Multiple Sclerosis Brain Lesion

Researchers are investigating the relationship between functional measures of balance and gait and objective kinetic and kinematic parameters in people with Multiple Sclerosis (MS). This cross-sectional observational study aims to understand how biomechanical gait and balance data collected through the Vicon motion analysis system relate to clinical assessments of balance, gait, and physical performance. The study seeks to identify which biomechanical factors are most closely linked to functional abilities and mobility challenges in MS. Participants will attend a single laboratory session where they will undergo biomechanical analysis of balance and gait using the Vicon motion capture system. They will also complete standardized functional tests including the Mini Balance Evaluation Systems Test, Functional Gait Assessment, Short Physical Performance Battery, and a 2-Minute Walk Test. Additionally, they will fill out questionnaires assessing fear of falling and fatigue and have their lower-limb spasticity evaluated with the modified Ashworth Scale. During the session, which takes about 40 minutes for the primary kinetic and kinematic analysis and additional time for functional assessments, researchers will collect detailed movement data alongside clinical measures. This data will be analyzed to explore correlations between biomechanical parameters and functional outcomes. The study includes assessments of postural control, gait performance, physical endurance, fatigue, and spasticity. The findings aim to improve understanding of movement impairments in MS and support better clinical assessments and rehabilitation approaches.

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 participant's 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 patient's 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 Crohn's 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 conducting a prospective, multicenter, observational study in Germany to evaluate the clinical value and impact of serum neurofilament light (sNfL) as a prognostic marker for disease activity in patients with relapsing Multiple Sclerosis (MS). The study focuses on patients who have received category 1 disease-modifying therapies (DMTs) and monitors routinely assessed sNfL values to better understand their role in patient management. Participants in the study either continue their current category 1 DMT treatment or switch to ofatumumab based on their physician's clinical judgment, independent of study enrollment. Category 1 DMTs include medications such as dimethylfumarate, diroximelfumarate, glatiramer acetate, interferon beta, and teriflunomide. Data will be collected over a maximum period of 24 months during routine clinical visits, with no specific protocol dictating observation frequency or diagnostic procedures. During the study, researchers will gather primary data including sNfL test results and track various outcomes like disease activity, treatment adherence, patient-reported fatigue, quality of life, and treatment satisfaction. Assessments will align with standard care practices and guidelines, and the study will measure outcomes at baseline, 12 months, and 24 months. The study aims to provide insights into the use of sNfL in clinical practice and its implications for managing relapsing MS.

Researchers are studying the combined effects of cognitive rehabilitation and exercise on new learning and memory in people with multiple sclerosis (MS) who have mobility disability. This study aims to evaluate whether combining the Kessler Foundation modified Story Memory Technique (KF-mSMT), a memory retraining program, with exercise can better restore learning and memory functions compared to cognitive rehabilitation alone. The study compares two types of exercise paired with KF-mSMT to support maximal functional recovery. Participants will be randomly assigned to one of two groups for 12 weeks. One group will perform aerobic exercise training with virtual reality (IDEAL) three days a week, doing only IDEAL for the first seven weeks and then adding KF-mSMT two days a week for the last five weeks. The other group will do supervised stretching and toning exercises three days a week for 12 weeks, with the same schedule for adding KF-mSMT in weeks 8 to 12. During the study, participants will be assessed on new learning and memory, everyday memory, and hippocampal volume and function before and after the intervention (at weeks 1-2 and 15-16). The study involves supervised exercise sessions, cognitive training, and various memory and brain function tests to measure changes. The total participation duration is about 16 weeks, including pre- and post-intervention 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, limited/blended, 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.