Evaluation of clINical reCovery After a Relapse: a Pilot Study assEssing the Neuronal Effects of D-Aspartate in RR-MS Subjects Treated With IntErferon Beta 1a 44 mcg TIW (INCREASE)
The purpose of this study was to evaluate the improvement in spontaneous recovery from clinical deficits at the time of an acute relapse in RR-MS participants already receiving interferon (IFN) beta 1a with D-aspartate (versus placebo) as add-on therapy.
NCT03387046 — Multiple Sclerosis, Relapsing-Remitting
Status: Terminated
http://inclinicaltrials.com/multiple-sclerosis-relapsing-remitting/NCT03387046/
Impact of Vitamin D Supplementation in Patients With Multiple Sclerosis
Vitamin D is important risk factor for developing multiple sclerosis (MS) and for disease progression. Patients with MS who had lower vitamin D levels were at increased risk for more clinical attacks and faster disease progression. It was also shown that patients with MS had lower vitamin D levels in serum than healthy controls. It is not clearly defined, which are the levels of vitamin D in serum, that are high enough to trigger immunomodulatory effect and are safe for patients. This double-blind randomized clinical trial was designed to compare impact of vitamin D supplementation in two different doses (1000 IU/day vs 4000 IU/day) in patients with relapsing remitting MS. The main goal of this trial is to compare dose response on vitamin D supplementation and to estimate more closely appropriate level of vitamin D in serum which triggers some of experimentally shown immunomodulatory actions.
NCT03385356 — Vitamin D Deficiency
Status: Completed
http://inclinicaltrials.com/vitamin-d-deficiency/NCT03385356/
Benefits of Drug Risk Aversion Calculation to Multiple Sclerosis Drug Choice and Patient Self-efficacy
The investigators seek to determine if the use of a Side Effect Aversion Calculator helps patients with multiple sclerosis (MS) more comfortably and rapidly identify the disease modifying drug (DMD) that is best suited for the patient.
NCT03375541 — Multiple Sclerosis
Status: Withdrawn
http://inclinicaltrials.com/multiple-sclerosis/NCT03375541/
Multiple Sclerosis Registry in Argentina (RelevarEM)
The main reason for RelevarEM project is the creation of a registry based on a web platform to facilitate the collection of epidemiological data of multiple sclerosis patients from multiple sources in Argentina. The platform will provide the data in a global way that will show the frequency and distribution of the disease in our environment at low cost.
NCT03375177 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT03375177/
A New App Home Based Dexterity Training in Multiple Sclerosis: a Randomized Controlled Trial
Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system and the most common cause of non-traumatic disability in young adults (Kamm et al. 2014; Vanbellingen & Kamm, 2016). It is a heterogeneous disease, which is associated with long-term disability, leading to reduced quality of life (QoL). Disease-modifying pharmacological therapies (DMT) decrease activity and progression of the disease, and symptomatic pharmacological treatments reduce complaints to a certain extent, however MS patients often still suffer from various neurological deficits during the course of their disease (Kamm et al. 2014). Consequently, specific non-pharmacological therapies are needed in order to further reduce disability, eventually resulting in better QoL (Lamers et al. 2016; Vanbellingen & Kamm, 2016). Impaired dexterity is a frequently observed impairment, affecting up to 76% of patients with MS (Johannson et al. 2007). The different neurological deficits caused by MS, such as ataxia, spasticity, sensory-motor deficits, and apraxia may be alone or in combination, impair manual dexterity (Kamm et al. 2012; Heldner, Vanbellingen et al. 2014). MS patients experience impairments in the performance of several activities of daily living (ADL), such as grooming, cooking, etc. Sometimes these problems are even associated with loss of work, and lack of social integration (Chruzander et al. 2013). The effectiveness of the app based exercises still needs to be proven. With respect to dexterity, a first new app has been developed called "Finger Zirkus", by a team of experts including an occupational therapist, graphic designer, and IT expert. The app is already available to be downloaded from google play store or apple store (see for more details: www.fingers-in-motion.de).
NCT03369470 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT03369470/
Wearable Biosensor to Track and Quantify Limb Dysfunction in Multiple Sclerosis Patients
Multiple sclerosis (MS) is a leading cause of neurological injury in young adults. Capturing the extent of multiple domains of MS-related disability is critical for effective clinical care and the development of new paradigms for patient-focused therapeutic approaches. To date outcomes research in MS has centered on clinical exams, which may be insensitive over the short term (the 1-2 years of early stage clinical trials) and only capture a single snapshot of the patient's performance. With the mass production of sensors in the gaming and computer control industry, there is an opportunity to transform the traditional neurological exam with biosensors already in use outside the realm of health applications. The investigators herein propose to use a commercialized wearable electroMYOgraphy sensor (MYO,Thalamic Labs Inc, Kitchener, ON, Canada) for detection of upper and lower limb dysfunction in MS patients. The investigators will determine if the device can differentiate the diseased states, refine signal processing algorithms to create reliable outcomes using this device in MS patients, and determine if these outcomes are strongly associated with patients and physicians reported ambulatory and dexterity metrics. The investigators hypothesize that this digital technology may be introduced in the standard neurological exam technique in a non-disruptive manner and more accurately and potentially remotely detect both physician-reported and patient-reported disability. In the scope of this study, the investigators will also develop signal processing methodology to comprehensively track ambulation features.
NCT03369171 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT03369171/
Mechanisms of Disease Severity in Multiple Sclerosis: an Integrative Multimodal Study
This study will identify a combination of disease severity markers (genetic, immunology, epigenetic, imaging) associated with disease severity and progression in a cohort of patients with multiple sclerosis.
NCT03369106 — Multiple Sclerosis
Status: Not yet recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT03369106/
Effect of Photobiomodulation Treatment in the Sublingual Region and Along the Spinal Column in Individuals With Multiple Sclerosis: Protocol for a Randomized, Controlled, Double-blind, Clinical Trial
Background: Multiple sclerosis (MS) is an autoimmune disease, for which the forms of treatment are medication and rehabilitation. However, in vitro and in vivo studies have demonstrated that photobiomodulation can be an effective treatment modality for inflammatory diseases, including MS. Photobiomodulation has a broad range of benefits, such as the avoidance of cell and tissue death, the stimulation of healing and injury repair, reductions in pain, edema and inflammation, cell proliferation and even apoptosis. The outcomes of photobiomodulation include the regeneration of cells, the stimulation of the growth of Schwann cells, a reduction in spasticity, functional improvements, a reduction in nitric oxide levels and the upregulation of the cytokine IL10, demonstrating that this therapeutic modality can offer neuro-protection. Methods: A randomized, controlled, double-blind, clinical trial is proposed. The patients will be divided into six groups. Groups 1 and 2 will receive sham and active photobiomodulation in the sublingual region, respectively. Groups 3 and 4 will receive sham and active photobiomodulation along the spinal cord, respectively. Group 5 will receive placebo treatment with photobiomodulation on the skin in the region of the radial artery with a specific bracelet. Group 6 will be treated with photobiomodulation on the skin in the region of the radial artery with a specific bracelet. Discussion: Treatment for MS is directed at the immune response and slowing the progression of the disease. This is one of the first clinical trials with sublingual and along the spinal cord photobiomodulation, which could help establish a new, promising treatment of the disease associated with pharmacological treatment.
NCT03360487 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT03360487/
Pediatric Multiple Sclerosis in Egypt. A Multi-center Registry of 186 Patients
A medical record review of historic and current information on 237 patients attending 5 tertiary referral centers [Kasr Al-Ainy Multiple Sclerosis Research Unit (KAMSU) - Cairo University Hospitals, Abo El Reesh Pediatric Hospital and 3 private centers] in Cairo, Egypt from period between 2011 and December 2015. Initially, medical records of 251 patients with the first acquired demyelinating events started before age of 18 years were reviewed. Fourteen patients (5.58%) were excluded due to missing data that could not be obtained.
NCT03360188 — Multiple Sclerosis in Children
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis-in-children/NCT03360188/
Prognostic Value of Three New Biomarkers of Multiple Sclerosis Compared to Reference Biomarker in Patients With Radiologically Isolated Syndrome
To look at the prognostic value of new biomarkers in CSF and serum for characterisation of multiple sclerosis
NCT03357887 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT03357887/