The Effect of Vestibular Rehabilitation on the Kinetic and Kinematic Parameters of Walking in Patients With Multiple Sclerosis
In the literature, the results of vestibular rehabilitation treatment applied in patients with Multiple Sclerosis (MS) have been investigated in detail under the headings such as fatigue, physical activity level, and quality of life, and its effects on walking have also been tried to be examined. However, in the studies conducted, gait assessments were made through questionnaires and timed tests, and devices that provide more objective data such as 3-dimensional gait analysis were not used. Again, the effects of vestibular rehabilitation programs on dual-task were not examined in previous studies. Therefore, the aims of our study are: 1. To determine the effect of individually designed vestibular rehabilitation exercises on the kinetic and kinematic components of walking; 2. To determine the effect of vestibular rehabilitation exercises specially designed for the person on gait parameters during cognitive and motor tasks.
NCT05299151 — Multiple Sclerosis
Status: Active, not recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05299151/
Drug Repurposing Using Metformin for Improving the Therapeutic Outcome in Multiple Sclerosis Patients
This study aims to evaluate the effect of Metformin as add- on therapy for improving the outcome in RRMS patients.
NCT05298670 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05298670/
Efficacy, Safety and Cost-effectiveness of B Cell Tailored Ocrelizumab Versus Standard Ocrelizumab in Relapsing Remitting Multiple Sclerosis: a Randomized Controlled Trial
Rationale: B-cell depleting therapies like ocrelizumab are very effective in the treatment of relapsing remitting multiple sclerosis (RRMS). As B cell repopulation varies extensively between individuals (ranging from 27-175 weeks), using a treatment scheme with a fixed infusion interval may be suboptimal. So far personalized adapted treatment of ocrelizumab in RRMS has not been studied in a prospective setting. Objective: Evaluating the efficacy, safety and cost-effectiveness of ocrelizumab when administered in personalized B cell tailored intervals in RRMS patients. Study design: This is a national multicenter randomized controlled trial with 96 week follow-up. Study population: The study population consists of 296 adult RRMS patients who have received ocrelizumab treatment for a minimum of 12 months (2x 300 mg infusion and 1x 600mg infusion). Intervention: Patients will be randomized into the standard interval group (600 mg infusions every 24 weeks) or the personalized interval group in which the infusions will be extended as long as the serum CD19 B cell count is below 10 CD19 cells/µL, determined every 4 weeks. Main study parameters: To conclude non-inferiority of personalized B cell tailored ocrelizumab there will be two co-primary endpoints: 1. the difference of percentage of confirmed relapse-free patients between the two groups after 96 weeks and 2. the difference of percentage of patients free from new/enlarging T2 lesions on MRI between the two groups after 96 weeks. Secondary study parameters are number of confirmed relapses, annualized relapse rate, number of new T2 lesions and brain atrophy on MRI, disability progression, no evidence of disease activity (NEDA), MS disease biomarkers (serum neurofilament light), quality of life, burden of treatment, immunoglobulin levels and (serious) adverse events including occurrence of infections and COVID-19. Furthermore, various immune cell subsets will be studied in relation to ocrelizumab concentration in a subgroup. Nature and extent of the burden and risks: All patients will be subjected to visits every 24 weeks including clinical scoring and questionnaires. Blood samples and MRI scans will be taken and performed every 48 weeks. Continuous assessment of key stroke dynamics on the patients smartphone and monthly digital cognitive test and walk test will be performed in most patients. As CD19 B cells are kept near complete depletion, the estimated risk of recurrence of disease activity is very low.
NCT05296161 — Multiple Sclerosis, Relapsing-Remitting
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis-relapsing-remitting/NCT05296161/
Cellular microRNA Signatures in Multiple Sclerosis
A limited number of studies on microRNA expression variation in immune cells have been reported in relapsing-remitting multiple sclerosis (RRMS). These studies have been performed mostly on a small scale and on whole blood mononuclear cells (PBMC). In a number of cases, RRMS progresses to a severe secondary neurodegenerative form. In this context, it is important to look for biomarkers that could indicate the pathogenic activity of certain immune cell subpopulations.
NCT05290688 — Multiple Sclerosis, Relapsing-Remitting
Status: Not yet recruiting
http://inclinicaltrials.com/multiple-sclerosis-relapsing-remitting/NCT05290688/
Kesimpta® (Ofatumumab) in Swiss Multiple Sclerosis Patients - an Observational Study (KOSMOS)
This is a multi-center, observational study carried out in Switzerland that aims to describe the effects of Ofatumumab in a setting of routine medical care.
NCT05285904 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05285904/
Randomized, Blinded Discontinuation Trial of Ocrelizumab in Early Relapsing Multiple Sclerosis (AMS05)
This study is a prospective, multi-center, randomized, double blinded, placebo-controlled study of OCR treatment-discontinuation in patients with early RMS. All eligible participants will be initiated on OCR using the standard approved administration schedule of two 300 mg infusions separated by 14 days (i.e., Days 0 and 14) for a total of 600 mg, followed by 600 mg infusions at Month 6 and Month 12. At Month 12, participants will be randomized (1:1:1) to one of three Arms with randomized treatment beginning at Month 18: Arm 1: placebo infusions every 6 months; Arm 2: OCR infusions at Months 18 and 24 and then after Month 24 switch to placebo infusions every 6 months; Arm 3: OCR infusions every 6 months. The treatment period will be for a total of 48 months.
NCT05285891 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05285891/
A Phase 2 Open Label Clinical Trial to Determine the Effect of Famciclovir on Epstein-Barr Virus Activity as Measured by EBV Shedding in Saliva of Patients With Multiple Sclerosis.
This is a proof-of-concept study in 30 patients with established Relapsing Remitting Multiple Sclerosis (RRMS). IMP is Famciclovir. It is a phase II type A open label study. Each individuals participation in the study will last 36 weeks and will be divided into three phases: pre-treatment (12 weeks), treatment with famciclovir (12 weeks), and post-treatment (12 weeks). During the first 12 week phase patients will remain on their usual treatment alone; this will be followed by three months of co-treatment with famciclovir and then followed by a final three months post-famciclovir treatment where participants will continue to take their usual treatment for RRMS. The primary aim is to explore the effect of famciclovir (500mg BD) on Epstein-Barr virus (EBV) shedding in the saliva of patients with MS
NCT05283551 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05283551/
Implementation of a Novel Functional Eye-Tracking Biomarker for Multiple Sclerosis
This study aims to develop and validate a sensitive and non-invasive eye-tracking software application. This study will obtain participant responses to brief cognitive tests designed to evaluate several key functions known to be affected by CIS and RRMS and non-invasive eye movement measurements in response to visually presented stimuli during specifically designed eye-tracking tests. The study data will be used to develop machine learning algorithms and validate a software application intended to identify which metrics-or combination thereof-can serve as reliable biomarker of CIS and RRMS disease progression and cognitive status.
NCT05277740 — Relapsing Remitting Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/relapsing-remitting-multiple-sclerosis/NCT05277740/
Translingual Stimulation Combined With Physiotherapy to Improve Walking and Balance in Multiple Sclerosis: an RCT
The overarching aim of this study is to examine if there is additional benefit to adding trans-lingual electrical stimulation to physiotherapy aimed at improving walking and balance in people with multiple sclerosis (MS).
NCT05275049 — Multiple Sclerosis
Status: Enrolling by invitation
http://inclinicaltrials.com/multiple-sclerosis/NCT05275049/
Neurorehabilitation and Functional Recovery in Multiple Sclerosis: Assessing Two Therapeutic Strategies Using Functional Magnetic Resonance Imaging.
Multiple sclerosis (MS) is an autoimmune disease that causes cognitive and motor disabilities and contributes to decrease patients life quality. Previous results described that there are some MS patients that showed (at least in some phases of the disease) neuroplasticity processes that are able to compensate some cognitive deficits. Moreover, neuroplasticity processes seem to be limited and related to the degree of gray matter atrophy (patients with less atrophy show grater neuroplasticity than those with higher atrophy level). The aims of this project are: 1. to study behavioral changes (post-training) induced by two different rehabilitation programs: a)cognitive training focused on exclusively enhancing working memory and b) aerobic + cognitive training aimed to enhance attention, working memory processes and motor capabilities using a virtual reality game. 2. to study neuroplasticity changes (post-training functional connectivity changes) induced by these rehabilitation programs 3. to observe the role of the atrophy in brain neuroplasticity processes. Neuropathological status and neuroplasticity processes (studied using neuroimaging tools) as well as cognitive performance using neuropsychological tools will be assessed in a group of MS patients (with different phenotypes) at two different time points: before any training (S1) and after 10 days of training (S2). This project will be financed by the Ministerio de ciencia, innovación y universidades of the Spanish government and also have been approved by the Ethical committee of Universitat Jaume I.
NCT05270239 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05270239/