Improving the Effect of Dimethyl Fumarate and Diroximel Fumarate (DRF) for Patients With Multiple Sclerosis by Chronobiology
A trial for evaluating the ability to improve the effect of dimethyl fumarate in patients with Multiple Sclerosis (MS) by chronobiology A controlled-randomization dosing regimen administered to patients with MS and provided by a designated app. The treatment limitations of time interval is pre-defined according to approved therapeutic windows.
NCT06385197 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT06385197/
Effectiveness of the EXOPULSE Mollii Ⓡ Suit in Patients With Multiple Sclerosis: Randomized Clinical Trial
Abstract: Background: Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system with unknown etiology, causing a variety of symptoms including impaired balance, coordination, and walking difficulties. The Exopulse Mollii Ⓡ suit is an innovative approach for non-invasive, self-administered electrical stimulation designed to alleviate spasticity and improve motor function in various neurological conditions. Objective: To determine the effectiveness of the Exopulse Mollii Ⓡ suit in improving motor control in patients with MS. Methods: A randomized, double-blind clinical trial will be conducted, recruiting patients diagnosed with MS , aged 18 or above, with a Functional Ambulation Category (FAC) score between 2 and 4. Patients will be randomly assigned to two groups receiving either inactive or active Exopulse Mollii Ⓡ treatment for 60 minutes, three times a week, for three weeks. Outcome measures include pain, balance, gait speed, risk of falls, perception of walking difficulties, and quality of life assessed using validated scales. Statistical analysis will be performed using SPSS v.29.0.0.0. Results: Data on age, sex, weight, and MS-related factors will be collected at baseline. Primary outcomes include changes in pain, balance, and gait speed, while secondary outcomes encompass risk of falls, perception of walking difficulties, and quality of life. Analysis will compare mean differences between groups using appropriate statistical tests. Conclusion: This study aims to evaluate the efficacy of the Exopulse Mollii Ⓡ suit in enhancing motor function in MS patients. Findings may contribute to the development of novel therapeutic strategies for managing MS-related symptoms and improving patients' quality of life.
NCT06384729 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT06384729/
Evaluation of the Influence of a Core Muscle Control-Based Rehabilitation Program on Pelvic Floor Function in Patients With Multiple Sclerosis
Given the structural relationship of the CORE as a whole, in this study we propose an intervention based on the global motor control of all the structures that make up the CORE to assess its effectiveness on urinary incontinence, sexual dysfunction and balance, as well as its relationship with respiratory function. According to our hypothesis, a global intervention could also be taken into account during conventional treatment in the future, helping to prevent genitourinary dysfunctions derived from alterations in motor control.
NCT06384716 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT06384716/
Traditional Versus Progressive Robot-assisted Gait Training in People With Multiple Sclerosis and Severe Gait Disability: Study Protocol for a the PROGR-EX Randomized-controlled Trial
Multiple sclerosis (MS) is a demyelinating neurodegenerative disease. Qualitative alterations in walking function in MS people involve 75% of subjects with MS and are determined by reduced coordination, mobility, balance, and increased risk of falling. Robot assisted gait training (RAGT) devices seem effective in MS patients with severe motor disabilities, failing to show significant superiority when compared to intensive overground gait rehabilitation (OGT). This study aims to evaluate the effects of a low-intensity RAGT at progressively increasing intensity compared to conventional RAGT and OGT.
NCT06381440 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT06381440/
The Effect Of Medial Olivocochlear Efferents On Speech Discrimination In Noise In Multiple Sclerosis.
The aim of this clinical trial was to determine the effect of multiple sclerosis on speech reception and discrimination in noise and to compare the effects on the medial olivocochlear reflex, which is thought to affect speech intelligibility in noise, with a control group. The main questions it aims to answer are: Does MS disease affect the ability to discriminate speech in noise? Does MS affect contralateral suppression results assessing medial olivocochlear function? Is there a correlation between the ability to discriminate speech in noise and contralateral suppression skills of MS patients? Data from MS patients and healthy participants will be compared. Thirty relapsing remitting MS patients and 30 healthy participants admitted to the clinic will be evaluated.
NCT06381297 — Multiple Sclerosis-Relapsing-Remitting
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis-relapsing-remitting/NCT06381297/
Effects of Supervised Progressive Resistance Training on Central Nervous System Functioning (Corticospinal Excitability) and Walking Capacity in Persons With Multiple Sclerosis
The goal of the present study is to investigate effects of progressive resistance training on central nervous system functioning (corticospinal excitability (CSE)) and walking capacity in persons with multiple sclerosis (pwMS). A total of 54 pwMS will be enrolled and randomized into 1 of 3 groups: high dose resistant training (RT), low dose RT, and waitlist control.
NCT06374108 — Multiple Sclerosis
Status: Not yet recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT06374108/
Kappa Index Versus Csf Oligoclonal Bands in Diagnosis of Multiple Sclerosis and Prediction of Disease
To: 1. Compare the diagnostic performance of cerebrospinal fluid kappa index to that of cerebrospinal fluid IgG oligoclonal bands in differentiating multiple sclerosis from other inflammatory and non-inflammatory neurological diseases . 2. Assess the role of kappa free light chain and oligoclonal bands in predicting disease activity (conversion from clinical isolated syndrome to multiple sclerosis)
NCT06372977 — Multiple Sclerosis
Status: Not yet recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT06372977/
Effects of Head and Neck Cooling and Heating on Central and Peripheral Fatigue, Motor Accuracy and Blood Markers of Stress in Multiple Sclerosis and Healthy Men
Local head and neck cooling strategies can help reduce multiple sclerosis-related fatigue, while heating can exacerbate heat-related fatigue. However, no study has detailed the peripheral and central responses to head and neck cooling (at 18°C) and heating (at 43 ± 1°C next to the scalp and neck skin) during fatiguing isometric exercise in non-challenging ambient temperature in multiple sclerosis and healthy male subjects. In addition, there is a lack of data describing the effects of head and neck cooling/heating and strenuous exercise on blood markers, muscle temperature, motor accuracy, and rate of perceived exertion. The investigators hypothesized that: (i) men with multiple sclerosis would be more affected by central and peripheral fatigue compared to healthy subjects; (ii) local cooling will result in greater central fatigue but will be associated with greater peripheral fatigue, whereas heating will result in greater central and peripheral fatigue in multiple sclerosis men; (iv) local cooling and heating will have a greater effect on the release of stress hormones, rate of perceived exertion and motor accuracy compared to the control condition in both multiple sclerosis and healthy groups.
NCT06370403 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT06370403/
An Open-label, Non-randomized, Phase I Study of Allogeneic Placenta Derived Mesenchymal Stem Cells in Patients With Secondary-Progressive Multiple Sclerosis (SPMS),
To assess the safety and of a single dose of IV infusion of placenta derived Mesenchymal Stem Cells (PLMSCs) in patients with secondary progressive Multiple Sclerosis (SPMS) disease. Monitoring will be encompassed baseline assessments and follow-ups over subsequent months, evaluating clinical signs, Expanded Disability Status Scale (EDSS), cytokines, diffusion tensor imaging (DTI), functional MRI (fMRI), cognitive & psychological evaluations, and flow cytometry for B cell markers.
NCT06360861 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT06360861/
Lifestyle Physical Activity Intervention for Persons Newly Diagnosed With Multiple Sclerosis
The overall objective of the current study is to determine the efficacy of a 16-week remotely delivered lifestyle behavioral intervention compared with a control condition (i.e., waitlist control) in persons newly diagnosed with MS (disease duration ≤ 2 years). Specific Aim 1: To evaluate the changes in self-report and device-measured physical activity after the 16-week remotely delivered physical activity behavior change intervention compared with a control condition (i.e., waitlist control) in persons who have diagnosed with MS within the past two years. The investigators hypothesize that the 16-week behavior change intervention will yield greater improvements in physical activity levels than the control condition immediately after the intervention. Specific Aim 2: To investigate the efficacy of the 16-week, remotely delivered physical activity behavior change intervention compared with the control condition for improvements in fatigue, depression, anxiety, and QoL in persons newly diagnosed with MS. The investigators hypothesize that there will be beneficial effects on the symptoms and QoL outcomes immediately after the physical activity intervention compared with minimal changes in the control condition.
NCT06355804 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT06355804/