View clinical trials related to Multiple Sclerosis.
Filter by:- The investigators are conducting a magnetic resonance imaging (MRI) study comparing two MRI contrast agents in people with clinically isolated syndrome and relapsing remitting multiple sclerosis (MS). MS is a disease that affects the white matter and gray matter in the brain. MRI is used as a gold standard to visualize the degenerative changes in the brain and spine. The neurologist will usually order an MRI to confirm the diagnosis of MS using conventional imaging methods. These images reveal two main pieces of information regarding (a) the location of the lesions and (b) the status of the lesions. While the location of the lesions directly correlates with the clinical symptoms, the information about the status of the lesions informs the neurologist whether the lesion is new (active) or old (chronic). - This ability to differentiate new and old lesions requires the use of a contrast agent. Currently, used agents reveal some lesions but it is unclear if they reveal the full extent of the disease. In new lesions, there may be a leakiness in the blood vessels and if the contrast agent leaks out then the investigators can see this. In healthy controls, the blood brain barrier is usually intact and this leak does not happen. One open question is: "can the extravasation of the contrast agent to the brain precede the major tissue damage that we see in the structural MRI?" - Recently, a new FDA approved contrast agent (Gadavist) has been released and has enhanced characteristics in terms of affecting the MR signal resulting in a better contrast in the image and therefore, better diagnosis of the status of the disease. Given its high relaxivity, a small amount of Gadavist may show a better signal enhancement affected tissue for multiple sclerosis patients. The investigators hypothesize that Gadavist will reveal more tissue damage (lesions) than Magnevist and, therefore, may present a better tool for early diagnosis of brain damage. - The investigators' goal in this research project is to see if the newer contrast agent is able to detect changes and differentiate healthy from affected tissue in the white matter and gray matter earlier than current contrast agents so that detection can be possible before major damage occurs to the tissue. Each person will be scanned initially with one agent and then between 8 and 30 days later with the other agent. The MR data processing results will be compared to check the efficacy of each contrast agent.
The purpose of this study is to see if applying an anesthetic topical adhesive, Synera®, will reduce the injection pain. Relieving injection site pain may improve the tolerability of Multiple Sclerosis medications. Study Hypothesis: Pre-medication with Synera will have a significant effect on pain ratings as measured by the visual analog scale and Local injection site reaction scale.
This pilot study will compare how often people with multiple sclerosis (MS) fall before participating in the Free From Falls (FFF) educational program, during the program, and for 8 weeks after the program. The protocol will also evaluate the accuracy, efficiency and convenience of an email survey to count how often people fall.
The objective of this study is to determine the effect of home-based, aerobic exercise training on subclinical atherosclerosis and mobility disability in persons with Multiple Sclerosis (MS). Our central hypothesis is that aerobic exercise training reduces both subclinical atherosclerosis and mobility disability.
The main objective of this study is to evaluate the efficacy and tolerance of 2 years of treatment with cholecalciferol (vitamin D3) in patients with a clinically isolated syndrome at high risk for MS (CIS).
This study is a unique blend of new technologies never used in combination with individuals diagnosed with Multiple Sclerosis (MS). The results of this research will define changes in brain activity, functional brain activation and diffusion in the brain following 6 months of structured weight resistance and balance training. Positive changes would indicate that the therapy has ignited brain plasticity and may drive the brain to repair itself. These changes to the brain may affect recovery as a result of neuroplasticity, neuroprotection, and slowing of neural degeneration. No other trials have been published evaluating brain plasticity utilizing diffusion tensor imaging (DTI) and magnetoencephalography (MEG) in subjects with MS undergoing physical training. DTI has demonstrated the ability to find changes (plasticity) that occur in the brain and using the MEG findings to focus the DTI analysis will optimize the capacity to detect changes secondary to therapy. This quantification will give a better understanding of the repair that goes on in the brain, and may potentially revolutionize the field of the central nervous system (CNS) rehabilitation. One of the most innovative aspects of this study is the full integration of clinical neurobehavioral metrics and functional imaging data in conjunction with a proven MS therapy along with quality of life indicators. This approach will allow new links to be illuminated as the trajectories of functional and structural brain changes (neuroplasticity) are meshed with clinical improvement indices collected visit-by-visit. This study will also compare disease modifying treatments (DMTs) and their effect(s) on indices of brain plasticity and cognitive and behavioral assessments.
Multiple sclerosis - MS - affects 1.3m people worldwide, costing the European Union economy €9 billion/year, through both direct and indirect consequences of progressive disability. Despite the usual relapsing-remitting presentation, over 80% of patients develop progressive disability; 40% require a wheelchair within 10 years of diagnosis. At present, there are no treatments that reverse, halt or even slow progressive disability in MS. The investigators recently completed one of the first feasibility/safety trials in the world of reparative bone marrow cell therapy in 6 patients with longstanding MS (www.nature.com/clpt/journal/v87/n6/full/clpt201044a.html). Safety was confirmed, and intensive repeated tests on the patients measuring nerve conduction in various pathways in the brain and in the spinal cord showed statistically significant improvements at 12 months in every patient. While highly preliminary and involving only a very small number of patients, these results at least raise the possibility of a significant (though very partial) underlying repair effect within the damaged nervous system. The investigators believe this urgently requires further testing - both to accelerate benefit for patients, and to begin improving therapeutic efficacy. The investigators therefore propose a programme of translational and clinical stem cell research, aiming (1) to continue translation with a phase two controlled trial of bone marrow cells in patients with longstanding MS; and (2) to explore in parallel the potential mechanisms of action, by studying bone marrow cells from treated patients and control subjects, aiming to establish which of the various relevant bone marrow subpopulations contribute to efficacy, and which particular reparative mechanism(s) are important. The investigators hope these studies will not only confirm the therapeutic benefit of this approach, but also provide the basis for improving the magnitude and impact of this novel and exciting treatment modality.
The purpose of this study is to assess whether Multiple Sclerosis patients treated with Gilenya show a beneficial change over time in bone mass density and bone turnover markers as compared to matched controls treated with alternative FDA approved therapy or no therapy.
This is a 24-week phase 1b, randomized, double-blind, placebo-controlled, parallel-group, multicenter safety study comparing the tolerance profile of olesoxime (495 mg, od) when administered on top of Interferon beta in patients with stable Relapsing Remitting Multiple Sclerosis. Patients will be randomly allocated to olesoxime (495 mg, od) or placebo in a 1:1 ratio.
This is a 3-part study where Parts A, B (single-blind - investigator and subject blind) will enrol healthy volunteers and Part C (open-label) will enrol RRMS patients. Parts A (single ascending dose) and B (repeat ascending dose) will assess safety, tolerability, PK and PD of GSK2618960. Part C (repeat doses) will assess safety, tolerability, PK, PD, immunogenicity, paraclinical (magnetic resonance imaging [MRI] lesion counts) disease activity and markers of Th1 and Th17 mechanisms. Part A: Each of the 24 healthy volunteers (divided in 5 groups), will take part in only 2 of the planned 8 dosing sessions (A-active, P-placebo). Subjects in each group of Part A will be randomized in a 2:1:1 ratio to one of the following sequences: AA, AP or PA such that in each dosing session they will receive study treatment in a 3:1 ratio of active: placebo respectively. Part B: Dosing levels and regimen are dependent upon safety tolerability and PK/receptor occupancy (RO) data from Part A. In Cohort 1, 12 subjects will be randomized in a 3:1 ratio to A or P. Each subject will receive the same study treatment for repeated doses. If the duration of full RO from highest dose in Part A is less than 4 weeks, a second cohort of 12 subjects in Part B may be recruited, based on Dose Escalation Committee (DEC) decision Part C: The 20 RRMS patients will be assigned to active treatments for 2 to 4 repeated doses. Safety/tolerability and PK data monitoring and the decision to proceed to the next dose level of GSK2618960, and the decisions to proceed to Part B and Part C of the study will be made by a dose escalation committee.