Multiple Sclerosis Brain Lesion

Researchers are investigating how balance and walking abilities relate to detailed movement measurements in people with Multiple Sclerosis MS. This observational study focuses on understanding the connection between clinical tests of function and objective biomechanical data. The goal is to identify which movement characteristics best reflect balance, gait, and physical performance challenges faced by individuals with MS. Participants will attend a single laboratory session where they undergo biomechanical analysis using the Vicon motion capture system. They will complete functional assessments of balance, gait, and physical performance, as well as questionnaires about fear of falling and fatigue. Spasticity in the lower limbs will also be assessed during this visit. During the session, participants will perform tests such as the mini-BESTest for balance, Functional Gait Assessment, Short Physical Performance Battery, and a 2-minute walk test. Questionnaires like the Fall Efficacy Scale and Fatigue Severity Scale will be completed. Researchers will analyze these collected data to explore how biomechanical and functional measures relate, aiming to improve assessment tools for MS rehabilitation.

Researchers are evaluating a new, affordable way to monitor people with multiple sclerosis MS using patient-recorded selfie videos. This study aims to see if videos collected remotely on a mobile phone can provide the same walking and speech information as traditional in-person visits. The goal is to create a low-burden, patient-centered method that can be used widely and easily by diverse people with MS. Participants will record five short selfie videos at home during baseline, 3 months, 6 months, and 12 months. They will also attend in-person visits at baseline, 6 months, and 12 months for additional data collection. These videos capture daily activities like walking and talking, using the participants own device such as a smartphone, tablet, or computer without special software. During the study, participants will undergo several assessments including video uploads and in-person evaluations lasting about 15 minutes for video collection and one hour for in-person visits. Researchers will measure how well video data matches standard MS functional tests, the usability of the video method, and its ability to detect subtle changes over time. The study lasts one year and aims to improve remote monitoring for people living with MS.

This research aims to compare a new spinal cord imaging technique called the 3D OPTIMIZED WMN MPRAGE sequence with conventional MRI sequences for people with multiple sclerosis. Multiple sclerosis is a common inflammatory disease affecting the central nervous system, often causing spinal cord damage that leads to symptoms like sensory loss, pain, weakness, and bladder or bowel problems. Imaging the spinal cord is important for diagnosis and prognosis, but current methods have limitations in detecting lesions accurately. The study involves scanning patients at the cervical and thoracic levels of the spinal cord using both conventional MRI sequences including 2D sagittal T2 FSE, 2D sagittal STIR, 2D sagittal PSIR, and 3D MPRAGE and the new 3D OPTIMIZED WMN MPRAGE sequence. At the cervical level, the new sequence will be acquired in sagittal and axial views, while at the thoracic level it will be acquired sagittally. This comparison will help assess whether the new sequence provides better detection of spinal cord lesions. Participants will undergo MRI scans at one visit where researchers will evaluate the number and volume of lesions, presence of artifacts, contrast quality, and the relation of lesions to the patients disability. The study will also measure sensitivity, positive predictive value, and reproducibility of the new imaging method. The total participation time corresponds to the imaging session on day one, with no long-term follow-up reported.

Researchers are investigating the specific targets of T cells involved in autoimmune diseases by studying tissues from patients with active organ inflammation caused by autoimmune conditions. The study aims to identify which T cells are activated and expanding in diseased tissues compared to blood or normal tissues. This information will help discover new peptide targets and their associated T cell receptors TCRs to develop potential new therapies for autoimmune diseases. Participants will provide tissue samples and matched blood samples during clinical procedures such as endoscopy, arthrocentesis, lumbar puncture, skin biopsy, bronchoscopy, or surgery, depending on their autoimmune condition. The study includes several groups covering diseases like Crohns disease, ulcerative colitis, celiac disease, ankylosing spondylitis, multiple sclerosis, scleroderma, systemic sclerosis, and other autoimmune diseases. Samples may come from excess clinical materials or research-specific biopsies, with the possibility of serial sampling over time. During the study, participants will undergo standard clinical procedures with collection of additional tissue or fluid samples and companion blood draws. Researchers will analyze these samples to identify peptide targets linked to disease-reactive T cells over a period of up to three years. The study includes comprehensive assessments of tissues and blood to understand T cell activity in autoimmune disorders, with monitoring of participant safety and no interventions beyond routine clinical care.

Researchers are evaluating the pharmacokinetic profiles, safety, and tolerability of two investigational drugs, IVL3004 and IVL4002, compared to Vivitrol Naltrexone Long-Acting Injectable. This phase 1, open-label study involves healthy adult male volunteers aged 18 to 55 years. The purpose is to explore how these drugs behave in the body when given as single ascending doses and to assess any safety concerns. The study consists of multiple groups receiving single doses of either Vivitrol via intramuscular injection or varying doses of IVL3004 and IVL4002 administered either intramuscularly or subcutaneously. Participants will receive these injections in a fixed sequence to compare the pharmacokinetic properties of each drug. Participants will undergo assessments from before dosing up to day 57, including measurements of drug concentration over time AUC and Cmax. They will be monitored for safety and tolerability through physical exams, laboratory tests, and observation for adverse effects. The total study participation spans several weeks with follow-up visits to collect data on how the drugs are processed in the body and any side effects experienced.

This research focuses on people who have previously been treated with KYV-101, an autologous CAR T cell therapy, to monitor long-term safety and persistence of the treatment. It aims to collect information about delayed side effects and ongoing presence of the gene-modified cells in participants who received at least one infusion of KYV-101 in earlier clinical trials sponsored by Kyverna Therapeutics. Participants in this observational study will continue to be followed for up to 15 years after their initial KYV-101 treatment. The study will track various health outcomes including treatment-related adverse events, new or returning malignancies, neurological and autoimmune conditions, blood disorders, infections, and specific laboratory tests related to the therapy. For some participants with certain conditions, additional measures like medication use and functional assessments will be monitored for shorter periods. Throughout the study, participants will undergo regular health evaluations, lab tests, and questionnaires to assess the long-term effects of KYV-101. Researchers will collect data on safety events and laboratory markers up to 15 years, with some specific tests monitored up to 5 years. The overall goal is to better understand the long-term impact and safety profile of the gene-modified therapy in people treated previously.

Researchers are evaluating a new combined approach to improve new learning and memory NLM in people with multiple sclerosis pwMS who have mobility difficulties. This study looks at how combining cognitive rehabilitation using the Kessler Foundation modified Story Memory Technique KF-mSMT, a memory retraining program, with exercise may enhance recovery more than cognitive rehabilitation alone. The study aims to maximize functional recovery by addressing the limitations of cognitive rehabilitation when used by itself. Participants will be randomly assigned to one of two groups. One group will complete a supervised aerobic exercise training program with virtual reality IDEAL three days a week for 12 weeks for the first seven weeks, they do only the exercise, and for weeks 8 to 12, they also do the KF-mSMT memory program two days a week. The other group will do supervised stretching and toning exercises three days a week for 12 weeks, with the same schedule of adding KF-mSMT during weeks 8 to 12. Both interventions are supervised and aim to improve memory and physical activity. Participants will be assessed before the intervention weeks 1 and 2 and after the intervention weeks 15 and 16 to measure changes in objective learning and memory, everyday memory, and brain changes such as hippocampal volume and function. The study includes questionnaires and memory tests, with safety and progress monitored throughout. Participation lasts about 16 weeks in total, including the treatment and follow-up assessments.

Researchers are evaluating the impact of two different palliative care approaches on knowledge, attitudes, and decision-making among adults aged 18 to 65 with neuroinflammatory diseases such as Multiple Sclerosis MS, Neuromyelitis Optica Spectrum Disorder NMOSD, or anti-MOG. The study compares a video decision aid model to standard palliative care written information. The aim is to explore patients preferences for care goals, decisional conflict, knowledge, and preparation for making healthcare decisions, with assessments at baseline and after three months. Participants are randomly assigned to either view a 10-minute palliative care video or receive written informational sheets about palliative care conversations and advance care planning. The video includes empathic messaging, explanations of care goals using the Physician Orders for Life Sustaining Treatment POLST framework, and visual aids describing life-prolonging, limitedblended, and comfort care options. Both groups complete demographic forms and pre- and post-tests at baseline and after three months. The video group can review the video as needed using iPads, and an advance care planning facilitator guide supports consistent delivery of the intervention. During the study, participants will report their goals-of-care preferences, cardiopulmonary resuscitation CPR and ventilatory support choices at several timepoints baseline, immediately after the intervention or control material, and after three months via phone follow-up. Researchers will assess treatment preferences, knowledge about palliative care, decisional conflict, and preparation for decision making. They will also explore changes in preferences and documentation of palliative care conversations over time. The total participant involvement includes initial visits and a three-month follow-up assessment.

Researchers are evaluating the effects of a flavonoid-rich Mediterranean diet on individuals with multiple sclerosis MS, a condition influenced by environmental factors like nutrition. This study aims to understand how this specialized diet might impact disease parameters in people living with MS. Participants will follow a set of dietary guidelines focusing on consuming foods rich in flavonoids as part of an adjusted Mediterranean diet. The study includes three key assessment timepoints before starting the strict diet, after completing the diet, and following a three-month follow-up period. During the study, researchers will monitor changes in the participants gut microbiota at these three intervals. The total study duration includes initial diet adherence and a follow-up phase to evaluate lasting effects. Participants will be regularly assessed to track how the diet influences their condition over time.

This research aims to compare the rate of major congenital malformations MCM in pregnant participants with multiple sclerosis MS who have been exposed to BRIUMVI4 Ublituximab versus those who have not. The study focuses on participants who are currently or recently pregnant and evaluates pregnancy and infant outcomes related to exposure to this medication. The study is observational and collects data prospectively. Participants are divided into two groups one cohort includes pregnant individuals with MS who have received any dose of BRIUMVI4 during pregnancy or within six months before conception. The other cohort includes pregnant participants with MS who have not been exposed to BRIUMVI4 or other anti-CD20 monoclonal antibodies during pregnancy but may have used other MS treatments. There is no intervention administered as part of the study. During the study, researchers collect data up to 52 weeks after delivery to assess the percentage of participants with major congenital malformations. Participants provide authorization to share their medical data with the registry. The study monitors pregnancy outcomes and infant health, focusing on safety and developmental measures. The overall participation period extends from pregnancy through one year after delivery.