View clinical trials related to Multiple Sclerosis.
Filter by:KAIROS is a prospective, multicenter, non-interventional study (NIS) in Germany. Prospective, primary data will be collected via questionnaires and an electronic case report form (eCRF) over a period of one year (max. 1.5 years) of treatment. Additionally, medical history of participants will be collected including disease duration, EDSS, MRI parameters and relapses.
Multiple sclerosis (MS) is the most prevalent chronic inflammatory disease of the central nervous system (CNS), affecting more than 2 million people worldwide,1 it is a degenerative disease that selectively affects the central nervous system and represents the main cause of non-traumatic disability in young adults. Gait and balance disturbances in MS are common even in the early stages of the disease. Half of the patients report some alteration in the quality of walking within the first month after diagnosis, reaching 90% after 10 years of evolution. 4 5 In addition, it is the symptom to which patients give the most importance 6 and the one that most conditions their activity and participation. 7 The causes of gait disturbance are multifactorial and are influenced by different aspects such as muscle strength, balance, coordination, proprioception, vision, spasticity, fatigue and even cognitive aspects4. There are multiple interventions, including aerobic, resistance training, yoga, and combined exercise, that have shown significant improvements in walking endurance, regardless of outcome measures (six-minute walking test (6MWT), two-minute walking test 2MWT). 8 In recent years, evidence has been growing around rehabilitation with robotic equipment in people with multiple sclerosis (PwMS), in their study Ye et al. concluded that robotic locomotor training has limited impact on motor functions in multiple sclerosis, but improves fatigue and spasticity, is safe and well-tolerated for PwMS, and less demanding for physical therapists.10 Bowman et al. concluded that robot-assisted gait therapy (RAGT) improves balance and gait outcomes in a clinically significant way in PwMS, RAGT appears more effective compared to non-specific rehabilitation, while showing similar effects compared to non-specific rehabilitation. specific balance and gait training in studies with level 2 evidence. RAGT has several advantages in terms of patient motor assistance, training intensity, safety and the possibility of combining other therapeutic approaches and should be promoted for PwMS with disability in a multimodal rehabilitation setting as an opportunity to maximize recovery.11 In this setting, more larger-scale and better-designed studies with longer training duration and more studies evaluating satisfaction, usability, and effectiveness are needed. of RAGT.
The study is a 4-week double-blind, randomized, controlled, parallel design investigation to investigate the impact of intermittent negative pressure on spasticity and pain in people with multiple sclerosis (pwMS). The investigational device (FlowOx2.0™) is composed of a Pressure Chamber and a Control Unit (and disposable parts). All subjects will receive the same pressure chamber but be randomized to either a Control Unit that generates intermittent negative pressure (INP) of - (minus) 40 mmHg or a Control Unit that generates INP of - 10 mmHg. FlowOx2.0™ generating -40 mmHg is the investigational device, and FlowOx2.0™ generating -10 mmHg, is the comparator device. After the initial 4-week double-blind period, all participants will be offered the -40mmHg control unit to be used during a 6-months optional extension part.
Endurance training is a cornerstone of rehabilitation in Multiple Sclerosis (MS) due to its beneficial effects on multiple MS-related symptoms, such as health-related quality of life, aerobic capacity (VO2peak), functional mobility, gait, depressive symptoms, and fatigue. Persons with progressive phenotypes of MS, namely primary progressive MS (PPMS) and secondary progressive (SPMS), represent a minor proportion of the total MS population, thus having been underrepresented in previous studies. The generalizability of existing evidence may be compromised by differences in symptom expression between MS phenotypes, with a dominance of motor symptoms (i.e., paraspasticity and/or paraparesis) in PPMS and SPMS. Adding up to this, clinical experiences of neurologists and sports scientists reveal that the effects of endurance exercise are characterized by a distinct time course, firstly inducing a minor and transient deterioration of motor symptoms that is followed by motor symptom alleviation beyond baseline level. This phenomenon was mainly related to the performance of High-Intensity Interval training (HIIT), but not to moderate-intensity continuous training (MCT). Therefore, this pilot study aims to systematically investigate the time course of acute motor effects on spasticity, functional mobility, gait, and dexterity in persons with PPMS and SPMS following two different endurance training protocols, that are HIIT and MCT.
The investigator will set up a study evaluating vocal biomarkers in people with MS in order to identify persons with non-motor symptoms: depression, cognitive deterioration, and fatigue. Up to now, to the best of the investigator's knowledge, there is no study reporting the use of vocal biomarkers to predict these three non-motor symptoms in people with MS.
Over 90% of persons with MS (pwMS) complain of difficulty with walking. High intensity interval gait training (HIIGT), where persons alternate brief periods of walking at high speeds with periods of rest has been found to improve walking in other neurologic diagnoses. However its impact on pwMS is not known. Most gait training in MS is done continuously at a slower pace. The purpose of this study is to compare the effects of HIIGT to traditional Moderate Intensity Continuous Gait Training (MICGT) in pwMS.
This work is aimed to assess the long term effect of TDCS in fatigue management among MS patients
Multiple sclerosis is the most common disabling neurological disease in young adults. Inflammation, demyelination, neurodegeneration, gliosis and repair processes are involved in its process, which are responsible for the heterogeneity and individual variability in the expression of the disease, the prognosis and the response to treatment. Clinically, MS manifests itself with the following symptoms: sensory focus, motor focus, spasticity, balance disorders, visual disturbances such as loss of vision or double vision or sphincter dysfunction. The main subtypes of MS are relapsing-remitting, secondary progressive, primary progressive, and progressive relapsing. Clinically, RRMS presents the initial inflammatory phase, characterized by reversible flares with neurological dysfunction, followed by periods of remission. Approximately 40-50% of these patients progress to SPMS, where the disease gradually progresses from intermittent flare-ups to steadily progressive worsening, resulting in permanent disability due to massive axonal loss. PPMS is the most severe subtype, affecting approximately 10% of all cases, and manifesting as progressive degeneration without any remission.
Interleukin 2 (IL-2) is a critical cytokine for the survival and function of regulatory T cells (LTreg). This cytokine has a dual role in the immune system. IL-2 stimulates immune responses by acting on the intermediate affinity IL-2R receptor, IL-2Rβγ, expressed by conventional T cells (LTconv) during activation, but also contributes to the inhibition of immune responses via LTreg that express the high affinity receptor IL-2Rαβγ. This difference in IL-2 receptor affinity for IL-2 has led to the development of low-dose IL-2 therapy to stimulate LTreg and improve control of excessive inflammation in autoimmune (AID), inflammatory or alloimmune diseases Low-dose IL-2 therapy is being studied in several of these diseases such as systemic lupus erythematosus, type 1 diabetes, alopecia, HCV (hepatitis C virus)-induced vasculitis, atopic dermatitis and chronic allo-transplantation-related graft-versus-host disease (GVHD). Some of these studies have shown an increase in LTreg numbers and an improvement in certain clinical signs. To improve LTreg targeting in autoimmune diseases, inflammatory diseases or GVHD, mutated IL-2s (muteins) have been developed with selective LTreg agonist properties. These IL-2 muteins are linked to an Fc fragment to increase their half-life. Two IL-2 variants (IL-2Vs)-Fc preferentially stimulate STAT5 phosphorylation in LTregs compared to conventional FoxP3- (LTconv) CD4+ or CD8+ T cells
The focus of this work is the evaluation of a measure of cognitive functioning- intra-individual variability (IIV) - derived from a computer-based continuous reaction time (RT) task (Cogstate) as an early marker of prodromal MS.