting multiple sclerosis patients.

Ther Clin Risk Manag 2018 26;14:1765-1788. Epub 2018 Sep 26.

Department of Experimental Neurology, IRCCS Centro Neurolesi "Bonino Pulejo", Messina, Italy,

Purpose: We performed a pharmacovigilance study of 10 drugs used in patients with relapsing-remitting multiple sclerosis (RR-MS). Our aim was to provide an overview of the safety of these drugs by the evaluation of reported expected and unexpected adverse reactions.

Patients And Methods: We collected and analyzed adverse drug reactions from RR-MS patients belonging to four hospitals in three Italian regions, for a period of 24 months.

Results: We received a total of 411 adverse reactions, of which 84.18% were expected and only 15.82% were unexpected. We found no correlation between the number of reported adverse reactions and the route of administration (injectable/intravenous drugs N=224, oral drugs N=187). However, oral agents have caused a greater number of unexpected moderate-to-severe adverse reactions while, in injectable and infusion therapies, they have been evaluated as mild-moderate adverse reactions.

Conclusion: Our results underscore the importance of monitoring the safety profile of multiple sclerosis therapies, with particular attention to oral agents that have been introduced later in the clinical practice.
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http://dx.doi.org/10.2147/TCRM.S174864DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6165854PMC
September 2018

Association between brain atrophy and cognitive motor interference in multiple sclerosis.

Mult Scler Relat Disord 2018 Oct 31;25:208-211. Epub 2018 Jul 31.

Multiple Sclerosis Center, Department of Medical Science and Public Health, University of Cagliari, Via Is Guadazzonis 2, Cagliari 09126, Italy.

Introduction: Cognitive motor interference (CMI) is performance impairment due to simultaneuous task execution and is measured using the dual task cost (DTC). No pathological feature of MS has to date been associated with CMI.

Aim: To assess the relationship between brain volumes and CMI, as measured using the DTC, in a cross-sectional study.

Methods: A group of persons with MS (pwMS) and an age- and sex-matched healthy control (HC) group underwent 3D gait analysis during using the dual task paradigm. Brain volumes were measured on T1-weighted gradient echo scans using SIENAX software. The relationships between brain volumes and the DTCs of spatial temporal parameters were evaluated using Pearson correlation. A multiple regression model was used to evaluate the ability to predict the DTC of cadence based on brain volume and grey matter (GM) volume.

Results: Forty-four patients and 16 HCs underwent MRI and gait analysis. The mean expanded disability status scale (EDSS) was 2.4 ± 1.5. Significant relationships between brain volumes and DTC were found only in the pwMS group, with higher rho scores for the DTC of mean velocity, DTC of cadence, and DTC of stride time. A statistically significant regression equation with an R value of 0.684 was found using GM and Z-score on the Stroop test as predictors of the DTC of cadence (p < 0.001).

Conclusion: Brain atrophy, especially than in the GM, is a major determinant of DTC, although other pathological markers also contribute to CMI in patients with MS.
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http://dx.doi.org/10.1016/j.msard.2018.07.045DOI Listing
October 2018

Does focal inflammation have an impact on cognition in multiple sclerosis? An MRI study.

Mult Scler Relat Disord 2018 Jul 16;23:83-87. Epub 2018 May 16.

Multiple Sclerosis Centre, Binaghi Hospital, Department of medical sciences and public health, University of Cagliari, Cagliari, 09126, Italy.

Objective: Cognitive impairment concerns a significant percentage of patients with multiple sclerosis (MS). A transient impairment of cognition with a simultaneous presence of non-symptomatic gadolinium (Gd)-enhancing lesions in patients with MS was previously described. Our study aimed to evaluate modifications in cognitive function before and after the occurrence of asymptomatic MRI gadolinium (Gd)-enhancing lesions in relapsing MS patients.

Patients And Methods: All patients underwent a neuropsychological evaluation before (30-60 days) and after (30-60 days) brain MRI with Gd administration. Patients were classified as Gd positive (presence of enhancing-lesions) and Gd negative (absence of enhancing-lesions). We also recruited a healthy controls group underwent to the same neuropsychological assessment for two times with the same timing of MS patients.

Results: We included 84 relapsing-remitting patients and 40 healthy controls. Brain MRI results showed that 14/84 (16.7%) patients had asymptomatic Gd-enhancing-lesion. No significant variation in cognitive performance between baseline and follow-up was observed in patients with or without MRI-enhancing lesions. However, an increase between baseline and follow-up was observed in the mean scores of the Symbol Digit Modality Test (41.9 at baseline versus 46.7 at follow-up, p :< 0.001). This increase was significantly lower in Gd positive patients compared to Gd negative patients (mean increase 1.1 in Gd positive versus 4.9 in Gd negative, p: < 0.001) and to healthy controls groups (mean increase 7.2; p < 0.001) CONCLUSIONS: In our study, the absence of a practice effect in Gd positive compared to Gd negative patients and to healthy controls suggests a possible role of focal inflammation on cognitive function of MS patients.
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http://dx.doi.org/10.1016/j.msard.2018.05.012DOI Listing
July 2018

A cross-sectional and longitudinal study evaluating brain volumes, RNFL, and cognitive functions in MS patients and healthy controls.

BMC Neurol 2018 May 11;18(1):67. Epub 2018 May 11.

Multiple Sclerosis Center Binaghi Hospital, Department of Medical Sciences and Public Health, University of Cagliari, via Is Guadazzonis 2, 09126, Cagliari, Italy.

Background: The principal biomarker of neurodegeneration in multiple sclerosis (MS) is believed to be brain volume, which is associated with cognitive functions and retinal nerve fibre layer (RNFL). A cross-sectional and longitudinal assessment of the relationship between RNFL, cognitive functions and brain volume.

Methods: At baseline, relapsing patients and healthy controls underwent 1.5 T MRI to estimate the normalized volume of brain (NBV), grey (NGV), white (NWV) and peripheral grey (pNGV) matter. Cognitive functions were evaluated by BICAMS, RNFL by Spectral-Domain OCT. Patients were re-evaluated after 12 months.

Results: Cognitive functions, brain volume, and RNFL differed between the group of 66 patients and that of 16 healthy controls. In the MS group, at baseline, an association was found between: p-NGV and symbol-digit (SDMT) (p = 0.022); temporal-RNFL and NBV (p = 0.007), NWV (p = 0.012), NGV (p = 0.048), and p-NGV (p = 0.021); papillo-macular bundle-RNFL and NBV (p = 0.013), NWV (p = 0.02), NGV (p = 0.049), and p-NGV (p = 0.032). Over the observational period, we found a reduction of brain volume (p < 0.001), average-RNFL (p = 0.001), temporal-RNFL (p = 0.006), and papillo-macular bundle-RNFL (p = 0.009). No association was found between OCT, MRI, and cognitive changes.

Conclusions: Brain volume, cognitive functions, and RNFL are continuous measures of different neurodegenerative aspects. BICAMS and OCT have low costs and can be easily used in clinical practice to monitor neurodegeneration.
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http://dx.doi.org/10.1186/s12883-018-1065-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5946463PMC
May 2018

Fatigue, as measured using the Modified Fatigue Impact Scale, is a predictor of processing speed improvement induced by exercise in patients with multiple sclerosis: data from a randomized controlled trial.

J Neurol 2018 Jun 24;265(6):1328-1333. Epub 2018 Mar 24.

Department of Medical Sciences and Public Health, Multiple Sclerosis Center, University of Cagliari, Cagliari, Italy.

Background: Few studies have evaluated the impact of physical activity (PA) on cognition and fatigue, and none have considered the effects of PA on the relationship between cognition and fatigue.

Objectives: We evaluated the effect of PA in people with multiple sclerosis (pwMS) in a 6-month-long single-blind randomized controlled trial. We focused on the impact of exercise on cognition, fatigue, and the relationship between cognition and fatigue.

Methods: We recruited pwMS, who were then randomly assigned 1:1 to either a PA protocol group or a control group (CG). All patients underwent assessments using the Brief International Cognitive Assessment for Multiple Sclerosis including symbol digit modality test (SDMT), Berg Balance Scale (BBS), gait analysis, 6-Minute Walk Test, Timed Up and Go (TUG) test, and the Modified Fatigue Impact Scale (MFIS) at the beginning of the study (T0), at the end of the study (EOS) 24 weeks after T0, and at 24 weeks following the EOS (FU).

Results: A Wilcoxon test revealed a significant effect of exercise in the PA group, but not in the CG. Significant differences between T0 and EOS were found in the spatiotemporal parameters of gait, and performance on the SDMT, TUG, BBS, and MFIS. These differences were also present during the FU period. A regression model revealed that the baseline MFIS score predicted processing speed improvement (R = 0.65, p < 0.01), as the SDMT T score increased by 0.3 for each one-unit increase in the MFIS score at T0.

Conclusion: PA affects multiple aspects of the pathology in pwMS. Patients with greater fatigue must not be discouraged from exercise, as they may greatly benefit from PA. Specifically, PA was shown to improve information processing speed.
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http://dx.doi.org/10.1007/s00415-018-8836-5DOI Listing
June 2018

Autoimmune comorbidities in multiple sclerosis: what is the influence on brain volumes? A case-control MRI study.

J Neurol 2018 May 5;265(5):1096-1101. Epub 2018 Mar 5.

Department of Medical Sciences and Public Health, Multiple Sclerosis Center, Binaghi Hospital, ATS Sardegna, University of Cagliari, via Is Guadazzonis 2, 09126, Cagliari, Italy.

Background: Several studies indicated that multiple sclerosis (MS) is frequently associated with other autoimmune diseases. However, it is little known if the coexistence of these conditions may influence the radiologic features of MS, and in particular the brain volumes.

Objectives: To evaluate the effect of autoimmune comorbidities on brain atrophy in a large case-control MS population.

Methods: A group of MS patients affected by a second autoimmune disorder, and a control MS group without any comorbidity, were recruited. Patients underwent a brain MRI and volumes of whole brain (WB), white matter (WM), and gray matter (GM) with cortical GM were estimated by SIENAX.

Results: The sample included 286 MS patients, of which 30 (10.5%) subjects with type 1 diabetes (T1D), 53 (18.5%) with autoimmune thyroiditis (AT) and 4 (0.1%) with celiac disease. Multiple regression analysis found an association between T1D and lower GM (p = 0.038) and cortical GM (p = 0.036) volumes, independent from MS clinical features and related to T1D duration (p < 0.01), while no association was observed with AT and celiac disease.

Conclusions: Our data support the importance of considering T1D as possible factors influencing the brain atrophy in MS. Further studies are needed to confirm our data and to clarify the underlying mechanisms.
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http://dx.doi.org/10.1007/s00415-018-8811-1DOI Listing
May 2018

Exploring cognitive motor interference in multiple sclerosis by the visual Stroop test.

Mult Scler Relat Disord 2018 May 24;22:8-11. Epub 2018 Feb 24.

Department of Mechanical, Chemical and Materials Engineering, University of Cagliari, Cagliari, Italy. Electronic address:

Background: The dual task paradigm (the simultaneous performance of motor and cognitive task) is used in a laboratory setting to evaluate walking impairments that affect patients' daily lives. Although promising, it is poorly standardized and neither the cognitive task nor the motor task have been validated in a matched healthy control group (HC) for multiple sclerosis (MS).

Objective: Our aim was to set up a standardized instrument to evaluate cognitive motor interference in MS using the interference test par excellence: the stroop colour word test (SCWT).

Methods: Patients with MS and HC underwent 3D gait analysis with a dual task protocol, using the SCWT as a cognitive task. Gait performance impairment during the dual task was evaluated by dual task cost (DTC). A MANOVA was used to verify the effect of status (MS, HC) on DTC, calculated for the spatiotemporal parameter of the gait.

Results: In MS, the DTC was higher for the following gait parameters: speed (p = .013), cadence (p = .004), stride time (p = .005) stance phase (p < .001), and swing phase duration (p = .032).

Conclusion: DTC is present in MS and HC, but the motor cost in MS is higher. The present work provides a useful and validated basis for future studies about cognitive motor interference in MS.
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http://dx.doi.org/10.1016/j.msard.2018.02.026DOI Listing
May 2018

Pregnancy decision-making in women with multiple sclerosis treated with natalizumab: I: Fetal risks.

Neurology 2018 03 7;90(10):e823-e831. Epub 2018 Feb 7.

From IRCCS Don Gnocchi Foundation (E.P.), Florence; Multiple Sclerosis Study Center (P.A., A.G., M.Z.), ASST Valle Olona, Gallarate Hospital (VA); Scientific Institute University Vita-Salute San Raffaele (L.M., V.M., G.C.), Milan; Department of Neurosciences, Reproductive and Odontostomatological Sciences (R.L., V.B.M.), Federico II University of Naples; Department of Neurosciences (F.R., P.G.), Multiple Sclerosis Centre-Veneto Region (CeSMuV), University Hospital of Padova; Department of Neurology (C.T., D.P., M.T.), University of Bari; Department of Neurology and Psychiatry (C.P., L.D.G.), "La Sapienza" University, Rome; Department of Neurology (P.C.), University of Torino; Department of Medical Sciences and Public Health (E.C., M.G.M.), University of Cagliari; Department of Neurology (F.P.), University of Catania; Department of Neurology (C.S.), ASL3 Genovese; Multiple Sclerosis Center (P.B.), IRCCS Neuromed, Pozzilli; Department of Neurology (A.U., A.L.), University of Genova; and Department of NEUROFARBA (L.P., M.G., M.P.A.), University of Florence, Italy.

Objective: To assess fetal risk after pregnancy exposure to natalizumab in women with multiple sclerosis (MS), with a specific focus on spontaneous abortion (SA) and congenital anomalies (CA).

Methods: Data of all pregnancies occurring between 2009 and 2015 in patients with MS treated with natalizumab and referring to 19 participating sites were collected and compared with those of pregnancies in untreated patients and patients treated with injectable immunomodulatory agents. Rates of SA and CA were also compared with those reported in the Italian population. Multivariable logistic and linear regression models were performed.

Results: A total of 92 pregnancies were tracked in 83 women. In the multivariable analysis, natalizumab exposure was associated with SA (odds ratio [OR] 3.9, 95% confidence interval [CI] 1.9-8.5, < 0.001). However, the rate of SA (17.4%) was within the estimates for the general population, as well as the rate of major CA (3.7%). Moreover, exposure to natalizumab and interferon-β (IFN-β) was associated with lower length and weight of the babies ( < 0.001).

Conclusion: Our results showed that natalizumab exposure to up 12 weeks of gestation is associated with an increased risk of SA, although within the limits expected in the general population, whereas the risk of CA needs further investigation. Taking into account the high risk of disease reactivation after natalizumab suspension, pregnancy could be planned continuing natalizumab while strictly monitoring conception.

Classification Of Evidence: This study provides Class III evidence that in women with MS, natalizumab exposure increases the risk of spontaneous abortion as compared to IFN-β-exposed or untreated patients (OR 3.9, 95% CI 1.9-8.5).
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http://dx.doi.org/10.1212/WNL.0000000000005067DOI Listing
March 2018

Pregnancy decision-making in women with multiple sclerosis treated with natalizumab: II: Maternal risks.

Neurology 2018 03 7;90(10):e832-e839. Epub 2018 Feb 7.

From IRCCS Don Gnocchi Foundation (E.P.), Florence; Scientific Institute University Vita-Salute San Raffaele (L.M., V.M., G.C.), Milan; Multiple Sclerosis Study Center (P.A., A.G., M.Z.), ASST Valle Olona, Gallarate Hospital (VA); Department of Neurosciences, Reproductive and Odontostomatological Sciences (R.L., V.B.M.), Federico II University of Naples; Department of Neurosciences (F.R., P.G.), Multiple Sclerosis Centre-Veneto Region (CeSMuV), University Hospital of Padova; Department of Neurology (C.T., D.P., M.T.), University of Bari; Department of Neurology and Psychiatry (C.P., L.D.G.), "La Sapienza" University, Rome; Department of Neurology (P.C.), University of Torino; Department of Medical Sciences and Public Health (E.C., M.G.M.), University of Cagliari; Department of Neurology (C.S.), ASL3 Genovese; Department of Neurology (A.U., A.L.), University of Genova; and Department of NEUROFARBA (L.P., M.G., M.P.A.), University of Florence, Italy.

Objective: To assess the risk of disease reactivation during pregnancy after natalizumab suspension in women with multiple sclerosis (MS).

Methods: Data of all pregnancies occurring between 2009 and 2015 in patients with MS treated with natalizumab and referring to 19 participating sites were collected and compared with those of pregnancies in untreated patients and patients treated with injectable immunomodulatory agents through a 2-factor repeated measures analysis. Predictors of disease activity were assessed through stepwise multivariable logistic regression models.

Results: A total of 92 pregnancies were tracked in 83 women receiving natalizumab. Among these pregnancies, 74 in 70 women resulted in live births, with a postpartum follow-up of at least 1 year, and were compared with 350 previously published pregnancies. Relapse rate during and after pregnancy was higher in women treated with natalizumab ( < 0.001). In multivariable analysis, longer natalizumab washout period was the only predictor of relapse occurrence during pregnancy ( = 0.001). Relapses in the postpartum year were related to relapses during pregnancy ( = 0.019) and early reintroduction of disease-modifying drugs (DMD; = 0.021). Disability progression occurred in 16.2% of patients and was reduced by early reintroduction of DMD ( = 0.024).

Conclusions: Taken as a whole, our findings indicate that the combination of avoiding natalizumab washout and the early resumption of DMD after delivery could be the best option in the perspective of maternal risk. This approach must take into account possible fetal risks that need to be discussed with the mother and require further investigation.

Classification Of Evidence: This study provides Class IV evidence that in women with MS, the risk of relapses during pregnancy is higher in those who had been using natalizumab as compared to those who had been using interferon-β or no treatment.
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http://dx.doi.org/10.1212/WNL.0000000000005068DOI Listing
March 2018

The impact of visible and invisible symptoms on employment status, work and social functioning in Multiple Sclerosis.

Work 2018 ;60(2):263-270

Department of Medical Sciences and Public Health, Multiple Sclerosis Centre, University of Cagliari, Sardinia, Italy.

Background: Frequently diagnosed in young adulthood, multiple sclerosis (MS) and several MS-related factors can influence patients' unemployment status and negatively affect work productivity and daily functioning.

Objective: We examined MS patients' employment status and evaluated clinical features influencing it. Furthermore, we investigated patients' burdens due to visible and invisible MS symptoms through their worsening daily functioning.

Methods: The study included outpatients affected by MS according to the 2010 McDonald criteria. The co-occurrence of invisible symptoms (fatigue, depression and apathy) was stated using validated, self-administered tools: Fatigue Severity Scale (FSS); Beck Depression Inventory-Second Edition (BDI-II); Apathy Evaluation Scale (AES). Impairment in daily functioning due to MS was assessed using the Work and Social Adjustment Scale (WSAS). Descriptive statistics, hierarchical regression analyses, Pearson's correlation, and the t-test were conducted.

Results: Of the 123 participants, 52 (42.3%) were unemployed. Results showed employment to be positively associated with higher education levels (p 0.01); female gender (p 0.03) and higher disability (p 0.02) showed negative associations with employment. No associations were found between employment and fatigue or clinically relevant depressive and apathetic symptoms. High correlations were found between WSAS score and Expanded Disability Status Scale score (r = 565, p < 0.001), BDI-II score (r = 588, p < 0.001), and FSS score (r = 545, p < 0.001).

Conclusion: Our study revealed physical disability's significance in determining MS patients' unemployment. Alternatively, invisible MS symptoms negatively affected principally patients' social lives. Therefore, programs should be designed to improve MS patients' work integration and daily activities.
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http://dx.doi.org/10.3233/WOR-182682DOI Listing
January 2019

Pulse steroid therapy in multiple sclerosis and mood changes: An exploratory prospective study.

Mult Scler Relat Disord 2018 Feb 31;20:104-108. Epub 2018 Jan 31.

Multiple Sclerosis Center, Binaghi Hospital, ATS Sardegna, Department of Medical Sciences and Public Health, University of Cagliari, via Is Guadazzonis, 2, 09126 Cagliari, Italy.

Background: Several reports suggest a higher risk of psychiatric disorders after high-dose corticosteroids (HDC), routinely used to treat clinical relapses in multiple sclerosis (MS). The present study aimed to examine the possible effect of HDC on mood in patients with MS and to determine the specific factors that influence mood changes.

Methods: The study included MS patients prior to receive HDC. The presence of depressive and bipolar symptoms was determined with the Beck Depression Inventory-Second Edition (BDI-II) and the Mood Disorder Questionnaire (MDQ). These assessments were made at three time points: prior to HDC initiation, after HDC completion, and 1 month after HDC.

Results: The study included 101 MS patients. At baseline, 32 (31.7%) patients had depressive symptoms (BDI-II scores ≥ 14) and 20 (19.8%) patients had bipolar symptoms (MDQ scores ≥ 7). While it was observed a reduction of BDI-II scores after HDC, an increase in MDQ score was found in patients with MDQ positivity at baseline, resulting associated with a higher number of HDC infusions (p 0.018).

Conclusions: Our results emphasize the importance of accurate screening for mood disorders in patients with MS prior to HDC initiation, and indicate that HDC should be used with caution in patients with MDQ positivity.
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http://dx.doi.org/10.1016/j.msard.2018.01.012DOI Listing
February 2018

Correction to: Management of pregnancy-related issues in multiple sclerosis patients: the need for an interdisciplinary approach.

Neurol Sci 2018 Feb;39(2):395

Department of Neurology, INSPE, San Raffaele Scientific Institute, Milan, Italy.

The original version contained a mistake. The authors have specified only in a few paragraphs that all the contents of the paper are meant for Copaxone but not for unbranded glatiramer acetate, Authors ask to add the specification of Copaxone or branded glatiramer acetate everytime.
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http://dx.doi.org/10.1007/s10072-017-3226-9DOI Listing
February 2018

Intrathecal oligoclonal bands synthesis in multiple sclerosis: is it always a prognostic factor?

J Neurol 2018 Feb 22;265(2):424-430. Epub 2017 Dec 22.

Multiple Sclerosis Center, Department of Medical Sciences and Public Health, University of Cagliari, Via Is Guadazzonis 2, 09126, Cagliari, Italy.

Background: Oligoclonal IgM (OCMB) and IgG (OCGB) bands were found to be associated with poor multiple sclerosis (MS) prognosis.

Objective: We aimed to evaluate the prognostic value of OCMB/OCGB in a cohort of Sardinian MS patients.

Materials And Methods: We recruited patients from the University of Cagliari. They underwent lumbar puncture for diagnostic purposes. Demographic and the following clinical data were recorded: clinical course; time to reach EDSS 3 and 6; EDSS at last follow-up; and MS treatments. The influence of gender, clinical course, age at onset, treatments, and OCGB/OCMB on reaching EDSS 3 was analysed using Cox regression. Kaplan-Meier curves were used to study the time to reach EDSS 3 considering OCMB/OCGB and therapies.

Results: The enrolled number of subjects was 503. The variables influencing the achievement of EDSS 3.0 were: male gender (p = 0.005); progressive course (p = 0.001); age at onset (p < 0.001); and disease-modifying drugs (p < 0.001). The OCGB/OCMB status was not significant. Kaplan-Meier analysis showed no difference in time to reach EDSS 3 for patients with and without OCGB or OCMB in both treated and non-treated groups.

Conclusion: Our study did not confirm the poor prognostic value of OCMB/OCGB. These results may be influenced by the peculiar genetic background associated with the risk of MS in Sardinians.
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http://dx.doi.org/10.1007/s00415-017-8716-4DOI Listing
February 2018

Long-term follow-up more than 10 years after HSCT: a monocentric experience.

J Neurol 2018 Feb 21;265(2):410-416. Epub 2017 Dec 21.

Department of Medical Sciences and Public Health, Multiple Sclerosis Center, ATS Sardegna, Ospedale Binaghi, University of Cagliari, Via Is Guadazzonis 2, 09126, Cagliari, Italy.

Background: Autologous hematopoietic stem cell transplantation (aHSCT) is used in aggressive relapsing and progressive multiple sclerosis (MS). The multicentre studies and case series reported have relatively short follow-up.

Aim: To evaluate long-term effect and safety of HSCT in MS.

Materials And Methods: Patients referred to the MS centre of Cagliari and undergoing HSCT were included. Variations in relapses and EDSS before and after HSCT were evaluated by Wilcoxon test. A descriptive analysis was made for other clinical data.

Results: Nine patients (female 6, males 3; 5 relapsing-remitting, 2 secondary progressive, 1 primary progressive, and 1 progressive relapsing) performed HSCT (1999-2006). The median follow-up was 11 years (11-18). Eight patients underwent aHSCT, seven using a low intensity conditioning regimen, and one an intermediate intensity. The primary progressive underwent allogeneic HSCT, due to onco hematological disease. The relapses number decreased in the 2 years following the procedure compared to the two preceding years (p = 0.041). New relapses or disease progressions were observed after a range of 7 (low intensity regimen)-118 (intermediate intensity) months. At last follow-up, the EDSS was stable in two patients, improved in two, and worse in five (maximum 2 EDSS in one patient). Six patients showed new lesions, and seven gadolinium-enhancing on brain MRI after a mean of 23.3 and 19.8 months, respectively. Two serious adverse events were reported: melanoma, and progressive multifocal leukoencephalopathy.

Conclusions And Discussion: Our results confirm in a long follow-up the efficacy of HSCT in reducing relapses and disability progression. The risk/benefit profile is better for intermediate intensity regimens.
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http://dx.doi.org/10.1007/s00415-017-8718-2DOI Listing
February 2018

PML in a person with multiple sclerosis: Is teriflunomide the felon?

Neurology 2018 01 6;90(2):83-85. Epub 2017 Dec 6.

From University of Cagliari (L.L., G.F., J.F., G.C., M.G.M., E.C.); IRCCS San Raffaele Hospital (S.G.), Milan; and Binaghi Hospital (M.A.B., F.C.), ATS Sardegna, Italy.

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http://dx.doi.org/10.1212/WNL.0000000000004804DOI Listing
January 2018

Multiple sclerosis and HLA genotypes: A possible influence on brain atrophy.

Mult Scler 2019 01 7;25(1):23-30. Epub 2017 Nov 7.

Multiple Sclerosis Center, Binaghi Hospital, ATS Sardegna, Cagliari, Italy/Department of Medical Science and Public Health, University of Cagliari, Cagliari, Italy.

Background: The strongest genetic determinant for multiple sclerosis (MS) is located at the human leukocyte antigen (HLA) class II DRB1 and DQB1 loci.

Objectives: To investigate the possible role of predisposing HLA genotypes in determining brain atrophy.

Methods: HLA genotypes were categorized as high risk (two predisposing haplotypes) or medium/low risk (one or no predisposing haplotypes). Patients underwent a brain magnetic resonance imaging (MRI) study and volumes of white matter (WM), gray matter (GM), and whole brain (WB) were estimated with SIENAX. Longitudinal atrophy was also assessed with SIENA.

Results: The study included 240 MS patients. In 51/240 (21%) subjects, a high-risk HLA genotype was observed, while medium- and low-risk HLA genotypes were 109/240 (45%) and 80/240 (34%), respectively. Multiple regression analysis found that the high-risk HLA genotype was associated with significant reduction in WB ( p = 0.02) and GM ( p = 0.03) volumes compared with the medium-/low-risk HLA genotypes, independently from MS clinical features. The longitudinal study included 60 patients and showed a brain volume loss of -0.79% in high-risk HLA genotype group versus -0.56% in low-risk HLA genotype.

Conclusion: Our results suggest an influence of HLA genotype on WB and GM atrophy. Further investigations are necessary to confirm these findings.
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http://dx.doi.org/10.1177/1352458517739989DOI Listing
January 2019

Smoothness of gait detects early alterations of walking in persons with multiple sclerosis without disability.

Gait Posture 2017 10 24;58:307-309. Epub 2017 Aug 24.

Multiple Sclerosis Centre, Department of Medical Sciences and Public Health University of Cagliari, Cagliari, Italy.

In people with Multiple Sclerosis (pwMS) with little or no signs of disability, early detection of walking impairments represents a challenging issue, as simple gait metrics (e.g. speed, cadence, stride length, etc.) may not significantly differ from those of healthy individuals. In this study, we aimed to assess the existence of possible differences in spatial-temporal parameters and smoothness of gait measures (assessed through Harmonic Ratio, HR) obtained from trunk accelerations between 50pwMS without disability (Expanded Disability Status Scale score =1) and 50 age-matched healthy controls. The results show no differences in terms of gait velocity, stride length, stance/swing and double support phases duration, while HR in the direction of motion was significantly lower in pwMS (2.92 vs. 3.67, p<0.001), thus indicating a less smooth gait. The study of trunk accelerations through calculation of HR represents a fast, non-intrusive technique that allows early identification of anomalies in gait patterns of pwMS in absence of disability.
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http://dx.doi.org/10.1016/j.gaitpost.2017.08.023DOI Listing
October 2017

Management of pregnancy-related issues in multiple sclerosis patients: the need for an interdisciplinary approach.

Neurol Sci 2017 Oct 2;38(10):1849-1858. Epub 2017 Aug 2.

Department of Neurology, INSPE, San Raffaele Scientific Institute, Milan, Italy.

Multiple sclerosis (MS) is a demyelinating and neurodegenerative disease of the central nervous system (CNS), most probably autoimmune in origin, usually occurring in young adults with a female/male prevalence of approximately 3:1. Women with MS in the reproductive age may face challenging issues in reconciling the desire for parenthood with their condition, owing to the possible influence both on the ongoing or planned treatment with the possible consequences on the disease course and on the potential negative effects of treatments on foetal and pregnancy outcomes. At MS diagnosis, timely counselling should promote informed parenthood, while disease evolution should be assessed before making therapeutic decisions. Current guidelines advise the discontinuation of any treatment during pregnancy, with possible exceptions for some treatments in patients with very active disease. Relapses decline during pregnancy but are more frequent during puerperium, when MS therapy should be promptly resumed in most of the cases. First-line immunomodulatory agents, such as interferon-β (IFN-β) and glatiramer acetate (GA), significantly reduce the post-partum risk of relapse. Due to substantial evidence of safety with the use of GA during pregnancy, a recent change in European marketing authorization removed the pregnancy contraindication for GA. This paper reports a consensus of Italian experts involved in MS management, including neurologists, gynaecologists and psychologists. This consensus, based on a review of the available scientific evidence, promoted an interdisciplinary approach to the management of pregnancy in MS women.
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http://dx.doi.org/10.1007/s10072-017-3081-8DOI Listing
October 2017

Localized pigmentation disorder after subcutaneous pegylated interferon beta-1a injection.

Mult Scler 2018 02 28;24(2):231-233. Epub 2017 Jul 28.

Multiple Sclerosis Center, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.

We report the case of a 42-year-old female patient who developed peculiar skin lesions due to subcutaneous polyethylene glycol (PEG) interferon beta-1a. The dermatological examination showed hypochromic macules that had coalesced into a 10-cm-diameter patch. On the abdomen injection sites, there was a greyish diffuse hyperpigmentation arranged irregularly in annular macules. Fungal infection, vitiligo and pityriasis alba were excluded. After 6 months, the lesions had worsened. This is the first case of localized pigmentation disorder reported with interferon beta, and while the clinical findings are not ascribable to vitiligo or interferon-related facial/mucosal hyperpigmentation, they may partially share the underlining mechanisms.
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http://dx.doi.org/10.1177/1352458517708465DOI Listing
February 2018

Metabolomic analysis identifies altered metabolic pathways in Multiple Sclerosis.

Int J Biochem Cell Biol 2017 12 16;93:148-155. Epub 2017 Jul 16.

Department of Biomedical Sciences, University of Cagliari, Italy. Electronic address:

Multiple sclerosis (MS) is a chronic, demyelinating disease that affects the central nervous system and is characterized by a complex pathogenesis and difficult management. The identification of new biomarkers would be clinically useful for more accurate diagnoses and disease monitoring. Metabolomics, the identification of small endogenous molecules, offers an instantaneous molecular snapshot of the MS phenotype. Here the metabolomic profiles (utilizing plasma from patients with MS) were characterized with a Gas cromatography-mass spectrometry-based platform followed by a multivariate statistical analysis and comparison with a healthy control (HC) population. The obtained partial least square discriminant analysis (PLS-DA) model identified and validated significant metabolic differences between individuals with MS and HC (R2X=0.223, R2Y=0.82, Q2=0.562; p<0.001). Among discriminant metabolites phosphate, fructose, myo-inositol, pyroglutamate, threonate, l-leucine, l-asparagine, l-ornithine, l-glutamine, and l-glutamate were correctly identified, and some resulted as unknown. A receiver operating characteristic (ROC) curve with AUC 0.84 (p=0.01; CI: 0.75-1) generated with the concentrations of the discriminant metabolites, supported the strength of the model. Pathway analysis indicated asparagine and citrulline biosynthesis as the main canonical pathways involved in MS. Changes in the citrulline biosynthesis pathway suggests the involvement of oxidative stress during neuronal damage. The results confirmed metabolomics as a useful approach to better understand the pathogenesis of MS and to provide new biomarkers for the disease to be used together with clinical data.
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http://dx.doi.org/10.1016/j.biocel.2017.07.004DOI Listing
December 2017

The burden of multiple sclerosis and patients' coping strategies.

BMJ Support Palliat Care 2018 Mar 24;8(1):38-40. Epub 2017 Jun 24.

Department of Medical Sciences and Public Health, Multiple Sclerosis Centre, University of Cagliari, Cagliari, Italy.

Objectives: Multiple sclerosis (MS) is a chronic disease that mainly affects young people. Patients with MS experience several emotional responses to changed perceptions of themselves and manage this situation in ways focused on controlling the overall burden of disease. This present study aimed to evaluate differences between patients with MS and healthy controls (HCs) in coping styles, identifying the MS clinical features that influence adaptive responses.

Methods: Patients with MS, according to the McDonald 2010 criteria, and HCs were recruited. Coping strategies were assessed using the Coping Orientation to the Problems Experienced (COPE-NVI; Italian version) questionnaire.

Results: A cohort of 135 patients with MS (female: 89/135, 65.9%) and 94 HCs (female: 64/94, 68%) were enrolled. Impaired was noted for MS group (p=0.005). In the MS group, the worsened with increasing disease duration (p=0.002) independently of the level of disability. Associations between a higher Expanded Disability Status Scale score and (p<0.01), as well between a and a previous depression diagnosis (p<0.001) were reported.

Conclusion: Our findings highlight the negative impact of MS on various aspects of patients' life. Therefore, psychosocial interventions are needed to increase adaptive coping mechanisms aimed to manage the burden of MS.
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http://dx.doi.org/10.1136/bmjspcare-2017-001324DOI Listing
March 2018

Are static and functional balance abilities related in individuals with Multiple Sclerosis?

Mult Scler Relat Disord 2017 Jul 11;15:1-6. Epub 2017 Apr 11.

Multiple Sclerosis Centre, Department of Medical Sciences and Public Health University of Cagliari, Cagliari, Italy.

Background: In people with Multiple Sclerosis (pwMS), balance assessment is essential in estimating the risk of falls, monitoring disease progression and verifying the effectiveness of rehabilitative treatment. Clinical tools and instrumental techniques are available for testing static and dynamic balance, but the relationship between such abilities is still not clear. Having information about this link would be important in properly planning the type and number of tests to administer.

Methods: One hundred and six pwMS (Expanded Disability Status Scale, EDSS 0-6.5) stratified in three sub-groups (Class 1 EDSS 0-1.5, Class 2 EDSS 2-4 and Class 3 EDSS 4.5-6.5) and 42 healthy controls (HC) participated in the study. All underwent static posturography and instrumented Timed-Up-and-Go (TUG) performed using a wearable inertial sensor. Raw data were processed to extract postural sway features, overall duration of TUG and its main sub-phases (i.e. sit-to-stand, 180° turns and stand-to-sit).

Results: All sway parameters of pwMS of Classes 2 and 3, as well as total TUG duration and time necessary to perform 180° turns, were found significantly higher than HC and Class 1 participants. However, poor correlations were found between sway and TUG parameters. When pwMS are grouped, small/moderate correlations (in the range 0.20-0.41) were found between all sway parameters and total TUG duration.

Conclusions: Static and dynamic balance in pwMS appear scarcely correlated, although both worsen as disability increases. This implies that they should be separately assessed using specific tests to have a complete view of postural control performance in MS.
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http://dx.doi.org/10.1016/j.msard.2017.04.002DOI Listing
July 2017