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Sclerosis clinical trials

View clinical trials related to Sclerosis.

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NCT ID: NCT06441617 Not yet recruiting - Multiple Sclerosis Clinical Trials

Confirmatory Trial for Alleviating Fatigue in Multiple Sclerosis

CAFE-MS
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

CAFE-MS will assess the effectiveness of two online programs for fatigue in multiple sclerosis (MS). Although they differ, both of these online programs contain information about MS and fatigue intended to help people with MS understand and manage their fatigue. This large-scale, decentralized clinical trial is projected to enroll 2,000 people with MS. The collaboration between iConquerMS and 5 Veterans Affairs (VA) sites in the MS Centers of Excellence is designed to ensure sufficient representation of people with MS from populations traditionally under-represented in MS clinical trials. The study is a 3-arm, randomized controlled clinical trial with study participation lasting 1 year. Two of the trial arms will include one of two online programs for managing fatigue in MS added to the trial participants' usual MS treatment, and the third arm will include usual MS treatment alone. The online program phase of the trial lasts for 6 months after randomization followed by a final study visit at 12 months. Participants in the usual MS treatment alone arm for the first 6 months will have an opportunity to choose one of the online programs for the final 6 months of the trial.

NCT ID: NCT06436547 Not yet recruiting - Clinical trials for Epilepsy, Drug Resistant

Subiculum Electrical Stimulation for Temporal Lobe Epilepsy With Biliteral Hippocampus Sclerosis(SESTB)

Start date: May 30, 2024
Phase: N/A
Study type: Interventional

The primary objective of this research is to study the efficacy and safety of deep brain stimulation (DBS) of Subiculum as adjunctive therapy for reducing the frequency of seizures in drug-resistant temporal lobe epilepsy with bilateral hippocampal sclerosis

NCT ID: NCT06433765 Not yet recruiting - Multiple Sclerosis Clinical Trials

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

Start date: June 1, 2024
Phase:
Study type: Observational

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®.

NCT ID: NCT06433752 Not yet recruiting - Multiple Sclerosis Clinical Trials

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

ENABLE
Start date: June 30, 2024
Phase:
Study type: Observational

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

NCT ID: NCT06428006 Not yet recruiting - Multiple Sclerosis Clinical Trials

Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms in Individuals With Multiple Sclerosis

CALM
Start date: June 1, 2024
Phase: Phase 2
Study type: Interventional

The incidence of insomnia is estimated to be as high as 90% in individuals with MS due to insomnia being underdiagnosed. Sleep disturbances in people with MS have been associated with reduced cognitive performance, physical function, psychological well-being, quality of life, and occupational function, as well as increased prevalence of fatigue, pain, depression, and anxiety. The objective of the proposed study is to determine the efficacy of cognitive behavioral therapy for insomnia (CBT-I) to improve insomnia symptoms (Aim 1) fatigue, and health-related quality of life (Aim 2) in individuals with multiple sclerosis compared to an active control group, and to determine the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 3).

NCT ID: NCT06415552 Not yet recruiting - Multiple Sclerosis Clinical Trials

Implementation of Online Mindfulness-Based Stress Reduction Tailored for People With Multiple Sclerosis

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

This project aims to implement and investigate a mindfulness-based stress reduction (MBSR) in people with multiple sclerosis (PwMS). The main objective is to implement MBSR intervention for PwMS in a major tertiary care clinic for PwMS. We will iteratively refine the intervention as required based on stakeholder feedback and any other emergent contextual findings. Participants will be asked to take part in an 8-week MBSR course and report changes in anxiety, depression, quality of life, emotional regulation, self-compassion, mindfulness, and health services use.

NCT ID: NCT06414135 Not yet recruiting - Systemic Sclerosis Clinical Trials

Relmacabtagene Autoleucel for the Treatment of Systemic Sclerosis

Start date: June 2024
Phase: Phase 1
Study type: Interventional

Relma-cel is a product containing CD19-CAR-transduced T cells. The purpose of this study is to evaluate the safety of Relma-cel at different dose levels in patients with early diffuse systemic sclerosis. Efficacy will be explored too. If enrolled, participants will undergo leukapheresis, lymphodepleting chemotherapy and administration of Relma-cel.

NCT ID: NCT06413602 Not yet recruiting - Multiple Sclerosis Clinical Trials

The Synergistic Effects of AIH and FES in Persons With MS

Start date: August 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to examine how neuromuscular electrical stimulation (NMES), may synergistically enhance corticospinal excitability in people with relapsing form multiple sclerosis (MS). This is an important intermediate step to evaluate the potential of AIH + NMES as a plasticity-priming strategy for more efficacious interventions for persons with MS. This study will measure ankle torque generation and amplitude of motor evoked potentials (MEPs) using a repeated measures study design in order to better understand the effects of AIH combined with NMES, as compared to only receiving NMES, and only receiving AIH.

NCT ID: NCT06412614 Not yet recruiting - Systemic Sclerosis Clinical Trials

Evaluation of Patients With Systemic Sclerosis Without Specific or Associated Autoantibodies

SCLERONAB
Start date: September 2, 2024
Phase:
Study type: Observational

Systemic sclerosis (SSc) is a complex systemic autoimmune disease with variable phenotype and prognosis. Autoantibodies are important diagnostic biomarkers in SSc. More than 90% of patients with SSc had anti-nuclear antibodies. Autoantibodies specific to SSc (anti-topoisomerase I antibodies, anti-centromeres, anti-RNA polymerase III, anti-Th/To, anti-fibrillarin, anti-NOR90) or associated with overlap syndromes (anti-RNA polymerase III antibodies -PM/Scl, anti-KU, anti-U1RNP, anti-TRIM21) are detected in most patients. Excluding anti-TRIM21 antibodies, autoantibodies are usually mutually exclusive and are associated with distinct phenotypes. Around 5 to 10% of patients with SSc have no autoantibodies detectable with routine biological tests. Recently, new autoantibody specificities have been described in SSc (anti-eIF2B, anti-RuvBL1/2, anti-BICD2, anti-U11/U12 RNP antibodies). "Seronegative" patients could represent new specificities of autoantibodies (unknown or not currently routinely evaluated) associated with different phenotypes of the disease. Primary objective is to compare the phenotype of patients with systemic sclerosis with or without detectable specific or associated autoantibodies. Secondary objectives are: - to determine homogeneous groups of patients with systemic sclerosis without detectable specific or associated autoantibodies - to compare the phenotype of patients with systemic sclerosis without detectable specific or associated autoantibodies according to anti-nuclear antibodies status

NCT ID: NCT06412003 Not yet recruiting - Multiple Sclerosis Clinical Trials

Home-based Balance Training in Adults With Multiple Sclerosis

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

This single-group pretest-posttest study aims to examine the feasibility domains in response to 12 weeks of home-based balance training in persons with multiple sclerosis (MS). The feasibility domains include 1) process (e.g., recruitment, attendance, adherence rate), 2) resources (e.g., total monetary costs), 3) management (e.g., assessment time), and 4) scientific outcomes (adverse events, intervention acceptability, satisfaction, treatment effects). Moreover, this study aims to evaluate physical function (i.e., balance, mobility, dual-task ability), cognitive function (i.e., cognitive processing speed, verbal memory, visuospatial memory), real-world ambulation (i.e., gait speed, gait variability, gait quantity), and self-report questionnaires (fatigue, fear of falling, walking disability, dual-tasking difficulty). Our proposed intervention is expected to deliver a feasible and accessible exercise modality for balance and cognitive improvement in persons with multiple sclerosis.