COVID-19 Booster Vaccination in Persons With Multiple Sclerosis
The success of the U.S. vaccination program against SARS-Cov-2 is shown by a dramatic drop in infection rates, hospitalizations and deaths.However, it appears that many persons who take medications that chronically suppress the immune system do not produce neutralizing antibodies to COVID-19 proteins in response to vaccination. This group includes a significant number of persons with multiple sclerosis (PWMS), many of whom are on therapies that chronically suppress their immune function. It is unclear what advice clinicians should provide regarding COVID-19 precautions to patients who fail to develop detectable COVID-19 spike protein antibodies using standard commercially-available tests after a standard series of vaccination, or whether they should test for antibody responses to COVID-19 vaccines in the absence of guidelines. A key research question is whether, in the absence of stopping or reducing potentially immune-altering therapies, there is a way to increase the likelihood of a neutralizing antibody response to COVID-19 vaccination in PWMS who are taking immune suppressive medications.
NCT05081271 — Multiple Sclerosis
Status: Terminated
http://inclinicaltrials.com/multiple-sclerosis/NCT05081271/
Feasibility Study of Tolerogenic Fibroblasts in Patients With Refractory Multiple Sclerosis
Fibroblasts have demonstrated potent immune modulatory and therapeutic activity in the experimental autoimmune encephalomyelitis (EAE) model of multiple sclerosis, as well as in other models of autoimmune and inflammatory diseases. This study will assess primary safety and secondary efficacy endpoints of intravenous administration of 100 million tolerogenic fibroblasts to 5 patients with relapsing remitting MS resistant to interferon. While the safety of fibroblasts administered clinically is established, it is unknown whether these cells are effective in the treatment of multiple sclerosis (MS). Our hypothesis is that the tolerogenic fibroblasts will be well-tolerated and meet our primary objective. In addition, The investigators are optimistic that they will see signs of efficacy based on the following: Neurological assessment of the MS functional composite assessment which comprises of EDSS, the expanded EDSS (Rating Neurologic Impairment in Multiple Sclerosis, the Scripps neurological rating scale (NRS), paced auditory serial addition test (PASAT), the nine-hole peg test, and 25-foot walking time, short-form 36 (SF-36) quality of life questionnaire and gadolinium-enhanced MRI scans of the brain and cervical spinal cord.
NCT05080270 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT05080270/
Trial of the Efficacy and Safety of Pathogenetic Therapy of Multiple Sclerosis and Other Autoimmune Diseases Using Intrathecal Rituximab
Considering the accumulated data on the pathogenesis of multiple sclerosis, indicating a significant role of B cells in the progression of the disease, the use of monoclonal antibodies to CD20 antigen, administered intrathecally to achieve adequate B-lymphodepletion in the barrier tissues can increase the duration of the recurrence-free course of autoimmune diseases, suspend their progression, and also prevent clinical relapse when memory B cells are detected.
NCT05078177 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05078177/
Sema 4A as a Marker for Inflammatory Disease in Multiple Sclerosis
Measure serum and cerebrospinal fluid Sema4A levels in female subjects with newly diagnosed and untreated relapsing multiple sclerosis, clinically stable relapsing multiple sclerosis receiving disease modifying therapy, relapsing multiple sclerosis receiving disease modifying therapy with breakthrough disease, or non-multiple sclerosis controls (patients without inflammatory central nervous system disease).
NCT05077956 — Multiple Sclerosis
Status: Withdrawn
http://inclinicaltrials.com/multiple-sclerosis/NCT05077956/
A Multicentre Observational Study for the Evaluation in Clinical Practice of the Initial Diagnostic-therapeutic Path of Urinary Disorders in Multiple Sclerosis
The major part of people with multiple sclerosis (pwMS) experiences Low Urinary Tract Symptoms (LUTS) secondary to neurogenic Low Urinary Tract Dysfunctions (n-LUTDs) during the course of MS, reaching almost 100% after about 10 years. N-LUTDs represent an important issue for pwMS, especially for their negative impact on Quality of Life (QoL), as they are mainly youngs in the prime of their life. Moreover n-LUTDs can lead to serious complications on the urinary tract as infections or renal failure. Therefore, the neurologist in daily clinical practice must intercept the possible presence of LUTS as soon as possible so that he can promptly initiate optimal management. To do this, it is essential to provide neurologists with validated, reproducible and sensitive tools that are, above all, easy to use in an outpatient setting. Our clinical research seeks, for the first time, to show whether pwMS get any improvement after the initial LUTS management, whether this improvement, if any, is related to the professional figure takes care about LUTS (neurologist vs urologist) and if there is an objective improvement of voiding performances on standardized measures.
NCT05075642 — Multiple Sclerosis
Status: Not yet recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05075642/
LONGEVITY OF IMMUNE RESPONSE TO COVID-19 VACCINE IN VACCINATED MULTIPLE SCLEROSIS PATIENTS TREATED WITH TERIFLUNOMIDE (AUBAGIO) OR ALEMTUZUMAB (LEMTRADA)
Phase IV, 3-armed, prospective, open-label, single-center, Israeli study, examining the response to SARS-CoV-2 vaccination in 30 teriflunomide-, 10 alemtuzumab-treated patients, and 30 age-matched (for the teriflunomide group) untreated MS patients. Treatments will be administered according to common local practice. Demographic, clinical, treatment-related and COVID-19-related data will be collected. Blood samples will be drawn for each participant at baseline (before COVID-19 vaccination), and at 1, 3, 6, (and possibly 12) months post 2nd dose of COVID-19 vaccine. Humoral, B-cell and T-cell responses will be evaluated.
NCT05075499 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05075499/
Investigation of the Effects of the Synchronized Telerehabilitation-based Upper Extremity Training Program on Hand-arm Function, Pain, Fatigue, Quality of Life, and Participation in People With Multiple Sclerosis
In this studly, the effects of an 8-week telerehabilitation-based upper extremity training in persons with multiple sclerosis will be investigated.
NCT05073731 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05073731/
Prognostic Value of Cerebrospinal Fluid Immunoglobulin Free Light Chains in Patients With Multiple Sclerosis
Multiple sclerosis (MS) is a chronic inflammatory autoimmune disease of the central nervous system, usually presenting as clinically isolated syndrome (CIS). The course of MS following first symptoms is unpredictable, as approximately 30% of patients with MS have a benign course and don't develop significant disability while another 20-30% progress to severe disability within a relatively short time period. In this context, it is difficult to counsel an individual patient and choose the best treatment option at time of diagnosis. For these reasons, prognostic markers that could be used to predict future disease course are extremely useful. The only cerebrospinal fluid (CSF) prognostic biomarker currently used in clinical practice are oligoclonal bands (OCB) that can predict conversion from CIS to clinically definite MS, although this observation is not consistent. However, OCB analyses are qualitative with issues in reproducibility and a limited dynamic range. CSF immunoglobulin (Ig) free light chains (FLC) are a quantitative measure of humoral response in CSF that has showed greater sensitivity and specificity than OCB for confirming diagnosis of MS. Moreover, in few recent studies they seem to have also a prognostic value, predicting conversion from CIS to clinically definite MS and correlating with the Expanded Disability Status Scale (EDSS). Optic Neuritis (ON) can be a first clinical relapse of MS and is particularly interesting because it may constitute a suitable clinical model for neuroprotection studies, as visual function can be measured with quantitative methods, including Visual Evoked Potential (VEP) and Optical Coherence Tomography (OCT). The investigators aim to better explore the utility of CSF Ig FLC as potential prognostic biomarker for MS, and to predict the recovery of visual function after ON, as model of MS relapse. The investigators will study its potential correlation with MS relapses, with changes in several functional outcome scores, exploring physical disability, fatigue, behavior, cognition, upper and lower extremity function, and with MRI disease activity. For a subgroup of patient, the investigators aim to explore its potential correlation with in vivo measures of demyelination and neuronal and axonal loss after ON, as model of potential recovery after MS relapse. The investigators aim also to compare the prognostic value of Ig FLC with Neurofilament light chain (NfL), a potential prognostic biomarker wider studied in MS.
NCT05072691 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05072691/
To Evaluate the Activity and the Efficacy of Traditional Swallowing Therapy (TST) Plus Neuromuscular Electrostimulation (NMES) vs TST Plus Sham- NMES in Multiple Sclerosis People With Dysphagia
Dysphagia is a disabling, life-threatening symptom that can cause death in Multiple Sclerosis people (pwMS) through aspiration pneumonia. Speech therapists use behavioural therapies (compensatory and rehabilitative) to alleviate such swallowing problems, with limited benefit. Compensatory strategies such as postural changes and changes in food consistency, have been found to be partially effective, especially in patients with mild dysphagia and may be ineffective in patients with more severe dysphagia. The rehabilitative strategies include "no swallow exercises" which aim to strengthen isolated muscles used in swallowing (such as tongue strengthening) and "swallowing exercises" that aim at strengthening all the muscles used in swallowing while executing a hard, effortful, or prolonged swallow. To date, no randomized clinical trials have shown that rehabilitative strategies are effective. Neuromuscular electrical stimulation (NMES), often referred to as electrical stimulation, was introduced as a novel therapy for dysphagia in the late 2001. The principles of NMES in the limb rehabilitation literature are well established. However published protocols applying NMES to swallowing function have shown mixed results in people with stroke and only one study was published on MS people. This will be a double blinded, randomized clinical trial (patients and research staff blinded) with two arms: standard speech therapy plus Active NMES vs speech therapy with Sham NMES. The aim of this study is to determine whether NMES added benefit to a therapy program comprised of standard swallowing exercises in dysphagic pwMS.
NCT05063708 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05063708/
PET Imaging of Cyclooxygenases in Multiple Sclerosis
Background: Multiple sclerosis (MS) is an autoimmune disease that has no cure. MRI is the main tool used in the study and treatment of people with MS. A tracer has been developed for cyclooxygenase-2 (COX-2), an enzyme found in the brain during inflammation. Researchers want to explore the role inflammation plays in MS and see if COX-2 is measurable in the brains of people with the disease. Objective: To see if COX-2 is detectable in the brains of individuals with MS. Eligibility: People ages 18 and older with MS who are otherwise healthy. Design: Participants will be screened with their medical history and a physical exam. They will have an EKG to check the electrical activity of the heart. Participants study involvement requires 2 to 3 visits and will last between 1 week and 4 months. Participants will have 2 PET scans of the brain. These might occur on the same day or on separate days. A small amount of a radioactive chemical will be injected through an intravenous catheter. A needle will be used to guide a thin plastic tube into an arm vein. The needle will be removed. Only the catheter will be left in the vein. The PET scanner is shaped like a doughnut. Participants will lie on a bed that slides in and out of the scanner. They will wear a plastic mask molded to fit the head. The scan will last about 90 minutes. Participants will receive the medication celecoxib orally about 2 hours before the second scan. Participants will have blood tests. Participants must avoid certain medications a month prior to the PET scans. ...
NCT05062083 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT05062083/