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441 active trials for Multiple Sclerosis

Semi-inmersive Virtual Reality on Upper Limb in Multiple Sclerosis

Video games based on VR technology are emerging as valid tools used in neurorehabilitation for patients with neurological disorders, and as a low cost and easily accepted adjunct to traditional therapy. Standard games such as the Nintendo Wii, Playstation Move and Kinect plus XBOX 360 have been used in PD rehabilitation. However, often these are either too difficult for patients or the games progress too quickly, failing to provide impairment-focused training or specifically address patients' needs [10]. Therefore, it is necessary to develop specific serious games for PD patients. Serious games are defined as games designed for a primary purpose other than that of pure entertainment, and which promote learning and behavior changes for PD patients. In this context, new low-cost markerless devices have emerged, such as Nintendo Switch Joy-Con ®, which uses a sensor that captures the movement of the patient's forearms and hands without the need to place sensors or devices on the body. This generates a virtual image of the upper limbs on a computer screen and the patient is prompted to perform movements according to the functional task proposed. This system presents important advantages over other motion capture systems, namely thanks to its portability, ease of use, commercial availability, low cost and non-invasive nature. However, evidence is lacking that supports the therapeutic use of Nintendo Switch Joy-Con in the treatment of upper limb (UL) motor disorders in EM.

Start: November 2019

Anakinra for the Treatment of Chronically Inflamed White Matter Lesions in Multiple Sclerosis

Background: Multiple sclerosis (MS) is a disease of the central nervous system (CNS). People who have MS may have lesions that form on parts of the CNS, such as the brain. Some of these lesions may be inflamed for a long time. This causes MS to progress. There is no treatment for these lesions. Researchers believe that a drug that decreases inflammation can help. Objective: To see if a drug called anakinra can help clear inflammation in MS brain lesions. Eligibility: People 18 and older with MS and at least one white matter lesion. Design: Participants will be screened with one or more Neuroimmunology Clinic protocols. Participants will have a medical history and physical exam. They will have blood and urine tests. They will have a lumbar puncture. For this, a needle is inserted between the bones in the back, and cerebrospinal fluid is removed. They will also have an MRI of the brain. The MRI scanner is a cylinder surrounded by a strong magnetic field. Participants will lie on a table that slides in and out of the scanner. Participants will repeat the above procedures throughout the study. Participants will get their first dose of anakinra at the clinic. They will administer the rest of the doses themselves, by injection under the skin. Participants will track their daily dosage electronically or in a written drug diary. Participants will have 4 visits while taking the drug. At each visit, sharps boxes and empty vials will be collected. Participants will have 2 follow-up visits after completing treatment. The study will last 28 weeks.

Start: October 2019

TELEMS: Feasibility of Remote Patient Visits in MS

This trials randomizes patients with multiple sclerosis (MS, pwMS) to a remote visit (via phone or videochat) or a regular outpatient visit. Outcomes include satisfaction on the patients' and doctor's side.

Start: November 2020

The Effect of Telerehabilitation Based Pilates Training in Multiple Sclerosis Patients

Multiple Sclerosis (MS) is a chronic inflammatory disease of the central nervous system characterized by myelin, oligodendrocyte, and axon damage. MS usually begins with attacks due to demyelination of axons in the brain, optic nerve, and spinal cord; over time it develops into a neurodegenerative disease associated with neurotrophic support deficiency and neuronal loss. In MS, various loss of strength, balance, fatigue, cognitive and gait disturbances arise in the central nervous system due to sensory and/or motor neuron degeneration. These disorders affect the quality of life by limiting the individual's activities and participation in their daily lives. Therefore, it is important to treat these disorders in the treatment of MS. There are various pharmacological treatments and invasive procedures for the management of MS symptoms and one of the most commonly used treatment options is rehabilitation. Clinically-based exercise and rehabilitation are some of the most beneficial rehabilitation strategies in people with MS (PwMS). Clinically-based exercise and rehabilitation have been shown to stabilize or improve many physical symptoms of MS including loss of strength, balance dysfunction, impaired mobility, and fatigue. These benefits have led many practitioners to consider physical exercise as a nonpharmaceutical disease-modifying treatment. However, due to various factors such as mobility disorders, fatigue, and related problems, geographic location, time constraints, transportation difficulties, health insurance coverage, and financial burden, clinical-based exercise may be problematic in some pwMS. To overcome these challenges, approaches to rehabilitation have been developed such as telerehabilitation. The telerehabilitation system provides benefits such as continuity in patient education and rehabilitation, showing progress in rehabilitation, making changes in the treatment program, and saving individuals time and financial expenses. It is also an innovative and potential alternative to face-to-face interventions for treating disease-related disorders in pwMS. In literature, there are many studies examining the effectiveness of telerehabilitation in pwMS. According to these studies, ?t has been shown that telerehabilitation, with its technical facilities, had the potential to make clinical interventions widely accessible and effective for MS, however, telerehabilitation-based interventions could not replace traditional interventions but could perfectly complement. It has been found that telerehabilitation improved balance and postural control in MS patients and had no side effects. However, it was emphasized that the evidence levels of the studies were insufficient for methodological reasons. It has been determined additional studies are needed to investigate examining the effect on walking. Another clinical-based exercise method is Pilates. Pilates is a "core" stability-based exercise method that includes endurance, flexibility, movement, posture, and respiratory control. Studies have shown that Pilates training can improve balance, mobility, and muscle strength, fatigue in pwMS due to its structure consisting of balance and strengthening exercises. When the literature is reviewed in terms of Telerehabilitation based on Pilates in pwMS, it is seen that there are only two studies. In both studies, pwMS were given 20 minutes of yoga, 20 minutes of Pilates, and 20 minutes of dual-task exercise. However, these studies were in the project phase and the results are still not reported. On the other hand, in both studies, Pilates is given as combined training. As a result, telerehabilitation is an alternative method to MS treatment. In addition, while there are many clinical-based Pilates studies in the literature, telerehabilitation-based Pilates studies are insufficient. Telerehabilitation-based Pilates training studies are needed. Therefore, the investigators planned this study to investigate the effect of telerehabilitation-based pilates training on physical performance and quality of life in pwMS.

Start: April 2021

Home Based Tele-exercise for People With Chronic Neurological Impairments

To assess the impact of a 12-week virtual seated physical intervention on cardiovascular health and wellness in people with chronic neurological impairments (CNI).

Start: January 2021

TRAIN-BW: Backward Walking Training in Multiple Sclerosis

Individuals with multiple sclerosis (MS) experience in impairments in mobility and cognition that increase the risk for accidental falls. More than 50% of individuals with MS experience injurious falls within a 6-month period. Current interventions to improve fall risk have focused on forward walking (FW) and balance training, resulting in small declines in the relative risk for falls with a large degree of variability. Interestingly, motor differences between MS and healthy controls are more pronounced in backward walking (BW), yet no studies have investigated BW training as an intervention to reduce fall risk in persons with MS. Further, the underlying pathological and cognitive factors that impact BW performance and its potential to impact fall risk in persons with MS remain unknown. This study will investigate the feasibility, acceptability and impact of BW training compared to forward walking training on motor function, brain structure, and fall risk in persons with MS.

Start: January 2020

A Pilot Study to Explore the Role of Gut Flora in Multiple Sclerosis

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Multiple Sclerosis.

Start: March 2020

Impact of Neuropsychological Disorders in Multiple Sclerosis

The study involves MS patients with and without neuropsychological disorders. The patient will benefit from: A routine neuropsychological assessment, including a cognitive and emotional assessment A clinical examination A three-dimensional analysis of movement

Start: April 2021

A Study of Suvorexant in Patients With Multiple Sclerosis Fatigue and Insomnia

This study assesses the safety, tolerability, and efficacy of suvorexant in multiple sclerosis patients. Enrolled subjects will receive 2 weeks of treatment during treatment period 1 with either suvorexant or matching placebo (1:1). After treatment period 1, subjects will undergo a washout period of 1 week then 2 weeks of the alternate treatment (either suvorexant or placebo). The primary hypothesis is that suvorexant will provide greater improvement in sleep, as measured by symptom rating scales, compared to placebo.

Start: March 2017

The Effect of the Arabic Otago Exercise Program on Falls in People With Multiple Sclerosis

People with multiple sclerosis (MS) need exercise training programs throughout their life in order to prevent secondary complications of the disease. Coronavirus disease of 2019 (COVID-19) forced people with chronic disorders to stay at home in order to prevent the transmission of the virus. Therefore, people with MS now are facing a new challenge in going outside their home to perform their rehabilitation sessions. One of the solutions to keep them exercising is a home-based exercise program and one of the home exercise programs that are well validated in older adults is the Otago exercise program (OEP). Investigators suggest that the balance would improve and fall incidences would reduce using the OEP in people with MS compared to health awareness videos only. 50 participants with confirmed diagnosis of MS will be recruited in both groups. Using a randomized controlled trial this study aims to examine the effectiveness of the OEP compared to a control group that gets health awareness videos only on falls and falls-related factors in people with MS.

Start: June 2021

Effects of a Multiple Sclerosis Relapse Therapy on Offspring Neurocognitive Development and Behaviour

Introduction: Fetal exposure to glucocorticoids (GCs) used to induce fetal lung maturation in women threatened by premature labour is known to induce aberrations in brain development and stress sensitivity, cognitive dysfunction and neuro-psychiatric disorders in later life which all predict early brain ageing. Another common source of fetal GC exposure is the treatment of relapses in multiple sclerosis (MS), the most common neurological disease in young women. Despite the lack of studies, the 300-fold higher dosage of GCs for MS relapse treatment compared to obstetric indications is considered harmless for the fetus . Objectives: To examine the effects of GCs for MS relapse treatment during pregnancy on offspring structural and functional brain development, stress sensitivity, and cognitive and behavioural performance. Methods: Epidemiological multi-centre cohort study in 80 children and adolescents aged 8 to 18 years whose mothers received GCs to treat a MS relapse during pregnancy compared to unexposed participants. Expected Impact: Creating a guideline-changing evidence-based risk-benefit assessment regarding benefits of the MS relapse therapy for the mother and potential harm to the child.

Start: October 2020

Exercise Training Effects on Cognition and Brain Function in Multiple Sclerosis: Project EXACT

Cognitive impairment is highly prevalent, poorly-managed, and disabling in persons with MS and exercise training might represent a promising approach to manage this symptom of the disease. The proposed study aims to examine the effects of 3-months of supervised, progressive (both intensity and duration) treadmill walking exercise training (designed based on pilot work and American College of Sports Medicine guidelines) compared with an active control condition (i.e., stretching-and-toning activities) on cognitive processing speed and functional MRI outcomes in 88 cognitively-impaired persons with MS. This study is critical for providing evidence supporting treadmill walking exercise training as a behavioral approach for managing slowed cognitive processing speed (i.e., the most common MS-related cognitive impairment) and improving brain health in persons with MS.

Start: February 2019

Assessment of tDCS-Induced Neuronal Responses in Multiple Sclerosis (MS) With Advanced MRI

The objective of this trial is to measure the changes in neural activities during tDCS session using Magnetic Resonance Imaging (MRI). Participants (N=60) (20 Healthy Controls and 40 participants with neurological disorders, ie. multiple sclerosis) will be recruited to complete self-report measures and a brief cognitive assessment and then undergo an hour long stand-alone MRI scan while simultaneously undergoing tDCS stimulation. Methodology for this study is the administration of 15-minutes of of active tDCS during MRI acquisition compared to time without active tDCS.

Start: July 2018

PTNS on Urinary and Global Quality of Life in MS Patients

This is a single-centered, prospective, longitudinal, observational cohort study of patients with MS who suffer from lower urinary tract symptoms (LUTS) and are refractory to two prior treatment modalities who have elected to pursue PTNS therapy for LUTS.

Start: February 2019

Study of the Mechanisms of Action of Cladribine in Multiple Sclerosis

The main objective of the project is therefore to study and thus better understand the immunomodulatory / anti-inflammatory effects of cladribine during multiple sclerosis. Most current and developing therapies targeting the immune system have no effect on the progressive phase of MS, during which neurodegeneration plays a predominant role. As mentioned above, the very promising results of clinical trials with cladribine tablets for the early and progressive phase of the disease have revealed immunomodulatory properties and suggested potential neuroprotective effects. It therefore plans to further dissect one of these two parameters by designing in vitro studies with peripheral blood mononuclear cells (PBMC) from healthy donors and MS patients.

Start: July 2020

Botulinum Toxin A vs Anticholinergic Treatment of Neurogenic Overactive Bladder in Patients With Multiple Sclerosis

Botulinum toxin type A injections into the detrusor at a dose of 200 units (U) of BOTOX® are a recognized second-line treatment for the treatment of adult neurogenic lower urinary tract disorders. Anticholinergics are established as the usual first-line treatment for neurogenic detrusor hyperactivity, but are oft not sufficiently effective and have significant side effects. In patients with multiple sclerosis (MS) suffering from overactive bladder, the 200 U dose of BOTOX® is very effective but induces a risk of urinary retention in 30% of patients requiring the temporary use of self-catheterization1. At 100 U, a recent study shows the efficacy and very good tolerance of botulinum toxin A in terms of probing risk in MS patients with overactive bladder and failure of anticholinergics. Furthermore, the efficacy of anticholinergics in MS has been little studied and is also disputed. The investigators plan to test the therapeutic alternative as the first line of treatment in two groups of randomized MS patients from a homogeneous population suffering from overactive bladder: a group testing the effectiveness of low doses of botulinum toxin type A (100 U, BOTOX®), the other group receiving the standard anticholinergic treatment (solifenacin succinate, Vesicare®). During this pilot study, the efficacy and side effects profile of each treatment will be analyzed in order to determine the amplitudes of effect and the safety profiles in this population and in order to establish the statistical hypotheses for a subsequent randomized multicenter study. The aim of this study will be to establish the benefit of botulinum toxin at a dose of 100 U as a first-line treatment instead of anticholinergics

Start: May 2021

Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Upper Limb Spasticity

A Phase 2/3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Treatment Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Upper Limb Spasticity Followed by an Open-Label Extension, Multiple-Treatment Safety Study of MYOBLOC®,

Start: March 2021

Feasibility of the Multiple Sclerosis Performance Test in Participants With Multiple Sclerosis

The primary objective is to evaluate the feasibility of the Multiple Sclerosis Performance Test (MSPT) in a clinical care setting when used by participants with Multiple Sclerosis (MS).

Start: June 2019

Validation of DigiCog and Konectom Tools to Support Digitalized Clinical Assessment in Multiple Sclerosis

The primary objective of this study is to establish scores of Cognitive impairment (CI) of the 3 DigiCog [Brief Computerized Cognitive Assessment for Multiple Sclerosis (BCCAMS) app] tests [Computerized Speed Cognitive Test (CSCT), Computerized Episodic Visual Memory Test (CEVMT) and the French Learning Test (FLT), a verbal memory test similar to the CVLT], using a tablet application in a sample of healthy participants matched to persons with MS (PwMS). The secondary objectives of this study are to determine the ability of the DigiCog app to detect cognitive impairment (CI) compared to the classical Brief International Cognitive Assessment for MS (BICAMS) in PwMS; to determine the relationship between depressive symptoms and cognitive performance in Multiple Sclerosis (MS) sample; to determine the relationship between subjective perception of CI and cognitive performance ; to evaluate the reliability of Konectom™ digital outcome assessments (DOAs) in healthy subjects (HS) and PwMS; to evaluate the convergent validity of Konectom™ digital outcome assessments (DOAs) against in-clinic conventional disability outcome assessments in PwMS; to evaluate differences in Konectom™ DOAs [self administered at home and in-clinic] between PwMS and HS; to evaluate the variability of Konectom™ DOAs self-administered at home in free-living environment in HS and PwMS; to compare Konectom™ DOAs between in-clinic supervised administration versus self-assessments in free-living environment in HS and PwMS; to evaluate the clinical meaningfulness of Konectom™ DOAs against Patient-Reported Outcomes (PRO) in PwMS.

Start: October 2020

Novel Nanosensor Array for Detection of Volatile Biomarkers From Skin in Multiple Sclerosis

Multiple Sclerosis (MS) is the most common chronic neurological disease affecting young adults, with onset usually at the age 20-40 years. The disease is characterized by two main phenotypes: Relapse-Remitting MS (RR-MS) and Primary Progressive MS (PP-MS). RR-MS is the most common type of disease, for long-term management of the disease patients are treated with immunomodulatory drugs (IMD) which reduce disease activity. Response to therapy varies among patients. Presently there are no biomarkers available for diagnosis and routine follow-up of MS. Many MS patients suffer from unexpected relapsing episodes that influence dramatically their mental and physical conditions, with high stress levels, tremors, motoric disabilities, blindness and more. Therefore, early target treatment in relapse episodes is crucial, yet sufficient tools for predicting and identifying early symptoms of an upcoming relapse episode are not available. The investigators have most recently shown that breath VOCs can be used to classify among MS and non-MS patients. The major aims of the current proposal is to study the plausibility of skin based VOCs as biomarkers for MS diagnosis and To Identify and characterize skin-based VOCs as biomarkers of the clinical relapse and disease activity.

Start: December 2019