Rheopheresis for Raynaud's and Digital Ulcers in Systemic Sclerosis
Systemic SclerosisRaynaud Phenomenon2 moreIn this feasibility study, we aim to explore therapeutic Rheopheresis (RheoP) as a novel treatment option for SSc-associated Raynaud's phenomenon and/or digital ulcers and compare it to the standard of care treatment (intravenous iloprost. RheoP has been used for RP/DU with some success in observational studies, nevertheless, the optimal treatment modality, duration, or frequency of RheoP (and PEX in general) in SSc has not been established as of yet.
Sleep Quality, Stress, Depression, Blood Pressure Responses to Diaphragmatic Respiratory Exercise...
Systemic Sclerosissystemic sclerosis women usually report problems such as stress/depression, fatigue, not deep sleep. complementary therapies may improve the reported problems in those patients
Function Magnetic Resonance Imaging to Assess Two Therapeutic Strategies in Multiple Sclerosis (NeuroRehEM)....
Multiple SclerosisMultiple sclerosis (MS) is an autoimmune disease that causes cognitive and motor disabilities and contributes to decrease patients life quality. Previous results described that there are some MS patients that showed (at least in some phases of the disease) neuroplasticity processes that are able to compensate some cognitive deficits. Moreover, neuroplasticity processes seem to be limited and related to the degree of gray matter atrophy (patients with less atrophy show grater neuroplasticity than those with higher atrophy level). The aims of this project are: to study behavioral changes (post-training) induced by two different rehabilitation programs: a)cognitive training focused on exclusively enhancing working memory and b) aerobic + cognitive training aimed to enhance attention, working memory processes and motor capabilities using a virtual reality game. to study neuroplasticity changes (post-training functional connectivity changes) induced by these rehabilitation programs to observe the role of the atrophy in brain neuroplasticity processes. Neuropathological status and neuroplasticity processes (studied using neuroimaging tools) as well as cognitive performance using neuropsychological tools will be assessed in a group of MS patients (with different phenotypes) at two different time points: before any training (S1) and after 10 days of training (S2). This project will be financed by the Ministerio de ciencia, innovación y universidades of the Spanish government and also have been approved by the Ethical committee of Universitat Jaume I.
Ketamine for Multiple Sclerosis Fatigue
Multiple Sclerosis FatigueThe proposed study is a single-center, phase II, randomized, double-blind, parallel-group, active-placebo-controlled trial of intravenous low-dose ketamine in patients with MS fatigue.
Treatment of Cognitive Deficits in Multiple Sclerosis With High-Definition Transcranial Direct Current...
Multiple SclerosisRelapsing-RemittingThe 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.
Adjunctive GNX Treatment Compared With Placebo in Children and Adults With TSC-related Epilepsy...
Tuberous Sclerosis ComplexThis is a Phase 3, global, double-blind, randomized, placebo-controlled study of adjunctive GNX treatment in children and adults with TSC-related epilepsy. The study consists of a 4-week prospective Baseline phase, defined as the first 28 days following screening, followed by a double-blind phase consisting of a 4-week titration period (Day 1 to Day 28) and a 12-week maintenance period (Day 29 to Week 16).
An Open-label Extension Trial of HZNP-HZN-825-301 in Adult Participants With Diffuse Cutaneous Systemic...
Diffuse Cutaneous Systemic SclerosisSclerosis1 morePrimary Objectives: The primary efficacy objective is to assess the efficacy of 52 weeks of open-label treatment with HZN-825 in participants with diffuse cutaneous systemic sclerosis, as measured by change from both baselines in forced vital capacity percent (FVC %) predicted. The primary safety objective is to examine the safety and tolerability of 52 weeks of open-label treatment with HZN-825, inclusive of, but not limited to, adverse events (AEs), serious AEs (SAEs) and the adverse event of special interest (AESI), from Day 1 to 4 weeks after last dose.
Don't be Late! Postponing Cognitive Decline and Preventing Early Unemployment in People With Multiple...
Multiple SclerosisThe goal of this randomized controlled trial is to compare the effectiveness of two innovative interventions aimed at preventing cognitive decline and work-related problems to enhanced usual care in improving quality of life in people with multiple sclerosis. Secondary objectives are: to compare the effectiveness of the investigated interventions in improving cognitive, psychological, and work functioning, and in enhancing the brain's functional network to examine which factors (i.e., baseline cognitive, psychological, work, and brain MRI-parameters) are predictive of the response to the investigated interventions aim to qualitatively reflect on the process and outcome of the investigated interventions considering the perspectives of relevant stakeholders to allow for smooth and successful implementation in clinical practice Participants will follow the intervention for four months, with follow-up measurements at six months after intervention and 12 months after intervention.
A Study to Evaluate the Safety, Pharmacokinetics and Biodistribution of an Imaging Agent, 18F-OP-801...
Amyotrophic Lateral Sclerosis (ALS)A Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics and Biodistribution of an Imaging agent, 18F-OP-801 (18F Hydroxyl Dendrimer), After Intravenous Administration to Patients with Amyotrophic Lateral Sclerosis (ALS) and Healthy Volunteers (HV)
Stopping TSC Onset and Progression 2B: Sirolimus TSC Epilepsy Prevention Study
Tuberous Sclerosis ComplexEpilepsyThis trial is a Phase II randomized, double-blind, placebo controlled multi-site study to evaluate the safety and efficacy of early sirolimus to prevent or delay seizure onset in TSC infants. This study is supported by research funding from the Office of Orphan Products Division (OOPD) of the US Food and Drug Administration (FDA).