Sustainability of Exercise Therapy by the Use of Exercise Booster Sessions in People With Multiple Sclerosis.
This study wants to investigate whether exercise booster sessions applied in the follow-up period after an exercise intervention can increase the sustainability of exercise induced effects in persons with multiple sclerosis. The study will be a randomized, multi-site, controlled trial. Participants will from the beginning be allocated to either aerobic training group, resistance training group or control group. After a 12 week exercise intervention, the exercise groups will be additionally randomized to receive either exercise booster sessions + standard care or just standard care in the 40 week follow up period. It is hypothesized that exercise booster sessions can increase the sustainability of exercise induced effects.
NCT04913012 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT04913012/
A Phase IIa, Open-label, Multicentre Dose-Finding Trial in Patients With Relapsing Forms of Multiple Sclerosis (RMS) to Evaluate the Safety, Tolerability and Preliminary Efficacy of EHP-101
The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of EHP-101 in adult subjects with Relapsing Forms of Multiple Sclerosis (RMS).
NCT04909502 — Relapsing Forms of Multiple Sclerosis
Status: Suspended
http://inclinicaltrials.com/relapsing-forms-of-multiple-sclerosis/NCT04909502/
Creating Satisfying Engagement in Daily Life Through Coaching for People With Multiple
Multiple sclerosis (MS) is a complex disease that negatively impacts a person's ability to participate in a wide range of important and meaningful activities1-4. MS rehabilitation interventions often focus on reducing symptoms, with the assumption that fewer symptoms will lead to improved participation in daily activities5-8. Yet, literature shows that engagement in necessary and desired activities requires more than symptom reduction - it requires people with chronic diseases like MS to apply their knowledge and skills to a complex self-management process9-11 that balances personal values, and activity and environmental demands. Core self-management skills include self-monitoring, problem-solving, decision-making, goal setting, action planning, and the ability to adjust plans when necessary12. Looking beyond MS, coaching interventions have enabled people with stroke13-16, traumatic brain injury17, and Parkinson's disease18, 19 to develop self-management skills and achieve personally meaningful activity goals. Occupational Performance Coaching (OPC) is a well-developed form of coaching that builds competence in core self-management skills and improves participation in daily activities20, 21. The investigator's preliminary work indicates that OPC is an acceptable and feasible intervention for people with MS22. The investigators now must determine if OPC reduces the impact of MS on participation in daily activities and increases the satisfaction of people with MS in performance of personally important daily activities. Therefore, the investigators will conduct a waitlist-control randomized clinical trial (RCT) with 30 adults with MS to determine if receipt of six OPC sessions improves participants' satisfaction with performance in daily activities (primary outcome). The investigators will also examine whether OPC reduces illness intrusiveness (MS impact), improves resilience, and improves autonomy and participation (secondary outcomes).
NCT04908085 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT04908085/
The Therapeutic Effects of Forced Aerobic Exercise in Multiple Sclerosis
This project will investigate the feasibility and initial efficacy of two aerobic exercise training approaches, forced and voluntary, to improve motor function in persons with multiple sclerosis (MS). We hypothesize that intensive aerobic exercise training elicits a neurorepairative and neurorestorative response on the central nervous system, which may improve motor function as it relates to gait and mobility. Should aerobic cycling, forced or voluntary, improve gait and functional mobility in persons with MS, it would serve as a new model to restoring function, rather than current models that focus on compensation.
NCT04906057 — Multiple Sclerosis
Status: Active, not recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT04906057/
An Observation Monocentric Study to Analyse the Possible Neuroprotective Effect of Ocrelizumab Via VEGF Protein Expression in Relapsing Multiple Sclerosis Patients
Ocrelizumab (OCR) is a humanized anti-CD20 antibody approved for Relapsing Multiple Sclerosis (RMS) and Primary Progressive Multiple Sclerosis (PPMS), due to neuroprotective effects of partially unknown origin. While its mechanism of action is mainly thought to occur via B cell depletion, previous studies on rituximab, another anti-CD20 drug, showed that CD20 binding elicits several intracellular signalling pathways, also including Protein Kinase C (PKC) activation. Of interest, the β isoform of PKC is known to modulate, through the RNA-binding protein ELAV/HuR, the expression of Vascular Endothelial Growth Factor (VEGF), a signaling protein that has been suggested to play deleterious effects in the first phases of MS. Therefore, the hypothesis is that part of the neuroprotective effects exerted by OCR may also be due to the modulation of VEGF expression via PKCβ /HuR cascade. The primary objective is to evaluate the variation of the expression of VEGF (protein and mRNA) in Peripheral Blood Mononuclear Cells (PBMCs) induced by OCR therapy. No additional visits will be required outside of clinical practice. Additional laboratory testing (VEGF protein expression and PKCbeta/HuR cascade) will be performed on extra blood which will be taken during the routine blood exams. This study is an observational, longitudinal, monocenter and single arm study, in patients with RMS who are newly prescribed with OCR as per clinical practice. The study consists of the following visits as per clinical practice - T0 visit: at the first dose of OCR, blood sample and clinical/radiological MS data will be collected. - T6: after 6 months of OCR treatment, blood samples and clinical MS data will be collected. - T12 visit: after 12 months of OCR treatment, blood samples and clinical MS data will be collected.
NCT04902690 — Multiple Sclerosis Relapse
Status: Not yet recruiting
http://inclinicaltrials.com/multiple-sclerosis-relapse/NCT04902690/
Evaluation of Clinical, Morphologic and Biochemical Markers in Multiple Sclerosis - MarkMS
By combining clinical, morphological and biochemical markers a better understanding of the formation and progression of multiple sclerosis (MS) should be obtained
NCT04892134 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT04892134/
Investigation of the Effects of Technology Supported Different Physiotherapy Approaches on Patients With Multiple Sclerosis
Multiple Sclerosis (MS) is an autoimmune disease characterized by chronic inflammation, demyelination and axonal loss of the central nervous system. The etiology of the disease is not known exactly and possible causes are; genetic, vitamin D deficiency, viral, environmental and autoimmune factors have been identified. Common findings of MS are in the literature; sensory, visual problems, fatigue, urinary retention / incontinence, motor problems (inability to walk, upper extremity skills, coordination and balance problems), cognitive deficits, tone, speech and swallowing disorders. In the rehabilitation of MS; It is seen that balance, coordination, strengthening, aerobic and neurodevelopmental exercise methods are used and these approaches have reached moderate / high level evidence in the literature. Task-oriented circuit therapy(TOECT), one of the current neurophysiology-based approaches; It is a motor learning-based exercise approach based on the theory of dynamic systems, one of the theories of motion control, aiming at the acquisition of skills for a specific functional activity. When the existing studies are examined, it has been determined that there are a limited number of randomized controlled studies examining the effects of TOECT and that sufficient evidence cannot be obtained with these studies. In previous studies, it has been observed that standardization of exercise approaches applied to the control group could not be achieved and the control groups generally included applications that could create passive or effect summation compared to the experimental groups. In addition, in the literature, TOECT, which includes rehabilitation games to be applied in the form of station training, in MS patients; There is no randomized controlled study examining the effects on balance, walking, fatigue, trunk and upper extremity functions and kinematics. In this direction, the purpose of the research is; To examine the effects of technology-supported TOECT and technology-supported home program applied as station training on walking, quality of life, fatigue, balance, trunk and upper extremity functions of patients with MS, using kinematic and clinical methods. Volunteers who agree to participate in the study will be divided into two groups by the block randomization method. Both groups will receive exercise training 3 sessions per week (24 sessions in total) for 8 weeks. Evaluations will be made before and after 8 weeks treatment
NCT04891341 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT04891341/
Holter of Movement in Patients With Multiple Sclerosis. Acti-SEP Study: Controlled Environment.
ActiSEP is a multicentric academic study. Ambulant patients with multiple sclerosis may be included on a voluntary basis. We plan to include a group of approximately 20 patients with MS. This study include a unique evaluation in the laboratory of analysis of human movement. A set of tasks will be performed by patients wearing of two magneto-inertial sensors.
NCT04888689 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT04888689/
Holter of Movement in Patients With Multiple Sclerosis. Acti-SEP Study: Uncontrolled Environment.
ActiSEP is a multicentric academic study. Ambulant patients with multiple sclerosis may be included on a voluntary basis. The investigators plan to include a group of approximately 80 patients with MS, fulfilling the McDonald's 2017 criteria, of whom 40 of them show a progressive course according to the Lublin classification. The investigators have planned two visits (at baseline and 1 year later). On both visits, participants will perform few tests (timed 25-Foot Walk (T25-FW), 9-Hole Peg Test (9-HPG), 6-minutes walk test (6MWT), Berg balance scale) and will answer to some questionaires (Godin Leisure Time Exercice Questionnaire, multiple sclerosis walking scale, modified fatigue impact scale, Hospital Anxiety and Depression Scale) After each visit, participants will wear Actimyo for three months in daily living.
NCT04882891 — Multiple Sclerosis
Status: Active, not recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT04882891/
Sport, Rehabilitation and Nutrition in Multiple Sclerosis: An Innovative Multidisciplinary High Impact Intervention for the Lifestyle Change
Only a limited percentage of persons with MS (pwMS) participate to multidisciplinary rehabilitation because of poor support, knowledge and motivation. The investigators reasoned that pwMS should be more effectively prepared to increase their adherence. This study propose the implementation of an innovative collaborative approach, called "brief high-impact preparatory experience" (b-HIPE), inspired by an overarching model based on the interplay between competence, motivation and opportunity to increase in a short time awareness and motivation of pwMS. The aim of the study is the evaluation of its feasibility. For this pilot study the investigator chose a single-group design with repeated measurements at baseline and post intervention.
NCT04881422 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT04881422/