Clinical Research Directory

Mastication, Cognition, and Nutritional Status in Multiple Sclerosis

The aim of this study is to investigate the relationship between chewing function and cognitive functions, disease severity, and nutritional status in individuals diagnosed with Multiple Sclerosis

Treatment of Memory Retrieval Impairments in MS With HDtDCS to the LIFG in a Placebo Controlled Trial

The purpose of the study is to test whether low-level electric stimulation, called High Definition transcranial Direct Current Stimulation (HDtDCS), on the part of the brain (i.e., left inferior frontal gyrus) thought to aid in memory will improve verbal retrieval in multiple sclerosis patients. The primary outcome measures are neuropsychological assessments of verbal retrieval, and the secondary measures are neuropsychological assessments of other cognitive abilities and electroencephalography (EEG) measures.

MS-DETECT: Early Detection of Multiple Sclerosis Progression With MSCopilot® Detect

The study aims to evaluate MSCopilot® Detect, a smartphone application for at-home monitoring of patients with Multiple Sclerosis (MS). The primary objective is to enhance and standardize remote monitoring of MS patients to accurately assess disease progression caused by either Relapse Activity Worsening (RAW) or Progression Independent of Relapses (PIRA). The study also aims to assess the safety, usability, and satisfaction of the solution. A secondary objective is to determine MSCopilot® Detect's ability to provide early detection of disease changes and predict changes in Expanded Disability Status Scale (EDSS) scores in more patients. Exploratory objectives include evaluating the relationship between MSCopilot® Detect composite and individual scores and other biomarkers such as MRI, soluble glial fibrillary acidic protein (sGFAP), and soluble neurofilament light chain (sNfL). Patients will be able to download the free MSCopilot® Detect app. They will participate in 1 inclusion visit and 3 follow-up visits, scheduled at 6 months, 12 months, and 18 months (an additional visit at 24 months may be scheduled if necessary). Every 3 months, patients will complete validated questionnaires regarding MS symptoms and quality of life and participate in digital tests designed to monitor MS symptom progression. The study will include 336 MS patients and will be conducted in the United States, Canada, Germany, Italy, Spain, Denmark and France

Motor Learning in Health and Movement Disorders: Role of Physical Activity and Advanced Devices

The goal of this clinical trial is to investigate motor responses in healthy subjects and patients with movement disorders, brain and spinal cord injury, neuromuscular diseases, or cardiovascular diseases. This study aims to evaluate the effectiveness of traditional physical activities combined with innovative interventions such as cryotherapy, ultrasound therapy, laser therapy, transcranial magnetic stimulation (TMS), and transcranial direct current stimulation (tDCS). It will also assess the impact of proprioceptive stimuli provided by either the immersive virtual reality (CAREN), or visuo-cognitive-motor enhancement (S.V.T.A.), and music therapy. The main questions it aims to answer are: How do these interventions affect motor activities and their functional recovery? What are the temporal and spatial changes in activation sequences related to motor learning and maintenance? When there is a comparison group: Researchers will compare outcomes between different intervention arms (e.g., physical activity with advanced devices vs. traditional methods) to find out if the advanced interventions result in better motor control and functional recovery. Participants will: * Undergo various rehabilitation protocols including physical activity and advanced interventions. * Be assessed using different tool, such as fMRI, dtMRI, and NIRS to study in vivo neuroimaging and assess changes in brain function and connectivity.

Classification of Upper and Lower Limb Spasticity Patterns and Their Impact on Quality of Life in Patients With Multiple Sclerosis

Multiple sclerosis (MS) is a chronic neurological disease frequently associated with spasticity, which may lead to functional limitations and reduced quality of life. Although spasticity is common in MS, detailed descriptions of upper and lower extremity spasticity patterns are limited. A better understanding of spasticity patterns may help improve individualized rehabilitation and treatment planning. The aim of this study is to classify upper and lower extremity spasticity patterns in patients with multiple sclerosis and to investigate their association with quality of life. Adult patients with MS and clinical spasticity will be recruited from a tertiary care outpatient clinic. Spasticity will be evaluated using the Modified Ashworth Scale, and extremity postures will be recorded to define spasticity patterns. Functional performance will be assessed using the Timed 25-Foot Walk Test and the 9-Hole Peg Test. The impact of spasticity on quality of life will be evaluated using the Patient-Reported Impact of Spasticity Measure (PRISM). This prospective cross-sectional study is designed to provide a systematic description of spasticity patterns in patients with multiple sclerosis and to examine their relationship with functional outcomes and quality of life.

Cladribine Tablets Level of Response Predictors in Clinical Practice (CLODINA)

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.

Chewing Under Dual-Tasking in MS

This study aims to investigate the effects of visual, auditory, and motor dual-task conditions on chewing performance in individuals with multiple sclerosis, compared with healthy controls.

Serum GFAP, NfL, VEGF and Clinical Progression in Progressive MS

This study aimed to investigate whether the biomarkers GFAP, NfL, and VEGF-recently considered important guides for better understanding the pathophysiology of MS-also serve as indicators of clinical progression in MS.

In Vivo Characterization of Inflammation With Ferumoxytol, an Ultrasmall Superparamagnetic Iron Oxide Nanoparticle, on 7 Tesla Magnetic Resonance Imaging

Background: \- Contrast agents help things show up better on magnetic resonance imaging (MRI) scans. Researchers want to see if the drug ferumoxytol is a good contrast agent. They want to determine that it does not cause prolonged MRI changes in the brain and to see if it helps identify inflammation in multiple sclerosis Objective: \- To learn how ferumoxytol can be used to image inflammation in multiple sclerosis (MS). Eligibility: * Adults ages 18 70 who have MS. * Healthy volunteers ages 18 70. Design: * Participants will have 5 clinic visits over 6 months. * Participants will be screened with a medical history, neurological exam, and blood draw. Full clinical measures will be obtained. * Participants will have a 7 tesla brain MRI scan that may include gadolinium contrast agent. The MRI is a metal cylinder in a strong magnetic field. The participant will lie on a table that can slide in and out of the cylinder. * During visit 2, ferumoxytol with be given through a catheter (a thin plastic tube) that is inserted with a needle into a vessel in the arm. \<TAB\>- Participants will then have a 7 tesla MRI scan of the brain.. * At each of the next 3 clinic visits, participants will have a 7 tesla brain MRI and have blood drawn. The MRIs may include gadolinium. * Participants may have a full neurologic exam at these visits. At the final visit, full clinical measures will be obtained. * Participants may have more MRI scans if a 6-month MRI shows ferumoxytol still in the brain.

Understanding and Enhancing Human Health and Movement

By doing this study, investigators hope to learn how electrical stimulation can improve human movement, biomechanics, and function and to gather information on the safety and effectiveness of an implanted electrical stimulation system after paralysis from spinal cord injury, stroke, multiple sclerosis, and traumatic brain injury.

HOBSCOTCH-MS-Efficacy Trial

The purpose of this study is to assess the ability of the home-based intervention, HOBSCOTCH-MS to improve the quality of life and cognitive function in Service Members, Veterans and civilians who have multiple sclerosis with cognitive and memory problems (MS participants). This study will also assess the ability of the HOBSCOTCH-MS program to improve quality of life in caregivers of patients with multiple sclerosis and to reduce caregiver burden. Enrolling with a Caregiver is optional for MS participants. Investigators will compare two groups of MS participants and their Caregiver (enrolling with a Caregiver is optional): one who receives HOBSCOTCH-MS immediately (Group 1) and another group that will receive HOBSCOTCH-MS (Group 2) after a 3-month waiting period. Participants will be in the study for about 6 months total. HOBSCOTCH-MS involves 45 to 60 minute one on one virtual sessions with a certified Cognitive Coach including a "pre" program session and 8 weekly sessions thereafter. Participants will learn about problem solving therapy and mindfulness or relaxation training. MS participants are asked to do short homework assignments and both MS and Caregiver participants are asked to keep a brief daily diary on a smart phone app. All participants complete study questionnaires or surveys at enrollment, 3 months later and at 6 months (at the end of the study). After completing the intervention, MS Participants and their Caregivers may also participate in an optional one-time Key Informant Interview for qualitative analysis in an effort to further adapt and improve the HOBSCOTCH-MS in the future.

MSCopilot Users' Feedback in Real Life - Outcomes Regarding Integration in Patients' pathWay and Users' ExpeRience

This US multicenter, prospective cohort study aims to evaluate how MSCopilot can be seamlessly integrated into the current care pathway and identify potential optimizations to enhance its impact on both MS patients and clinicians, facilitating broader implementation. Specifically, the study will assess: * The overall integration of MSCopilot into routine clinical practice, * Patients' ability to use MSCopilot at home without supervision, * The need for patient support when using MSCopilot at home, * User behavior based on usage analytics data from the MSCopilot mobile app and dashboard, * Patient adherence to MSCopilot use in routine clinical practice, * The adequacy of the onboarding/training process for HCPs, * The effectiveness of HCPs onboarding/training in ensuring successful patient onboarding, * The variances in user behavior and adherence to MSCopilot use according to socio-demographic factors and EDSS scores

Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis

The purpose of the study is to describe the safety profile of fingolimod in the Taiwanese multiple sclerosis population. This study aims to collect the safety data in patients newly initiated on fingolimod for one year.

Aerobic Fitness in Multiple Sclerosis: The Relationship Between Balance and Sensory Dual-Tasking

The aim of this study is to comparatively examine the effect of aerobic fitness levels on walking and balance performance, sensory dual-task (proprioceptive and vestibular) performance, balance confidence, and fatigue levels in individuals diagnosed with MS. Research hypotheses H1: MS patients with high aerobic fitness exhibit superior walking speed and balance performance compared to MS patients with low aerobic fitness. H2: In sensory dual-task tests involving proprioceptive and vestibular manipulations (BOSU ball, soft surface, and head movements synchronized with a metronome), MS patients with high aerobic fitness demonstrate better performance than the group with low aerobic fitness. H3: MS patients with high aerobic fitness report higher levels of balance confidence compared to the group with low aerobic fitness. H4: Perceived fatigue is greater in MS patients with low aerobic fitness compared to the group with high aerobic fitness. H5: There is a significant relationship between aerobic capacity levels and sensory dual-task performance, balance confidence, and fatigue severity in MS patients.

Switch to Ofatumumab and Level of Immunoglobulins

This real-life study aims to describe IgG levels after switching from ocrelizumab 600 mg IV every 6 to 8 months in Patients with Multiple Sclerosis (PwMS) to ofatumumab 20 mg SC every month and showing a decreasing level of IgG during treatment by ocrelizumab in real life practice in France over 24 months of follow-up. The primary objective is therefore to determine if the downward trend of IgG observed during ocrelizumab treatment is modified after a switch to ofatumumab, in PwMS treated during at least 18 months of ocrelizumab in real life practice, over 24 months of follow-up.

Oral Cladribine B-cell Study

To study the impact of cladribine on peripheral and intrathecal B-cell, plasma cells, T cells and Tregs

A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy

The purpose of this study is to assess the imaging biomarkers, patient outcomes, safety, tolerability, and treatment satisfaction of ocrelizumab (OCR) combined with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) in participants with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS) after switching from another anti-cluster of differentiation 20 (aCD20) therapy approved for RMS (ofatumumab SC, ublituximab-xiiy intravenous \[IV\], ocrelizumab IV) or PPMS (ocrelizumab IV).

ADAs to Alemtuzumab

The main aim is to quantify the changes in alemtuzumab antibody-anti-alemtuzumab over a 24 months period

A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)

The purpose of this study is to evaluate safety, effiectiveness, and to gain insight into the treatment experience of participants prescribed BRIUMVI® (ublituximab-xiiy) in the real-world setting

A Study Evaluating the Effect of BRIUMVI® (Ublituximab) on Pregnancy and Infant Outcomes in Participants With Multiple Sclerosis (MS)

The primary objective of the study is to compare the prevalence rate of major congenital malformations (MCM) between 2 cohorts of pregnant participants with MS who are exposed to BRIUMVI® and who are unexposed to BRIUMVI®.

A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)

The purpose of this study is to evaluate the PK and safety of ublituximab SC at different sites of administration and relative bioavailability of ublituximab SC administered with a prefilled pen versus syringe.

Relating Genetic and Environmental Risk Scores to Multiple Sclerosis Susceptibility

Background: \- Research shows that both genes and the environment influence a person s risk for getting multiple sclerosis (MS). However, it is not possible to accurately predict who will develop MS. Researchers want to study people with MS and their family members. They have developed a Genetic and Environmental Risk Score for MS. This score combines information from a person's medical history and genes. It also includes environmental factors that may be related to developing MS. This study will test this risk score to see if it can help predict who will develop MS. Objectives: \- To evaluate a score for genetic and environmental risk factors that may help predict whether a person will develop MS. Eligibility: * Individuals at least 18 years of age who have MS. * Individuals between 18 to 50 years of age who are the parent, brother, sister, or child of a person with MS. Design: * People with MS will allow researchers to look at their personal and medical data. These data will have been collected in other MS-related studies. * Relatives of people with MS will fill out a questionnaire and give blood and saliva samples. They will fill out the questionnaire again one year later. * Some relatives will have additional optional testing. These tests will include a physical exam and imaging studies. There may also be other tests. These tests may be repeated every 1 to 5 years for 20 years.

Dry Needling in Multiple Sclerosis

This study is being conducted at the Human Functional Performance Laboratory in the School of Physical Therapy and Rehabilitation Sciences (MDT Building) at the University of South Florida. The study is supported by the Consortium of Multiple Sclerosis Centers. The investigators are conducting this study to determine whether a treatment called dry needling can improve chronic pain in the lower body (from the low back to the foot) in people with Multiple Sclerosis. Dry needling involves inserting tiny needles, similar to those used in acupuncture, into specific muscles, such as the thigh or calf muscles. Unlike traditional acupuncture, dry needling targets specific muscle areas to reduce muscle stiffness and pain. Dry needling may help reduce pain without medication. The investigators also aim to determine whether dry needling can improve balance and walking abilities, potentially leading to better day-to-day functioning. Participants will be assigned to one of two groups. Both groups will receive six treatment sessions. One group will receive actual dry needling, while the other group will receive a sham procedure designed to mimic dry needling. Treatment assignment will be determined randomly, similar to flipping a coin. Neither participants nor the study doctor will choose the assigned treatment. Each participant will have an equal chance of receiving actual dry needling or the sham procedure. Participants will not be informed of the assigned treatment; however, the study doctor will know the treatment assignment. Participants are being invited to take part in this study because of a diagnosis of Multiple Sclerosis and the presence of chronic pain in the lower body, including the buttocks, thighs, calves, or feet. The investigators aim to determine whether dry needling can help reduce chronic lower-body pain in people with Multiple Sclerosis.

Short Sprint Interval Training in People With Multiple Sclerosis

The goal of this clinical trial is to learn whether a short sprint interval training protocol on a cycle ergometer can improve physical function, walking, muscle strength, exercise capacity, fatigue, cognitive processing speed, and patient-reported outcomes in people with multiple sclerosis. The main questions it aims to answer are: 1. Does short sprint interval training improve walking performance, lower-limb coordination, muscle strength, exercise capacity, fatigue, and cognitive processing speed in people with multiple sclerosis? 2. How do participants respond to short sprint interval training in terms of heart rate, power, cadence, perceived exertion, and affective valence? 3. What adverse events or unintended effects, if any, occur during the intervention? Researchers will compare short sprint interval training with usual physical activity to see if this exercise program improves physical, cognitive, and patient-reported outcomes. Participants will: 1. Be randomly assigned to either a short sprint interval training group or a usual physical activity group. 2. Complete assessments before and after the 2-week training period. 3. Continue their usual physical activity if they are assigned to the control group. 4. Complete 6 supervised exercise sessions over 2 weeks if they are assigned to the short sprint interval training group. 5. During each exercise session, perform short 5-second high-intensity cycling sprints on a recumbent cycle ergometer, separated by recovery periods. 6. Complete walking, strength, stepping, calf endurance, fatigue, and cognitive processing speed assessments.