Evaluation of MRI Biomarkers Predictive of Disability Progression in Patients With Multiple Sclerosis
The transition from relapsing-remitting multiple sclerosis to secondarily progressive multiple sclerosis (SPMS) is difficult to identify. Typically, SPMS is diagnosed retrospectively, with a significant delay, on the basis of a clinical history of progressive worsening, independent of relapses. Thus, SPMS is often associated with a considerable period of diagnostic uncertainty. The use of ultra-high field imaging can shed light on the mechanisms of disability progression thanks to its better spatial resolution and advanced imaging techniques. The new morphological imaging techniques make it possible to visualize chronic inflammatory lesions and to evaluate their evolution. It also allows for the precise measurement of brain atrophy, a reference in the evaluation of neurodegeneration. Metabolic imaging via proton spectroscopy allows the analysis of several promising cerebral metabolites that can provide information on cellular energy metabolism, mitochondrial function, or oxidative stress, and can help identify tissues at risk of neurodegeneration. Sodium imaging can provide information on axonal energy metabolism before the occurrence of stable and irreversible axonal damage. This technique is promising as an early marker of neurodegeneration.
NCT05491031 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05491031/
Optimal Conditioning Regimen Protocol for Autologous Hematopoietic Stem Cell Transplantation of Relapsing Remitting Multiple Sclerosis
This study is designed to compare two non-myeloablative conditioning regimens (combination of chemotherapy and immune specific proteins against immune cells) for relapsing remitting multiple sclerosis (RRMS). The two conditioning regimens are the most commonly used world wide in clinical practice for the treatment of multiple sclerosis (MS). The first investigational conditioning regimen is cyclophosphamide (chemotherapy) and rATG (rabbit anti-thymocyte globulin, a protein against immune cells). The second investigational conditioning regimen includes the same dose of cyclophosphamide (chemotherapy) and rituximab (a protein against immune cells). Both cyclophosphamide and either rATG or rituximab are given to kill immune cells that are thought to be causing MS, followed by return of one's own previously collected blood stem cells (autologous stem cell transplant) to hasten recovery. The goal of this study is to assess the difference of these treatments in terms of toxicity and efficacy.
NCT05482542 — Multiple Sclerosis, Relapsing-Remitting
Status: Withdrawn
http://inclinicaltrials.com/multiple-sclerosis-relapsing-remitting/NCT05482542/
Hybrid Rehabilitation Approach Through Group Exercise and Telerehabilitation in Patients With Multiple Sclerosis
The aim of the study is to determine the benefits of outpatient group rehabilitation with subsequent telerehabilitation. The patient will participate in a 12-week circuit training, including training once a week in a group of six under the guidance of two physiotherapists. After the outpatient rehabilitation, the patient will gain access to a mobile application and will be asked to record all physical activities there.
NCT05469568 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05469568/
Strategies and Techniques for the Rehabilitation of Memory Deficits in Patients With Multiple Sclerosis
The clinical characteristics of MS are extremely variable from one patient to another. In about 60% of cases, motor disabilities are associated with cognitive deficits. The present study aims to compare three forms of cognitive / motor rehabilitation in three groups of patients with MS: rehabilitation of verbal memory with the Rehacom program; combined rehabilitation, associating a motor rehabilitation path with the Rehacom program; only motor rehabilitation course. Aims of the study will be: to verify whether the combined cognitive / motor rehabilitation can induce a significantly greater improvement in the memory performance of patients with MS compared to rehabilitation alone; check whether any improvement is objectively verifiable by patients and the impact it may have on patients' quality of life; monitor these effects after 6 months. For these purposes, three homogeneous groups of 20 patients each will be enrolled, diagnosed with MS according to Mc Donald's criteria revisited by Polman (2011). The study will be divided into an initial clinical, cognitive, emotional, quality of life and functional self-perception (T0) assessment. Subsequently, the patients assigned to the three conditions will be provided with the pre-established rehabilitation treatments for a total duration of 12 weeks; at the end, each patient will undergo an overall re-evaluation (T1). Finally, a further overall reassessment will be carried out after 6 months, aimed at follow-up monitoring (T2). Statistical analyzes will be of two types: Within Group (aimed at assessing any improvement in the cognitive performance of each group of patients by comparing the assessments at T0 with those at T1 and T2); Between Group (aimed at comparing the results obtained by each group with those of the other 2 groups at T0, T1, and T2).
NCT05462678 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT05462678/
Fatigue and Sleep Quality in Multiple Sclerosis Patients: Does Reiki Application Affect?
This study was planned to examine the effect of reiki application on fatigue and sleep quality in patients with multiple sclerosis.
NCT05456464 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT05456464/
Combined Neurofilament Light Chain ,Chitinase-3 Like-1 Protein Levels and Tolerogenic Plasmacytoid Dendritic Cells in Defining Disease Course in Multiple Sclerosis Patients
Multiple sclerosis (MS) is an autoimmune neurodegenerative disease characterized by demyelination and neurodegeneration of the central nervous system (CNS) . Current diagnostic criteria and management depend on MRI, clinical status, and oligoclonal immunoglobulin g bands . These markers often fail to predict relapse, progression and therapy response .There is an increased need to identify biomarkers for clinical endpoints . One of the hallmark features of MS is axonal damage which associated with brain and cervical atrophy.Nf levels indicate the extent of axonal damage. Neurofilaments are composed of four subunits: neurofilament light polypeptides (NfL) is the most abundant and soluble and it is highly sensitive to neurodegenerative processes . Chitinase 3-like 1 (CHI3L1) is expressed in astrocytes in the brain tissue of MS patients . CHI3L1 plays a role as prognostic biomarker in patients with MS. CHI3L1 cerebrospinal fluid levels were associated correlated with disease activity and neurological disability. Dendritic cells (DCs) are highly specialized antigen-presenting cells with a key role in activating and preventing CNS immune-mediated damage in MS . Dendritic cells express Human Leukocyte Antigen-antigen D Related (HLA-DR) . Plasmacytoid dendritic cells characterized by the expression of blood dendritic cells antigen-2 (BDCA-2) .Plasmacytoid dendritic cells are present in the cerebrospinal fluid (CSF), leptomeninges and demyelinating lesions of patients with MS . Plasmacytoid dendritic cells also exhibit up-regulation of chemokine (CCR7C) expression. It was demonstrated increased amounts of chemokine CCR7 in the CSF from MS patients during relapses .CCR7 controls migration and functional activity of regulatory T cells and plays an important role in the establishment of tolerance . Tolerogenic DCs (TolDCs) present an intermediate phenotype between immature dendritic cells (iDCs) and mature dendritic cells (mDCs) regarding costimulatory molecules, a pronounced shift toward anti-inflammatory . TolDCs exhibit tolerogenic molecules such as HLA-G and CD274 [programmed death-ligand 1 (PD-L1)] either in peripheral blood or in CSF. These characteristics lead to T cell clonal anergy and T cell unresponsiveness due to Ag presentation in the presence of low co-stimulation .We aim to investigate the role of NfL,(CHI3L1) and markers of plasmacytoid dendritic cells in MS.
NCT05451069 — Multiple Sclerosis
Status: Not yet recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05451069/
Sensory Integration Disorders in Multiple Sclerosis
the aim of the study was to assess the occurrence of sensory integration disorders in people with SI depending on the stage of the disease and relapses in the last year;analysis of sensory integration disorders in patients with Ms and healthy people
NCT05449574 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT05449574/
Examination of the Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis: A Randomized Controlled Single-Blind Trial
Multiple Sclerosis (MS) is a chronic, inflammatory, neurodegenerative, and autoimmune disease that progresses with progressive neurological dysfunction and affects the central nervous system. A multidisciplinary rehabilitation approach is crucial in the systematic and supportive treatment of MS. Exercise training is a therapeutic approach that minimizes functional capacity loss and slows progression in MS. Randomized controlled studies have shown that exercise training improves physical fitness, reduces motor fatigue, and improves the quality of life and psychological state in individuals with MS. When the literature is examined, it is seen that popular exercises such as pilates, yoga, and Tai-Chi are used in addition to aerobics, strengthening, endurance, and stretching exercises in the treatment of individuals with MS. In order to eliminate the economic burden, which is one of the exercise barriers of individuals, and to gain exercise habits, home exercise programs should be expanded. When the literature is examined, it is emphasized that the importance of home exercise programs is emphasized, and it is very important in the treatment of patients who cannot attend an exercise program, especially by going to any center for various reasons. However, there is little information on the effectiveness and content of home exercise programs in patients with MS. From this point of view, this study is capable of supporting the missing part of the literature.
NCT05447143 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT05447143/
Multiple Sclerosis Outcome Determination Evaluating Real Differences After TimE
To provide real world evidence evaluating whether a strategy of early initiation and escalation of disease modifying treatment (DMT) in relapsing-remitting multiple sclerosis (RRMS) affects disease outcome over a 10 year period. Our aim is to provide evidence for clinicians and patients regarding the benefits and risks of early initiation and active escalation of disease modifying treatments (DMTs) in relapsing-remitting multiple sclerosis (RRMS), using real world data.
NCT05446285 — Relapsing Remitting Multiple Sclerosis
Status: Enrolling by invitation
http://inclinicaltrials.com/relapsing-remitting-multiple-sclerosis/NCT05446285/
A 96-Week, Prospective, Multicenter, Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare Efficacy and Safety of Masitinib Dose Titration to 4.5 mg/kg/Day Versus Placebo in the Treatment of Patients With Primary Progressive or Secondary Progressive Multiple Sclerosis Without Relapse
To evaluate the efficacy and safety of oral masitinib versus placebo in the treatment of patients with primary progressive or secondary progressive multiple sclerosis without relapse.
NCT05441488 — Progressive Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/progressive-multiple-sclerosis/NCT05441488/