Bright Light Therapy for Sleep Disturbance in People With Multiple Sclerosis
Sleep disturbance is common in people with multiple sclerosis (MS) and contributes to diminished quality of life. Bright light therapy may be an innovative strategy to reduce sleep disturbance in MS, possibly through its effects on a subtype of retinal ganglion cells that help regulate circadian rhythms and sleep. This pilot study will evaluate whether, in people with MS, bright light therapy reduces sleep disturbance and explore whether light therapy improves function of these cells.
NCT04054050 — Multiple Sclerosis
Status: Enrolling by invitation
http://inclinicaltrials.com/multiple-sclerosis/NCT04054050/
Regulation of Lipid Metabolism in Autoimmune Disease: Multiple Sclerosis
The aim of this research is to understand how lipids such as cholesterol affect the disease process in people with MS.
NCT04053374 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT04053374/
A Multicenter Randomized Controlled Trial of Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Treatment-Resistant Relapsing Multiple Sclerosis (ITN077AI)
This is a multi-center prospective rater-masked (blinded) randomized controlled trial of 156 participants, comparing the treatment strategy of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) to the treatment strategy of Best Available Therapy (BAT) for treatment-resistant relapsing multiple sclerosis (MS). Participants will be randomized at a 1 to 1 (1:1) ratio. All participants will be followed for 72 months after randomization (Day 0, Visit 0).
NCT04047628 — Relapsing Remitting Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/relapsing-remitting-multiple-sclerosis/NCT04047628/
Calorie Restriction as a Novel Therapeutic Tool to Manipulate Immunity and Improve Therapeutic Potential of First Line Drug Treatments During Relapsing Remitting Multiple Sclerosis
There is a strong relationship between metabolic state and immune tolerance through a direct control exerted on immune cells by specific intracellular nutrient-energy sensors. An increased "metabolic work load" represents a novel issue linking metabolism with loss of self-immune tolerance. Several disease-modifying drugs have been approved for Relapsing-remitting Multiple Sclerosis (RR-MS) treatments and have shown to reduce relapse rates by modulating immune responses; however, their impact on long-term disease progression and accrual of irreversible neurological disability remains largely unclear, underlining the need for novel therapeutic strategies. In this context, both acute fasting (AF) and chronic caloric restriction (CR) have been shown to improve experimental autoimmune encephalomyelitis (EAE). Despite this evidence, no specific studies have been performed to dissect at the cellular level the mechanism of action of CR in the context of autoimmunity and MS. This study aims at investigating this specific point in order to pave the way for a wider utilization of a nutritional approach to alter MS progression and activity. The aim of this study is to improve the outcome of RR-MS and the efficacy of first line drug treatments (ie. Copaxone or Tecfidera) by altering the metabolic state of the host via calorie restriction with the aim to re-equilibrate immune/inflammatory responses of patients.
NCT04042415 — Multiple Sclerosis, Relapsing-Remitting
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis-relapsing-remitting/NCT04042415/
Prebiotic and Probiotic Treatment Trial in Multiple Sclerosis
This is a randomized crossover-designed study to explore the immunologic effects of Prebiotics, as opposed to direct supplementation with beneficial bacteria (Probiotics) in the immune system of patients with MS and Clinically Isolated Syndrome (CIS). Eligible patients will take 6 weeks of two different supplements - Prebiotics and Probiotics. Participants will be randomly assigned to take either of two agents for 6 weeks as their first supplement. Then, participants enter a 6-week washout period. After the washout period, participants will take the second supplement for 6 weeks. After taking the second supplement, participants will have a 6-week washout period.
NCT04038541 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT04038541/
Prospective Stratification of Infectious Risks in Multiple Sclerosis (InRIMS-Study)
This monocentric study is to identify factors that increase the susceptibility for infections and establish a questionnaire-based infection score that allows a prospective stratification for infectious risks in patients with multiple sclerosis (MS) (InRIMS-Study). The study will utilize a validated, MS-adapted questionnaire and infection diary from the Airway Infection Susceptibility (AWIS) study in a regularly followed, prospective cohort of MS patients. It is a nested project of the prospective observational Swiss MS Cohort (SMSC) and SUMMIT (Serially Unified Multicenter Multiple Sclerosis Investigation) studies.
NCT04036097 — Multiple Sclerosis
Status: Active, not recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT04036097/
A Randomized, Crossover Pilot Trial of Melatonin for Sleep Disturbance in Adults With Multiple Sclerosis (MS)
Many people with MS report sleep disturbances. However, objective data on sleep quality in MS, such as those obtained using actigraphy, remain scant, as do data about optimal therapeutic management. Melatonin is frequently used to improve sleep parameters, both in healthy and neurological populations. Altered melatonin regulation and signaling has been implicated in MS, through observations including (1) MS risk associated with shift work, (2) contribution of melatonin to seasonal risk of MS relapses, and (3) possible reduction of endogenous melatonin levels from exogenous corticosteroid administration. To the best of our knowledge, no studies have evaluated melatonin vs. placebo as a low-cost, low-risk agent to treat sleep disturbance in MS. To test this, we are conducting a randomized controlled pilot trial.
NCT04035889 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT04035889/
Decision Making in Multiple Sclerosis Care Under Uncertainty
The main objectives of this study are: i) To determine patient-level, physician-level and health system factors influencing therapeutic decisions in multiple sclerosis (MS) care by applying conjoint discrete experiments. ii) To determine the prevalence of therapeutic inertia among participating neurologists. iii) To compare clinical judgement vs. a qualitative or quantitative approach when assessing for a given case-scenario. iv) To evaluate the influence of decision fatigue in treatment decisions.
NCT04035720 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT04035720/
Cerebral Blood Flow in People With Multiple Sclerosis During Transcranial Direct Current Stimulation
With this study, the investigators will substantiate if regional cerebral blood flow (CBF) is affected by tDCS, assess the amount of CBF change in relation to different currents, and measure differences in regional CBF under stimulation reactivity between healthy subjects and people with Multiple Sclerosis (PwMS)using Water O-15 PET (Water Oxygen-15 Positron EmissionTomography) imaging. The objective is to investigate the changes in regional CBF after transcranial direct current stimulation (tDCS) at different intensities (1 mA, 2 mA, 3 mA, 4 mA) in healthy subjects and PwMS. The design is a cross-sectional proof of principle study in 10 healthy subjects and 10 PwMS. Relative regional brain CBF (rCBF) will be analyzed semi-quantitatively using voxel-wise and region of interest-based approaches. Changes in CBF associated with tDCS-application will be calculated with a general linear model in a ramp function of the task-specific rCBF, according to previous work in our group using a glucose analogue. Exploratory statistical testing will be done using a paired samples t-test between task and rest conditions and unpaired t-tests between PwMS and healthy controls at the same intensities. With this study the investigators will be able to dose-dependently measure real-time rCBF changes after non-invasively stimulating the superficial parts of the dorsolateral prefrontal cortex (DLPFC), a commonly used target in therapeutic tDCS applications. This will provide further insight into whether tDCS is capable of inducing changes in rCBF.
NCT04033133 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT04033133/
The Effect of a Telerehabilitation Virtual Reality Intervention on Functional Upper Limb Activities in People With Multiple Sclerosis
This study aims to investigate the effectiveness of a home-based telerehabilitation program specifically designed for upper limbs, based on Virtual Reality (VR) in individuals affected by Multiple Sclerosis.
NCT04032431 — Multiple Sclerosis
Status: Not yet recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT04032431/