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Sclerosis clinical trials

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NCT ID: NCT04063852 Completed - Multiple Sclerosis Clinical Trials

PTNS on Urinary and Global Quality of Life in MS Patients

PTNSinMS
Start date: February 27, 2019
Phase:
Study type: Observational

This is a single-centered, prospective, longitudinal, observational cohort study of patients with MS who suffer from lower urinary tract symptoms (LUTS) and are refractory to two prior treatment modalities who have elected to pursue PTNS therapy for LUTS.

NCT ID: NCT04061681 Completed - Multiple Sclerosis Clinical Trials

Efficacy of BIPAMS for Restless Legs Syndrome in Adults With Multiple Sclerosis: A Pilot Study

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the efficacy of a 16-week behavioral intervention for increasing physical activity and reducing restless legs syndrome (RLS) severity in persons with multiple sclerosis (MS) and RLS. The study includes a proposed sample of 20 persons with MS and RLS that will be randomized into either a 16-week behavioral intervention arm aimed at increasing physical activity or a 16-week wait-list control arm.

NCT ID: NCT04057222 Completed - Multiple Sclerosis Clinical Trials

Effect of Need to Void on Rectal Sensory Function in Multiple Sclerosis

Start date: July 26, 2019
Phase:
Study type: Observational

Multiple sclerosis causes demyelinating lesions, which can induce multiple symptoms. Ano-rectal avec urinary disorders are frequent due to specific lesions in inhibitor/activator encephalic centers, or interruption on medullary conduction. It seems to be evident that anorectal and urinary disorders are link, because of similar anatomic ways and control process. To our knowledge several studies test the effect of rectal distension and bladder sensory function but only one study examined the effect of bladder filling on rectal sensitivity on healthy people. The effect of bladder filling on rectal sensory function in patient with neurological disease stay unknown, while dysfunction often occur concomitant, and therapeutic actions in one organ may influence function of the other. Anorectal manometry is the gold standard for the evaluation of rectal sensory function and the volume of constant sensation to need to defecate is reported in literature as the most reproducible measure. Primary aim is to assess the effect of need to void on volume of constant sensation to need to defecate in multiple sclerosis with anorectal symptoms. Secondary aim is to identify the effect of need to void on modulation of rectoanal inhibitory reflex (RAIR) and external anal sphincter resting pressure. Patient with multiple sclerosis over 18 years old, consulting for anorectal disorders in a tertiary center, with an indication to realize an anorectal manometry are included. History and treatment, height, weight, Expanded Disability Status Scale (EDSS), anorectal and urinary symptoms severity by Bristol, Neurogenic Bowel Dysfunction (NBD), Cleveland, Kess, Urinary Symptom Score (USP) scores, and last urodynamic data are recorded. Patient are asked to drink water until they feel a strong need to void, for which they would go to urinate at home. 3 void volume with portable sonography are done, and the higher is recorded. Anorectal manometries are realized by the same doctor, in a specific place, with calm. Before the manometric examination, thermal and vibratory sensory thresholds on the right hand are collected. The patient is then placed in a left lateral position. Then the anorectal manometry's catheter is inserted and collect of the external anal sphincter resting pressure begins. Then the investigator proceed to search for RAIR by 5 brief distensions of the intrarectal balloon with increasing volumes of 10 mL from 10 mL to 50 mL. Finally, the investigator collect the threshold volumes of perception, need and maximum tolerable by gradually distending the intra-rectal balloon to 5 mL/s from 0 mL to 300 mL. Toilets are just next to the table of examination. Next, patient can urinate. 3 post void residual volume with portable sonography are done, and the higher is recorded. The same tests are realized after urinate, in the same order. After the classical complete manometry was performed. Primary outcome is the volume of constant sensation to need to defecate Secondary outcomes are the modulation of RAIR and the external anal sphincter resting pressure. Manometric data are collected. Influence of age, EDSS, severity of symptoms, manometric data and detrusor overactivity on rectal sensory function will be study in secondary analysis.

NCT ID: NCT04057066 Completed - Multiple Sclerosis Clinical Trials

Internet-based Physical Activity Promotion and Exercise Prescription for People With Multiple Sclerosis (Feasibility Study)

Start date: February 28, 2019
Phase: N/A
Study type: Interventional

This study evaluates the feasibility of a 12-week internet-based exercise and physical activity counseling intervention for people with Multiple Sclerosis (MS).

NCT ID: NCT04040322 Completed - Clinical trials for Raynaud's Phenomenon Secondary to Systemic Sclerosis

Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 3)

Start date: October 14, 2019
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of iloprost on the frequency of and relief from symptomatic digital ischemic episodes in subjects with systemic sclerosis.

NCT ID: NCT04038541 Completed - Multiple Sclerosis Clinical Trials

Prebiotic vs Probiotic in Multiple Sclerosis

MS
Start date: March 11, 2020
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04035889 Completed - Multiple Sclerosis Clinical Trials

Melatonin for Sleep in MS

Start date: September 23, 2019
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04033133 Completed - Multiple Sclerosis Clinical Trials

Cerebral Blood Flow and tDCS

Start date: December 20, 2019
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04027114 Completed - Multiple Sclerosis Clinical Trials

Individualized Physiotherapy and Activity Coaching for Multiple Sclerosis

IPAC-MS
Start date: July 12, 2019
Phase: N/A
Study type: Interventional

Multiple Sclerosis (MS) is a chronic neurological disease that places a high burden on patients, families and society. Physical activity in MS is associated with improved fitness, symptoms, and function, fewer relapses, and fewer brain lesions on MRI. Saskatchewan has one of the highest rates of MS worldwide, and a recent survey estimated approximately 80% of persons living with MS are not sufficiently active for health benefits. Individuals living with MS recognize the importance of physical activity, but often indicate a lack support, including limited access to professionals knowledgeable about both MS and physical activity. There is a need to identify effective interventions for improving activity levels safely and appropriately. Behaviour change strategies target specific behaviours involved in increasing and maintaining physical activity. The primary objective of this project is to determine if individualized behaviour change strategies delivered by neurophysiotherapists increases physical activity in MS. Participants will be randomly assigned into two groups. The intervention group will receive individualized behaviour change strategies delivered through the support of neurophysiotherapists for 12 months. The wait-list control group will receive usual care for 12 months, and then be offered the intervention for a 6-month period at the end of the study period. The long-term goal of this research is to help decrease the burden of MS by identifying new opportunities for increasing physical activity.

NCT ID: NCT04025554 Completed - Multiple Sclerosis Clinical Trials

Anakinra for the Treatment of Chronically Inflamed White Matter Lesions in Multiple Sclerosis

Start date: October 25, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Background: Multiple sclerosis (MS) is a disease of the central nervous system (CNS). People who have MS may have lesions that form on parts of the CNS, such as the brain. Some of these lesions may be inflamed for a long time. This causes MS to progress. There is no treatment for these lesions. Researchers believe that a drug that decreases inflammation can help. Objective: To see if a drug called anakinra can help clear inflammation in MS brain lesions. Eligibility: People 18 and older with MS and at least one white matter lesion. Design: Participants will be screened with one or more Neuroimmunology Clinic protocols. Participants will have a medical history and physical exam. They will have blood and urine tests. They will have a lumbar puncture. For this, a needle is inserted between the bones in the back, and cerebrospinal fluid is removed. They will also have an MRI of the brain. The MRI scanner is a cylinder surrounded by a strong magnetic field. Participants will lie on a table that slides in and out of the scanner. Participants will repeat the above procedures throughout the study. Participants will get their first dose of anakinra at the clinic. They will administer the rest of the doses themselves, by injection under the skin. Participants will track their daily dosage electronically or in a written drug diary. Participants will have 4 visits while taking the drug. At each visit, sharps boxes and empty vials will be collected. Participants will have 2 follow-up visits after completing treatment. The study will last 28 weeks.