Integrated Dual-task EMG Biofeedback Balance Training to Improve Balance in Individuals Living With Multiple Sclerosis
The goal of this clinical trial is to test the impact of a novel dual-task EMG Biofeedback training method for improving balance in individuals living with multiple sclerosis. The main question[s] it aims to answer are: - Does dual-task EMG biofeedback training deliver lasting balance benefits up to 3 months following the intervention? - Are the benefits greater than those for participation in traditional balance training exercises? - Do the benefits vary with the severity of disability? Participants will receive either EMG Biofeedback (EMG-BF) training or traditional balance exercise (BAL-EX) training. Both treatments involve three 30-minute sessions of the training every week for 6 weeks (18 sessions). During the sessions, participants in the EMG-BF treatment group will perform targeted exercises using feedback from adhesive (sticker) sensors on their arms and legs. Participants in the BAL-EX treatment group will following an instructor through balance training movements that are traditionally prescribed by physiotherapists to improve balance. Measurements will be taken at the beginning of the study, after six weeks of training, and three months after the end of training. Researchers will compare the groups to see if balance and related outcomes are improved more by 6-weeks of EMG-BF training than BAL-EX.
NCT06461741 — Multiple Sclerosis
Status: Not yet recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT06461741/
Assessment of COVID-19 Vaccination Immune Response in Multiple Sclerosis Patients Treated With Ofatumumab in the United States: A Multicenter Medical Record Review Study
This was a non-interventional, retrospective, observational cohort study involving the abstraction and review of pertinent data from medical records by participating physicians, who completed a customized electronic case report form hosted on the secure electronic data capture system.
NCT06460324 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT06460324/
Baseline Characteristics, Adherence, and Persistence Among Multiple Sclerosis Patients Treated With FDA-approved Disease-Modifying Therapies
This retrospective, observational cohort study used administrative claims data contained in the International Business Machines (IBM)® Truven Marketscan® Research Databases to describe demographic, clinical, and treatment characteristics in patients with multiple sclerosis (MS) who were initiated on siponimod, and other Food and Drug Administration (FDA)-approved disease-modifying therapies (DMTs). The study time period was from March 2018 through June 2020 (most recent available data) and included a 1-year baseline period and a variable-length follow-up period (a minimum of 6 months follow-up required for post-index outcomes). The index date was defined as the date of the first claim for siponimod or other MS-specific treatment on or after March 2019. The data analysis was performed on a combination of early view and standard view data. The initial data analysis was from Standard Marketscan data used for patients with index data prior to the year 2019. Both standard view and early view data were used for patients indexed after January 1, 2019. The early view data provided additional visibility as it contains an additional 2 quarters of data compared to standard data.
NCT06459232 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT06459232/
The Effect of Trunk Rehabilitation Compared to Core Stability on Balance, Gait, Falls and Community Mobility in Patients With Multiple Sclerosis
BACKGROUND Balance, gait, community mobility, and risk of falls are often associated with trunk impairment among people with Multiple Sclerosis (PwMS). Consequently, there is a pressing need for interventions addressing these concerns and exploring the potential effects of trunk rehabilitation. LONG-TERM GOAL Offering guidance for effective plan selection, potentially included in rehabilitation guidelines for PwMS. HYPOTHESIS Trunk exercises performed in multiplanar movement on unstable surfaces incorporated with dual-tasks (DT) could improve the functional outcomes more than standard one-plane core stability exercises. SPECIFIC AIMS Investigating the effectiveness of trunk rehabilitation in PwMS and determining the optimal intervention strategy. METHODS 50 PwMS randomly assigned into two groups. Trunk Group received trunk exercises on unstable surfaces with DT training, while the Core Group underwent standard one-plane core stability exercises on stable surfaces without DT. Additionally, both received conventional treatment. Primary outcome was the trunk impairment scale (TIS). Secondary outcomes included the Berg balance scale (BBS), Timed Up and Go (TUG), Modified Falls Efficacy (FES), Modified Fatigue Impact Scale (MFIS), Hospital Anxiety and Depression Scale (HADS), and Reintegration to Normal Living Index (RNLI). SIGNIFICANCE Enhancing our understanding of trunk exercises' benefits and providing valuable guidance to clinicians for choosing the optimal treatment plan.
NCT06447571 — Multiple Sclerosis
Status: Active, not recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT06447571/
A Phase IV, Prospective, Multicenter, Open-label, Mother-milk Study to Evaluate Ofatumumab Concentration in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis Receiving Ofatumumab
This study will evaluate whether ofatumumab is excreted at quantifiable levels and at which concentrations in breast milk of lactating women with RMS). The study will include lactating mothers who plan to breastfeed and initiate/re-initiate ofatumumab 2-24 weeks post-partum.
NCT06444113 — Multiple Sclerosis
Status: Not yet recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT06444113/
Confirmatory Trial for Alleviating Fatigue in Multiple Sclerosis
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.
NCT06441617 — Multiple Sclerosis
Status: Not yet recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT06441617/
The Effects of In-phase Bilateral Exercise on Cognitive and Motor Outcome Measures, in Patients With Progressive Multiple Sclerosis, a Randomized Control Trial.
Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system. MS, typical presents with progression of clinical symptoms which mainly include motor and cognitive impairment, as well as reduction of patients' quality of life. Exercise is an effective approach in the management of the symptoms in people with progressive MS. Previous studies in healthy and in people with MS, reported a close relationship between cognitive functions and upper limb performance. Since patients with progressive MS facing difficulties with performing complex exercises due to cognitive dysfunctions and given the close relationship between cognitive functions and manual dexterity, a reasonable question arises whether a type of upper limbs exercises with less cognitive demands will improve the information processing speed in people with progressive MS. The aim of the current study is to investigate the effects of in-phase bilateral upper limbs exercises on the information processing speed, in patients with progressive MS, given that in-phase bilateral movements needs less attentional load than the other types of bilateral coordination. The intervention protocol lasted for 12 consecutive weeks (30-60 minutes /session x 3 sessions/week) and included in-phase bilateral exercises of the upper limbs, adapted to different sports activities and to functional training. Results from the statistical analysis indicated improvement of the experimental group compared to the control group, on the information processing speed alongside with improvement of motor skills.
NCT06436131 — Multiple Sclerosis, Secondary Progressive
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis-secondary-progressive/NCT06436131/
Multicenter, Phase Ib/IIa Study on the Safety and Efficacy of Autologous Peptide-coupled Red Blood Cells in Patients With Relapsing Remitting Multiple Sclerosis - RED4MS Trial
RED4MS is a clinical trial to assess the safety, tolerability and efficacy of autologous peptide coupled red blood cells (CLS12311) in patients with relapsing remitting multiple sclerosis (RRMS). CLS12311 consists of autologous red blood cells (RBCs) chemically coupled with antigenic peptides and aims to treat RRMS by induction of antigen-specific immune tolerance.
NCT06430671 — Relapsing-remitting Multiple Sclerosis (RRMS)
Status: Recruiting
http://inclinicaltrials.com/relapsing-remitting-multiple-sclerosis-rrms/NCT06430671/
Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms and Fatigue in Individuals With Multiple Sclerosis
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).
NCT06428006 — Multiple Sclerosis
Status: Not yet recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT06428006/
The Effect of a Mindfulness-Based Stress Reduction Program On Fatigue, Self-Efficacy And Stress in Patients With Multiple Sclerosis: A Randomized Controlled Trial
The aim of this study is to investigate the effect of an mindfulness-based stress reduction (MBSR) program designed in accordance with the literature and the basic principles of the program on fatigue, self-efficacy and stress for individuals with multiple sclerosis (MS). Thirty members of the Multiple Sclerosis Society with multiple sclerosis were randomized as experimental and control groups. Participants in the experimental group received an 8-week MBSR program by an MBSR instructor. The patients in the control group continued to visit the society for their scheduled examinations and controls; no intervention was given to them. Outcome measurements consisted of Fatigue Impact Scale (FIS), Self-Efficacy Scale and Perceived Stress Scale.
NCT06416176 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT06416176/