Active clinical trials for "Multiple Sclerosis"

Several prospective monocentric cohorts of between 250 and 1000 patients have been set up in order to characterize more precisely the evolution of the disease. Nevertheless, due to an initial recruitment carried out in the years 2000-2010, they do not constitute a faithful representation of the patients followed in clinical routine, in particular in terms of distribution of treatments. Indeed, the introduction, about 10 years ago, of high efficacy treatments (HET) has changed the management of the disease and a significant proportion of patients not controlled by medium efficacy treatments (MET) of the disease are now stable on HET. Nevertheless, if their short-term efficacy has been clearly demonstrated, it remains important to be able to confirm the superiority of HET over MET with the help of prospective cohorts (thus ensuring a retention of patients > 90% over the long term) analyzing all clinical and imaging biomarkers, imaging and biological data. The measurement of cerebral atrophy and its progression is probably one of the most interesting and most easily used biomarkers that can be used clinically to assess this silent progression in these groups of patients. The progression of brain atrophy is also dependent on many other non-modifiable but also modifiable factors outside of MS that need to be better evaluated and eventually managed. Nevertheless, the existence of various neurological comorbidities (sleep disorders, headaches) on this atrophy has not been specifically analyzed to date. The functional assessments used in routine follow-up are most often performed in a care facility and have many limitations: lack of reproducibility, inter/intra operator variability, poor correlation with functional and quality of life scales, etc. It is therefore extremely important to be able to identify new clinical biomarkers of disease progression of the disease by evaluating the physical capacities of the patients as precisely as possible. This study is a single-center, prospective cohort study of a population of 400 patients with relapsing remitting MS (RRMS). The main objective of this study is to compare, on morphological imaging criteria (T1 volumetry), the progression of brain atrophy (biomarker of disease progression) at 3 years in RRMS patients according to treatment line (MET vs HET).

This is a randomized pragmatic clinical trial fully embedded in the Swiss Multiple Sclerosis Cohort to assess whether sNfL biomarker monitoring improves patient-relevant outcomes and care of patients with relapsing-remitting (RR)MS by either increasing the proportion of patients with no evidence of disease activity (EDA) or by improving patients' health-related quality of life.

The study aims to evaluate MSCopilot®, a smartphone application for at-home monitoring of patients with Multiple Sclerosis (MS). The primary objective is to enhance and standardize remote monitoring of MS patients to accurately assess disease progression caused by either Relapse Activity Worsening (RAW) or Progression Independent of Relapses (PIRA). The study also aims to assess the safety, usability, and satisfaction of the solution. A secondary objective is to determine MSCopilot®'s ability to provide early detection of disease changes and predict changes in Expanded Disability Status Scale (EDSS) scores in more patients. Exploratory objectives include evaluating the relationship between MSCopilot® composite and individual scores and other biomarkers such as MRI, soluble glial fibrillary acidic protein (sGFAP), and soluble neurofilament light chain (sNfL). Patients will be able to download the free MSCopilot® app. They will participate in 1 inclusion visit and 3 follow-up visits, scheduled at 6 months, 12 months, and 18 months (an additional visit at 24 months may be scheduled if necessary). Every 3 months, patients will complete validated questionnaires regarding MS symptoms and quality of life and participate in digital tests designed to monitor MS symptom progression. The study will include 243 MS patients and will be conducted in the United States, Canada, Germany, Italy, Spain, Denmark and France

Relapsing-remitting multiple sclerosis (RRMS) is associated with changes of the corticospinal tract integrity, which is quantified by means of corticospinal plasticity. Several factors, such as exercise and interlimb coordination can influence such corticospinal plasticity. Previous work in healthy and in stroke participants showed that the greatest improvement of corticospinal plasticity occurred during in-phase bilateral arm exercises. Here, the investigators propose a concurrent multiple baseline design study which has the advantage to verify the cause-effect inference by the staggered duration through separate baseline phases. The proposed study includes five people with RRMS, who will follow an intervention protocol which includes in-phase bilateral movements of the upper limbs, adapted to different sports activities and to functional training. The aim of the study is to investigate the effects of in-phase bilateral exercises on corticospinal plasticity and on clinical measures, using transcranial magnetic stimulation and standardized clinical assessment. To meet quality standards, the present study has been designed and will be conducted according to the "What Works Clearinghouse" criteria for single case studies.

In multiple sclerosis (MS), the sequence of events leading to irreversible neuro-axonal degeneration, which is a major determinant of clinical disability, is poorly understood. Recently, the key role of neuronal energy dysfunction in driving axonal degeneration has been highlighted. In the neuronal injury pathway triggered by inflammation and myelin disruption, multiple adaptive changes force the neuron to a temporary condition of "virtual hypoxia", characterized by a mismatch between energy demand and supply. If this condition of energy dysregulation is not reversed within an appropriate time-window, neurons enter an irreversible axonal degeneration. Two key questions on the relationship between early energy dysregulation and neurodegeneration remain unanswered: i) whether brain energy dysfunction measured at a given time point can predict the subsequent occurrence of neurodegeneration; ii) to what extent and for how long neurons can bear this "virtual hypoxia" before undergoing structural damage. Tracking the "energetic signature" of MS and defining its temporal distance from irreversible damage is essential for the development of neuroprotective therapies.The recent optimization of innovative magnetic resonance (MR)-based techniques such as sodium (23Na) MRI, phosphorus MR spectroscopy (31P-MRS), and diffusion-weighted 1H MRS (DW-MRS) has allowed the generation of promising in vivo data on cellular energy dysregulation in MS. The main objective of this project is to explore whether MR-derived metrics of energy dysregulation predict MR-derived parameters of cortical neurodegeneration developing over 2 years, as reflected by cortical atrophy. To address this key question, the Investigators will use a combination of 23Na MRI, 31P MRS, and DW-MRS associated with advanced MRI sequences to explore energy dysregulation in the sensorimotor region, and measurements of cortical atrophy in the same area after 24 months in 40 patients with either relapsing-remitting or progressive MS and 15 age- and gender-matched healthy controls. The Investigators will also test whether MR-derived metrics of energy dysregulation at study entry correlate, both cross-sectionally and longitudinally, with: i) global cortical atrophy; ii) functional cortical reorganization resulting from the condition of energy dysregulation, which precedes the occurrence of structural damage; iii) cortical demyelination and remyelination; iv) clinical, neuropsychological and biological measures.

This is a placebo-controlled, double-blinded, randomized trial design, whereby all patients are eligible to start an injectable therapy, and then randomized to either placebo or FMT for approximately 1 year.

Multiple sclerosis (MS) in children, a rare disease, follows a relapsing remitting course with a shorter interval between the first 2 clinical events and higher annualized relapse rate as compared with MS in adults. Residual deficits following clinical events are less frequent. The vast majority of children and adolescents with MS are thought to have a greater potential for myelin repair than adults. However convincing data in the literature to support this hypothesis are lacking, because until now no imaging technique has been validated to measure remyelination in vivo.

The goals of this observational study are to evaluate (1) the feasibility, usability, and satisfaction with the Cubii elliptical and (2) the preliminary efficacy of the Cubii elliptical for increasing activity (primary outcome), physical function, and quality of life, and decreasing physical and psychological symptom (e.g., pain, fatigue, depression) severity in people with MS. The main question it aims to answer is how usable and feasible is the Cubii as a mode of exercise for people with MS? Participants will use the Cubii as they choose and keep a written log of this use. They will answer questions about their demographics, MS disease-related variables (e.g., pain, fatigue, falls), activity, exercise, quality of life, and biopsychosocial symptom variables) and provide additional data regarding the feasibility, usability, and satisfaction with use of the Cubii.

Multiple Sclerosis (MS), causing damage to myelin sheath and axons; It is a chronic disease with diffuse demyelinating lesion of the Central Nervous System (CNS) that often affects young adults, progresses with attacks and remissions, and may bring about functional limitation, disability or decrease in quality of life. The fact that Multiple Sclerosis is chronic and irreversible, the uncertainty and destructiveness of the disease process affect individuals physically over time, but it can also cause many negative symptoms from a mental perspective. Studies have shown that MS disease; anxiety, depression, loss of life purpose, intense hopelessness and suicide. Life purpose has been defined as struggling to achieve one's goals and creating meaning against existential neurosis. Having a life purpose increases the subjective well-being, life satisfaction and hope level of individuals. According to the Turkish Language Association, hope, which is defined as "the feeling of trust arising from hope" and which indicates the feeling of having positive expectations for the future, positively affects mental health by giving people the feeling that they can cope with negative experiences that they may encounter in the future. Hopelessness, which is the opposite of hope, is a feeling that causes mental problems such as depression and suicide as well as negatively affecting the mental health of the individual and is a part of these clinical pictures. Setting a life purpose has positive effects on hope. While a purposeful life increases the level of hope in people, it reduces hopelessness and causes the person to live a more meaningful life. The decrease or loss of hope and the purpose of life can cause significant problems for people such as depression, addiction or suicide may occur in people who have lost their life purpose and hope. Positive psychotherapy (PPT), one of the psychosocial-based intervention methods, is a therapy method with a humanistic approach, the theoretical foundations of which were established by Pesesschkian in 1970. There are three basic principles of therapy: hope, balance and consultation. In Positive Psychotherapy, the symptoms and ailments in the person; It is positively reinterpreted, emphasizing real talents. Sharing the function of the existing symptom with the client increases the client's acceptance and hope for himself and his situation, which in turn activates the hope principle.

The goal of this clinical investigation is to evaluate the effectiveness of home use of a lightweight robotic lower limb exoskeleton as a walking aid device on quality of life in patients with multiple sclerosis with gait disorders. Participants will wear an exoskeleton (Keeogo) for 8 weeks at home during the experimental phase. This phase is compared to an 8-week control phase at home with advice on regular physical activity adapted to their abilities.