Clinical Research Directory

Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study

This pilot mixed-method study will evaluate the feasibility, preliminary efficacy, and user experience of a home-based wearable Focal Vibration Therapy (FVT) intervention for improving upper extremity (UEx) function in people with multiple sclerosis (MS). Fifteen adults with relapsing-remitting MS (PRMS) and self-reported UEx impairments will participate in a 4-week FVT program using MyovoltTM wearable FVT devices applied to arm muscles.

Monthly Monitoring of Plasma NfL in Treated Relapsing-remitting Multiple Sclerosis to Detect Persistent Infraclinical Disease Activity

Reference MRI scan is recommended 6 months after treatment onset in patients with multiple sclerosis (MS), and follow-up scans at 12 months later to monitor subclinical activity. When monitoring treatment response in patients treated with disease modifying treatments (DMTs), the measurement of new or enlarging T2/FLAIR hyperintense lesions (NELs) is the preferred MRI method supplemented by contrast-enhancing lesions (CELs) for monitoring treatment response. However, some studies have suggested the deposition of gadolinium-based contrast agents in the basal ganglia and dentate nucleus of patients who underwent serial MRI acquisitions. Although significant clinical consequences of these deposits have not been demonstrated, further studies are required to better understand the potential long-term biological and clinical effects of gadolinium administration. To circumvent this potential risk, several recommendations suggested avoiding unnecessary use of gadolinium for follow-up scans. New sequences are also developed to replace gadolinium injection for the detection of active lesions. Moreover, MRI remains costly and time-consuming. In addition, systematic yearly MRI monitoring is not adapted to detect silent active lesions. This can delay identification of treatment failure and increase the risk of relapses and disability worsening, especially in the context of escalation therapy. Therefore, biological markers could allow more frequent analysis of disease activity and detect treatment failure earlier than classical clinical and MRI monitoring. Their use would greatly help clinicians to switch for high efficacy treatments (HET) and avoid potential relapses. Measurement of a structural axonal protein, neurofilament, in serum or plasma has shown promise as a marker of neuroaxonal injury and a measure of treatment response. In MS, cerebrospinal fluid (CSF) neurofilament-light chain (NfL) is also increased and is positively associated with MRI lesion load and disability scores and is a marker of treatment response. WThe study authors hypothesize that monthly plasma neurofilament-light chain (pNfL) monitoring can sensitively highlight subclinical (radiological disease activity) RDA by performing early MRI scans to confirm EDA and lead to timely treatment escalation. The main objective of this study is to compare the time to EDA in both arms (monthly pNfL monitoring vs. standard care with regular MRI scans), in patients with EDA.

Tai Chi Training for Persons With Multiple Sclerosis.

Tai Chi combines strength and neuromuscular training with diaphragmatic breathing, attention, imagery and relaxation. After an initial learning period, participants can practise independently, potentially supporting self-efficacy and sustained self-management. Studies in chronic disease report benefits for physical function and psychological wellbeing. The investigators will evaluate a 12-week Tai Chi rehabilitation programme in a clincial trial. The Multiple Sclerosis Impact Scale (MSIS-29) is the primary clinical outcome, reflecting the physical and psychological consequences of multiple sclerosis (MS). Assessments take place before training and at 12 weeks (the primary endpoint). The study will address whether Tai Chi improves physical and mental health; reduces fatigue, anxiety, depression and pain; improves lower-limb strength, gait and balance; and improves quality of life and self-efficacy.

REAL-MS: Observational Database Study of AHSCT and MS Therapies

Multiple sclerosis (MS) is a condition in which the immune system damages the brain and spinal cord. Treatments called disease-modifying therapies can reduce inflammation and disease activity. For some people with highly active MS, autologous haematopoietic stem cell transplantation (AHSCT) may be used. AHSCT uses a person's own blood-forming stem cells after treatment that suppresses the immune system. REAL-MS is an observational study that will collect and analyse information from routine clinical care to compare the longer-term effectiveness and safety of AHSCT with high-efficacy disease-modifying therapies for adults with MS. High-efficacy therapies include medicines such as alemtuzumab, cladribine, natalizumab, and anti-CD20 antibody treatments, as well as other high-efficacy disease-modifying therapies that may become available during the study.

Educational Programs Based on Healthy Habits to Improve Quality of Life and Psychosocial Profile in Women With Neurodegenerative Diseases: the ADVICE Protocol Study (Phase 2)

This phase of the project aims to compare in-person, supervised educational programs (EP) with online self-guided EPs in individuals with relapsing-remitting multiple sclerosis. A total of 75 participants will be randomly assigned to one of three groups: a supervised and individualized educational program focused on HIIT training, a supervised and individualized educational program focused on strength training, and a non-supervised, self-guided educational program based on resistance band training. Additionally, sessions on the Mediterranean diet (both supervised and non-supervised) and cognitive-behavioral interventions will be included. A control evaluation will be conducted three months after the intervention to assess the effects of the educational programs, followed by another evaluation three months later to analyze residual effects. Women who participated in Phase 1 of the study will be invited to take part in this second phase.

Psychological Interventions for Multiple Sclerosis: Effects on Anxiety, Depression, and Cognition.

This study evaluated the efficacy of two structured psychological interventions in individuals with relapsing-remitting multiple sclerosis (RRMS). The main objective was to evaluate whether Group-Based Cognitive-Behavioral Therapy (CBT) and Psychophysiological Regulation Therapy (PRT) improved emotional well-being and objective cognitive functioning compared with Standard Care (SC). A total of 153 individuals with RRMS were assessed for eligibility, of whom 148 were randomized to one of three study conditions: Group-Based CBT, PRT, or SC (waiting-list control). Participants were allocated using a simple computer-generated randomization sequence with a 1:1:1 allocation ratio. Both active interventions were delivered in small groups over 12 weekly sessions. CBT and PRT shared a common therapeutic framework comprising psychoeducation, mindfulness, psychophysiological regulation strategies, and homework assignments. The CBT condition additionally incorporated specific cognitive-behavioral components during sessions 4-10. Assessments were conducted at baseline and immediately after completion of the 12-week intervention period using standardized psychological and neuropsychological measures. The study evaluated treatment effects across complementary domains of emotional functioning and objective cognitive performance.

A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Disease

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Synbiotic Supplementation as a Part of Dietary Modification in Multiple Sclerosis

Multiple Sclerosis (MS) is a chronic inflammatory and demyelinating disease of the central nervous system, influenced by genetic, epigenetic, and immunological factors, as well as environmental factors such as nutrition. Medical nutrition therapy (MNT) has the potential to improve the quality of life for individuals with MS and enhance the disease course, particularly by reducing inflammation, providing neural protection, and regulating metabolic factors such as body weight. Recently, probiotic/synbiotic-supported studies have been conducted to investigate the effects of gut microbiota on the disease; however, only a few studies have thoroughly evaluated detailed dietary patterns. This study aims to examine the effects of the Mediterranean Diet, which is thought to have an impact on MS patients and many autoimmune diseases, along with synbiotic use, on the disease and quality of life of MS patients. All patients were given MNT during the study period. At the 6th week, the study group received probiotics while the control group received placebo twice a day as recommended. In the 1st (W1), 6th (W6) and 12th (W12) weeks, three- day food consumption and 24-hour physical activity records, anthropometric measurements, hand grip strength and biochemical indicators, Healthy Eating Index-2015 (HEI-2015), Beck Depression Inventory (BDI), Mediterranean Diet Adherence Scale (MEDAS), Multiple Sclerosis Quality of Life Scale-54 (MSQoL-54), Expanded Disability Status Scale (EDSS) scores were evaluated.

A Study of Remibrutinib Using MR Imaging in Relapsing or Progressive MS

The study is an investigator-run, study following participants for 2 years with twice-daily remibrutinib. MRI is the main endpoint. Safety, tolerability, and efficacy are secondary endpoints. Approximately 20 participants with relapsing or progressive forms of MS will be recruited.

Brain Imaging and Immune Changes During Remibrutinib Treatment in Multiple Sclerosis.

REDEFINE-MS is a research study for people with relapsing multiple sclerosis (MS) who are participating in the RESHAPE-MS trial. The study aims to better understand how remibrutinib affects inflammation in the brain and spinal cord by using PET imaging, MRI scans, blood samples, and cerebrospinal fluid (CSF) samples collected before treatment and again six months later. \[REDEFINE\_p...2026\_clean \| Word\] The main question the study is trying to answer is whether remibrutinib changes immune activity and inflammation in people with MS, and whether these changes can be measured using imaging and biological markers that may help predict future disease progression and treatment response.

Effect of Low Histamine-Based Modified Mediterranean Diet in Multiple Sclerosis

This randomized controlled trial will evaluate the effects of a low histamine-based modified Mediterranean diet in adults with relapsing-remitting multiple sclerosis (RRMS). The study will compare three groups: a low-histamine modified Mediterranean diet, a traditional Mediterranean diet, and a control group without dietary intervention. The main outcomes include clinical measures such as disability status, fatigue, migraine, gastrointestinal symptoms, and quality of life, as well as blood markers including plasma histamine, diamine oxidase activity, total antioxidant capacity, and oxidative stress indicators. The goal is to determine whether reducing dietary histamine within a Mediterranean diet pattern provides additional benefits beyond a traditional Mediterranean diet in improving symptoms and biological markers related to inflammation and oxidative stress in RRMS.

Educational Programs Based on Healthy Habits to Improve Quality of Life and Psychosocial Profile in Women With Neurodegenerative Diseases: The ADVICE Protocol Study (Phase 1)

This phase of the project aims to analyze the interaction between physical exercise and the phases of the menstrual cycle, evaluating its impact on fatigue, functional capacity, and exercise perception in women with and without Multiple Sclerosis. To achieve this, a controlled, single-blind, prospective, 2x3 crossover, randomized clinical trial will be conducted, involving women with Multiple Sclerosis (MS), matched by age, lifestyle habits (smoking, physical activity), and geographic location with a group of women without MS. This study, aligned with previous findings, seeks to deepen the understanding of the role of exercise in managing Multiple Sclerosis symptoms and to promote greater adherence to personalized physical activity programs adapted to the phases of the menstrual cycle.

Exploration of Novel Imaging Biomarkers on OCT for Ublituximab Treatment Response in Multiple Sclerosis

The purpose of the research study is to explore new retinal imaging biomarkers of immune cell activity in MS during use of ublituximab (Briumvi) treatment. A biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. This study will evaluate the efficacy of ublituximab to modulate MS pathology in a new manner. In order to assess this new biomarker, a specialized optical coherence tomography (OCT) scan will be performed at enrollment into the study and at 2 other timepoints throughout the study. Subjects asked to take part in this study should have been diagnosed with relapsing multiple sclerosis (MS) and have recently been advised to start the medication ublituximab (Briumvi) or are currently on another medication for the treatment of their MS. We plan to enroll 30 patients into this study. Fifteen (15) patients with Relapsing Remitting Multiple Sclerosis (RRMS) who are being initiated on B-cell depletion therapy by their treating physician at the University of Maryland Center for MS Treatment and Research will be offered enrollment into this study. Additionally, 15 age/sex matched patients with stable RRMS who are not undergoing any change in treatment and are not currently on B-cell depleting therapies will be enrolled as control subjects.

Study to Investigate Vagus Nerve Stimulation Paired With Motor Task for Remyelination and Functional Recovery

The goal of this clinical trial is to learn if stimulating the vagus nerve in combination with a motor task in people with multiple sclerosis can improve motor function. The main questions it aims to answer are: * Is stimulating the vagus nerve safe and feasible after demyelinating episodes? * Does a paired motor task with vagus nerve stimulation improve motor function with someone who has multiple sclerosis? Researchers will compare active vagus nerve stimulation to a sham stimulation to see if the paired vagus nerve stimulation can improve motor control. Participants will: * Come in for study visits over a six month period. Study visits are three times weekly for the first month, then single follow up visits at two, three, and six months. * During study visits, participants will complete 30 minutes of the paired vagus nerve stimulation with a motor task, specifically the grooved peg test. * At various timepoints throughout the study, motor, disability, and neurophysiological assessments will be administered, including the Timed 25-Foot Walk Test, Expanded Disability Status Scale (EDSS), Upper Extremity portion of the Fugl-Meyer Assessment, Dellon-Modified Moberg Pick-Up Test, Multiple Sclerosis Impact Scale-29 (MSIS-29), motor evoked potentials (MEPs), and visual evoked potentials (VEPs). MRI assessments will also be performed to evaluate exploratory imaging metrics of potential remyelinative efficacy.

Transcranial Direct Current Stimulation for Fatigue, Mood, and Cognition in Multiple Sclerosis

Multiple sclerosis (MS) is a chronic, inflammatory and disabling disease of the Cnetral Nervous System characterized by relapsing and / or progressive somatosensory, motor and vestibular clinical manifestations. Moreover, fatigue, depression, anxiety, and cognitive impairment are also present in most MS patients. These symptoms substantially impact quality of life and often show limited response to conventional pharmacological treatment. Transcranial direct current stimulation (tDCS) is a non-invasive technique that applies a weak direct current to the scalp via surface electrodes, modulating cortical excitability in a polarity-dependent manner. The objective of this study is to evaluate the efficacy and safety of tDCS for fatigue, depression, anxiety, and cognitive performance in patients with relapsing or progressive MS.

RESET-MS: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Multiple Sclerosis

RESET-MS: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T cells (CABA-201) in Participants with Multiple Sclerosis

Effects of Low-Load Blood Flow Restriction Exercise on Rectus Femoris Muscle Morphology in Individuals With Relapsing-Remitting Multiple Sclerosis

Multiple sclerosis (MS) is a chronic neurological disease associated with reduced muscle strength, impaired mobility, increased fatigue, and deterioration in muscle morphology. Rectus femoris muscle atrophy and reduced muscle quality have been linked to functional limitations and decreased mobility in individuals with MS. Blood flow restriction (BFR) training is a rehabilitation strategy that combines low-load exercise with partial vascular occlusion, enabling muscular adaptations comparable to those achieved with higher exercise loads. Although BFR has demonstrated promising results in several clinical populations, evidence regarding its effects on muscle morphology in individuals with relapsing-remitting multiple sclerosis (RRMS) remains limited. The purpose of this randomized controlled trial is to investigate the effects of low-load BFR exercise on rectus femoris muscle morphology in individuals with RRMS. Thirty participants with RRMS (EDSS 2.5-3.5) will be randomly assigned to one of three groups: a BFR exercise group, a sham-BFR exercise group, or an exercise-only control group. All participants will complete the same supervised exercise program twice weekly for eight weeks. The primary outcome will be rectus femoris muscle thickness assessed by ultrasonography. Secondary outcomes will include rectus femoris echo intensity, knee extensor muscle strength, Timed 25-Foot Walk performance, Nine-Hole Peg Test performance, Symbol Digit Modalities Test scores, and Modified Fatigue Impact Scale scores. This study aims to determine whether the addition of blood flow restriction to a standardized low-load exercise program results in superior morphological and functional adaptations compared with sham-BFR and exercise-only conditions in individuals with RRMS.

Acute Intermittent Hypoxia Combined With Gait Training in Multiple Sclerosis

This interventional, randomized, sham-controlled study will examine whether Acute Intermittent Hypoxia (AIH) delivered immediately before Myoelectric Interface Neurorehabilitation Training (MINT)-based locomotor training improves gait in people with Multiple Sclerosis. The primary objectives are to evaluate changes in gait speed and endurance, with secondary objectives assessing spatiotemporal gait parameters, fatigue, and safety. Participants will receive AIH or sham priming followed by standardized treadmill and/or overground gait training, with outcome measures collected before and after the intervention across multiple sessions.

Behavioral and Electrophysiological Evidence of the Modulation of Fatigue in RR-MS

To furnish behavioral and electrophysiological evidence of the possible modulation of fatigue in Multiple Sclerosis - relapsing remitting form, through a verbal placebo.

Healthy Eating and Active Living for People Living With Multiple Sclerosis (HEAL MS): A Lifestyle Program for People With Multiple Sclerosis

The goal of this clinical trial is to learn whether a structured lifestyle program can improve health and wellbeing in people living with multiple sclerosis (MS). The program focuses on four areas: nutrition, physical activity, sleep, and stress management. The study will also examine how lifestyle changes affect biological markers related to inflammation, metabolism, and immune function. The main questions the study aims to answer are: Can a 12-week lifestyle program improve fatigue, physical function, sleep, and quality of life in people with MS? Do lifestyle changes influence biological markers related to inflammation, metabolism, and mitochondrial function? Participants will first complete a 12-week observation period to measure their usual lifestyle and health. After this, they will take part in the 12-week HEAL MS lifestyle program. Participants will: Attend four assessment visits at Yas Clinic (baseline, before the intervention, after the intervention, and three months later) Participate in two supervised online exercise sessions per week during the 12-week program Follow a structured nutrition plan, with meals provided during the first two weeks Use a mobile application to log daily habits related to exercise, nutrition, sleep, and stress Complete questionnaires and physical tests and provide blood, saliva, and stool samples during assessment visits Researchers will analyze these data to understand whether lifestyle interventions can support symptom management and overall health in people living with MS.

Combined Motor Imagery and Vestibular Rehab for MS

This trial investigates the first combined use of motor imagery and vestibular rehabilitation in multiple sclerosis, aiming to evaluate their joint effect on balance, cognition, and quality of life.

Multicenter Prospective Study Analyzing the Occurrence of Multiple Sclerosis Relapses Without Radiological Evidence: Myth or Reality?

The MYTH-MS study is a multicenter prospective study investigating the occurrence of clinical relapses in patients with relapsing-remitting multiple sclerosis (RRMS) in the absence of radiological activity on MRI. While MS relapses are typically associated with gadolinium-enhancing lesions on MRI, some patients present with acute neurological symptoms without radiological correlates, referred to as acute clinical events with stable MRI (ACES). The frequency, mechanisms, and clinical relevance of these events remain unclear due to limitations in previous studies. The primary objective is to determine the proportion of RRMS patients experiencing a relapse without gadolinium-enhancing lesions on early brain and spinal MRI. Secondary objectives include identifying clinical, radiological, biological, and psychological predictors, assessing neurologists' diagnostic accuracy, and evaluating clinical outcomes such as disability, cognition, and quality of life over a 6-month follow-up. A total of 136 patients with recent neurological exacerbations will be included. Each participant will undergo clinical assessment, cognitive and psychological evaluation, and early MRI, with follow-up at 6 months. An ancillary study will explore blood biomarkers (NfL, GFAP, and circulating DNA) to help differentiate true inflammatory relapses from ACES. This study aims to improve the understanding and diagnosis of MS exacerbations and to optimize patient management by reducing misdiagnosis and unnecessary treatments.

Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis

In this prospective, open-label, single-arm, single-institution trial, the investigators will accomplish the following two aims: 1. study the safety and tolerability of Ublituximab (Briumvi) twice annually in participants with early MS over a treatment observation period of \~12 months. 2. study the pre- and post-treatment change in plasma neurofilament light chain, tested at baseline pre-Ublituximab treatment, and q24 weeks for 96 weeks post Ublituximab treatment initiation.

Effects of Ublituximab on Motor Functions in Multiple Sclerosis

The purpose of this study is to test if ublituximab changes walking functions and fall risk in people with relapsing multiple sclerosis (RMS). Twenty-five qualified people with RMS will undergo a 48-week ublituximab treatment. Before, 24 weeks into, and after the treatment, their ambulatory function, disability status, and cognition will be assessed. Additionally, they will experience large-scale slip perturbations on a treadmill under the protection of a safety harness at the last assessment. The outcome measures will be compared across the assessments to examine the effects of ublituximab on improving their walking function, disability status, cognition, and the responses to the unexpected slip perturbation.