View clinical trials related to Sclerosis.
Filter by:The goal of this randomized controlled trial is to evaluate the effects of a digital group based self-management fall prevention program, "Fewer Falls in MS", in people with multiple sclerosis (PwMS). The main questions it aims to answer are:. - Is the Fewer falls in MS program effective in reducing fall incidence in PwMS at 6 and 12 months after start of intervention? - Does the program have an effect on secondary outcomes at 3, 6 and 12 months? - How do process evaluation components (context, implementation, mechanisms of impact) inform interpretation of outcomes? - What is the cost effectiveness of the fall prevention program 12 months after start of intervention? Participants in the intervention group will participate in a group-based self-management fall prevention intervention of eight 2-hour sessions delivered online by a group leader. The group leader will participate in an online education program before intervention start. Home assignments are completed by the participants between group sessions. Participants in the intervention group and the control group will receive a brochure on fall risk factors and fall prevention Researchers will compare the intervention group and the control group to see if there are any differences in fall incidence, sense of control of falls prevention, fear of falling, falls self-efficacy, activity curtailment, perceived impact of MS, self-reported health, and health economic costs. Researchers will also study factors and mechanisms that support or hinder how the fall prevention program builds participants' ability to manage their fall risk; and if and how PwMS have implemented and use self-management fall prevention behaviours into their daily lives.
Every-day life means being part of a complex environment and performing complex tasks that usually involve a combination of motor and cognitive skills. However, the process of aging or the sequelae of neurological diseases such as Multiple Sclerosis (MS) compromises motor-cognitive interaction necessary for an independent lifestyle. While motor-cognitive performance has been identified as an important goal for sustained health across different clinical populations, little is known about underlying brain function leading to these difficulties and how to best target these motor-cognitive difficulties in the context of rehabilitation and exercise interventions. The challenge of improving treatments of motor-cognitive difficulties (such as dual-tasking and navigation) is daunting, and an important step is arriving at a method that accurately portrays these impairments in an ecological valid state. The investigators aim therefore to explore brain function during complex walking in MS (in comparison with people with Parkinson's disease and healthy controls) by investigating the effects of neurological disease on motor-cognitive performance and its neural correlates during three conditions of complex walking (dual-task walking, navigation and a combination of both) using non-invasive measures of brain activity (functional near infrared spectrometry, fNIRS) and advanced gait analysis in real time in people with MS (in comparison with people with Parkinson's disease and healthy adults).
The main purpose of the study is to evaluate the efficacy of vixarelimab compared with placebo on lung function in participants with idiopathic pulmonary fibrosis (IPF) and in participants with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Participants who complete 52-weeks of treatment in the Double-blind Treatment (DBT) period can choose to enroll in the optional Open-label Extension (OLE) period to receive treatment with vixarelimab for another 52 weeks.
The goal of this pilot study is to assess the feasibility of a larger study on the efficacy of mycophenolate mofetil in people diagnosed with systemic sclerosis with mild lung involvement. Participants will be recruited over 12 months at 3 academic centers and assigned randomly to receive either mycophenolate mofetil or placebo, a look-alike substance that contains no active drug, for 96 weeks.
Multiple Sclerosis is the most common cause of neurologic chronic disability in young adults. Fatigue is one of the principal symptom in this disease. In the past it was demonstrated how, with appropriate frequencies and amplitude of vibration, it is possible both to select the activated afferents, and to determine the frequency of action potentials sent to the Central Nervous System. The purpose of this study is to verify how the use of vibrations can induce positive effects on the mobility and postural control of patients with MS, as well as reduce fatigue. The study is an interventional type. The subjects are undergoing to baseline examinations (T0) including 3D gait analysis (using a BTS system), stabilometric analysis, and a battery of neuropsychological assessments. Subsequently, eligible subjects are undergoing to intensive multidisciplinary training for a total of 5 sessions per week for 4 weeks, with a total of 20 treatment sessions. The experimental group receive additional vibration treatment. At the end of the treatment cycle (T1), the patients will undergo the same evaluation tests as at baseline. The Clinical and instrumental exams used for this study (as per normal clinical practice) are: Expanded Disability Status Scale (EDSS), Fatigue Severity Scale (FSS), Modified Fatigue Impact Scale (MFIS), Fatigue Scale for Motor and Cognitive Functions (FSMC), Borg Scale, Medical Research Council Scale (MRC), 6 minutes walking test. The Psychological Assessment Battery used are: Multiple Sclerosis Quality of Life-54 (MSQOL-54) scale, Beck Depression Inventory-II, Coping Orientation to Problems Experienced (COPE). Sample size: The sample consist of patients with MS admitted to the C.A.R.E.N. or Casazza facilities of the IRCCS Centro Neurolesi Bonino-Pulejo in Messina. Twenty eligible subjects recruited and treated with traditional rehabilitation approach plus vibrational therapy. The results will be compared to those obtained from a group of 20 patients who have undergone a traditional rehabilitation treatment without the application of vibrations and who will represent the control group.
The goal of this clinical trial study is to evaluate the presence of relationships between PET and MRI images indicative of chronic inflammatory activity (smoldering plaques), apparent absence of inflammatory activity (silent plaques without microglial rim), or indicative of more recent inflammatory activity, in contrast-enhanced areas or in T2/Flair-positive areas of not distant onset in patients diagnosed with progressive (secondary or primary) stage multiple sclerosis and in patients in relapse and remission. Laboratory analysis of serum markers will be performed: neuronal and glial cytoskeletal proteins (e.g., Nf-L, pN-FH, GFAP), and the levels of neurotrophic factors (e.g., BDNF, GDNF) and cytokines (e.g., TNFα, IL-6, IL-1β, interferon) will be evaluated.
To measure the effectiveness of a Remote Patient Monitoring solution based on the use of a smart insole wearable device (and associated smart phone app), for monitoring MS patients' condition on a day-to-day basis. The main focus is the objective measurement of gait, given that 75% of people with MS display clinically significant gait impairments. Initial gait lab "gold standard" data indicate that the Artificial Intelligence (AI)-based digital biomarker will prove to be highly effective at detecting changes in the MS patient's condition.
The present study recruits female patients aged 45-65 years with a diagnosis of Systemic Sclerosis according to the EULAR/ACR 2013 criteria and age and gender-matched healthy control subjects. The purpose of the study is to investigate the possible role of Klotho and other cytokines involved in the osteoimmunological control of bone turnover as a possible determinant of the microvascular damage and fibrosis observed in SSc patients
This is a prospective interventional study with a 12-month follow-up of patients diagnosed with Multiple Sclerosis. Enrollment includes patients for whom Ozanimod will be prescribed based on regular clinical practice. It is proposed to integrate the measurements obtained using multiple instruments, with the aim of analyzing the immunological landscape, connectivity networks and anatomical traits of neurodegeneration. Patients will return for imaging and noninvasive electrophysiological studies 3, 6, and 12 months after initiation of therapy. On the same day, blood samples will be taken and immunological and biochemical tests will be performed.
Multiple Sclerosis (MS) is an autoimmune disease characterized by inflammation, demyelination and axon damage. Affecting approximately 2.5 million individuals around the world and seen mostly in young adults, MS can cause different levels of disability in functional activities, cause limitations in social and professional life, and impair quality of life. Multiple sclerosis is thought to be an autoimmune disease that develops on the basis of genetic predisposition and environmental factors. Nutritional habits and physical activity are important environmental factors. These can be effective in the course of MS and change the quality of life. Compatibility of nutrition with the Mediterranean diet and providing adequate physical activity may be beneficial in increasing physical and mental well-being in general, and therefore the quality of life of the person. In our country, there is not enough information about the ongoing nutritional habits and physical activity levels of MS patients in their daily lives, and quality of life studies are limited. Our limited knowledge on these issues narrows the possibility of movement in an area that can be corrected in MS patients and thus have a positive impact on their quality of life. The aim of this study is to determine compliance with the Mediterranean diet, the tendency to use various nutritional supplements, physical activity habits, walking-related problems and quality of life in MS patients and to evaluate whether there is a significant relationship between these parameters.