Technological Balance and Gait Rehabilitation in Patients With Multiple Sclerosis: Effects on Functional, Motor and Cognitive Outcomes (ROAR-MS).
Multiple sclerosis (MS) is a chronic, inflammatory and neurodegenerative disease of the central nervous system that often results in motor and/or cognitive impairment. Epidemiologically, the onset occurs between the ages of 20 and 40, with a peak around the age of 30. MS is an extremely heterogeneous disease in terms of signs and symptoms, both in terms of the neurological systems involved and the degree of impairment and severity. The most common symptoms include, among others, difficulty walking and lack of balance. The lack of stability and coordination reduces independence and mobility, predisposing people with MS to accidental falls and compromising mobility in daily life. Another symptom that characterises MS is cognitive impairment, which mainly alters information processing speed and short- and long-term memory. MS-related cognitive impairment is detectable at every stage of the disease. Very often, people with MS have co-existing cognitive and motor deficits, which add to the complexity of managing MS. In order to address this condition, a treatment strategy that combines cognitive and motor rehabilitation needs to be identified. Despite the increasing availability of effective drug therapies that may impact on balance, rehabilitation is a very important means to counteract the progression of disability and improve physical function, affecting social participation and improving quality of life. In recent years, rehabilitation makes use of various robotic devices, which are based on repeatable, intense and motivating exercises, integrated with an enriched virtual environment, capable of improving the quality of movement. In light of the literature, which mainly focuses on robotic therapy for walking, this pilot study aims to evaluate the effects of a specific robotic treatment for balance in MS patients. The primary objective of the study is the evaluation of the effects of technological rehabilitation by means of a robotic platform (Hunova® Movendo Technology srl, Genoa, IT) on static balance. The secondary objective is the evaluation of the effects of technological rehabilitation by means of a robotic platform (Hunova® Movendo Technology srl, Genoa, IT) 1. on dynamic balance and walking (assessed with clinical and instrumental scales) 2. on fatigue and cognitive performance in terms of sustained attention, dual-task cost and cognitive-motor interference; 3. on quality of life.
NCT05983809 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05983809/
Longitudinal Investigation of Cortical Demyelination and Meningeal Inflammation in Multiple Sclerosis and Related Disorders
In this protocol, a combination of MRI, blood, and cerebrospinal fluid (CSF) analysis will be used to understand the natural history, underlying immunologic mechanisms, and clinical implications of central nervous system (CNS) lesions, in particular lesions in the cerebral cortex, in multiple sclerosis (MS) and other inflammatory and autoimmune disorders affecting the CNS. Patients with these disorders, as well as healthy controls, will undergo baseline clinical evaluation and testing, bloodwork, and MRI, with follow up clinical evaluation, bloodwork, and MRI at years 1, 3, and 6. Additional MRIs may be performed in patients with possible new lesion formation or to compare MRI techniques. Lumbar puncture will be performed on participants who are not currently being treated with disease modifying therapies and who are willing to undergo the procedure.
NCT05982925 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05982925/
Clinical and Radiological Evaluation of Movement Disorders in Multiple Sclerosis Patients.
The aim of this study is to determine the prevalence of movement disorders in MS patients. Also,To know the clinical type of movement disorders occurring with multiple sclerosis patients and the MRI finding of those patients. Moreover, to find the correlation between the movement disorder and the different types of MS.
NCT05973929 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05973929/
A Crossover Study Evaluating the Impact of the Cionic Neural Sleeve on Mobility, Disability, Fall Risk, and Physical Activity in Multiple Sclerosis
The purpose of this research is to support the clinical value of the Cionic Neural Sleeve for individuals diagnosed with multiple sclerosis (MS).
NCT05964829 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05964829/
Montpellier PROspective Cohort in Relapsing Remitting Multiple Sclerosis Using Imaging and Serologic
Several prospective monocentric cohorts of between 250 and 1000 patients have been set up in order to characterize more precisely the evolution of the disease. Nevertheless, due to an initial recruitment carried out in the years 2000-2010, they do not constitute a faithful representation of the patients followed in clinical routine, in particular in terms of distribution of treatments. Indeed, the introduction, about 10 years ago, of high efficacy treatments (HET) has changed the management of the disease and a significant proportion of patients not controlled by medium efficacy treatments (MET) of the disease are now stable on HET. Nevertheless, if their short-term efficacy has been clearly demonstrated, it remains important to be able to confirm the superiority of HET over MET with the help of prospective cohorts (thus ensuring a retention of patients > 90% over the long term) analyzing all clinical and imaging biomarkers, imaging and biological data. The measurement of cerebral atrophy and its progression is probably one of the most interesting and most easily used biomarkers that can be used clinically to assess this silent progression in these groups of patients. The progression of brain atrophy is also dependent on many other non-modifiable but also modifiable factors outside of MS that need to be better evaluated and eventually managed. Nevertheless, the existence of various neurological comorbidities (sleep disorders, headaches) on this atrophy has not been specifically analyzed to date. The functional assessments used in routine follow-up are most often performed in a care facility and have many limitations: lack of reproducibility, inter/intra operator variability, poor correlation with functional and quality of life scales, etc. It is therefore extremely important to be able to identify new clinical biomarkers of disease progression of the disease by evaluating the physical capacities of the patients as precisely as possible. This study is a single-center, prospective cohort study of a population of 400 patients with relapsing remitting MS (RRMS). The main objective of this study is to compare, on morphological imaging criteria (T1 volumetry), the progression of brain atrophy (biomarker of disease progression) at 3 years in RRMS patients according to treatment line (MET vs HET).
NCT05962177 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05962177/
Safety and Efficacy of Subcutaneous Cladribine for Nonrelapsing, Secondary Progressive Multiple Sclerosis (CLASP-MS): a Randomized, Placebo-controlled, Double-blind, Phase 2 Study.
The purpose of the study is to evaluate the efficacy and safety of subcutaneously administered cladribine versus placebo to stop inflammation and treat disease progression of non-active secondary progressive multiple sclerosis. Multiple sclerosis is an inflammatory disease of the central nervous system. In most patients, it starts with a relapsing course (RMS) which is caused by acute inflammatory lesions in the brain and spinal cord. RMS transforms at later stages into progressive disease (secondary progressive MS). Currently approved disease-modifying treatments are effective in reducing clinical relapses and brain and spinal lesions visible in MR, but they perform poorly in preventing disease progression and overall disability accumulation. The growing evidence shows that disease progression partially depends on chronic inflammation present in the CNS. Drugs, which may cross the blood-brain barrier and reach inflammatory cells residing in the CNS might be effective in this stage of the disease. Cladribine is one of the DMT approved for RMS. It is a synthetic purine analog with selective lymphocyte toxicity, which enter the CNS and is found in cerebrospinal fluid. In patients treated with cladribine, the oligoclonal bands tend to disappear proving that neuroinflammation is diminished. The participants of this clinical trial with the later non-active stage of MS are enrolled to be treated with cladribine subcutaneously or a non-active comparator (placebo) for 6 months and followed for the next 2 years, with an MRI scan and clinical evaluation every 6 months. The main questions it aims to answer are if in the non-active stage of MS cladribine is potent to lessen brain volume loss and if it is potent to attenuate inflammation in the CNS.
NCT05961644 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05961644/
Treatment of Cognitive Deficits in Multiple Sclerosis With High-Definition Transcranial Direct Current Stimulation
The purpose of the study is to test whether low level electric stimulation, called transcranial Direct Current Stimulation (tDCS), on the part of the brain (i.e., presupplementary motor area) thought to aid in memory will improve verbal retrieval in multiple sclerosis patients. The primary outcome measures are neuropsychological assessments of verbal retrieval, and the secondary measures are neuropsychological assessments of other cognitive abilities and electroencephalography (EEG) measures. Additionally, the study will examine the degree to which baseline assessments of cognition and concussion history predict responses to treatment over time, both on assessments administered within the intervention period and at follow-up.
NCT05958381 — Multiple Sclerosis, Relapsing-Remitting
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis-relapsing-remitting/NCT05958381/
The Effects of Structured Exercise Training on Disease Course in Newly Diagnosed Multiple Sclerosis
the effectiveness of structured exercise training will be investigated for individuals with MS who are newly diagnosed and have no clinical problems. Individuals with MS included in the study will be randomly divided into two groups a Structured Exercise Group (SEG) and a Control Group (CG). In order to compare baseline and follow-up data, the Healthy Group (HG) will be taken and all three groups will be evaluated initially, 8. weeks and 24. weeks with primary and secondary outcome measurements. SEG, CG, and HG will be evaluated initially for postural sway, muscle strength, mobility, dexterity, cognitive function, trunk strength-endurance, and fatigue. Afterward, SEG will receive structured exercise training consisting of clinically supervised aerobic exercise and resistance training on unstable surfaces for 8 weeks, 2 days a week, with a minimum session duration of 60 minutes. Stretching and mobility exercises will be added to warm up and cool down before and after the program. CG will be on the waiting list during this process. At the end of 8 weeks, both groups will be reassessed with their initial assessment. After the 8-week program, the SEG physical activity recommendation will be given and the KG group will continue on the waiting list, and a follow-up evaluation will be made in the 24th week. This study will allow the comparison of newly diagnosed individuals with MS who do not have any physical or cognitive effects on neurological examination and healthy controls with objective and detailed evaluations, and will also reveal the evidence on the effects of planned structured exercises specific to individuals with newly diagnosed MS. During the 24-week follow-up period, the change in the clinical status of individuals with MS who received or did not receive any exercise training can be interpreted.
NCT05957809 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05957809/
Analysis of the Effectiveness of Dry Needling for Improving Gait in the Patient With Multiple Sclerosis: a Randomized Single-blind Clinical Trial
Multiple sclerosis (MS) is a chronic, inflammatory, autoimmune disease characterized by the appearance of lesions, characterized by heterogeneity in its pathological, clinical and radiological presentation. It has a significant socioeconomic impact, affecting interpersonal relationships and causing a significant reduction in quality of life. Patients with MS suffer from a series of symptoms (ocular, spasticity, cerebellar, sensory, fatigue, depression) that may be independent of the course of the disease and their management significantly influences quality of life and also requires multidisciplinary therapeutic measures. Physiotherapy and occupational therapy techniques are essential to reduce spasticity and prevent complications derived from it. Amongst physiotherapy techniques, we can find minimally invasive techniques such as dry needling which uses a fine filiform needle to penetrate the skin and mechanically break the myofascial trigger points, charactewrized by abnomral/pathological electrical activity. There have been previous studies with dry needling in stroke patients which have shown improvements in gait, but its effectiveness in other populations such as multiple sclerosis is still unclear. In addition, dry needling has proven to be a cost-effective treatment for spasticity in patients with chronic and subacute stroke and could be an alternative to other pharmacological treatments, although more studies are necessary to compare both the effectiveness and the cost-effectiveness . Recent studies carried out in patients with multiple sclerosis suggest that dry needling can improve mobility and gait speed. The main objective of the study is to analyze the effect of the application of a single session of dry needling in the lower limbs on the gait of patients with multiple sclerosis. A prospective randomized parallel group clinical trial with blinded outcome assessment will be conducted. Participants will be recruited from the Hospital Universitario de Canarias.
NCT05956119 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT05956119/
Effect of High Intensity Interval Training in Patients With Multiple Sclerosis: Systematic Review
In this study, we are aiming to systematically review the literature on the effect of HIIT on MS patients as improving physical performance, cognitive function, aerobic fitness and muscle strength. This could help guide the development of standardized clinical guidelines and direct clinical decision making by the physical therapists whether to implement this type of exercises or not.
NCT05954195 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05954195/