Active clinical trials for "Multiple Sclerosis"

Multiple Sclerosis (MS) is an inflammatory disease of the brain leading to disability. Brain MRI is very useful for MS diagnosis but prognostic biomarkers are still needed. New therapies are also expected to improve MS care. Cytokine arrays provide measure of many different inflammation-related molecules that could help understanding the disease. Moreover, individual prognosis could be linked with the level of such molecules in the CSF of MS patients. The investigators will analyze the cytokine profile of MS and control patients CSF to determine a specific profile of MS and look for prognosis implication in a cohort of patients with clinically isolated syndromes (first manifesatation of MS).

Multiple Sclerosis (MS) can be associated to many psychological symptoms. One of the most relevant is the experience of distress related to the disease, that can lead to the development of Post Traumatic Stress Disorder (PTSD). As far as we know there are no studies on the efficacy of psychological treatments in MS in spite of its relevance for patients' quality of life. Primary aim is to evaluate the efficacy of the treatment with Eyes Movement Desensitization and Reprocessing(EMDR) in PTSD secondary to MS. EMDR is the elective treatment (together with Cognitive Behavioural Therapy) for PTSD according to international guidelines. The secondary aims are to evaluate the efficacy of EMDR on the PTSD-associated symptoms of anxiety and depression and Quality of Life. The study design is a randomized clinical trial. Sixty patients with MS and PTSD will be pre-screened by using the IES-R and the Clinician Administered PTSD Scale. The patients will be randomized in two groups (30 in the experimental group and 30 in the control group).The psychological assessment will be performed in both groups with the same timing and tools: at baseline (T0), after treatment (T1) and 6 months later (T2) by two trained clinical psychologists (independent and blind to treatment) with the CAPS and the administration of self reports: Trauma Antecedent Questionnaire, Chicago Multiscale Depression Inventory, Hospital Anxiety and Depression Scale and Functional Assessment of Multiple Sclerosis. The experimental group will undergo 10 weekly sessions of 60 minutes each with EMDR following Shapiro's protocol for traumatic events. The efficacy will be evaluated comparing the results between T0, T1 and T2 and comparing the scores of the experimental and the control groups. Primary outcome measures will be: 1) the proportion of participants at T1 and T2 no longer meeting the Diagnostic and Statistical Manual (DSM IV-TR) diagnostic criteria for PTSD; 2) the reduction of CAPS scores for the four PTSD dimensions from pre-treatment to post-treatment evaluation and follow-up (avoidance, reexperiencing the traumatic event, hyperarousal and numbing). Secondary outcome measures will be: comparison of the scores of CMDI, HADS and FAMS of the two groups at T0, T1 and T2. The statistical procedure applied will be a repeated measures analysis of covariance both on the primary outcome continuous measures and on the secondary ones.

Spasticity - movement disorder, which is part of the syndrome of defeat top motor-neuron, characterized by the rate-dependent increase in muscle tone and increased dry-core reflections from hyperexcitability of stretch receptors (Lance, 1980). Spasticity - a frequent symptom of neurological diseases (Valero-Cabre, Pascual-Leone, 2005) and may be accompanied by such a disorders consequences of stroke, multiple sclerosis, head trauma and spinal cord, cerebral palsy, etc. The magnitude and severity of spasticity depends on the level of the lesion, the duration of its existence from the time before the disease, and possible plastic changes in axons and synapses on the affected level. There are two basic models of spasticity: cerebral (hemiplegic) and spinal (paraplegicheskaya) (Nikitin, 2005). Cerebral model appears with the direct injury of the brain and is characterized by increased excitability of monosynaptic reflexes with the rapid development of pathological ref-plexes and characteristic hemiplegic posture. Model is characterized by spinal spasticity opposite lower segmental inhibition polysynaptic reflexes slow increase of nervous excitability due to the mechanism of cumulative excitation perevozbuzhdeniem flexor and razgibate-ing, as well as expansion of the area of segmental responses (Nikitin, 2005). As spinal and cerebral spasticity are extremely difficult corrected by standard medical clinic and physiotherapy methods. In this regard, in the world literature actively searched for addi-tional search correct this symptom. A new modern methods that could affect the syndrome of spasticity is rhythmic transcranial magnetic stimulation (Mori et al., 2009).

In multiple sclerosis (MS) sub cortical cognitive impairments are frequently reported. Nevertheless, cortical cognitive troubles, with hippocampic memory troubles have been described. Besides inflammatory damage, early cortical and degenerative damage are well known. In neurodegenerative diseases, three biomarkers of the cerebro spinal fluid (CSF), reflecting lesional mechanisms, are measured: the beta amyloid peptide, the tau total protein, and the phospho tau protein. Preliminary studies shown increased level of tau in MS. No study compare cognitive impairment and biomarkers of CSF.The aim of this study is to measure in the CSF of MS patients these three biomarkers (beta amyloid peptide, tau total and phosphotau) in order to establish correlations between a profile of biomarkers and a pattern of cognitive troubles, cortical or subcortical.The possibility to show, in MS patients with memory hippocampic troubles, a profile of biomarkers closed from the one encountered in AD, could argue in support of the degenerative hypothesis in MS and lead to discuss the interest of the use of AD treatment in MS.

The efficacy of oral corticosteroids for the treatment of relapses of multiple sclerosis has not been proved. French neurologists treat such patients with intravenous corticosteroids. The aim of the study is to check if the efficacy of high dose oral methylprednisolone is similar to the efficacy intravenous (IV) prednisolone. The main criteria of efficacy is symptom recovery within 28 days after inclusion.

RTL1000 is a new agent that has not been previously tested in humans. It is thought that RTL may specifically control the abnormal immune response or attack against the insulation on the nerves that occurs in multiple sclerosis. The purpose of this study is to evaluate the possible side effects of a single intravenous dose of RTL1000 in subjects with multiple sclerosis. Some subjects will also be asked to participate in one or both of two substudies, one to test blood samples to see how the body's immune system responds after administration of RTL1000, and the other to test blood samples to see how the body absorbs and eliminates the RTL1000.

Clinical and experimental evidences suggests an immunomodulatory effect of sex hormones in multiple sclerosis. The role of oral estroprogestins in the pathogenesis and in the clinical course of the disease is actually unknown. The aim of the study is to investigate safety and tolerability of association of estroprogestins in two different doses with interferon-beta 1a in patients with relapsing-remitting multiple sclerosis.

OBJECTIVES: I. Evaluate the effectiveness of plasma exchange in the treatment of acute severe attacks of inflammatory demyelinating disease in patients who have failed intravenous steroid therapy.

The purpose of this study is to determine whether Dysport® (abobotulinumtoxinA) injections for lower extremity spasticity showed a significant reduction of lower extremity spasticity after being injected with Dysport® (abobotulinumtoxinA) in patients with MS.

Determine the effects of Apitox add-on therapy on the progression of disability in all forms of multiple sclerosis (MS) utilizing the Expanded Disability Status Scale (EDSS) and the MS Functional Composite (MSFC) measure. b. Evaluate the safety and tolerability of add-on Apitox therapy for the treatment of patients with all forms of MS: relapsing-remitting MS (RRMS), primary progressive MS (PPMS) and secondary progressive MS (SPMS). The