View clinical trials related to Sclerosis.
Filter by:The primary objective of the study is to describe absolute lymphocyte count (ALC) reconstitution after Dimethyl fumarate (DMF) discontinuation, in Relapsing-Remitting Multiple Sclerosis (RRMS) participants with lymphopenia. The secondary objectives of the study are characterization of lymphopenia in overall population; characterization of lymphopenia in participant with DMF discontinuation ; description of the evolution of ALC during DMF treatment; description of the time to reach a discontinuation of DMF treatment; exploration of the time to reach clinical outcomes (Expanded Disability Status Scale [EDSS] and relapse) according to lymphopenia; description of the event rate of the serious or opportunistic infections in overall population from DMF initiation and according to DMF discontinuation and lymphopenia; description of the event rate of serious and opportunistic infections in overall population from DMF initiation and according to lymphopenia; estimation of the associations between the baseline demographic and clinical characteristics and the risk to reach a lymphopenia; estimation of the associations between the baseline demographics and clinical characteristics and the risk to reach an ALC reconstitution after DMF discontinuation in participants with lymphopenia; and investigation of the changes of absolute cluster of differentiation 4 (CD4) and cluster of differentiation 8 (CD8) count in overall population on DMF if available.
The Main Hypothesis of this extension trial is that among those who have successfully discontinued their DMT as part of the DISCOMS trial (i.e. did not have a new MS relapse or brain MRI lesion) and remain off DMT after DISCOMS are at no greater risk of new or worsened MS disease activity compared to those who successfully continued their DMT as part of DISCOMS and remain on DMT, each assessed at least one year after termination of the primary DISCOMS study.
Extracorporeal photopheresis (ECP), also known as extracorporeal photoimmunotherapy or photochemotherapy, is a leukapheresis-based therapy that has been in clinical use for over three decades after receiving FDA approval in 1988. Extracorporeal photopheresis was initially used for the treatment of T-cell lymphoma. Since its introduction, indications for initiating ECP were continuously extended to the treatment of Graft-versus-Host Disease (GvHD), systemic sclerosis, and in the field of solid organ transplantation. There is also evidence supporting the use of ECP in generalized morphea, a form of scleroderma limited to the skin, and in eosinophilic fasciitis, which is a rare, localized fibrosing disorder of the fascia. Concluding the results of the published studies, there is evidence that ECP has a positive effect on fibrosing disorders of the skin. Furthermore, in clinical practice, it has been observed that patients with systemic sclerosis, who undergo ECP treatment, show improvement of the skin lesions or a deceleration in the formation progress of such lesions during the therapy. Same findings can be observed in patients with sclerotic skin lesions of the skin, for example in the context of a GvHD. There are no clinical studies so far that describe these processes using objective measuring methods. Furthermore, the mechanism of action of ECP in systemic sclerosis and other fibrosing disorders with skin manifestations, has not yet been conclusively clarified. Serological markers for monitoring the progress of the therapy and determining the prognosis are also missing. Thus, a consensus regarding the frequency and duration of ECP for the therapy of systemic scleroderma or sclerotic diseases has not yet been reached. This study aims at evaluating the influence of Extracorporeal Photopheresis on the quality and functionality of sclerotic skin lesions assessed by several objective methods. Furthermore, potential biomarkers, which are being investigated in current studies, are to be determined in order to evaluate the influence of ECP on those biomarkers and better understand the mechanism of action of ECP on systemic sclerosis and fibrosing disorders involving the skin.
Optimal trunk control relies on somatosensory, motor and musculoskeletal integrity, which is often damaged in multiple sclerosis (MS). Researches on postural control in people with MS (PwMS) have revealed that reduced somatosensory conduction may adversely affect some functions. PwMS have increased postural sway in upright posture than healthy people. They move closer and slower when reaching out or taking a step. Trunk controls are weak and postural responses are delayed. The activation of core muscles is very important for an effective trunk control. Because the core region is considered a kinetic link that facilitates the transfer of torque and angular momentum between the upper and lower extremities during body movements. The decrease in core stability affects both trunk control and the quality of limb movements due to the kinetic chain in the body. There are a limited number of studies in the literature showing that core stability is reduced in PwMS. Our knowledge about the effects of this reduction on function in PwMS is very limited.
Multiple Sclerosis (MS) is a chronic inflammatory disease leading to the demyelination of the central nervous system. Promoting physical activity has gathered attention as an effective means to improve health-related quality of life and to mitigate symptoms such as fatigue and depressive symptoms in individuals suffering from MS. However, persons suffering from MS often experience difficulties in staying active. A comprehensive understanding of barriers to staying physical active for persons with MS in Switzerland is currently lacking. Given the importance of physical activity in the context of MS a detailed understanding of this matter would be key for future research and treatment. A key challenge when studying physical activity in the context of MS is to obtain objective and accurate measurements that are not prone to reporting bias. While accelerometer-based measurements hold promise in this regard they are not convenient for routine implementation in real-world environments. Initial research has identified consumer-grade wearables such as Fitbits as a promising alternative whereby focusing on the main outcome average step count. Given the rich detail of activity patterns that can be derived from such devices, research has so far underutilized the available information that has the potential to provide more comprehensive insight into this matter. Objectives: The present project aims to determine the common factors in real-life settings limiting physical activity in persons with MS and the impact of these barriers on physical activity. Further, the present study aims to provide precedence for future research investigating physical activity in MS by examining the quality, reliability, internal consistency, and validity of PA metrics derived from the wide-spread consumer-grade activity tracker Fitbit in comparison to an accelerometer.
The primary objective of this study is to determine the safety, and evaluate the efficacy of GS-248 versus placebo on Raynaud's Phenomenon (RP) in subjects with Systemic Sclerosis (SSc).
MS is characterized by clinical symptoms caused by lesions of the brain, spinal cord, or optic nerves that can affect balance, gait, and risk of falls. 50-80% of patients with MS have different levels of balance-related pathological findings. In addition, the imbalance is one of the most complained about findings by MS patients. Balance and postural control disorders are the most common signs in patients with cerebellar tract damage. Many patients have reported problems with balance and gait causing serious disability. Therefore, disorders of balance and postural control in patients with MS are associated with difficulty in standing and performing functional activities. Effective quantitative methods are needed to assess postural imbalance to help clinicians assess the progression of this disorder. Current literature suggests that home tele-rehabilitation and tele-medicine practices may be an alternative method effective enough to be equivalent to face-to-face physiotherapy treatments for patients with Ms. The advantages of Tele-medicine over normal care include increased social support, participant engagement, quality of care, cost-effectiveness, access to services (due to lack of transportation), and reducing the burden on healthcare professionals to make services easier to deploy. In cases such as Pandemic conditions, where face-to-face service is disrupted in clinics, tele-rehabilitation can be applied as a suitable alternative treatment method accessible to patients. The effectiveness of Tele-rehabilitation raises the question of whether tele-evaluation is as effective and accurate as in the clinic. Studies examining the effectiveness of Tele-assesment are still insufficient. The study is planned to address this deficiency. The aim of this study is to compare the results of MS patients by applying valid and reliable methods used in balance assessment with face-to-face and online access methods, thereby investigating the effectiveness of balance assessment through online access. The hypothesis in this study is that the results of the balance assessment with online access in MS patients will be consistent with the results of the balance assessment conducted face-to-face. H0: Tele-assessments of balance do not give the same results as face-to-face balance assessments in MS patients. H1: Tele-assessments of balance do not give the same results as face-to-face balance assessments in MS patients.
The aim of the study is to report the results of manual dexterity using the Minnesota Manual Dexterity Test in people with Multiple Sclerosis.
This study will test a new technique for improving balance while walking in people with multiple sclerosis (MS). The technique focuses on having people with MS safely practice walking on simulated, uneven terrain that challenges balance and more accurately mimics walking in the community. The goal is to improve balance while walking in order to improve mobility and decrease the risk of falls. Recently, we developed a state-of-the-art treadmill system that allows us to create a challenging walking environment by placing a treadmill onto a motion base. We are able to simulate uneven terrain through movements of the walking surface while maintaining a safe walking environment. We will use this system to conduct tests of balance while walking and to train people to walk on uneven surfaces. Our objective is to evaluate the use of uneven terrain for training gait and balance in people with MS. Participants will undergo a four-week training protocol designed to disrupt and challenge balance while walking. We anticipate that training on uneven terrain will enhance gait stability, improve overall walking function and balance and increase balance confidence compared to training on a stable surface.
Inclusion visit (D0): - verification of inclusion and non-inclusion criteria - information and collection of consent - standard imaging protocol prescribed as part of the usual treatment: sagittal T1 and T2 slices after injection of contrast product (Gadolinium), o 3D STIR sequence. - 3D PSIR sequence at the level of the cervical cord for the duration of the additional sequence is 10 minutes, for a total examination time of 45 minutes (instead of 35 minutes).