Active clinical trials for "Multiple Sclerosis"

Fatigue is the most common symptom and the most disabling symptom of Multiple Sclerosis, and its inefficient management can be a source of multiple consultations (increase in health costs) and a reduction in productivity (work stoppages). Hence the need to define the most effective therapeutic strategy to reduce fatigue in Multiple Sclerosis. One of the aims of this project is to provide clinical indicators that can serve as evaluation criteria for determining the most effective fatigue management strategy in Multiple Sclerosis. The primary objective of the study is to determine the Minimal Clinically Important Difference (MCID) and the Patient Acceptable Symptomatic State (PASS) for fatigue in Multiple Sclerosis. The source population consists of all people with Multiple Sclerosis living in Lorraine and registered in the Lorraine Registry of Multiple Sclerosis (RelSEP).

Multiple sclerosis (MS) is a chronic, progressive and demyelinating disease that affects more than 2.5 million people in the world and is frequently seen in young adults between 20 and 40 years of age, especially in women. Although the exact MS in Turkey is not known, it is estimated as 40/100,000. According to epidemiological studies in recent years, the prevalence and incidence of MS tend to increase. The most common clinical signs and symptoms include loss of sensation in the extremities, partial or total vision loss, acute or subacute motor dysfunction, cognitive impairment, double vision and gait dysfunction. Currently, MS has no definitive cure. Progressive symptoms related to the disease need to be managed in order to increase and maintain the quality of life of individuals with MS. Pharmacological, physiotherapeutic and psychotherapeutic methods are the most effective effective methods in the management of symptoms. However, the efficacy of these methods has been demonstrated in clinical trials. The outcomes cannot be generalized to the entire MS population because of the inclusion and exclusion criteria that exist in clinical trials. In addition, clinical trials are conducted at a specified time interval (usually a short time interval is selected) and generally, short-term results are provided. In order to better understanding the course of MS, it is of utmost importance that long-term follow-up studies are carried out where as many patients are included and patients are followed from the date of initial diagnosis. The aim of this study is to investigate the change of physical, psychosocial and cognitive characteristics over time and the correlated variables. The volunteers from MS patients who attend routine control of the MS outpatient clinic of Dokuz Eylül University Hospital will participate in the study. Physical and clinical assessments will be performed by physicians and physiotherapists, and cognitive evaluations will be performed by psychologists with 6-month intervals.

Although the majority of the French population is covered by social security, the effects of social inequalities on health are still very visible and are even increasing in France and in Europe. Thus, according to INSEE, excess mortality is observed among the most disadvantaged populations. Similarly, the prevalence of certain chronic diseases in France and Europe, particularly cardiovascular diseases, is linked to social inequalities and excess morbidity can be observed in the most disadvantaged populations. In addition to social inequalities, which refer to disparities in health levels according to social category, there are the effects of territorial inequalities. In France, there are geographical areas of excess mortality, which essentially correspond to areas far from urban centers. Similarly, there are major geographical differences in terms of medical supply and equipment, and the distance between patients and health centers is a direct obstacle to the use of the health care network. The underlying explanations for social inequalities in health are multiple. While it is likely that difficulties in accessing and using care play a role, it is also possible that they are due to differences in exposure to certain environmental (e.g. pollution) or individual (e.g. smoking) risk factors. But it is also possible that the causal relationship is the opposite and that diseases create or reveal social inequalities. For multiple sclerosis (MS) the impact of social and territorial inequalities is more debated. Indeed, with regard to the relationship between disease prevalence and social inequalities, a recent literature review found 21 separate studies on the subject, of which 13 failed to show a link between socioeconomic status and MS risk, 5 concluded that there was an increased risk of MS in advantaged populations and 3 concluded that there was an increased risk of MS in disadvantaged populations. There are plausible pathophysiological explanations for either direction of the relationship, but the question remains open. To our knowledge, the link between MS prognosis and social inequalities has been little studied, as disadvantaged populations are more often exposed to the poor prognostic factor of smoking [6-8], the hypothesis of a negative prognostic role of social inequalities remains plausible. Similarly, the current consensus is that the diagnosis and treatment of MS should be as early as possible [9,10] in order to preserve brain capital. Easy access to a neurologist and MRI are therefore potentially prognostic factors for MS in relation to territorial inequalities. It should be noted that the link between social and geographical inequalities and a potential delay in treatment has not been demonstrated in France in the case of cancer, but it is possible that the importance of the means implemented in the fight against cancer erases these effects. In MS, a study showed a link between delay in starting a second disease-modifying therapy and socio-economic status. While the causal link between MS and socio-professional status has not yet been demonstrated, the socio-economic impact of MS has been measured. In particular, it has been shown that having MS is associated with an increased risk of unemployment and/or early retirement. The primary objective of our study is to determine whether delay in treatment, as a marker of difficulties in access to care in MS, is associated with social and territorial inequalities in MS. Secondary objectives will be to explore the link between MS prognosis and social and territorial inequalities. Exposure to sunlight is a known protective factor and is consistent with the north-east-south-west gradient observed in France. The choice of centers associated with the research, spread over the French territory, will make it possible to monitor and measure this effect in the prognosis of MS. As the available treatments have evolved considerably over the last ten years, and in order to avoid a period effect, the patients recruited in the study will have to have a date of onset of the disease after 1 January 2009. Primary objective Determining the relationship between socio-economic inequalities and the time to start disease-modifying therapy in MS Secondary objective To determine the relationship between geographical inequalities and delay in starting disease-modifying therapy in MS To determine the relationship between socio-economic inequalities and time to walking disability (EDSS 4) To determine the relationship between geographical inequalities and time to walking disability (EDSS 4) To measure the impact of disability on socioeconomic status in MS patients

The study explores the application of marker-less motion analysis (visual-perceptive computing, VPC) using a consumer grade infrared and video camera (Microsoft Kinect) for clinical assessment in MS. It includes as the primary outcomes a short assessment battery of simple motor tasks (PASS-MS) that can be performed in front of the sensor after standard oral instructions given by the operator. For each task, the sensor data are transformed into a set of kinematic parameters that may be used as motor outcome reflecting specific neurological dysfunction. For validation against both clinical and patient-reported outcomes as well as MRI findings, we here prospectively investigate a large cohort of patients with multiple sclerosis. This will allow to determine the usefulness of the various kinematic parameters generated and to define a reduced set of the most meaningful parameters for potential use in future MS trials. Data on repeatability and benchmarks for clinically relevant change are essential to interpret test results and, more importantly, changes thereof. Further, this prospective study will yield estimates of progression rates that are required for planning future studies using this motion analysis tool and assessment battery as an outcome. The study is designed to obtain benchmarks for sensitivity and clinical responsiveness. Primary analysis aims to answer the question: Does the SMSW - Maximum Speed worsen with disease progression established as confirmed disability progression based on EDSS after 24 months (defined as 1 step increase in EDSS ≤ 5.5 and 0.5 step in EDSS > 5.5)?

The central hypothesis is that lutein supplementation will improve MPOD and cognition. Accordingly, the specific aims are to 1) to determine the process feasibility associated with participating in 4-month lutein supplementation trial; and 2) to investigate the scientific feasibility of 4-month daily lutein supplementation on biological markers of lutein status and cognitive function among persons with MS.

The purpose of this research study is to investigate the effectiveness of MS Disease modifying medications on cognitive fatigue in persons with relapsing remitting multiple sclerosis (RRMS). Cognitive fatigue is the kind of fatigue that occurs after intense mental concentration as after a session of problem solving.

People with multiple sclerosis (MS) often experience problems with cognitive functioning, which can be debilitating and interfere with their daily functioning. However, research has shown that MS disease modifying agents have had some success in treating cognitive problems. The main purpose of this research study is to investigate how well two medicines (alemtuzumab (Campath®) and interferon beta-1a (Rebif®)) work in treating MS-related cognitive problems (e.g., attention, memory, speed of thinking). Participants enrolled will be assessed prior to their first study-related medication dose and re-assessed throughout treatment. It is expected that participants taking Campath® will demonstrate relative stability in cognitive functioning relative to those taking Rebif®. Specifically, the cognitive performance of Rebif® participants will decline somewhat over time, but the cognitive performance of Campath® participants will remain stable.

Alemtuzumab is a highly effective therapy in relapse remitting multiple sclerosis (RRMS). The aim of this study is to elucidate the mechanism of action of the neuroprotective potential of alemtuzumab in RRMS. Therefore, the investigators will semi-annually analyse blood samples of RRMS patients treated with alemtuzumab up to 36 months. Using in vitro/ ex vivo assays the investigators aim to detect and characterize immune cells including their functional activity. Furthermore, the study aims to combine this analysis with clinical data (MRI, EDSS: Expanded Disability Status Scale, MSFC: Multiple Sclerosis Functional Composite) to reveal the underlining mechanism of action of alemtuzumab to further improve its efficacy and safety for present and future patients.

This study is a case-control observational study, involving persons with multiple sclerosis and healthy controls. The study contains 1 descriptive and 4 experimental sessions. In the descriptive session, participant's clinical motor and cognitive functions are collected. In the first experimental session, participant's beat perception and synchronisation abilities is examined within a finger tapping paradigm. In the following experimental sessions participants synchronsiation abilities is examined during walking paradigms, to music and metronomes, at different tempi and alignment strategies. In the latter three sessions, apart from outcome measures of synchronization the following will be collected as well: spatio-temporal gait parameters, perceived fatigue, perceived motivation and perceived speed of walking.

The overall study aims are to explore the feasibility, acceptability, and usability of More Stamina, a mobile app for fatigue self-management for persons with MS.