View clinical trials related to Multiple Sclerosis.
Filter by:The purpose of this project is to determine if specific gut microbiome or gut-derived metabolites are associated with depression in patients with Multiple Sclerosis (pwMS). Mechanistically, the investigators further hypothesize that depression in pwMS is related to decreased abundance of gut bacteria with GABA-producing activities and/or with anti-inflammatory properties. To determine if the presence of depression in pwMS is associated with specific gut microbiome, gut-derived metabolites or peripheral blood immune profiles. The investigators will perform a cross-sectional study in clinically stable pwMS recruited at the John L. Trotter MS Center. The investigators will evaluate the presence of depression using the Quality of Life in Neurological Disorders (Neuro-Qol) depression scale, one of the 13 scales in the Neuro-Qol recently developed by the NIH using modern psychometric techniques and validated in pwMS. A total of 120 pwMS will be recruited: 60 with and 60 without depression based on the Neuro-Qol depression scale. At the study visit each participant will be asked to provide a stool sample for microbiome analyses and a blood sample for peripheral blood immunophenotyping. Potential confounders will be collected and treated as covariates in the analyses. These include: 1) degree of disability (EDSS); 2) treatment with anti-depressants and DMTs; 3) a 4-days food diary to evaluate diet composition; 4) weight and height to calculate the BMI; 5) fatigue; 6) level of physical activity; 7) sleep quality.
This purpose of this study is research the usefulness of MRI with PET/CT imaging for measuring brain inflammation and its relation to Multiple Sclerosis (MS).
The primary objectives are to investigate the safety and tolerability of BIIB091 monotherapy in participants with relapsing multiple sclerosis (RMS) (Part 1), and to evaluate the effects of BIIB091 combination therapy with Diroximel Fumarate (DRF) compared with the DRF monotherapy arm, on the key Magnetic Resonance Imaging (MRI) measure of active Central Nervous System (CNS) inflammation (Part 2). The secondary objectives are to evaluate the effects of BIIB091 monotherapy on the MRI measures of active CNS inflammation, to evaluate the effects of BIIB091 combination therapy with DRF compared with the DRF monotherapy arm on additional MRI measures of active CNS inflammation, to investigate the safety and tolerability of BIIB091 combination therapy with DRF in participants with RMS.
This study aims to describe participants characteristics that can predict the safety and effectiveness of cladribine tablets, as assessed by time-to-discontinuation of treatment with cladribine tablets, and to assess other patient-reported, clinical, and imaging outcomes in participants with relapsing multiple sclerosis (RMS) in the long term, in a real-world setting.
TARGET-NEURO is an observational research study to conduct a comprehensive review of outcomes for patients living with chronic neurological diseases: Alzheimer's disease and related dementia (ADRD), mild cognitive impairment (MCI), Parkinson's disease (PD), and multiple sclerosis (MS).
Over the past 10 years, the rates of multiple sclerosis (MS) have nearly doubled in the United States. This chronic, neuroinflammatory, and neurodegenerative disease is most often diagnosed between the ages of 20-40. Cognitive impairment effects up to 70% of people with MS (PwMS) and has a detrimental impact on mental health, social connections, and employment. Further, up to 50% of PwMS also struggle with depression. Numerous cognitive rehabilitation programs are available to address cognitive impairment, but few interventions have simultaneous effects on cognition and emotional well-being. Music interventions have potential to fill this gap. Brain imaging studies on music and emotion show that music can modulate activity in the brains structures that are known to be crucially involved in emotion. Further, music engages areas of the brain that are involved with paying attention, making predictions, and updating events in our memory. The purpose of this study is to determine the feasibility of an online musical training intervention (MTI) for PwMS and explore the potential effect on cognition, psychosocial, and functional well-being compared to an active control group (music listening (ML)). The specific aims are to: 1) determine the feasibility and acceptability of delivering the MTI virtually over three months to PwMS; 2) evaluate the effect of the MTI on cognitive functioning (processing speed, working memory, cognitive flexibility, response inhibition), psychosocial (anxiety, depression, stress, quality of life, self-efficacy) and functional (insomnia) well-being compared to ML; and 3) (exploratory aim) to utilize non-invasive neuroimaging to determine if pre-intervention brain activity predicts post-intervention cognitive functioning.
The goal of this randomized controlled trial is to evaluate the effects of a digital group based self-management fall prevention program, "Fewer Falls in MS", in people with multiple sclerosis (PwMS). The main questions it aims to answer are:. - Is the Fewer falls in MS program effective in reducing fall incidence in PwMS at 6 and 12 months after start of intervention? - Does the program have an effect on secondary outcomes at 3, 6 and 12 months? - How do process evaluation components (context, implementation, mechanisms of impact) inform interpretation of outcomes? - What is the cost effectiveness of the fall prevention program 12 months after start of intervention? Participants in the intervention group will participate in a group-based self-management fall prevention intervention of eight 2-hour sessions delivered online by a group leader. The group leader will participate in an online education program before intervention start. Home assignments are completed by the participants between group sessions. Participants in the intervention group and the control group will receive a brochure on fall risk factors and fall prevention Researchers will compare the intervention group and the control group to see if there are any differences in fall incidence, sense of control of falls prevention, fear of falling, falls self-efficacy, activity curtailment, perceived impact of MS, self-reported health, and health economic costs. Researchers will also study factors and mechanisms that support or hinder how the fall prevention program builds participants' ability to manage their fall risk; and if and how PwMS have implemented and use self-management fall prevention behaviours into their daily lives.
The purpose of this research study is to try and identify risk factors and biologic changes that suggest that someone may go on to develop multiple sclerosis before a person has shown any symptoms of the disease.
Every-day life means being part of a complex environment and performing complex tasks that usually involve a combination of motor and cognitive skills. However, the process of aging or the sequelae of neurological diseases such as Multiple Sclerosis (MS) compromises motor-cognitive interaction necessary for an independent lifestyle. While motor-cognitive performance has been identified as an important goal for sustained health across different clinical populations, little is known about underlying brain function leading to these difficulties and how to best target these motor-cognitive difficulties in the context of rehabilitation and exercise interventions. The challenge of improving treatments of motor-cognitive difficulties (such as dual-tasking and navigation) is daunting, and an important step is arriving at a method that accurately portrays these impairments in an ecological valid state. The investigators aim therefore to explore brain function during complex walking in MS (in comparison with people with Parkinson's disease and healthy controls) by investigating the effects of neurological disease on motor-cognitive performance and its neural correlates during three conditions of complex walking (dual-task walking, navigation and a combination of both) using non-invasive measures of brain activity (functional near infrared spectrometry, fNIRS) and advanced gait analysis in real time in people with MS (in comparison with people with Parkinson's disease and healthy adults).
Multiple Sclerosis is the most common cause of neurologic chronic disability in young adults. Fatigue is one of the principal symptom in this disease. In the past it was demonstrated how, with appropriate frequencies and amplitude of vibration, it is possible both to select the activated afferents, and to determine the frequency of action potentials sent to the Central Nervous System. The purpose of this study is to verify how the use of vibrations can induce positive effects on the mobility and postural control of patients with MS, as well as reduce fatigue. The study is an interventional type. The subjects are undergoing to baseline examinations (T0) including 3D gait analysis (using a BTS system), stabilometric analysis, and a battery of neuropsychological assessments. Subsequently, eligible subjects are undergoing to intensive multidisciplinary training for a total of 5 sessions per week for 4 weeks, with a total of 20 treatment sessions. The experimental group receive additional vibration treatment. At the end of the treatment cycle (T1), the patients will undergo the same evaluation tests as at baseline. The Clinical and instrumental exams used for this study (as per normal clinical practice) are: Expanded Disability Status Scale (EDSS), Fatigue Severity Scale (FSS), Modified Fatigue Impact Scale (MFIS), Fatigue Scale for Motor and Cognitive Functions (FSMC), Borg Scale, Medical Research Council Scale (MRC), 6 minutes walking test. The Psychological Assessment Battery used are: Multiple Sclerosis Quality of Life-54 (MSQOL-54) scale, Beck Depression Inventory-II, Coping Orientation to Problems Experienced (COPE). Sample size: The sample consist of patients with MS admitted to the C.A.R.E.N. or Casazza facilities of the IRCCS Centro Neurolesi Bonino-Pulejo in Messina. Twenty eligible subjects recruited and treated with traditional rehabilitation approach plus vibrational therapy. The results will be compared to those obtained from a group of 20 patients who have undergone a traditional rehabilitation treatment without the application of vibrations and who will represent the control group.