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Multiple Sclerosis clinical trials

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NCT ID: NCT03087136 Active, not recruiting - Multiple Sclerosis Clinical Trials

A Multicenter Observational Study to Evaluate Pediatric Multiple Sclerosis in Brazil

EMOCEMP
Start date: March 1, 2017
Phase:
Study type: Observational

Pediatric Multiple sclerosis (MS) is a chronic inflammatory disease defined by multiple episodes of demyelination of the central nervous system (CNS) separated by time and space as specified in adults not explained by acute disseminated encephalomyelitis (ADEM). Several studies have indicated that at least 5% of MS patients are in the pediatric population, but no prospective study was performed in Brazil. There are particular characteristics of Pediatric MS that differs from the adult population and have been focus of interest in the last years. However, we still lack high evidence data, specially concerning treatment, of this age group. This is an observational non-interventional multicenter study in pediatric MS patients in which participating subjects will be characterized by their clinical, MRI and immunological features. In this observational study, we will select 8 MS centers in Brazil to recruit at least 100 pediatric patients currently followed on each center with idiopathic inflammatory CNS disorders over a 2-year study period. We will collect retrospective and prospective clinical and MRI data to determine the proportion of patients who fulfill the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for MS,7 especially on those below 10 years where the use of McDonald 2010 criteria is not recommended routinely. Following the inclusion on the study, subjects will be followed for at least 2 years. All subjects enrolled in this study will have serum collected to test autoantibodies including anti-AQP4 and anti-MOG using cell-based assays with transfected cells.8 Pediatric patients with positive testing for these autoantibodies will be analyzed separately. Exploratory MRI sub-study In 10 patients recruited at Hospital São Lucas PUCRS, we will perform an exploratory substudy with advanced MRI using q-space diffusion protocol on a 3-Tesla MRI (GE Signa HDx 3.0T, General Electric, Milwaukee, WI, USA) and a 8-channel head coil to visualize remyelinating brain MS lesions. Normalized leptokurtic diffusion (NLD) data will be acquired using diffusion-weighted echo planar imaging. All MRI scans from this exploratory study will be performed at the Brain Institute of Rio Grande do Sul (BraIns). Only patients with previous brain demyelinating lesions will be included in this exploratory sub-study.

NCT ID: NCT03077971 Active, not recruiting - Clinical trials for Carer Stress Syndrome

Effectiveness of Acceptance and Commitment Therapy Self-Help for Carers of People With Multiple Sclerosis

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

This is a feasibility study to evaluate whether it is possible to conduct a larger study to evaluate whether providing psychological support to carers of people with MS is effective in reducing carer strain. Whilst not all carers experience distress as a result of their caring duties, some do. This study is testing the use of Acceptance and Commitment Therapy (ACT) in a self-help format. Participants will learn about and use ACT by reading a book provided to them by the study. One group will receive the ACT book, another will receive the same book alongside weekly telephone support to use the book, and a third group will act as a control group and therefore will not have extra support. Participants are allocated to the groups based on chance (a computer will decide group allocation). Participants will complete questionnaires before group allocation, and then again 3 months after they were allocated to a group, and one final time 6 months after group allocation. Those who receive the self-help book will get sent chapters each week for 8 weeks. The groups will be compared on scores from the questionnaires and complete feedback interviews with a subgroup of those who receive the book, to gain feedback about their experiences of the study.

NCT ID: NCT03001284 Active, not recruiting - Multiple Sclerosis Clinical Trials

Multiple Sclerosis Produces Cardiovascular Subclinical Dysfunction

Start date: October 2012
Phase: N/A
Study type: Observational

Multiple sclerosis (MS), debilitating disease involving primarily the central nervous system, may cause cardiovascular dysfunction, due to autonomous nervous system dysfunction, physical invalidity, increased oxidative stress, and systemic inflammatory status, but the detailed mechanisms are not elucidated. The investigators aimed to assess left and right ventricular (LV and RV) function, left atrial (LA) function, arterial function, and atrial-ventricular-arterial coupling in patients with MS, compared to control subjects. LV systolic and diastolic function and RV function were assessed by 2D- and 3D- echocardiography, tissue Doppler, and speckle tracking echocardiography. LA function was assessed by LA volume index and LA strain. Arterial remodeling and stiffness were assessed by intima media-thickness, pulse wave velocity, and parameters of wave intensity and endothelial function

NCT ID: NCT02914964 Active, not recruiting - Multiple Sclerosis Clinical Trials

Dietary Approaches to Treat Multiple Sclerosis-Related Fatigue Study

Waves
Start date: August 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the effect of the Swank Diet (low saturated fat) and the Wahls Elimination Diet (modified paleo) on fatigue levels in individuals with relapsing-remitting multiple sclerosis who have documented fatigue. Participants will follow their usual diet for 12 weeks and then be randomly assigned to follow one of the two diets for 24 weeks.

NCT ID: NCT02913209 Active, not recruiting - Multiple Sclerosis Clinical Trials

Quantitative Fatigue and Muscle Performance in Multiple Sclerosis

Start date: April 2016
Phase:
Study type: Observational

Fatigue is consistently rated as the top symptomatic complaint for individuals with multiple sclerosis (MS). Currently, the MS Fatigue Impact Scale (MFIS), a subsection of the Multiple Sclerosis Quality of Life (MSQoL), is the clinical standard used by neurologists for monitoring and tracking fatigue in individuals with MS. However, fatigue is multidimensional phenomenon and subjective measures have had poor or limited relationships with functional status. While previous study has focused on contributing factors to fatigue such as sleep disorders and diminished cortical excitability, this line of inquiry has neglected the role of muscle structure and function on fatigue in every day functional tasks. An alternative approach is to assess quantitative fatigue using anaerobic testing methods. However, more knowledge is needed to understand the role that quantitative fatigue plays in self-reported fatigue measures and function of daily activities. Our purpose is to determine the association between quantitative fatigue tests with performance-based measures of mobility and self-reported health-related quality of life. Our secondary goal is to understand how the intrinsic properties of muscle tissue influence muscle performance in Veterans with MS.

NCT ID: NCT02858778 Active, not recruiting - Multiple Sclerosis Clinical Trials

Timing of Acute Palliative Care Consultation in Critically Ill Patients

Start date: June 2016
Phase: N/A
Study type: Interventional

A prospective randomized controlled trial studying the ordering of palliative care consultations in the emergency department (Ig) versus later palliative care consultations in the hospital--ICU or hospital ward(Cg). Patients will be randomly allocated to Ig or Cg with a 1:1 ratio.

NCT ID: NCT02772666 Active, not recruiting - Multiple Sclerosis Clinical Trials

Novel Portable Diagnostic Device for Automatic Detection of Relative Afferent Pupillary Defect

Start date: December 2015
Phase: N/A
Study type: Observational

This study is to evaluate the ability of a newly designed device, Optic Nerve Glass (O-Glass) to detect relative afferent pupillary defect (RAPD). In this prospective observational study, 44 patients (diagnosed RAPD- positive) enrolled the study. Three groups of masked examiners observed patients for an RAPD by swinging flashlight method (SFM) and O-Glass. The instrument captured and recorded eye pictures. The images were processed and analyzed using computerized software to calculate pupillary measurements. The results were compared between two methods and three different groups of examiners. Twenty six patients were known cases of multiple sclerosis related optic neuritis, fourteen of them had glaucoma and four patients had history of traumatic optic neuropathy. The mean age (SD) of the study participants (18 female and 26 male) was 35. All three groups of examiners were satisfactory with successful diagnosis by O-Glass. Conclusion: O-Glass is a simple eye-glass along with mobile friendly software that any care giver can use to perform the tests to identify a RAPD automatically and rapidly. The ability to store and archive the objective and quantifiable results for referencing and follow-ups, makes the device more valuable.

NCT ID: NCT02740361 Active, not recruiting - Multiple Sclerosis Clinical Trials

Online Program to Reduce Depression in MS

Start date: February 15, 2017
Phase: N/A
Study type: Interventional

This is an international, multicenter, randomized controlled trial of an internet-based CBT intervention for depression (Deprexis) conducted in five MS centers in the US and Germany. The trial consists of a three-arm primary trial phase and an extension phase targeted at maintenance.

NCT ID: NCT02618902 Active, not recruiting - Multiple Sclerosis Clinical Trials

A "Negative"Dendritic Cell-based Vaccine for the Treatment of Multiple Sclerosis: a First-in-human Clinical Trial

MS-tolDC
Start date: May 30, 2017
Phase: Phase 1
Study type: Interventional

A first-in-human clinical trial to treat patients with multiple sclerosis by vaccination with tolerogenic dendritic cells (tolDC), generated using Good Manufacturing Practice (GMP) will be conducted. In doing so, the feasibility and safety of administering myelin-derived peptide-pulsed tolDC in patients with MS will be assessed.

NCT ID: NCT02596633 Active, not recruiting - Multiple Sclerosis Clinical Trials

A RCT of Telephone-supported ACT in MS

Start date: January 2015
Phase: Phase 3
Study type: Interventional

This study will investigate the feasibility of running a randomised controlled trial (RCT) of a psychotherapy called "Acceptance and Commitment Therapy (ACT)", delivered in a self-help format with additional telephone support from a therapist, for people with Multiple Sclerosis (MS) and low mood.