Effect of Bio-electromagnetic Energy Regulation Therapy on Erectile Dysfunction in Patients With Multiple Sclerosis
Multiple sclerosis (MS) is an inflammatory disease that affects the brain and spinal cord. There are potential impacts on neurological functions, including sensory and autonomic functions. The Primary observed in males with MS is erectile dysfunction (ED), which substantially impacts the quality of life. There is increasing literature on electromagnetic fields' biological and clinical effects, particularly on ED.
NCT05615454 — Multiple Sclerosis, Relapsing-Remitting
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis-relapsing-remitting/NCT05615454/
The Effect of Motor Imagery on Balance in Persons With Multiple Sclerosis
This study will investigate if the use of motor imagery to practice a balance task is as effective as physically practicing balance tasks as measured by the Berg Balance Scale (BBS) in persons with MS. A secondary purpose is to investigate if using a motor imagery balance intervention will limit fatigue typically experienced with physical movement in this population.
NCT05615207 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05615207/
Multicentre Randomized Blinded Controlled Study of Specific Telerehabilitation of Multidomain Cognitive Impairment in Multiple Sclerosis Using Mixed Evaluation and Ecological Validity
Treating cognitive impairment (CI) in multiple sclerosis (MS), the leading cause of disability due to nontraumatic neurological disease in young adults, is an important challenge. The contribution of CI to disability in MS has been increasingly recognized, and CI has been shown to decrease health-related quality of life (HR-QOL), even in the early stages of the disease. CI negatively impacts daily activities such as driving, vocational status, absenteeism, and instrumental activities in persons living with MS (PwMS). No medication has proven to have a consistent symptomatic effect on CI in MS, and disease-modifying therapies only have a small impact on CI progression. CI in MS is dominated by a slowdown in information processing speed (IPS), as well as by disturbances of more specific cognitive functions such as attention, episodic memory (EM), working memory (WM) and executive function (EF). The alteration of IPS has consequences for WM, attention, EF and EM. IPS impairment predicts subsequent disability and vocational status and changes in quality of life (QOL). Cognitive rehabilitation (CR) is the most promising approach for treating MS-related CI, as concluded by recent reviews and meta-analyses, despite important methodological shortcomings. Methodological limitations in early studies have led to disappointing results, and well-designed studies are still scarce. As noted recently, many studies lack a randomized controlled design that includes passive or active control conditions, primary neuropsychological end-points identified a priori, evidence of the sustainability of CR and the inclusion of near and far transfer outcomes. Tertiary outcomes of QOL, metacognition, or other patient-reported outcomes (PROs) are rarely used. In view of the results of these different studies, the investigators propose a single-blind randomized controlled trial of a telerehabilitation program for MS associated CI, based on Rehacom software, using appropriates modules according to specific CI, but complemented by individual remote online rehabilitation sessions allowing a better adaptation of the program to the patient's deficit, a more efficient supervision and meta-cognitive work. This program will be evaluated in terms of effectiveness on neuropsychological tests, effectiveness on specific cognitive domains re-educated according to the impairments detected in the baseline, an ecological evaluation and the impact on daily cognitive functioning. Specific active rehabilitation will be compared to a placebo intervention of the same duration and intensity. Only a multi-center study will make it possible to achieve sufficient number of patients to meet these objectives.
NCT05611047 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05611047/
An Open 6-month Investigation, to Evaluate the Performance and Long-term Safety of FlowOx2.0™ in Patients With Multiple Sclerosis (Optional Continuation From NCT05562453)
This study is based on a 4-week double-blind, randomized, controlled, parallel design investigation to investigate the impact of intermittent negative pressure on spasticity and pain in people with multiple sclerosis (pwMS) (NCT05562453). The investigational device (FlowOx2.0™) is composed of a Pressure Chamber and a Control Unit (and disposable parts). All subjects will receive the same pressure chamber but be randomized to either a Control Unit that generates intermittent negative pressure (INP) of - (minus) 40 mmHg or a Control Unit that generates INP of - 10 mmHg. FlowOx2.0™ generating -40 mmHg is the investigational device, and FlowOx2.0™ generating -10 mmHg, is the comparator device. After the initial 4-week double-blind period (NCT05562453), all participants will be offered the -40mmHg control unit to be used during a 6-months optional extension part. The participants who volunteer to continue in the 6-months optional extension part will be included in this study.
NCT05598736 — Pain
Status: Enrolling by invitation
http://inclinicaltrials.com/pain/NCT05598736/
Immunogenicity of the Recombinant Zoster Vaccine (Shingrix ®) in Multiple Sclerosis Patients Treated With Anti-CD20 Antibodies Compared to Controls- a Phase IV Monocentric Study
The purpose of this study is to provide evidence as to whether RZV is immunogenic with an acceptable safety profile in Multiple Sclerosis patients on anti-CD20 treatment.
NCT05596526 — Shingles
Status: Recruiting
http://inclinicaltrials.com/shingles/NCT05596526/
Optimal Diagnostic Algorithm for Neurogenic Lower Urinary Tract Symptoms in Patients With MS
There is no consensus in the literature upon the neurourological diagnostic algorithm of the patients with multiple sclerosis (MS). The primary aim of the study is phenotyping the patients with MS. These phenotypes might guide Neurology and Urology specialists during diagnosis and treatment. Secondary aim of this study is to define the presence and severity of urological symptoms' and disorders', involving the patients with diagnosis of MS less than 5 years into a urological follow-up and treatment process. Our study might include 4 visits (the first visit, 3rd month, 6th month and 12th month visit). Questionnaires, uroflowmetry and bladder diary might be repeated on each visit. Filling cystometry and pressure-flow study will be performed only on the first visit. All patients will receive 6 different questionnaires which aim to define the severity and presence of lower urinary tract symptoms. Bladder diary is an online application which will represent at least 3 days of frequency, urgency, incontinence episodes and the amount of fluid intake, and urination. The phenotypes would be defined after performing the first visit diagnostic tools (all of the tools are necessary during the diagnostic algorithm of neurogenic lower urinary tract symptoms). The phenotypes will be defined as: a. no symptoms with normal urodynamics, b. Lower urinary tract symptoms with normal urodynamics, c. no symptoms with abnormal urodynamics, d.lower urinary tract symptoms with abnormal urodynamics. During a follow-up period of 1 year, changes in the bladder diaries and scores in questionnaires of these groups will be compared on each visit.
NCT05587101 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05587101/
Comparison of the International Cooperative Ataxia Rating Scale (ICARS) and Scale for the Assessment and Rating of Ataxia (SARA) Scores With Face-to-Face and Tele-Assessment Methods in Ataxic Multiple Sclerosis Patients
Our aim is to compare ICARS and SARA scores with face-to-face and tele-assessment methods in ataxic multiple sclerosis patients. The hypotheses on which this study is based are; H1: Tele-assessment and face-to-face assessment results of the ICARS differ in patients with ataxic MS. H2: Tele-assessment and face-to-face assessment results of SARA differ in patients with Ataxic MS.
NCT05585541 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT05585541/
Characterization of Early Patients Initiating Ofatumumab for Treatment of Multiple Sclerosis in the Real-World
This was a retrospective cohort study utilizing secondary data from IQVIA's open source pharmacy claims database (i.e., IQVIA LRx) selecting patients with prescription claims for ofatumumab or other DMTs of interest.
NCT05576779 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT05576779/
Effectiveness of Telerehabilitation Interventions in Persons With Multiple Sclerosis: Patient Perspective
Multiple sclerosis (MS) is an inflammatory, demyelinating, neurodegenerative disease of the central nervous system of unknown etiology. The most common clinical signs and symptoms are motor dysfunction, fatigue, spasticity, impaired mobility, cognitive impairment, chronic pain, depression, decreased quality of life, and bladder and bowel dysfunction. 66% of people with MS have impaired upper extremity function. As a result of the deterioration in upper extremity function, the performance of many daily living activities affects performance. As a result of this influence, there is a decrease in the functional independence of people, quality of life, and participation in activities in the community. Exercise training represents an existing behavioral treatment approach to safely manage many functional, symptomatic, and quality-of-life outcomes in MS. Telerehabilitation has been defined as "the delivery of rehabilitation services through information and communication technologies." Telerehabilitation has proven to be useful for people with MS by increasing physical activity and reducing fatigue. In the studies, telerehabilitation and face-to-face rehabilitation services were compared, and stated that they had similar results. At the same time, it was stated that telerehabilitation provides people with gains in terms of time and cost. In addition to all these, the researchers emphasized the benefits they received from telerehabilitation from the people's statements. Therefore, the results of this study, which will be performed on MS patients, will enable the evaluation of telerehabilitation strategies from the patient's point of view. The participants was included in the study titled 'Investigation of the Effects of the Synchronized Telerehabilitation-based Upper Extremity Training Program on Hand-arm Function, Pain, Fatigue, Quality of Life, and Participation in People With Multiple Sclerosis (ClinicalTrials.gov Identifier: NCT05073731)' will be included in this study. Questionnaires that will enable individuals to evaluate their telerehabilitation service will be administered once. Physicians and physiotherapists will make evaluations.
NCT05571826 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05571826/
Investigation of the Effect of the Combination of Arm Ergometer Exercise and Balance Training on Upper Extremity Function in People With Multiple Sclerosis
This study will investigate the effects of a 12-week arm ergometer exercise and balance training on upper extremity function in persons with multiple sclerosis.
NCT05571631 — Multiple Sclerosis
Status: Not yet recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05571631/