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Sclerosis clinical trials

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NCT ID: NCT03567057 Completed - Multiple Sclerosis Clinical Trials

A Safety and Efficacy Study of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment

Start date: July 18, 2018
Phase: Phase 3
Study type: Interventional

This study assessed the long-term safety and tolerability of ADS-5102 in subjects with MS and walking impairment who had completed the double-blind, placebo-controlled study of ADS-5102 in subjects with MS (ADS-AMT-301).

NCT ID: NCT03566251 Completed - Physical Therapy Clinical Trials

Core Stability, Trunk Position Sense, Balance and Functional Mobility in Patients With Multiple Sclerosis

Start date: May 1, 2016
Phase: N/A
Study type: Interventional

The aim of this study is to compare balance, functional mobility, core stability and trunk position sense in patients with Multiple Sclerosis (PwMS) and healthy controls and investigate the relationship between core stability and trunk position sense with balance and functional mobility in PwMS. Balance and mobility disorders are seen in various degrees in patients with Multiple Sclerosis (PwMS). Balance and mobility impairments are observed in the beginning with the early period and are one of the most common causes of disability in PwMS. Coordination between the peripheral sensory system, the central sensory-motor system and the musculoskeletal system which generates motor responses is required to provide balance. If one or more of these systems do not function properly, this results in deficiency in trunk stability and also causes balance and mobility disorders. It has been shown that balance and mobility disorders are mostly associated with loss of strength, spasticity, coordination disorders and sensory loss. Especially, it is known that strength of core are related to balance and mobility. Although core muscle strength is a significant element of trunk stability, position sense is also responsible for trunk stability. When literature is examined, there is no study which examines the relationship between balance and mobility with core muscles' strength and trunk position sense in PwMS. For all these reasons, we think that balance and functional mobility may be related to core stability and trunk position sense in PwMS

NCT ID: NCT03564496 Completed - Multiple Sclerosis Clinical Trials

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

Start date: July 9, 2018
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03561233 Completed - Systemic Sclerosis Clinical Trials

Prevalence and Predictors of Proton Pump Inhibitor Partial Response in Gastroesophageal Reflux Disease in Systemic Sclerosis

Start date: May 2013
Phase: Phase 1
Study type: Interventional

Proton pump inhibitor (PPI) twice daily dosing regimen—a standard dose therapy for gastroesophageal reflux disease (GERD)—is an effective therapy for uncomplicated GERD in systemic sclerosis (SSc) but there is no data of response rate of standard dose of PPI and predictors of PPI-partial response (PPI-PR) GERD in SSc.Objectives of the study were to determine the prevalence of omeprazole partial response GERD in SSc and to define the predictors of PPI-PR GERD in SSc. Adult SSc patients having GERD were treated with omeprazole 20 mg twice daily 30 minutes before meal for 4 weeks. Severity of symptom-grading by visual analogue scale (VAS) and frequency of symptoms by frequency scale for symptoms of GERD (FSSG) were assessed at baseline and 4 weeks after treatment. PPI-PR GERD was defined by less than 50% improvement in VAS of severity of symptom and acid reflux score by FSSG after treatment compare to baseline.

NCT ID: NCT03561155 Completed - Multiple Sclerosis Clinical Trials

Robot-assisted Arm Training in Multiple Sclerosis

RAMSES
Start date: November 2014
Phase: N/A
Study type: Interventional

The upper limb (UL) plays an important role in the daily functioning of patients with Multiple Sclerosis (MS) and negatively influences their quality of life. Effective arm-hand training programs are needed. Various robotic systems have been developed for UL rehabilitation, mainly used in patients with stroke. Preliminary work in MS has focused on proximal sections of the arm. No study has evaluated the use of robotics for improving manual dexterity and their effects on cortical activity. The results of this research project could be relevant for the advancement of knowledge about UL functional recovery in individuals with MS and to determine the pattern of muscle activation underlying functional recovery.

NCT ID: NCT03560739 Completed - Multiple Sclerosis Clinical Trials

A 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS Patients

Start date: September 11, 2018
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to demonstrate pharmacokinetic bioequivalence of ofatumumab injected by Pre-filled Syringe (PFS) versus Auto-Injector (AI) devices and thereby establish a bridge between the ongoing Phase 3 program and the to-be-marketed drug-device combinations

NCT ID: NCT03560661 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

Acoustic and Perceptual Markers of Dysarthria in Amyotrophic Lateral Sclerosis (ALS)

SPEECH-ALS
Start date: July 5, 2018
Phase:
Study type: Observational

This study proposes to identify acoustic and perceptual markers related to upper motor neuron (UMN) degeneration and lower motor neuron (LMN) degeneration in the dysarthria of patients with amyotrophic lateral sclerosis (ALS) which involves the degeneration of both systems. ALS patients will be gathered in clinical groups according to electromyogram (EMG) and clinical signs observed in the bulbar site. UMN signs are defined as jaw clonus, gag reflex and pseudobulbar features (lability). LMN signs are defined as lingual atrophy and fasciculations. The dysarthria will be compared to dysarthria of patients involving an exclusive UMN system degeneration (in primitive lateral sclerosis) and an exclusive LMN system degeneration (Kennedy's disease). Patients will be compared to the controls who permitted to establish the standards of the "MonPaGe" tool. MonPaGe is a computerized tool based on a multidimensional and quantified assessment of voice and speech, by a set of targeted acoustic and perceptual criteria.

NCT ID: NCT03558854 Completed - Systemic Sclerosis Clinical Trials

Evaluation of Effectiveness of Acetylsalicylic Acid on Markers of Vascular Dysfunction in Scleroderma Patients

Start date: August 28, 2018
Phase: Phase 4
Study type: Interventional

Systemic sclerosis is a chronic autoimmune disease characterized by vascular changes in the microcirculation (small blood vessels) and progressive fibrosis of the skin and internal organs. It is believed that vascular changes, expressed early by the Raynaud phenomenon, precede fibrosis and organic dysfunction. There is no available treatment that reverses the vascular damage caused by the disease to the moment, although there are several medications recommended for the relief of manifestations due to vascular injury. Acetylsalicylic acid (ASA) is one of the medications that can be used for the treatment of vascular injury present in systemic sclerosis, but still without a fully proven benefit. This study aims to evaluate the effectiveness of ASA on microcirculation alterations in patients with systemic sclerosis by performing three exams: periungual panoramic capillary microscopy, videocapillaroscopy and laser Doppler imaging. In addition, a blood sample will be collected for dosing the following vascular lesion markers: endothelin-1, von Willebrand factor, thromboxane, and platelet-derived, endothelial-derived and monocyte-derived microparticles.

NCT ID: NCT03555253 Completed - Multiple Sclerosis Clinical Trials

Resilience-Based Program for Support Partners of Persons With Multiple Sclerosis

Start date: May 23, 2018
Phase: N/A
Study type: Interventional

This is a pilot feasibility study to examine the impact of providing a non-therapeutic resilience-based coaching telehealth program to the Support Partners (SP) of persons with MS (PwMS). Cognitive difficulties are a prominent feature in PwMS and prove to be a challenge for PwMS and the close family members that care for them. This study is a pilot telehealth program that aims to address these needs and improve the overall well-being of adults with MS and their Support Partners. A manualized program was developed utilizing the previous research study conducted literature, and the expertise and experience of the research study team. Funding was sought and obtained for 30 pairs to participate in the pilot. The 6-session program will address needs identified by this population and improve knowledge of cognition in PwMS. Study Objectives: Primary Objective: To conduct an evaluation of the feasibility of the resilience program by examining: 1. Recruitment (i.e. willingness to participate in program) 2. Participation rates and attrition 3. Participant satisfaction of the program. Secondary Objective (Support Partner): To assess the potential long-term benefits of the program to Support Partners of PwMS. Program benefits will be assessed using the following outcomes: 1. Sense of Competencies 2. Understanding of cognitive impairment in MS 3. Caregiver burden 4. Positive Emotions. Secondary Objective (PwMS): To assess the potential long-term benefits of the program to PwMS. Program benefits will be assessed using the following outcomes: 1. Relationship Satisfaction 2. Perceived Support.

NCT ID: NCT03552185 Completed - Multiple Sclerosis Clinical Trials

Depicting Neurogenic Dysphagia in Multiple Sclerosis Patients; Clinical and Endoscopic Studies

Start date: January 1, 2018
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to evaluate neurogenic dysphagia in Multiple Sclerosis patients using dysphagia questionnaires and endoscopic study; and to correlate that to MS types, severity, duration, and imaging modalities