Comparison of Vigorous Versus Low Intensity Cool Room Treadmill Training in People With Multiple...
Multiple SclerosisNeurological Rehabilitation3 moreNew research in animal models of MS suggests that greater training intensity is required to restore lost functions. We have developed and tested vigorous intensity cool room treadmill training that people with MS who have fatigue and heat-sensitivity can tolerate. This study will focus on the appropriate dosage of training.
Resting Postural Tremor in Multiple Sclerosis
Multiple SclerosisEarly diagnosis is a key factor for effective treatment of multiple sclerosis. Accelerometer and gyroscope measurement of tremor could screen potential motor control dysfunction and predict a risk for development of multiple sclerosis.
French Registry for Monitoring Pregnancies for Multiple Sclerosis
SclerosisMultiple3 moreThe influence of pregnancy on the course of multiple sclerosis (MS) has long been a controversial topic. After the publication of the first large prospective study of pregnancy and MS in 1998, counselling of women with MS has radically changed and many patients have been able to fulfill their desire of motherhood. However, there are still some challenges for the neurologist, who has to face old unanswered questions or new issues, regarding the use of disease modifying drugs (DMDs) in this period of life, effects on the short and long term outcome of the mother (in terms of relapses and disability) and the child, role of breast-feeding and locoregional analgesia. To set up a national prospective pregnancy registry for patients with MS, nested within the Observatoire Français de la Sclérose en Plaque (OFSEP) cohort, owing to a better knowledge of interactions between MS and pregnancy-related issues (pregnancy itself, locoregional analgesia, breastfeeding, impact of using or stopping DMDs on women/children…)
A Study to Investigate Arbaclofen ER Tablets for the Treatment of Spasticity in Patients With Multiple...
SpasticityThis is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral arbaclofen ER tablets in MS patients with spasticity. Arbaclofen ER will be compared with placebo.
Safety of Exposure to Natalizumab During Pregnancy
Multiple SclerosisMultiple sclerosis (MS) preferentially affects young adults with a female predominance. MS is not associated with an increased risk of complications or abnormal pregnancy outcomes. Nevertheless, disease-modifying therapies can have a teratogenic effect. Discussions about discontinuation should be made with a view to or upon discovery of pregnancy, taking into account the risk of untreated relapses and the risk of toxicity to the fetus. Natalizumab (NTZ) is a humanized anti-alpha4-integrin monoclonal antibody used as a treatment for highly active relapsing-remitting MS (RRMS). When it is stopped, there is frequent reactivation of the disease with possible relapses and a rebound effect could occur. At present, depending on the center, attitudes of neurologist may vary and 3 main scenarios can be observed: Pregnancy and postpartum under NTZ (group1), Pregnancy partially under NTZ (with or without immunomodulator (IM) supplementation, group 2), or NTZ stopped before pregnancy (with or without IM supplementation, group3). The first part of the BABYZUMAB study, a retrospective study of Natalizumab exposure during pregnancy, analysed the comparison the clinical activity of the disease (annualized relapse rate) according to these 3 scenarios of NTZ treatment The investigators analyzed the annual relapse rate (ARR) during a two-year period (9 months before and 15 months after the beginning of the pregnancy) in 117 patients identified in the OFSEP database. The investigators showed that the risk of relapses was four times higher in Group 2 versus Group 1 (p=0,014) and six times higher in Group 3 versus Group 1 (p=0,001). In the literature, there are few studies of newborns from NTZ-exposed pregnancies. No specific pattern of birth defects has been found, but mild to moderate transient thrombocytopenia and anemia have been reported in infants born to NTZ-exposed mothers in the third trimester of pregnancy.
Immunoglobulin Deficiency a Treatable Cause of Fatigue in Patients With Multiple Sclerosis (MS)?...
HypogammaglobulinemiaMultiple Sclerosis1 moreThe investigators hypothesize that hypogammaglobulinemia (defined as IgG serum concentration <7.0g/L) is a treatable cause of fatigue in people with MS: The primary objective is to prove the link between hypogammaglobulinemia and fatigue in patients with multiple sclerosis. The secondary objective is to show that fatigue is mediated via frequent infections in people with MS and hypogammaglobulinemia.
Prevalence and Impact of Obstructive Sleep Apnea in Multiple Sclerosis
Multiple SclerosisObstructive Sleep ApneaThis study will evaluate the influence of sleep apnea on clinical and radiological features of MS. Sleep apnea is associated with hypoxemia during sleep, which is likely detrimental to MS. Clinical data (MRI, lab results, medical history, labs, and sleep studies) of MS patients will be collected and analyzed. This will be done to study correlations between MRI, clinical data, lab studies and sleep studies. There is specific interest in the type of sleep apnea associated with MS, and whether MRI or clinical metrics of MS severity correlate with presence or absence of sleep apnea.
Impact of the Modifications of Environmental Exposures and Health Care Access During COVID-19 Lockdown...
Multiple SclerosisMultiple Sclerosis (MS) is a demyelinating auto immune disease of the central nervous system, affecting 2500000 people worldwide. Risk factors for MS severity are not yet well-known , but previous studies highlighted that relapse rate increased during influenzae epidemics, and air pollution could be a risk factor for MS relapses. MS is a neurological chronic disease that requires constant medical treatment and regular rehabilitation care. COVID-19 pandemic and restrictive measures taken to limit contaminations have drastically decreased air pollution and seasonal viral infections exposure, but sanitary crisis also limited care access for MS patients (medical treatment, rehabilitation). Therefore, this particular period offers a unique opportunity to evaluate the impact of air pollution, viral infections, and health care access on the severity of MS. The main objective is to evaluate the impact of air pollution and seasonal viral infections on the risk of MS relapse, using the year 2020 as a quasi-experimental model. The secondary objective will be to evaluate the impact of health care access limitations on the risk of neurological disability accumulation. This study will include 1500 MS patients, living in Ile de France, followed in the neurological department of "Pitié-Salpêtrière" Hospital. This is a retrospective observational study nested in OFSEP registry (French Multiple Sclerosis Observatory), which is a prospective cohort of MS patients in France. Air pollution data will come from AIRPARIF, and viral infections data will come from "Santé Publique France". A better knowledge of the impact of air pollution, viral infections, and health care access on the course of MS will enable to better guide information to patients and public health care decisions.
Nomad P-KAFO Study
Cerebrovascular AccidentPost-polio Syndrome4 moreThe goal of this clinical trial is to evaluate the impact of using the Nomad powered KAFO in people who have had a musculoskeletal or neurological injury that has affected their ability to walk. The main questions it aims to answer are to quantify the effectiveness of the Nomad in improving mobility, balance, frequency of falls, and quality of life in individuals with lower-extremity impairments compared to their own brace, over three months of daily home and community use. Participants will: Wear a sensor that records everyday activities and mobility. Perform measures of mobility and different activities of participation using their own brace. Perform measures of mobility and different activities of participation using the Nomad powered KAFO
Epstein Barr Virus Infection in Patients With Radiologically Isolated Syndrome
Multiple SclerosisRadiologically Isolated Syndrome1 moreThe clinical course of RRMS patients is variable. Among RIS-Consortium international cohorts, one third of RIS patients progressed to MS at 5 years and 52.2% at 10 years. Biomarkers predictive of MS conversion are key elements to organize personalized medical care, for both follow-up and treatment strategies. EBV seems to be an interesting candidate regarding its involvement MS pathophysiology. It can be easily assess in blood sample in contrast to others prognostic biomarkers validated in RIS : oligoclonal bands and NfL levels in cerebrospinal fluid and serum. In RIS, treatment targeting EBV could significantly modify the course of the disease. The investigators aim to make the fisrt description of the EBV epidemiology (immunoglobulin (Ig)M and IgG anti-viral capsid antigen (VCA), IgG anti Epstein-Barr nuclear antigen (EBNA)) among RIS patients and to investigate a correlation between the different antibodies' titers (IgM VCA, IgG VCA, IgG EBNA) and the course of the disease (clinical conversion or evidence of disease activity (EDA)).