
A Study of the Efficacy and Safety of Rituximab in Participants With Systemic Sclerosis
SclerodermaSystemic4 moreThis study evaluates the efficacy and safety of rituximab compared with placebo in SSc patients. This study consists of a 24-week, double-blind, placebo-controlled period followed by a 24-week active drug treatment period.

Safety and Efficacy of Anaerobic Cultivated Human Intestinal Microbiome Transplantation in Systemic...
Systemic SclerosisThis study evaluates the effect of intestinal microbiota therapy on gastro-intestinal symptoms in patients with systemic sclerosis (SSc). This is a mulicenter randomized controlled trial conducted at university hospitals in Oslo, Tromsø, Bergen and Trondheim in Norway. In part A1, half of the patients will receive active substance (intestinal microbiota cultured in the lab - "ACHIM") in the small intestine twice by gastroduodenoscopy, the other half will receive placebo. The primary outcome will be measured on week 12 by patient reported outcome measures. In part A2, all participants receive ACHIM at week 12, with an 8 week follow-up for all. A step-wise follow-up will be done in part B up to 16 weeks after week 20 until the last participant finish week 20 visit, which is defined as end of study.The blind from the first intervention will not be opened before end of study.

Clenbuterol on Motor Function in Individuals With Amyotrophic Lateral Sclerosis
Amyotrophic Lateral SclerosisThe purpose of this study is to assess the safety and tolerability of clenbuterol (taken by mouth) in subjects with ALS (amyotrophic lateral sclerosis) and to assess the effectiveness of clenbuterol with regard to motor function in subjects with ALS. Subjects will be in this study approximately 24 weeks. The study drug, clenbuterol, is taken twice a day. As part of this study subjects will have the following tests and procedures: medical history, vital signs, physical examination, blood tests, heart and lung function tests, muscle function test, ALSFRS-R (ALS Functional Rating Scale Revised), thyroid function and for women who can become pregnant, pregnancy tests.

Neurobiological and Immunological Mechanisms of Dyspnea in ALS (BIOPNEA)
Shortness of BreathDyspnea1 moreDyspnea; subjective experience of respiratory discomfort; which produces negative emotional experience, is the most common symptom of patients afflicted with chronic respiratory failure and its treatments are limited. Amyotrophic Lateral Sclerosis (ALS) related - dyspnea, due to diaphragmatic dysfunction, is similar to dyspnea during mechanical inspiratory load (activation of the supplementary motor area, SMA). The perception of pain and dyspnea is processed in similar brain areas (insula, dorsal anterior cingulate cortex, amygdala and medial thalamus) and in ALS; relieving dyspnea by noninvasive ventilation (NIV) is associated with decreased pain thresholds. Otherwise, it is reported systemic elevations of pro-inflammatory cytokines in chronic pain patients, correlating with intensity of pain, and during respiratory load in healthy volunteers. The objectives are to evaluate the cytokines and endorphins rates variations after initiation of NIV in ALS patients, and to correlate cytokines and endorphins rates with the intensity of the affective component and the intensity of the sensory component of dyspnea. The investigators will perform a prospective, experimental study, including 30 ALS patients. Dyspnea, ventilatory and cardiac settings, electromyographic recording of the scalene muscle and biological assays (ACTH, endorphin, Neuropeptide P, BDNF, IL1, IL6, IL8, IL10, TNF), will be measured during spontaneous breathing and during NIV at different times after initiation. The investigators expect a reduction of immunological and neurobiological markers after relieving dyspnea by NIV. This work could lead to the development of new treatments for dyspnea.

Cerebellar tDCS and Balance Training in PwMS
Multiple SclerosisMany people with multiple sclerosis (PwMS) have decreased balance and postural control, gait deficits, and a high frequency of falls. High fall rates and mobility impairments pose a significant risk to the independence and quality of life of PwMS. Therefore, effective interventions to improve balance and postural control are urgently needed to decrease the frequency of falls in PwMS. Balance training has been demonstrated to significantly improve postural control and gait in PwMS. One possible treatment modality to amplify the effects of balance training is transcranial direct current stimulation (tDCS), a non-invasive means to increase cortical excitability and potentially prime the brain for task specific learning. The cerebellum plays a vital role in balance and posture and may be an important target structure for tDCS studies seeking to reduce fall risk. Studies have shown that anodal cerebellar tDCS is effective in improving balance control in older adults with high fall risk and patients with chronic stroke. However, the most effective tDCS intensity and the duration of the effects on balance control has not been established. Moreover, no study has combined cerebellar tDCS and balance training to reduce fall risk in PwMS. The purpose of this study is to investigate the effects of cerebellar transcranial direct current stimulation (tDCS) on fall risk in people with relasping-remitting multiple sclerosis. We will conduct tDCS or SHAM followed by balance training on 4 consecutive days. We will evaluate fall risk with well-established functional tasks, such as the Berg Balance Scale, Timed Up and Go (TUG), the six minute walk test (6MWT), and static posturography. Prospective participants, men and women with relasping-remitting MS, will be recruited. To accomplish this study, 30 participants will be randomly assigned into 3 groups (2 mA tDCS, 4 mA tDCS, or SHAM). This study involves 4 daily visits at the Integrative Neurophysiology Lab at the same time of day for each subject and three follow-up visits. The duration of visit 1 will be approximately 2.5 hours and the duration of visits 2-4 will be approximately 1.5 hours. Visit 5, 6, and 7 will be approximately 24 hours, 1 week, and 3 weeks, respectively, after visit 4 and will last approximately 1.5 hours. During tDCS sessions, participants will undergo either Sham, 2 mA, and 4 mA tDCS for 20 minutes followed by balance training.

Remediation of Emotional Deficits in Multiple Sclerosis and Traumatic Brain Injury
Multiple SclerosisTraumatic Brain InjuryThis study will examine the efficacy of a clinical intervention for improving emotional processing in individuals with MS and TBI.(1)The main outcome measure will be changes in emotional processing measures from pre to post treatment. (2)This study will also assess the impact of the emotional processing intervention on changes in pre and post treatment depression and anxiety, as well as fatigue.(3) This study will additionally measure the impact of the emotional processing intervention on cognitive functioning, specifically processing speed, attention and executive abilities. This will be accomplished through the completion of a neuropsychological battery prior to and following the completion of treatment.(4)Finally, the investigators will measure the impact of the intervention on quality of life and social functioning, utilizing a pre and post treatment assessment consisting of measures of self-efficacy, quality of life, functional abilities, and awareness.

Exergaming in Persons With Multiple Sclerosis With Restless Legs Syndrome
Multiple SclerosisIn this studly, the effects of an 8-week videogame-based physical activity training in persons with multiple sclerosis will be investigated.

Intervention to Reduce Perceived Cognitive Impairment in Multiple Sclerosis
Multiple SclerosisMultiple sclerosis (MS) is among the most prevalent autoimmune diseases among young and middle-aged adults. Up to 65% of MS patients experience objective cognitive impairment including problems with information processing speed, memory, and executive functioning. However, patients commonly overestimate the extent of their cognitive dysfunction which can result in inaccurate perceptions of their true cognitive abilities. Exaggerated perceptions of cognitive impairment are predictive of future decline and associated with depression, anxiety, and reduced quality of life. Despite this, no study has examined an intervention aimed at changing misperceptions related to perceived cognitive impairment in MS when objective measures are incongruent with self-reported cognitive symptoms. The purpose of the present study is to develop and pilot a brief intervention for MS patients who perceive cognitive impairment, but perform in the normal or expected range on objective measures of cognition.

Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis...
Raynaud Phenomenon Secondary to Systemic SclerosisThis is a Phase 2, multicenter, double-blind, randomized, placebo-controlled study to evaluate the effect of iloprost on the symptomatic relief of Raynaud's Phenomenon attacks in subjects with symptomatic Raynaud's Phenomenon secondary to Systemic Sclerosis.

Combined Effect of Transcranial Direct Current Stimulation (tDCS) and Physical Activity on Gait...
Multiple SclerosisThis study is aimed to test the efficacy of transcranial direct current stimulation (tDCS) combined with a physical activity (PA) program, in 80 individuals affected by Multiple Sclerosis (MS). In particular, this study will evaluate the efficacy of tDCS when administered simultaneously with PA on walking, functional mobility, and fatigue. The subjects enrolled will be randomly assigned to the active group (active tDCS+PA) or the sham group (sham tDCS+PA). Portions of this study may be completed remotely.