Masitinib in the Treatment of Patients With Primary Progressive or Non-active Secondary Progressive...
Progressive Multiple SclerosisTo evaluate the efficacy and safety of oral masitinib versus placebo in the treatment of patients with primary progressive or secondary progressive multiple sclerosis without relapse.
TENS in Persons With MS
Multiple SclerosisPersons with multiple sclerosis (pwMS) often have an increased sense of fatigue. Furthermore, they present walking difficulties which negatively affects their mobility and results in an additional increase of fatigue. Previous literature suggests that transcutaneous electrical nerve stimulation (TENS) of leg muscles might increase their walking capacity and decrease perception of fatigue. In the present study we aim to investigate whether TENS of leg muscles reduces walking difficulties and sense of fatigue in pwMS in comparison with a short strength training protocol or no training. A similar aim is addressed after TENS of elbow flexor muscles. Subjects with relapsing remitting or progressive MS, age between 18 and 65 years, will undergo transcutaneous electrical nerve stimulation (TENS), strength exercises (SExerc), both TENS and SExerc (COMB) simultaneously, or sham stimulation without training (CON) of both leg and arm muscles. Force and fatigue measurements are performed before, directly after and three weeks after the training sessions and contain walking, fatigue, and strength assessments. Main study parameters are changes in the scores of i) the six-minute walking test (6-MWT), ii) the perceived walking disability (MSWS-12) and iii) fatigue questionnaires (FSS and MFIS). Additional study parameters are changes in muscle force and muscle fatigability.
Assessing Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin...
Multiple Sclerosis (MS)Multiple Sclerosis8 moreThe clinical trial is intended to assess for clinical evidence of Clemastine Fumarate as a myelin repair therapy in patients with chronic inflammatory injury-causing demyelination as measured by multi-parametric MRI assessments. No reparative therapies exist for the treatment of multiple sclerosis. Clemastine fumarate was identified along with a series of other antimuscarinic medications as a potential remyelinating agent using the micropillar screen (BIMA) developed at the University of California, San Francisco (UCSF). Following in vivo validation, an FDA IND exemption was granted to investigate clemastine for the treatment of multiple sclerosis in the context of chronic optic neuropathy. That pilot study was recently completed and is the first randomized control trial documenting efficacy for a putative remyelinating agent for the treatment of MS. The preselected primary efficacy endpoint (visual evoked potential) was met and a strong trend to benefit was seen for the principal secondary endpoint assessing function (low contrast visual acuity). That trial number was 13-11577. This study seeks to follow up on that study and examine clemastine fumarate's protective and reparative effects in the context of chronic demyelinating brain lesions as imaged by multi-parametric MRI assessments. The investigators will be assessing the effects of clemastine fumarate as a remyelinating therapy and assessing its effect on MRI metrics of chronic lesions found in patients with a confirmed diagnosis of relapsing-remitting multiple sclerosis. In addition to using conventional multi-parametric MRI assessments, this study will also evaluate a new MRI technique called Ultrashort Echo Time (UTE) MRI to assess the effects of clemastine fumarate as a remyelinating therapy of chronic lesions found in patients with a confirmed diagnosis of relapsing-remitting multiple sclerosis and compare it to the other assessments.
Effect of Corticosteroids on Inflammation at the Edge of Acute Multiple Sclerosis Plaques
Multiple SclerosisBackground: Multiple sclerosis (MS) affects the brain, spinal cord, and optic nerves. MS lesions can appear on the MRI (magnetic resonance imaging) scans in many ways. Sometimes they light up from the outer edge and fill inward. This is called ring enhancement. Researchers think this type of lesion may not heal as well as others. Corticosteroids are the standard treatment to reduce symptoms of MS relapse. But there is no standard treatment for people with enhancing MS lesions without signs of MS relapse. Researchers want to see if a short-term high-dose course of corticosteroids helps heal those lesions. Objective: To study the effects of short-term high-dose corticosteroids on ring-enhancing MS. Eligibility: Adults ages 25 and older who: Have MS and a rim-enhancing lesion on a prior brain MRI Are enrolled in another NINDS protocol Design: Participants will be screened under another protocol Participants will be randomly assigned to get either no treatment or 3 days of treatment with a corticosteroid. Participants will have: 1 baseline visit 3 days of high-dose steroids, intravenous or oral. If IV, participants will receive methylprednisolone by IV each day. Participants will also be prescribed medicine to protect their stomach. Follow-up visits will be at week 13 and week 25 after randomization to treatment or no treatment. Visits include medical history and physical exam. Participants will have blood and urine tests. Participants will also have neurological exams and MRIs. Participants lie on a table that slides into a cylinder. They are in the scanner 1.5-2 hours. They get a dye through a catheter: A needle guides a thin plastic tube into an arm vein.
A Phase IIIb, Multicenter, International Study to Evaluate the Efficacy, Safety and Tolerability...
Multiple SclerosisRelapsing-RemittingMultiple sclerosis is a chronic autoimmune, inflammatory neurological disease of the central nervous system. It is the most common disabling neurologic disease of young people. This study is planned for the evaluation of efficacy, safety and tolerability of neuropeptide combination of metenkefalin and tridecactide (EK-12) as compared to INF beta-1a (REBIF®) in patients with RRMS. The primary objective of this study is to prove the superiority of efficacy of neuropeptide combination of metenkefalin and tridecactide (EK-12) compared to INF beta-1a (REBIF®) in patients with RRMS on the basis of annualized protocol defined relapse rate by 144 weeks.
The Effects of Vestibular Exercise and Cervical Stabilization Exercise Training on Balance and Gait...
Multiple SclerosisVestibular1 moreThe population of this research consists of individuals between the ages of 18-65 with MS disease. MS patients to be included in the study will be directed by the Neurology outpatient clinic of Sanko University Hospital. All volunteers who agreed to participate in this randomized controlled pretest-posttest design study and met the sample criteria will be included in the study.Individuals who agree to participate will be divided into three groups by simple random method and closed envelope method. Vestibular exercise training group will be formed as Group 1 and Cervical stabilization exercise training group as Group 2, control group, and Group 3 as control group.Functional reach test, tandem stand test, 25 step walking test scale form, Multiple Sclerosis Quality of Life Scale form ( MSQOL-54),Fatigue Impact Scale,Beck depression inventory, MS walking scale (msys-12), dizziness disability inventory, four step square test, timed sit and stand test , 2 minutes walking test be performed before and after treatment,
Investigating the Effects of Wearable Robotic Exoskeleton for Improving Mobility and Cognition in...
Multiple SclerosisGait Disorders3 moreThe purpose of this research study is to evaluate the usefulness of a wearable robotic exoskeleton device (Ekso-GT), to improve learning and memory, and gait therapy in persons with walking disability due to Multiple Sclerosis. The study will evaluate the mobility, learning and memory, and walking abilities of individuals with multiple sclerosis who went through the traditional as compared to others who used the robotic exoskeleton as part of their therapy.
Sensor-based Assessment and Rehabilitation of Balance in Neurological Diseases
StrokeMultiple Sclerosis1 moreBalance impairment is one of the most common disorders due to a neurological diseases. Sensor-based technologies may be useful for falls prevention and balance recovery during patients hospitalization. OAK Elderly Care System (Khymeia Group, Noventa Padovana, Italy) allows the assessment of fall risk, the centre of pressure and the execution of balance exercises in a virtual environment.
A Prospective Biomarker Study in Active SPMS Subjects Treated With Cladribine Tablets
Multiple SclerosisThe purpose of this study is to explore the concept that biomarker sensitivity will detect activity in Multiple Sclerosis (MS) subjects and allow appropriate change in treatment to prevent dysfunction.
Deficit-specific Training in Spinal Disorders
Spinal Cord InjuriesMultiple Sclerosis4 moreImpairments of walking function after spinal cord lesion due to, for example, inflammation, ischemia or trauma are exceptionally diverse. Depending on the size, location and completeness of the spinal cord lesion, gait dysfunction is often multifactorial, arising from weakness of leg muscles, sensory impairments or spasticity. Locomotor function in humans with spinal cord damage can be improved through training. However, there are no evidence-based guidelines for the treatment of gait dysfunctions and no excepted standards of gait training in this large and heterogeneous group of patients. A lack of evidence-based guidance and standardisation prevents the development of optimal training programs for patients with spinal cord damage and rather broad and subjective clinical judgement is applied to determine patient care. Objective and quantitative techniques like three-dimensional (3D) full-body movement analysis capable of identifying the most relevant determinants of gait dysfunction at the single-patient-level are not yet implemented as diagnostic tool to guide physical therapy in this heterogeneous group of patients. The objective of this project is to further advance current clinical locomotor training strategies by applying a deficit-oriented gait training approach based on subject-specific, objective gait profiles gleaned from 3D gait analysis in chronic, mildly to moderately gait-impaired individuals with spinal cord damage due to inflammation (in multiple sclerosis, MS) or with traumatic or ischemic spinal cord injury (SCI; motor incomplete). Within a parallel-group clinical trial, gait impaired subjects will be characterized by detailed kinematic 3D gait analysis and either trained according to their individual deficits or treated with non-specific, standard walking therapy for six weeks. It is hypothesized that individually adapted, deficit-oriented training is superior in improving walking function than purely task-related, ambulatory training in patients with spinal cord damage. This project may pave the way to more efficient training approaches in subjects with spinal cord damage by transferring and implementing modern gait assessment techniques into clinical neurorehabilitation and to move towards individual, patient-tailored locomotor training programs.