View clinical trials related to Multiple Sclerosis.
Filter by:This is a Phase 2, randomized, double-blind, placebo-controlled 2 parallel-arm study to assess the effect on serum neurofilament light chain (sNfL), safety and tolerability of oral SAR443820 compared to placebo in male and female participants aged 18 to 60 years with relapsing-remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS) (relapsing or non-relapsing), or primary progressive multiple sclerosis (PPMS) followed by an open-label long-term extension period. The total study duration is approximately 100 weeks and includes the following: 4-week screening period 48-week double-blind treatment period (Part A) 48-week open-label long-term extension period (Part B)
Ultraviolet B (UVB) irradiation induces regulatory immune cell types that may transmigrate from the skin to the blood and to the central nervous system and exert regulatory effects. Vitamin D deficiency-associated gene variants should reduce this effect if this is mediated by vitamin D. For this study, participants will be irradiated with UVB for 4 weeks. Single cell RNA Sequencing will be performed on isolated immune cells from skin, blood and Cerebrospinal fluid (CSF), before and after irradiation.
This is a non-interventional, cross-sectional, qualitative study in which patients diagnosed with MS and clinicians with experience treating MS will be interviewed regarding patient experiences with the wearing off effect from ocrelizumab, natalizumab, and ofatumumab
Hospitalization is often a traumatic event so stressful for the life of patients. Isolation, loneliness, worries about clinical examinations, results from examinations and final diagnosis, uncertainty about the future are the most common feelings that patients report when during hospitalized for different disease conditions; these feelings are not related to the pathological condition. Also the discomfort of the caregivers is significant, as the necessities and priorities of the family change significantly during the hospitalization of a member (worries about the future, help and support are not enough to sustain the situation, problems with the work schedule ). Nowadays in North American and North European countries, mindfulness practice is offered to patients by multifaith Chaplaincy teams and health-care operators (e.g. physicians, nurses, psychologists), as a way of helping patients come to terms with diagnosis and adjust to their prognosis. To the extent that patients can bear it, instructions are given to keep coming back to the present moment, here and now, to bodily and affective experience, relaxing in it. To that purpose patients are encouraged to accept the situation as it develops, and let go of excessive concerns and unhelpful narratives that undermine the capacity to manage pain, fear and suffering. Moreover, similar programmes are designed for caregivers and the patients' families, aimed at developing their resilience in delivering the support, via face-to-face sessions, and instructions and encouragement for a regular practice at home. In the last years, due to the dramatic emergency for the COVID-19 pandemic, different applications for mindfulness have been realized by specific APPs or web platforms that allow patients to practice mindfulness regularly guided by a physician or an expert in mindfulness: patients can stay at home and mindfulness sessions can be delivered by technological modalities. In different hospitals, protocols have been implemented for the treatment of patients remotely, using specific platforms or APPs. These remote interventions are complementary to the regular face-to-face sessions and they are suitable for most patients and easily applied.
Multiple sclerosis (MS) is the most common acquired neurological disease leading to disability in young adults. MS often leads to the development of a physical and/or cognitive impairment that disables patients in their daily lives. Early use of disease modifying treatments for patients at risk of developing disability is therefore essential. However, disability progression is very heterogeneous between patients and currently impossible to predict at the individual level. Thus, numerous studies, particularly epidemiological and imaging studies, have identified prognostic factors for the development of disability such as age, gender, number of relapses during the first years of the disease, existence of a residual disability after a first relapse, number of gadolinium-enhancing lesions on initial MRI, early brainstem and spinal cord lesions. However, these different factors only explain incompletely the progression of the physical or cognitive disability in MS patients. In particular, some components of MS pathophysiology, more related to the progressive development of disability, such as axonal degeneration or the existence of chronic inflammation of the central nervous system (CNS) are usually not measured by these biomarkers. In this research project, the investigators will test promising biomarkers, focused on these components of the disease, on a large cohort of patients in a multicenter setting, in order to evaluate their added value to predict disability progression, in comparison with more classical biomarkers such as clinical characteristics, and brain and spinal cord lesion load. In particular, the investigators will test: - Imaging biomarkers extracted from brain and spinal cord MP2RAGE, brain and spinal cord QSM, brain and spinal cord relaxometry, brain diffusion and spinal cord magnetization transfer sequences - Biomarkers extracted from optical coherence tomography (OCT) - Biological biomarkers (serum neurofilament-light chain (NFL) and Glial Fibrillary Acidic Protein (GFAP))
Multiple sclerosis (MS) is an inflammatory disease that affects the brain and spinal cord. There are potential impacts on neurological functions, including sensory and autonomic functions. The Primary observed in males with MS is erectile dysfunction (ED), which substantially impacts the quality of life. There is increasing literature on electromagnetic fields' biological and clinical effects, particularly on ED.
This study will investigate if the use of motor imagery to practice a balance task is as effective as physically practicing balance tasks as measured by the Berg Balance Scale (BBS) in persons with MS. A secondary purpose is to investigate if using a motor imagery balance intervention will limit fatigue typically experienced with physical movement in this population.
Treating cognitive impairment (CI) in multiple sclerosis (MS), the leading cause of disability due to nontraumatic neurological disease in young adults, is an important challenge. The contribution of CI to disability in MS has been increasingly recognized, and CI has been shown to decrease health-related quality of life (HR-QOL), even in the early stages of the disease. CI negatively impacts daily activities such as driving, vocational status, absenteeism, and instrumental activities in persons living with MS (PwMS). No medication has proven to have a consistent symptomatic effect on CI in MS, and disease-modifying therapies only have a small impact on CI progression. CI in MS is dominated by a slowdown in information processing speed (IPS), as well as by disturbances of more specific cognitive functions such as attention, episodic memory (EM), working memory (WM) and executive function (EF). The alteration of IPS has consequences for WM, attention, EF and EM. IPS impairment predicts subsequent disability and vocational status and changes in quality of life (QOL). Cognitive rehabilitation (CR) is the most promising approach for treating MS-related CI, as concluded by recent reviews and meta-analyses, despite important methodological shortcomings. Methodological limitations in early studies have led to disappointing results, and well-designed studies are still scarce. As noted recently, many studies lack a randomized controlled design that includes passive or active control conditions, primary neuropsychological end-points identified a priori, evidence of the sustainability of CR and the inclusion of near and far transfer outcomes. Tertiary outcomes of QOL, metacognition, or other patient-reported outcomes (PROs) are rarely used. In view of the results of these different studies, the investigators propose a single-blind randomized controlled trial of a telerehabilitation program for MS associated CI, based on Rehacom software, using appropriates modules according to specific CI, but complemented by individual remote online rehabilitation sessions allowing a better adaptation of the program to the patient's deficit, a more efficient supervision and meta-cognitive work. This program will be evaluated in terms of effectiveness on neuropsychological tests, effectiveness on specific cognitive domains re-educated according to the impairments detected in the baseline, an ecological evaluation and the impact on daily cognitive functioning. Specific active rehabilitation will be compared to a placebo intervention of the same duration and intensity. Only a multi-center study will make it possible to achieve sufficient number of patients to meet these objectives.
The goal of this observational study is to longitudinally investigating subjects with inaugural acute optic neuritis (ON). The main questions it aims to answer are: - Does the time to corticosteroid treatment affect the visual outcome at 6 months in subjects with acute multiple sclerosis (MS)-, aquaporin 4-IgG positive (AQP4-IgG+) and myelin-oligodendrocyte-glycoprotein-IgG positive (MOG-IgG+) ON? - How differ clinical, structural, and laboratory biomarkers in subjects with acute ON, including clinical isolated syndrome (CIS), MS-ON, AQP4-IgG+ON, MOG-IgG+ON and seronegative non-MS-ON? Participants will undergo - clinical examination, including clinical history, neurovisual and neurological tests - serum and cerebrospinal fluid examination - optical coherence tomography (OCT) - magnetic resonance imaging (MRI) - assessment of depression, pain, quality of life through validated questionnaires Researchers will compare subjects with MS-ON, AQP4-IgG+ON, MOG-IgG+ON and other ON (CIS, seronegative non-MS-ON) to detect diagnostic and predictive markers for the disease course.
The purpose of this study is to determine the rates of adverse events of interest (AEIs) in a real-world population of participants with relapsing remitting multiple sclerosis (RRMS) receiving Ozanimod, sphingosine-1 phosphate (S1P) receptor modulator, compared to the rates of these events in two population of participants: - Participants not exposed to ozanimod with RRMS who have received treatment with other S1P-receptor modulators disease modifying treatments (DMTs) - Participants not exposed to ozanimod with RRMS who have received treatment with other non-S1P-receptor modulators disease modifying treatments (DMTs)