A Novel Wearable Digital Biomarker for Detecting Changes in Multiple Sclerosis (MS) Disease Condition Through Home Monitoring of MS Patients
To measure the effectiveness of a Remote Patient Monitoring solution based on the use of a smart insole wearable device (and associated smart phone app), for monitoring MS patients' condition on a day-to-day basis. The main focus is the objective measurement of gait, given that 75% of people with MS display clinically significant gait impairments. Initial gait lab "gold standard" data indicate that the Artificial Intelligence (AI)-based digital biomarker will prove to be highly effective at detecting changes in the MS patient's condition.
NCT05781113 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05781113/
Targeting the Gut Dysbiosis to Treat Inflammation-driven Synaptopathy in Multiple Sclerosis
Inflammatory synaptopathy is a prominent pathogenic process in multiple sclerosis (MS) induced by imbalanced immune system homeostasis. Its persistence causes excitotoxic neuronal damage, leading to motor and cognitive deficits. Although many advances have been made in MS treatment, the development of effective strategies for managing disease progression driven by excitotoxic synaptic dysfunctions is of great significance. Gut dysbiosis is commonly associated with both MS and obesity and high-fat diet (HFD) can exacerbate disease by acting on gut microbiota. Since gut microbiota can shape the immune response and brain functions, we propose to target gut dysbiosis by dietary supplementation of prebiotics and probiotics (Pre-Pro) to treat synaptopathy in both human and experimental model of MS, even when exacerbated by HFD. Overall, this project aims at unveiling the anti-inflammatory and neuroprotective pathways activated by Pre-Pro supplementation to modulate the immune-synaptic axis.
NCT05779449 — Patient Participation
Status: Recruiting
http://inclinicaltrials.com/patient-participation/NCT05779449/
Multidimensional Integrated Assessment of Neurological and Immunological Patterns to Test the Efficacy and Response to Ozanimod in Multiple Sclerosis.
This is a prospective interventional study with a 12-month follow-up of patients diagnosed with Multiple Sclerosis. Enrollment includes patients for whom Ozanimod will be prescribed based on regular clinical practice. It is proposed to integrate the measurements obtained using multiple instruments, with the aim of analyzing the immunological landscape, connectivity networks and anatomical traits of neurodegeneration. Patients will return for imaging and noninvasive electrophysiological studies 3, 6, and 12 months after initiation of therapy. On the same day, blood samples will be taken and immunological and biochemical tests will be performed.
NCT05777902 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05777902/
Determination of Compliance to Mediterranean Diet, Impacts on Walking and Quality of Life in Multiple Sclerosis
Multiple Sclerosis (MS) is an autoimmune disease characterized by inflammation, demyelination and axon damage. Affecting approximately 2.5 million individuals around the world and seen mostly in young adults, MS can cause different levels of disability in functional activities, cause limitations in social and professional life, and impair quality of life. Multiple sclerosis is thought to be an autoimmune disease that develops on the basis of genetic predisposition and environmental factors. Nutritional habits and physical activity are important environmental factors. These can be effective in the course of MS and change the quality of life. Compatibility of nutrition with the Mediterranean diet and providing adequate physical activity may be beneficial in increasing physical and mental well-being in general, and therefore the quality of life of the person. In our country, there is not enough information about the ongoing nutritional habits and physical activity levels of MS patients in their daily lives, and quality of life studies are limited. Our limited knowledge on these issues narrows the possibility of movement in an area that can be corrected in MS patients and thus have a positive impact on their quality of life. The aim of this study is to determine compliance with the Mediterranean diet, the tendency to use various nutritional supplements, physical activity habits, walking-related problems and quality of life in MS patients and to evaluate whether there is a significant relationship between these parameters.
NCT05777629 — Multiple Sclerosis
Status: Active, not recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05777629/
Clinical and Urodynamic Assessment of Bladder Sensation in Multiple Sclerosis
The aim of the study is to assess the association between bladder sensations progression during bladder filling and severity of Overactive bladder (OAB) in patients with multiple sclerosis.
NCT05772637 — Overactive Bladder
Status: Recruiting
http://inclinicaltrials.com/overactive-bladder/NCT05772637/
Assessing Osteoporosis Awareness and Knowledge Levels In Turkish Multiple Sclerosis Patients: An Observational Study
Osteoporosis is a condition that describes compromised skeletal microarchitecture in general, with clinical signs of decreased bone mineral density. Multiple sclerosis patients are at increased risk for developing osteoporosis. Identifying whether multiple sclerosis patients have information and awareness about this disease is crucial. This study is aimed to investigate awareness and knowledge of osteoporosis in multiple sclerosis (MS) patients. The study also aimed to assess potential differences and correlations in osteoporosis knowledge and awareness among MS patients based on gender, education levels, and risk of falls
NCT05760651 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT05760651/
A Prospective Randomized Trial of Non-inferiority Comparing RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis
The goal of this randomized clinical trial is to compare relapse remitting multiple sclerosis (RRMS) patients treated by ocrelizumab or by rituximab followed for 2 years. The main question it aims to answer is : • to demonstrate the non-inferiority of rituximab versus ocrelizumab in active relapsing MS patients on the % of patients without disease activity at 2 years. During the 2 years, the study includes 6 follow-up visits and the completion of various health and quality of life questionnaires. The protocol visits follow the usual schedule of treatment infusions for the disease (at initiation of treatment, 15 days after, and then every 6 months). Two comparison groups: Researchers will compare rituximab treated patients versus ocrelizumab treated patients to see the % of patients without disease activity at 2 years.
NCT05758831 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05758831/
Long-Term Aerobic Walking Exercise for Restoring Cognition and Brain in People With Multiple Sclerosis
This study is a randomized controlled trial (RCT) that compares the effects of two different 12-month aerobic walking exercise programs on cognitive processing speed (CPS), brain MRI, and other functional outcomes in 32 adults with multiple sclerosis (MS) who are able to walk without an assistive device but demonstrate slowed CPS. Participants (N=32) will initially undergo screening via telephone, and after satisfying relevant inclusion/exclusion criteria, will provide informed consent, followed by a baseline assessment of CPS remotely via a HIPAA-compliant virtual platform (i.e., Zoom for Healthcare). This assessment will also serve as a screen for ensuring impaired CPS. Following this virtual session, participants will come into Kessler Foundation (KF) and complete a 3-hour baseline assessment (T0) that includes a relatively short battery of neuropsychological tests, a 40-minute MRI scan, tests of walking function, a short questionnaire packet, followed by cardiopulmonary exercise testing on a motor-driven treadmill. Following T0, participants will be randomly assigned into one of the two aerobic walking ET programs that are remotely-delivered and supported by KF research assistants. As the conditions are delivered and supported remotely by KF personnel, the exercise itself takes place in the home/community setting. Both conditions involve behavior coaching via Zoom for Healthcare. The experimental condition involves high-frequency, high-intensity aerobic walking ET that exceeds the published guidelines for physical activity for adults with MS (GEMS+). GEMS + initially involves 10 minutes of moderate intensity aerobic walking exercise for 3 days per week and progresses to upwards of 40 minutes of vigorous intensity aerobic walking exercise for 5 days per week by month 12. The comparison condition involves mild-to-moderate aerobic walking exercise training that approximates published guidelines (GEMS). GEMS initially involves 10 minutes of light intensity aerobic walking exercise for 2 days per week and progresses up to 30 minutes of moderate intensity aerobic walking exercise for 3 days per week. Both conditions further will be monitored based on Fitbit-measured steps per exercise session. Of note, the sample size will be enrolled using 2 overlapping waves (Wave 1 = 14 participants, Wave 2 = 18 participants), 3 months apart. Participants will return to KF at the mid-point (i.e., T6) and end-point (i.e., T12) of the 12-month intervention period to complete the same assessments as T0. The T6 and T12 outcomes will be administered by treatment-blinded research assistants.
NCT05755061 — Multiple Sclerosis
Status: Active, not recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05755061/
Study of Ovarian Reserve Concerning Patients With Multiple Sclerosis, Compared to a Control Group
The investigators want to evaluate ovarian reserve concerning patients with multiple sclerosis, compared to a control group of healthy women. This study will include women from 25 to 35 years old.
NCT05754593 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05754593/
The Relation Between Physical Activity, Sedentary Behaviour, and Cardiometabolic Health in Multiple Sclerosis
This study evaluates the association between sedentary behaviour, physical activity, and the cardiometabolic health of Multiple Sclerosis via several cardiovascular, metabolic and anthropometric parameters.
NCT05752630 — Multiple Sclerosis, Relapsing-Remitting
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis-relapsing-remitting/NCT05752630/