
Efficacy and Safety of Nitrazine in the Treatment of ALS
Amyotrophic Lateral SclerosisTo evaluate the trend of safety and effectiveness of Nitroketazine tablets for ALS patients, and to explore the best effective dose.

Immune- and miRNA-response to Recombinant Interferon Beta in Healthy Volunteers and Patients With...
Relapsing-remitting Multiple SclerosisThere are two standard and a few second line treatments for RRMS. Since the disease cannot be cured by these existing treatments and all treatment options have significant limitations, there is the need to develop new treatment strategies to improve therapy of patients with RRMS. We developed a RIG-I ligand as a new therapeutic strategy for patients with MS. The RIG-I ligand functions partially via induction of Interferon beta (IFN-b), but has advantages over therapy with recombinant IFN-b. Identification of suitable biomarkers to monitor treatment with RIG-I ligand and to guide the dose steps would help to increase the safety of the volunteers in the early clinical trials with RIG-I ligand. The RESI study is designed to analyse immune readouts and potential biomarkers such as type I IFN levels, type I IFN dependent immune activation and miRNA expression following Rebif or Avonex (Interferon beta 1a) application. Rebif is applied s.c. at a dose of 44 µg three times a week (on day 1,3,5 and 8), and Avonex i.m. at a dose of 30µg once a week (on day 1 and 8), as they are routinely used in RRMS-therapy. The immune readouts are assessed on day 1, 3, 5 and 8 immediately before application of Rebif/Avonex and on day 1 and 8 at 1 / 6 / 12 /24 hrs after Rebif/Avonex application by analysing blood samples. Since studies of the RIG-I ligand will start in healthy volunteers and will be continued in MS patients we need data from both populations since they could show significant differences in response to IFN-b. Thus, the RESI study includes healthy volunteers, RRMS-patients already under Rebif/Avonex treatment, and RRMS-patients who have to yet started a therapy with Rebif/Avonex.

Effects of GE-O System on Gait Impairments in Multiple Sclerosis Subjects
Multiple SclerosisMultiple sclerosis (MS) is the most common non-traumatic cause of neurologic disability in young adults,affecting mobility and ambulation in the majority of patients. At least 50% of individuals with MS will require an assistive device to ambulate within ten years of diagnosis. Impaired mobility is one of the top three factors associated with inability to continue working. In addition,impaired mobility and the inability to walk functionally translate into significant costs for personal assistance, medical complications, and lost wages because of unemployment. Clearly,maximizing the ability to ambulate, as well as perform safe and effective transfers,is a fundamental goal in the management of individuals with MS. None of the currently available MS disease-modifying medications have been shown to stop or reverse gait disability. Repetitive locomotor training is an innovative approach in gait disturbances in patients with MS. Only scant data on this issue is available and all the studies have been performed by means of treadmill training or robot assisted gait training (RAGT) approaches. The recent introduction of a robotic device to gait rehabilitation showed a significant improvement in gait ability in patients with neurological disease due to the possibility of being trained under a graduated body weight support condition and being being guided to reproduce a physiologic gait pattern. In 2010 a novel device called GE-O System was developed. It enables patients to repetitively practice walking on the floor and also climb up and down stairs. To date, the effectiveness of this novel device has not yet been evaluated in patients with MS. The aims of the study are as follows: to evaluate the effectiveness of a specific gait training program consisting of the GE-O System in patients with MS in improving balance and walking ability,reducing fatigue,the frequency of falls,the fear of falling and disability in activities of daily living and finally,improving quality of life.

Reduced-intensity Immunoablation and Autologous Hematopoietic Stem Cell Transplantation (AHSCT)...
Multiple SclerosisThis is a patient-sponsored study that evaluates the safety and efficacy of reduced-intensity immunoablation followed by a single dose autologous hematopoetic stem cell transplantation in patients diagnosed with multiple sclerosis. Patients are followed-up after 1 month, 3 months, 6 months and 12 months post-transplantation.

Safety/Efficacy Study of 2nd Cycle Treatment After 6 Months of 1st Cycle HLA-haplo Matched Allogenic...
Amyotrophic Lateral SclerosisThe purpose of this study is to evaluate the safety and efficacy of HLA-haplo matched Allogenic Bone Marrow Derived stem cells("HYNRCS-Allo-ALS-02 inj"), through intrathecal delivery for the repeated treatment after 6 months of first treatment in patients with amyotrophic lateral sclerosis(ALS). This study is an open label, single-dose study to assess the safety and efficacy of HLA-haplo matched Allogenic Bone Marrow Derived stem cells("HYNRCS-Allo-ALS-02 inj")

The Effect of High Dose Methylprednisolone on Nailfold in Early Systemic Sclerosis ( SSc )
Systemic SclerosisRaynaud PhenomenaThis is a 12 week double-blind randomized placebo controlled trial in which 30 patients with very early SSc, fulfilling the Very Early Diagnosis Of Systemic Sclerosis (VEDOSS) criteria (9) will be randomized in a 2:1 fashion to receive intravenous methylprednisolone or placebo. Three-day treatment courses are given at week 0, week 4 and week 8. The final assessment is at week 12, and patients will be followed up to one year after baseline

Autologous Bone Marrow Derived Stem Cells for the Treatment of Multiple Sclerosis.
Multiple SclerosisUntil now, there is no effective approach to stop the progression of multiple sclerosis and stimulate re-myelination. Autologous stem cell transplantation shows hope and is quickly developing as an alternative therapy. We propose the use of autologous bone marrow-derived specific stem cell populations and mesenchymal stem cell transplantation (BM-MSC) associated with immuno-modulation to treat patients with relapsing-remitting MS (RRMS).

Virtual Reality and Manual Dexterity in in Patients With Multiple Sclerosis
Multiple SclerosisPhysical Activity3 moreIntroduction. Multiple sclerosis (MS) is the most common neurological disease causing disability in young adults. Neurorehabilitation is a fundamental aspect in the treatment approach for MS, in which new technologies have gained popularity, especially the use of virtual reality (VR), thanks to the therapeutic possibilities offered for patients with MS presenting cognitive, sensitive and motor dysfunctions. Aim. To analyze and compare an occupational therapy intervention (OT) compared with OT + VR (OT+VR) on the manual dexterity of patients with MS. Material and methods. 26 patients will be recruited. The control group (n=8) will recieve 20 conventional OT sessions distributed in two sessions per week. The experimental group OT+VR (n=8) will recieve 20 sessions of VR interventions, twice weekly and lasting 30 minutes, consisting of VR games accessed via the online webpage motiongamingconsole.com, including Flip Out, Air Hockey, Partículas, Dunkit, Cuenta peces and Robo Maro, in addition to the conventional OT sessions. Pre and post-intervention assessments will be based on the Purdue Pegboard Test, the Jebsen Taylor Hand Function Test and the Grooved Pegboard Test.

Neurofilaments for NEDA Assessing in MS
Multiple SclerosisGoal is to evaluate the achievement of biological NEDA as demonstrated by a drop in neurofilament levels in MS patients commencing Alemtuzumab therapy as part of their MS management.

Intramuscular Infusion of Autologous Bone Marrow Stem Cells in Patients With Amyotrophic Lateral...
ALS (Amyotrophic Lateral Sclerosis)The purpose of this study is to evaluate the safety of Intramuscular Infusion of Autologous Bone Marrow Stem Cells in Patients With Amyotrophic Lateral Sclerosis by a prospective, single-center, randomized, parallel, double-blind, placebo-controlled phase I clinical trial.