Study for the validation of the FeetMe® integrated sensor insole system compared to GAITRite® system to assess gait characteristics in patients with multiple sclerosis.

OBJECTIVE: To determine the concordance and statistical precision in gait velocity in people with multiple sclerosis (pwMS), measured with FeetMe® (insoles with pressure and motion sensors) compared with GAITRite® (classic reference system of gait analysis) in the timed 25-Feet Walk test (T25WT). METHODS: This observational, cross-sectional, prospective, single center study was conducted between September-2018 and April-2019 in pwMS aged 18-55 years, with Expanded Disability Status Scale (EDSS) 0-6.5 and relapse free ≥30 days at baseline. Primary endpoint was gait velocity. Secondary endpoints were ambulation time, cadence, and stride length assessment, while the correlation between gait variables and the clinical parameters of MS subjects was assessed as an exploratory endpoint. RESULTS: A total of 207 MS subjects were enrolled, of whom, 205 were considered in primary analysis. Most subjects were women (66.8%) and had relapsing-remitting MS (RRMS) (82.9%), with overall mean (standard deviation [SD]) age of 41.5 (8.0) year and EDSS 3.1 (2.0). There was a statistically significant (p<0.0001) and strong agreement (intra-class correlation coefficient (ICC) >0.830) in gait velocity, ambulation time and cadence assessment between FeetMe® and GAITRite®. CONCLUSIONS: Agreement between devices was strong (ICC≥0.800). FeetMe® is the first validated wearable medical device that allows gait monitoring in MS subjects, being potentially able to assess disease activity, progression, and treatment response.

Role of Inflammatory Cytokines in the Conversion of Mild Cognitive Impairment to Dementia: A Prospective Study.

BACKGROUND: The effect that cytokines can exert on the progression from mild cognitive impairment (MCI) to ongoing dementia is a matter of debate and the results obtained so far are controversial. OBJECTIVE: The aim of the study is to analyze the influence of markers of subclinical inflammation on the progression of MCI to dementia. METHODS: A prospective study involving a cohort of patients ≥ 65 years of age diagnosed with MCI and followed for 3 years was conducted. 105 patients were enrolled, and serum concentrations of several subclinical inflammatory markers were determined. RESULTS: After 3.09 (2 - 3.79) years of follow-up, 47 (44.76%) patients progressed to dementia. Alpha 1-antichymotrypsin (ACT) was found to be significantly higher in patients who progressed to dementia (486.45 ± 169.18 vs. 400.91 ± 163.03; p = 0.012), and observed to significantly increase the risk of developing dementia in patients with mild cognitive impairment (1.004, 1.001-1.007; p = 0.007). IL-10 levels were significantly higher in those who remained stable (6.69 ± 18.1 vs. 32.54 ± 89.6; p = 0.04). Regarding the type of dementia to which our patients progressed, we found that patients who developed mixed dementia had higher IL-4 levels than those who converted to AD (31.54 ± 63.6 vs. 4.43 ± 12.9; p = 0.03). No significant differences were observed between the groups with regard to the ESR and LPa, CRP, IL-1 and TNF-α levels. CONCLUSION: ACT levels have a significant predictive value in the conversion of MCI to dementia. IL-10 levels could be a protective factor. It is necessary to conduct studies with serial determinations of these and other inflammatory markers in order to determine their effect on the progression of MCI to dementia.

Effectiveness of Fingolimod versus Natalizumab as Second-Line Therapy for Relapsing-Remitting Multiple Sclerosis in Spain: Second-Line GATE Study.

BACKGROUND: There is a lack of head-to-head studies comparing the efficacy of fingolimod (FIN) and natalizumab (NTZ) as second-line therapy for relapsing-remitting multiple sclerosis (RRMS). METHODS: Multicenter, observational study, in which, information of 388 patients randomly selected and treated with FIN or NTZ in routine clinical practice was retrospectively collected with the main objective of comparing the annualized relapse rate (ARR) over the first year, after FIN or NTZ treatment initiation. RESULTS: Mean ARR during the first year of treatment was 0.28 in FIN group and 0.12 in NTZ group (p = 0.0064); nevertheless, the difference between groups lost statistical significance when the propensity score analysis was performed. Time to disability -progression was similar in both treatment groups (12.3 ± 6.7 months in FIN, and 12.8 ± 0.1 months in NTZ; p = 0.4654). Treatment persistence after the first year of treatment was higher in patients treated with FIN (95%) than in those treated with NTZ (84%; p = 0.0014). CONCLUSIONS: After 12 months of treatment, both FIN and NTZ reduced the ARR, but ARR percent reduction was significantly higher with NTZ. Treatment persistence was higher in patients receiving FIN.

Vascular Risk Factors and Lesions of Vascular Nature in Magnetic Resonance as Predictors of Progression to Dementia in Patients with Mild Cognitive Impairment.

BACKGROUND: Evidence of the effect of vascular risk factors and white matter lesions on the progression of mild cognitive impairment (MCI) to dementia is not conclusive. OBJECTIVE: The study aimed to analyze the impact of these factors on MCI progression to dementia from a global perspective. METHODS: Our study included a population of 105 patients with MCI. RESULTS: After a mean follow-up period of 3.09 years (range, 2-3.79), 47 patients (44.76%) progressed to dementia: 32 (30.8%) to mixed dementia, 13 (12.5%) to probable AD, and 2 (1.9%) to vascular dementia. Total cholesterol levels (OR: 1.015 [1.003-1.028]) and LDL cholesterol levels (OR: 1.018 [1.004-1.032]) increased the risk of progression to dementia. Cystatin C was a protective factor against progression to dementia (OR: 0.119 [0.015-0.944], p = 0.044). During the second year of follow-up, the presence of subcortical white matter hyperintensities increased the risk of progression to dementia (OR: 5.854 [1.008- 33.846]). Subcortical and periventricular white matter hyperintensities were also associated with an increased risk of progression to dementia during the second year of follow-up (OR: 3.130 [1.098-8.922] and OR: 3.561 [1.227-10.334], respectively). The same was true for silent infarcts (OR: 4.308 [1.480- 12.500]). CONCLUSION: A high percentage of patients progressed to dementia. Total cholesterol, LDL cholesterol, and white matter hyperintensities were found to be associated with MCI progression to dementia. In contrast, cystatin C was shown to be a protective factor against progression to dementia.

Impacto de las complicaciones neurológicas y médicas sobre la mortalidad y situación funcional de pacientes con ictus agudo / The impact of neurological and medical complications on the mortality and functional situation of acute stroke patients

Introducción. Los pacientes con ictus presentan un elevado riesgo de presentar complicaciones. Su aparición puede condicionar el pronóstico del ictus. Estudiamos la frecuencia y el impacto de la aparición de diversas complicaciones en el pronóstico precoz y a medio plazo en estos pacientes. Pacientes y métodos. Estudio observacional de los pacientes ingresados en una unidad de ictus. Se registraron las complicaciones durante su estancia, distinguiéndose entre complicaciones neurológicas y médicas. Se estudió la influencia de estas según subtipo de ictus en la mortalidad intrahospitalaria y a los 90 días, y en la situación funcional a los 90 días, analizándose los factores clínicos predictores para la aparición de complicaciones. Resultados. Muestra de 847 pacientes. Un 29,5% de los pacientes presento complicaciones, que fueron más frecuentes en el ictus hemorrágico (50,5% frente a 26,6%; p < 0,0001). Las complicaciones más habituales fueron las neurológicas (21%). Para ambos subtipos, la presencia de complicaciones se asoció a mayor mortalidad intrahospitalaria (2,1% frente a 12,6%; p < 0,0001) y a 90 días (5,7% frente a 29,6%; p < 0,0001), y menor probabilidad de independencia a 90 días (72,9% frente a 30,4%; p < 0,0001). La gravedad del ictus al ingreso se mostró como el predictor más potente en la aparición de cualquier tipo de complicación. Conclusiones. La aparición de complicaciones durante la fase aguda del ictus influye de forma diversa en la mortalidad y en el pronóstico funcional. La identificación de factores predictores podría disminuir el impacto sobre la evolución del paciente con un ictus agudo (AU)

Introduction. Stroke patients have a high risk of presenting complications, the appearance of which can condition the prognosis of the stroke. We studied the frequency and impact of the onset of several different complications on the early and mid-term prognosis of these patients. Patients and methods. We conducted an observation-based study of the patients admitted to a stroke unit. The complications that occurred while hospitalised were recorded, a distinction being drawn between neurological and medical complications. The study examined their influence, according to the subtype of stroke, on intra-hospital mortality and that at 90 days, as well as on the functional situation at 90 days, by analysing the clinical factors that are predictive for the appearance of complications. Results. The sample consisted of 847 patients. Altogether, 29.5% of the patients presented complications, which were more frequent in haemorrhagic stroke (50.5% versus 26.6%; p < 0.0001). The most usual complications were of a neurological nature (21%). For both subtypes, the presence of complications was associated with a higher rate of mortality both in hospital (2.1% versus 12.6%; p < 0.0001) and at 90 days (5.7% versus 29.6%; p < 0.0001), and a lower probability of independence at 90 days (72.9% versus 30.4%; p < 0.0001). The severity of the stroke on admission revealed itself as the most powerful predictor of the onset of any type of complication. Conclusions. The appearance of complications during the acute phase of the stroke has an adverse influence on mortality and on the functional prognosis. The identification of predictive factors could reduce the impact upon the progress of acute stroke patients (AU)

Atención extrahospitalaria del ictus. Réplica 2 / Extra-hospital stroke care. Reply 2

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[Development and response to intravenous treatment with tissue plasminogen activator with regard to referral hospitals. The experience of a stroke referral unit]. / Evolución y respuesta al tratamiento intravenoso conactivador del plasminógeno tisular en relación con el hospitalde derivación. Experiencia de una unidad de ictus de referencia.

INTRODUCTION: The intravenous administration of tissue plasminogen inhibitor is a safe and effective treatment for patients with an acute ischaemic stroke. The prognosis depends on a number of factors, the time that elapses between the onset of the stroke and its administration being one of those with the greatest impact. PATIENTS AND METHODS: This is a prospective observational study of the patients who received intravenous fibrinolysis in our stroke unit between June 2007 and December 2010. The patients were divided into two groups, a distinction being made between those who went directly to AE at our hospital and those who were referred from other hospitals in Extremadura. The baseline characteristics, response to treatment and development in each group were compared. RESULTS: The patients who came from outside our health district were mainly males, with a TACI-type stroke and they presented higher scores on the National Institutes of Health Stroke Scale (NIHSS). The time elapsed prior to administration of the fibrinolysis was shorter in the patients from our health district. The NIHSS score on discharge was higher in patients who came from another health district, but there were no differences in the Rankin scale at three months or in the mortality rate. CONCLUSIONS: Patients submitted to fibrinolysis who come from another hospital score higher on the NIHSS on discharge. This is probably due to a bias in the selection of the patients, since those referred are mainly males, who have a poorer clinical situation on admission and receive treatment in a significantly longer time interval following the onset of symptoms.