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Sclerosis clinical trials

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NCT ID: NCT03774407 Completed - Multiple Sclerosis Clinical Trials

Vaginal Estriol in Multiple Sclerosis

Start date: June 20, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Study to evaluate the efficiency of vaginal estriol, as a treatment for urogenital symptoms in female patients with RRMS. The secondary objective is to evaluate the potential role of vaginal estriol in re-myelination in RRMS patients.

NCT ID: NCT03768830 Completed - Pain Clinical Trials

Impact of Exercise on "Invisible" Symptoms and Quality of Life in Multiple Sclerosis Individuals

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

Patients with multiple sclerosis (MS) struggle on a daily basis with accompanying, "Invisible" symptoms like primary fatigue, pain and emotional-cognitive disorders. With the disease progression, these symptoms only intensify, and in combination with basic physical symptoms, quality of life (QOL) rapidly decreases. An important goal of researchers and clinicians involves improving the QOL of individuals with MS, and the exercise therapy represents potentially modifiable behavior that positively impacts on pathogenesis of MS and these "Invisible" symptoms, thus improving the QOL. However, the main barrier for its application is low motivational level that MS patients experience due to fatigue with adjacent reduced exercise tolerability and mobility, and muscle weakness. Getting individuals with MS motivated to engage in continuous physical activity may be particularly difficult and challenging, especially those with severe disability or Expanded Disability Status Scale (EDSS 6-8). Till now, researchers have focused their attention mainly on the moderate or vigorous intensity of exercise and on cardiorespiratory training in MS patients to achieve improvements in daily life quality, less indicating the exercise content, and most importantly, breathing exercises. In addition, it is investigators intention to make exercise for MS patients more applicable and accessible, motivational and easier, but most important, productive. Investigators think that MS patients experience more stress with aerobic exercise or moderate to high intensity program exercise, and can hardly keep continuum including endurance exercise, or treadmill. Hypothesis: Investigators hypothesis is that 8-weeks of continuous low demanding or mild exercise program with the accent on breathing exercise can attenuate primary fatigue, pain, headaches, emotional-cognitive and sleep dysfunctions in MS patients and provide maintenance of exercise motivation. Investigators also propose that important assistant factor for final goal achievement is social and mental support of the exercise group (EDSS from 0-8) led by a physiotherapist. This will help to maintain exercise motivation and finally make better psychophysical functioning, and thus better QOL.

NCT ID: NCT03766698 Completed - Multiple Sclerosis Clinical Trials

Muscle Architecture of Lower Extremity In Multiple Sclerosis

Start date: December 18, 2018
Phase:
Study type: Observational [Patient Registry]

The aim of this study was to determine the muscle architecture of the lower extremity muscles (pennation angle, muscle fiber length and muscle thickness) in patients with multiple sclerosis. Lower extremity muscles of patients with multiple sclerosis and healthy individuals; rectus femoris, biceps femoris, tibialis anterior, gastrosoleus and gastrocnemius muscles will be examined by ultrasound method.

NCT ID: NCT03758820 Completed - Fatigue Clinical Trials

Behavior Cognitive Therapy on Fatigue Impact in MS Patients

Start date: May 31, 2017
Phase: N/A
Study type: Interventional

Multiple sclerosis (MS) is a chronic inflammatory disease that leads to demyelination of the central nervous system. Fatigue is one of the most frequent and most disabling symptoms of MS. Up to 86% of individuals with MS experience fatigue at any one time; 65% consider it to be one of their three most troubling symptoms. Fatigue may limit or prevent participation in dayly activities and reduce psychological well-being (1, 2). Pharmacological and non-pharmacological treatments are available for MS-related fatigue, but evidence on effectiveness is mostly inconclusive or non-existent. The psychological approaches of fatigue management are interesting. To date, three RCTs using cognitive-behavioral group-based approaches in MS fatigue management programs have demonstrated their effectiveness (3-6). The results demonstrated a reduction in fatigue scores and better self-management of the disease in general. However, if these programs are effective at the time of their application and in the medium term, the issue of maintaining long-term therapeutic benefits is problematic. The aim of this research is to assess the effectiveness of the FACETS program (6), on a population of French patients with RRMS over a 18 month period. This program focuses on the management of fatigue and is based on a conceptual framework that incorporates elements of cognitive-behavioral, self-efficacy, self-management and energy effectiveness theories. It consists of six once-weekly sessions of 90 minutes, with homework activities between the sessions. It is designed for groups of 6 to 10 people. The investigators propose to add 4 booster sessions to the FACETS program, at week 6, 12, 18 et 36 after the end of the program, in order to activate and reinforce the cognitive and behavioral processes and enhance the benefits of FACETS in the longer term. This trial is randomized controlled comparative comparing a group receiving a FACETS program with a group receiving only a current local practice. Socio-demographic and medical data are measured as well as fatigue impact, fatigue severity, anxiety and depression, sleep disorder and quality of life. The expected results are a significantly greater decrease in fatigue severity and impact in the FACETS group than the control group post intervention and this difference will be maintained at 1 year.

NCT ID: NCT03757065 Completed - Multiple Sclerosis Clinical Trials

Cell Surface Marker Expression in Autoimmune Diseases

CASCADE
Start date: June 12, 2019
Phase:
Study type: Observational

This study is designed to explore the expression of cell-surface markers in the following seven disease areas: (a) systemic lupus erythematosus, (b) Sjogren's syndrome, (c) multiple sclerosis, (d) systemic sclerosis, (e) Crohn's disease, (f) ulcerative colitis and (g) inflammatory myositis.

NCT ID: NCT03756974 Completed - Clinical trials for Spasticity Due to Multiple Sclerosis

BX-1 in Spasticity Due to Multiple Sclerosis

Start date: February 18, 2019
Phase: Phase 3
Study type: Interventional

To investigate the efficacy and safety of orally administered BX-1 compared to placebo in patients with spasticity due to multiple sclerosis not sufficiently controlled by current anti-spasticity medication

NCT ID: NCT03756142 Completed - Multiple Sclerosis Clinical Trials

Biomechanical Characterization of the Locomotion in Multiple Sclerosis Patients

WALKING-SEP
Start date: November 19, 2018
Phase:
Study type: Observational

Multiple sclerosis (MS) is an inflammatory chronic disease of the central nervous system. Patients are suffering from balance and gait impairments at the early stage of the disease. 85 % of the MS patients report gait disorders, which impact their autonomy and their quality of life and increase the risk of fall. The three-dimensional analysis of the walking by a motion capture system associated with force platforms allows the quantification of the complex walking disorders, to look for the cause, as well as side effects such as compensation strategies. According to the 2006 report of the French National Authority for Health, the 3D analysis of walking is essential in chronic pathologies to evaluate and quantify gait disorders. This analysis allows the functional follow-up of the patients throughout their rehabilitation. Some studies, on a small and heterogeneous population of MS patients, showed changes during the walking concerning spatiotemporal, kinematic, dynamic parameters and muscular activation of lower limbs at early stages of the disease. Only two studies evaluate the joint power during walking in MS patients. However, these studies have some limits. The 3D analysis of the walking proposed in this study would allow the biomechanical characterization of the gait impairments of MS patients through tasks such as walking, gait initiation and orthostatic posture. This methodology would contribute to adapt treatments and the rehabilitation care, at an early stage of the disease. From a functional point of view, the gait initiation is an interesting dynamic task to be evaluated. Indeed, it represents the transition between the upright posture and the stabilized walking. Throughout this complex task, a stereotypical motor program is set up during a first phase of anticipatory postural adjustments, which allows the creation of dynamic conditions essential for the execution of the first step. The gait initiation is little documented for MS patients despite the risk of fall clinically highlighted. The articular power during the gait initiation was never estimated in MS patients. On the other hand, there is no study establishing correlations between the Expanded Disability Status Scale functional features and the impairments of the gait initiation.

NCT ID: NCT03752307 Completed - Multiple Sclerosis Clinical Trials

Safety and Tolerability of ISX (Isoxsuprine HCL) in MS Relapses

Start date: February 15, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This is a proof of concept, randomized, double-blind, placebo-controlled, 2-arm, parallel group study of Isoxsuprine in MS subjects experiencing a typical relapse. Evidence from preclinical stroke models and experimental allergic encephalomyelitis suggest that isoxsuprine hydrochloride may have neuroprotective activity and reduce disability in animal models. Given its potential neuroprotective effects in CNS injury models, the investigators propose to test it as a safe, tolerable add on treatment for acute relapses in patients with relapsing forms of MS.

NCT ID: NCT03750097 Completed - Multiple Sclerosis Clinical Trials

Validation of a Smartwatch in Persons With Multiple Sclerosis

Start date: May 1, 2018
Phase: N/A
Study type: Interventional

The study is designed to validate the accuracy of steps detected by a commercially available smartwatch in persons with multiple sclerosis. Specifically, the investigators examine whether a smartwatch can detect steps accurately during slow, comfortable and fast overground walking. The total steps counted by the smartwatch will be compared to those counted by an accelerometer commonly used in clinical studies and the actually walked steps.

NCT ID: NCT03745144 Completed - Clinical trials for Relapsing Multiple Sclerosis (RMS)

Effects of Cladribine Tablets on the PK of Microgynon®

Start date: January 17, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study was to investigate the potential effects of cladribine on the pharmacokinetics (PK) of monophasic oral contraceptive microgynon® by assessment of its constituents, ethinyl estradiol (EE) and levonorgestrel (LNG).