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Multiple Sclerosis clinical trials

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NCT ID: NCT05057338 Enrolling by invitation - Multiple Sclerosis Clinical Trials

Functions, Physical Activity and Employment for Individuals With MS: A Pilot Feasibility Study

CoreDISTp
Start date: August 27, 2021
Phase: N/A
Study type: Interventional

Multiple Sclerosis (MS) is a chronic disease affecting young adults. Impaired balance, walking, reduced physical activity and participation in employment are common, however, less integrated in the health care. The researchers have developed a multidisciplinary intervention and pathway delivered across health care levels targeting the promotion of balance, walking, physical activity and participation in employment. The research team will perform a pilot feasibility Randomized Controlled Trial (RCT) and interviews to investigate the feasibility of the new intervention compared to a standard care for individuals with lower levels of disability.

NCT ID: NCT04979650 Enrolling by invitation - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

Corticosteroid Effects on Asymptomatic Gadolinium-enhancing Lesions in Multiple Sclerosis

Start date: May 22, 2021
Phase: Phase 2
Study type: Interventional

to determine the rate of asymptomatic gadolinium-enhancing lesions conversion to the non-enhancing black hole (neBHs) with or without corticosteroid pulse therapy in patients with RRMS, and to analyze if treatment of asymptomatic gadolinium enhancement lesions has any effect on the expanded disability status scale. The study is performed in the MS clinic of Bu Ali Sina Hospital in Sari and Mazandaran University of Medical Sciences. 104 recurrent MS patients are admitted based on the admission criteria. They are divided into two groups of intervention and control based on a simple randomization block. The intervention group received 1 gram of methylprednisolone in 500 ccs of normal saline for 5 days and the control group received only 500 ccs of serum. After 6 months, a new MRI is taken from the patients and the possibility of asymptomatic active plaque conversion with or without intervention is compared in the two groups, as well as the amount of EDSS in the two groups. They do not know whether the patient is in the control group or the intervention.

NCT ID: NCT04887051 Enrolling by invitation - Multiple Sclerosis Clinical Trials

The Effects of Respiratory-based Telerehabilitaion in Patients With MS

MS
Start date: April 16, 2021
Phase: N/A
Study type: Interventional

During the pandemic, it is important for people who are isolated in their homes to stay inactive and exercise exercises in order to prevent their complaints from increasing due to inactivity. Individuals with multiple sclerosis are outpatient or inpatient with home exercise programs besides the rehabilitation practices. They are being monitored. It has been reported the rehabilitation of individuals is that they need to comply with their home exercise programs in order to contribute. However, very limited research studies suggest that any method can be used as home exercise has examined whether it has increased compliance with the program. However, examining the factors affecting the compliance of individuals with Multiple sclerosis to the home exercise program. The study was not found either. Exercise through tele-rehabilitation in individuals with multiple sclerosis in previous studies where their education contributed to the physical performance of patients shown. However, these studies are based on individual neurorehabilitation models. In the literature, the use of video-based exercise training in MS patients a study showing increased performance as well as increased participation in the home program available. However, in this study, a special program was applied to the individual and it is not a respiration-based program. There is no research on web-based group activity training in the field.

NCT ID: NCT04863586 Enrolling by invitation - Multiple Sclerosis Clinical Trials

COVID-19 and Multiple Sclerosis Disease Modifying Therapies

Start date: April 1, 2021
Phase:
Study type: Observational

The COVID-19 pandemic is a major concern for people on long-term treatments that modify the immune system function. People with multiple sclerosis (pwMS) form a large group who receive such treatments called disease modifying therapies (DMTs). Several types of DMTs with different effects on the immune system are being used for multiple sclerosis (MS). In the absence of large-scale national studies, the risk of COVID-19 among pwMS on various DMTs has not been established. A few physician-reported registry-based studies have suggested that anti-CD20 monoclonal antibodies, such as ocrelizumab and rituximab, used in the treatment of MS can increase the risk of COVID-19. However, in our community-based COVID-19 study of a large cohort of pwMS as part of the UK MS Register, we could not demonstrate an association between DMTs and susceptibility to COVID-19. Other studies have not found any relationship between DMTs and the outcome of COVID-19 among pwMS. To our knowledge, UK is the only country in the world that collects national data on DMT use, providing us with the opportunity to investigate the impact of DMTs on COVID-19 susceptibility and severity in a large population of pwMS. In England, no DMT is being dispensed without prior approval and specialised commissioning by the national Health Services (NHS) England & NHS Improvement (NHSE/I). The scheme, currently implemented in over 100 NHS Trusts in England, ensures that treatment decisions are made in line with agreed commissioning policy and are evidence-based. NHSE/I also has access to Public Health England (PHE) held data on all people who have had a SARS-CoV-2 test. By identifying all pwMS on DMTs and all those who have had a test for coronavirus and collecting data on the clinical outcome of their COVID-19 from their local NHS hospitals, we would be able to establish the risk of COVID-19 and the risk of contracting the infection associated with different DMTs. The findings of the study will help MS clinical teams address the concerns of pwMS about taking DMTs during the COVID-19 pandemic and update their guidelines on the measures pwMS need to take during these unprecedented times.

NCT ID: NCT04676204 Enrolling by invitation - Multiple Sclerosis Clinical Trials

Relationship Between Oral DMT Burden and Adherence in MS

STATURE
Start date: September 25, 2020
Phase:
Study type: Observational

STATURE is a prospective observational six-arm translation multi-site study that will run for approx. 4.5 years. The primary aim is to measure treatment burden and its relationship to medication adherence across six self-administered oral disease-modifying therapies (cladribine, dimethyl fumarate, fingolimod, teriflunomide, ozanimod, and diroximel fumarate) in multiple sclerosis (MS). The information gained will assist prescribing decision-making; accounting for medication burden at a patient level and potential implications on medication adherence and persistence, thus minimising primary and secondary healthcare costs. Three-hundred and twenty-three individuals with MS will be recruited into the study. Patient-reported outcome measures will be administered via Qualtrics, a secure online data collection tool. Medicare and pharmaceutical benefits scheme (PBS) data will also be collected.

NCT ID: NCT04625049 Enrolling by invitation - Multiple Sclerosis Clinical Trials

Does Microglial Activation Promote Lesion Growth and Progression Among Multiple Sclerosis Patients

FUP-MS
Start date: April 1, 2021
Phase:
Study type: Observational

The purpose of this study is to assess whether increased microglial activation (measured using TSPO-PET) at lesion rim is associated with more rapid lesion growth during 10 year follow up.

NCT ID: NCT04574024 Enrolling by invitation - Multiple Sclerosis Clinical Trials

HFP (High-Fiber Supplement) in MS (Multiple Sclerosis)

Start date: March 21, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

It has been suggested that dysbiosis of gut commensal bacteria increases the risk of autoimmune diseases including MS. However, there is no viable intervention available to correct dysbiosis. Since high-fiber supplement can promote the growth of healthy bacteria in the gut, the investigators propose to examine the effect of specially designed high-fiber supplement on the growth of short-chain fatty acid-producing gut bacteria and development of regulatory immune cells. Although dysbiosis is an alteration of microbial composition, enteric bacteria involved in gut dysbiosis of MS are different in ethnic groups due to difference in genetics, diet, and environmental exposures. Therefore, it is important to determine the intestinal bacterial composition involved in the MS dysbiosis in each ethnicity and geographical location. Additionally, it is necessary to find a non-invasive biomarker for gut dysbiosis-mediated CNS autoimmunity in MS. Since the investigators found that fecal Lipocalin 2 (Lcn-2) is a biomarker of gut dysbiosis-mediated CNS autoimmunity in MS animal models, the investigators will examine the association of fecal Lcn-2 levels with disease activation in MS.

NCT ID: NCT04415372 Enrolling by invitation - Multiple Sclerosis Clinical Trials

Macromolecular Imaging of White and Gray Matter Pathology in Multiple Sclerosis

Start date: November 19, 2021
Phase:
Study type: Observational

The overall purpose of this research is to determine whether new macromolecular measures optimized for whole brain (gray matter and white matter) magnetic resonance imaging (MRI), predict neuro-cognitive impairment in multiple sclerosis (MS) patients.

NCT ID: NCT04288011 Enrolling by invitation - Multiple Sclerosis Clinical Trials

Validation of the BeCare Multiple Sclerosis Assessment App

Start date: February 26, 2021
Phase:
Study type: Observational

This study involves data collection from use of the BeCare Link LLC mobile device app by subjects with Multiple Sclerosis.

NCT ID: NCT04281160 Enrolling by invitation - Multiple Sclerosis Clinical Trials

Patient Centered Outcomes Analysis for MS Using a Mobile Application

Start date: February 19, 2020
Phase:
Study type: Observational

Multiple Sclerosis (MS) is a demyelinating disease of the central nervous system (CNS) that can impact all aspects of nervous system function. Currently clinical assessments as part of the standard of care are performed in the health care providers office during regularly scheduled visits and are semi-quantitative or qualitative in nature. The goal of the BeCare Multiple Sclerosis Assessment App is to allow for patient centered, frequent, and quantitative assessments of neurologic function through a mobile App. The BeCare MS App integrates with all Android and Apple operating systems. The investigator's overall goal is to improve well-being of people with MS through accurate assessment of their neurologic function to be used by themselves as well as their health care providers. The purpose of this Clinical Trial is to validate the App based assessments versus Gold-Standard clinical assessments.