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Showing 1-11 of 11 trials
NCT07225361
In this prospective, open-label, single-arm, single-institution trial, the investigators will accomplish the following two aims: 1. study the safety and tolerability of Ublituximab (Briumvi) twice annually in participants with early MS over a treatment observation period of \~12 months. 2. study the pre- and post-treatment change in plasma neurofilament light chain, tested at baseline pre-Ublituximab treatment, and q24 weeks for 96 weeks post Ublituximab treatment initiation.
NCT07376772
This pilot mixed-method study will evaluate the feasibility, preliminary efficacy, and user experience of a home-based wearable Focal Vibration Therapy (FVT) intervention for improving upper extremity (UEx) function in people with multiple sclerosis (MS). Fifteen adults with relapsing-remitting MS (PRMS) and self-reported UEx impairments will participate in a 4-week FVT program using MyovoltTM wearable FVT devices applied to arm muscles.
NCT07360977
Glucosinolates (GLs) are phytocompounds mainly found in the Cruciferae (Brassicacea) and Moringa oleifera plants. The hydrolysis of GLs by myrosinase led to the production of isothiocyanate (ITCs). ITCs consumption was associated with different health promoting effects, including to neuroprotective, anti-oxidant and anti-inflammatory capacities. In particular, they showed neuroprotective effects in experimental models of neurodegenerative diseases, including multiple sclerosis (MS) and Parkinson's disease (PD). From different GLs, different ITCs are originated. In particular, from glucoraphanin (GRA) the ITC sulforaphane (SFN) is obtained. The PI of the project is one of the proprietor of a patent (EP2908850B1) for the application of (Rs)-GRA with myrosinase in a buffered solution for the treatment of neurodegenerative diseases. The aim of this project is to evaluate the effects of the administration of bioactivated GRA in different cohorts of adult patients, affected by MS and PD, but also a cohort of pediatric patients affected by neuromuscolar and degenerative diseases. The effects of bioactivated (Rs)-GRA administration will be evaluated with a combination of clinical evaluations and a multiomic (metabolomic, genomic) approach.
NCT07355387
The study involves a two-arm, Phase 1, randomized controlled clinical trial designed to establish the feasibility and effects of a Functional Balance Intervention (FBI) on physical and cognitive function, as well as measures of daily living among persons with multiple sclerosis (PwMS). Combined Specific Aims: Aim 1: Examine the effect of the FBI (Intervention Group) on physical function in PwMS compared to a stretching program (Control Group). Hypothesis 1: After four months of training, the FBI group will show significantly greater improvements in physical function compared to the stretching group. Aim 2: Examine the effect of the multicomponent FBI on cognitive function in PwMS compared to the stretching program. Hypothesis 2: After four months of training, the FBI group will show significantly greater improvements in cognitive function compared to the stretching group. Aim 3: Examine the effects of the multicomponent FBI compared to the Control Group among PwMS on measures of daily living (dual-task performance, balance confidence, community mobility, and quality of life). Hypothesis 3: After four months of training, the FBI group will show significantly greater improvements in measures of daily living compared to the stretching group. All assessment sessions will be conducted virtually via Zoom. All measures collected during the initial screening, pre-training assessment, training progression, and mid- and post-training assessment sessions will be administered either via Zoom with a Helper Buddy present or through survey links sent to participants via the UIC REDCap system. The training sessions will be performed independently by the participants in the presence of a Helper Buddy. The investigators will recruit 75 people with multiple sclerosis (PwMS) for this study. Eligible participants will be randomized to either the FBI (Intervention) or stretching (Control) group, followed by an onboarding session with a designated Helper Buddy. Training will occur twice weekly for four months. Based on the anticipated attrition rate, the investigators aim for 40 PwMS to complete the post-training assessments and finish the study.
NCT07233902
This randomized controlled study aims to compare the effects of synchronous and asynchronous exercise programs on individuals diagnosed with relapsing-remitting multiple sclerosis (RRMS). Participants meeting the inclusion criteria (EDSS score between 2 and 5.5, aged 18-55) were randomly assigned to either the Synchronous Exercise Group (SEG) or the Asynchronous Exercise Group (ASEG). The synchronous program was delivered via live online sessions using Google Meet and WhatsApp video calls, while the asynchronous program consisted of pre-recorded exercise videos accessible to participants. Both programs included structured exercises focusing on functional capacity, muscle strength, fatigue, independence, and quality of life. The sample size was determined using G\*Power software based on previous studies in individuals with multiple sclerosis, targeting a total of 16. Statistical analyses will be conducted using SPSS 26.0. Parametric and non-parametric tests will be used depending on data distribution, with significance set at p \< 0.05. The study seeks to improve accessibility to exercise programs for MS patients and provide evidence for the efficacy of remotely delivered synchronous versus asynchronous rehabilitation models.
NCT06925022
This phase of the project aims to analyze the interaction between physical exercise and the phases of the menstrual cycle, evaluating its impact on fatigue, functional capacity, and exercise perception in women with and without Multiple Sclerosis. To achieve this, a controlled, single-blind, prospective, 2x3 crossover, randomized clinical trial will be conducted, involving women with Multiple Sclerosis (MS), matched by age, lifestyle habits (smoking, physical activity), and geographic location with a group of women without MS. This study, aligned with previous findings, seeks to deepen the understanding of the role of exercise in managing Multiple Sclerosis symptoms and to promote greater adherence to personalized physical activity programs adapted to the phases of the menstrual cycle.
NCT06884579
This phase of the project aims to compare in-person, supervised educational programs (EP) with online self-guided EPs in individuals with relapsing-remitting multiple sclerosis. A total of 75 participants will be randomly assigned to one of three groups: a supervised and individualized educational program focused on HIIT training, a supervised and individualized educational program focused on strength training, and a non-supervised, self-guided educational program based on resistance band training. Additionally, sessions on the Mediterranean diet (both supervised and non-supervised) and cognitive-behavioral interventions will be included. A control evaluation will be conducted three months after the intervention to assess the effects of the educational programs, followed by another evaluation three months later to analyze residual effects. Women who participated in Phase 1 of the study will be invited to take part in this second phase.
NCT07273604
This study evaluated the efficacy of two structured psychological interventions for patients with relapsing-remitting multiple sclerosis (RRMS). The main goal was to determine whether a Cognitive Behavioral Therapy (CBT)-based program and a Psychophysiological Regulation Therapy (PRT) improved emotional well-being and cognitive functioning compared with Standard Care (SC). A total of 140 participants with mild to moderate disability and disease duration between 5.5 and 8.5 years were randomly assigned to one of three groups: CBT, PRT, or SC (waiting list). Each intervention was delivered in small groups over 12 weekly sessions. Assessments were conducted before and after treatment using validated clinical and neuropsychological measures. Results were analyzed to explore the effectiveness of both interventions in reducing anxiety and depressive symptoms and enhancing cognitive performance. The study aimed to provide evidence for the inclusion of psychological therapies as complementary treatments in comprehensive care for multiple sclerosis patients.
NCT07006805
RESET-MS: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T cells (CABA-201) in Participants with Multiple Sclerosis
NCT06705608
The goal of this retrospective observational study is to investigate the long-term safety of Fingolimod in individuals with Multiple Sclerosis (MS), specifically focusing on the risk of developing skin cancer. The main question it aims to answer is: • Does the use of Fingolimod increase the incidence of skin cancer in individuals with MS compared to those using other disease-modifying therapies? Participants who are new users of Fingolimod or other active comparators as part of their regular medical care for MS will be included in this study. Researchers will use advanced causal inference techniques to analyze healthcare data and compare the incidence of skin cancer between these groups.
NCT06611280
The goal of this case-control study is to investigate glucose brain metabolism in people with multiple sclerosis and age- and sex-matched healthy controls. The main questions it aims to answer are: * How does brain glucose metabolism in people with multiple sclerosis compare to age- and sex-matched healthy controls? * How is the brain glucose metabolism of people with multiple sclerosis associated with disease severity? Participants will come in for testing lasting approximately three hours and undergo deuterium metabolic imaging, physical function test, cognitive function test, and answer survey.