Efficacy of Alpha-blockers (Tamsulosin) in the Treatment of Symptomatic Dysuria in Multiple Sclerosis in Women
Multiple sclerosis (MS) is the leading non-traumatic cause of severe acquired disability in young people. The disease is defined by relapses, which can affect all neurological functions depending on the location of the new inflammatory lesion(s). The disease can thus manifest itself through bladder and bowel disorders (BWS), which affect approximately 80% of MS patients in all stages. Lower urinary tract dysfunction has a significant negative impact on the quality of life of patients and places a significant burden on the healthcare system in terms of resource allocation. In addition, there is a risk of long-term chronic renal failure, an infectious risk (recurrent cystitis and/or pyelonephritis, sometimes life-threatening) and a lithiasis risk. The most frequently observed urinary symptoms are: urinary frequency, urgency with or without urinary incontinence, dysuria and chronic retention of urine. These disorders most often combine bladder hyperactivity and dysuria. This dysuria may be responsible for recurrent urinary tract infections, lithiasis, alteration of renal function. The only therapeutic class currently used to treat dysuria in MS is alpha-blockers. Tamsulosin, alfusozin and doxazosin induce relaxation of the urethral smooth sphincter and prostatic urethral muscle fibers, facilitating the removal of subvesical obstruction and bladder emptying. The study investigators hypothesize that treatment with tamsulosin 0.4 mg daily in adult MS patients with dysuria will result in symptom improvement as assessed by the International Prostate Symptom Score (IPSS) and Urinary Symptom Profile (USP) scores, a decrease in post-void residual, and an improvement in urine flow and quality of life.
NCT05439902 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05439902/
Factors Affecting Time Elapsed From First Symptom Till Complete Diagnosis of Multiple Sclerosis, Initiation of Disease Modifying Treatment and Drug Adherence in Upper Egypt
The earlier that MS can be diagnosed; the sooner treatment can be initiated with timely reduction of subclinical disease activity and prevention of disability progression. However, significant delays can still occur between noticing the first symptoms and receiving a diagnosis even before a person with symptoms suggestive of MS sees a neurologist. Such delays could be due to heterogeneity of clinical and imaging manifestations, which not only differ between patients, but also vary in individual patients over time. Moreover, lack of awareness of the primary care physicians about MS presentations, the limited accessibility to specialized centers or the non-availability of diagnostic tools such as MRI scanners and lumbar puncture, may further add to this delay and increases the risk of disability. There are also many factors that can contribute to delayed initiation of DMT after diagnosis like inadequate knowledge with DMT, their high coast and limited access to health care insurance services. Like many chronic conditions, non- Adherence to drug therapies is estimated up to 50%, with associated increased morbidity, mortality, and health care costs. To the best of our knowledge, this is the first study in upper Egypt that tries to address these factors. By conducting this study, we aim at identifying factors leading to delayed diagnosis of MS, initiation and adherence to DMT in order to translate recent advances in the diagnosis and treatment of MS into improved outcomes in the lives of people with MS and their families and to avoid many of the long-term economic and personal costs that result from unnecessary irreversible disability.
NCT05438693 — Multiple Sclerosis, Relapsing-Remitting
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis-relapsing-remitting/NCT05438693/
A Therapeutic Experience Program (TEP) Study Assessing Adherence to On-Label PoNS® Therapy for Improvement of Gait in People With Multiple Sclerosis (MS) in a Real-World Clinical Setting
PoNS therapy is a rehabilitation program that uses the PoNS device in conjunction with individualized physical exercise. This is an outcome research open label observational interventional multi-center study investigating the relationship between subject's adherence to PoNS therapy and therapeutic outcomes.
NCT05437276 — Gait Impairment Due to Mild/Moderate Multiple Sclerosis (MS)
Status: Recruiting
http://inclinicaltrials.com/gait-impairment-due-to-mild-moderate-multiple-sclerosis-ms/NCT05437276/
The Reliability and Validity of the Figure of 8 Walk Test in Multiple Sclerosis
Balance disorder is common in people with MS. As the disease worsens, it is associated with impaired balance, difficulty walking, decreased mobility, and an increased risk of falling. Given the prevalence and clinical significance of balance dysfunction in individuals with MS, the assessment of balance has become an important focus in MS clinical practice and research. The figure of 8 Walk Test is a standard clinical measure used to evaluate the forward walking performance required in daily life. Beyond walking straight, turning ability is required in many situations in daily life such as walking around a table, avoiding obstacles and navigating the street. The gait characteristics of walking on a straight and curved road are different. During curved walking, the center of mass of the body shifts to the inner leg as the stance time of the inner leg increases, as opposed to walking on a straight track. Compared to other standardized tests, scoring is not dependent on the subjectivity of the examiner, can be administered by a person with minimal training, and requires minimal time, space, and equipment. The test assesses the ability to quickly change direction of movement and is a timed test involving the use of assistive devices.
NCT05433714 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT05433714/
A Pilot Project for Multifidus Muscle Evaluation in Patients With Multiple Sclerosis and Back Pain
This research study plans to evaluate if multifidus muscle dysfunction is associated with back pain in patients with Multiple Sclerosis (MS).
NCT05427045 — Multiple Sclerosis
Status: Terminated
http://inclinicaltrials.com/multiple-sclerosis/NCT05427045/
Artificial Intelligence in Predicting Progression in Multiple Sclerosis Study
The study proposal focuses on multiple sclerosis (MS), a chronic incurable disease of the central nervous system (CNS). The MS disease is characterised by recurrent transient disability progression, quantified by increase in the extended disability status score (EDSS), and subsequent remission (disappearance of symptoms and reduced EDSS score) or, alternatively, a gradual EDSS disability progression and exacerbation of associated symptoms. At the same time, the MS is characterised by multifocal inflammatory lesions disseminated throughout the white and grey matter of the CNS, which can be observed and quantified in the magnetic resonance (MR) scans. The proposed study will address the critical unmet need of computer-assisted extraction and assessment of prognostic factors based from an individual patient's brain MR scan, such as lesion count, volume, whole-brain and regional brain atrophy, and atrophied lesion volume, in order to evaluate the capability for personalized future disability progression prediction.
NCT05426980 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT05426980/
Percutaneous Tibial Nerve Stimulation (PTNS) Therapy for Female Patients Suffering From Multiple Sclerosis
This is a pilot, single blind, randomized, sham-controlled trial to assess the benefit of PTNS in treating OAB symptoms in MS patients. The data generated by this study would provide support for a future multi-institutional, randomized prospective trial.
NCT05422625 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05422625/
Designing Virtual Reality-based Testing and Rehabilitation for Upper Extremity Software for People With Multiple Sclerosis
The study aims to designing virtual reality-based testing and rehabilitation software for people with multiple sclerosis and assess the feasibility of software. Also, the effects of an 8-week virtual reality-based upper extremity training in persons with multiple sclerosis will be investigated.
NCT05420532 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05420532/
A Phase I/II Dose Escalation/Adaptive Design Study to Evaluate the Safety and Efficacy of IMCY-0141 in Patients With Relapsing Remitting-Multiple Sclerosis (RR-MS)
The IMCY-MS-001 study is a study to test a new experimental drug, IMCY-0141, for the treatment of Relapsing-Remitting Multiple Sclerosis (RR-MS). The pathophysiology of MS with known myelin autoantigens and T cell epitopes makes this disease a particularly attractive indication for development of an immunotherapeutic based on the Imcyse technology. Based on the unique mechanism of action of the drug, IMCY-0141 administered as early as possible after confirmation of the diagnosis may potentially switch-off the autoimmune process and limit the corresponding myelin destruction. Newly (recently) diagnosed patients will be targeted to tackle the disease at its onset. Before launching any efficacy studies, safety of IMCY-0141 in MS patients must be evaluated with a phase I, open-label, dose escalation clinical trial to evaluate the safety of three IMCY-0141 doses followed by a phase II, double-blind, randomized study with an adaptive design to determine if any IMCY-0141 dose(s) offer superior efficacy relative to placebo and to assess immune responses and biomarker data as potential early predictors of efficacy of IMCY-0141 in adults presenting with RR-MS.
NCT05417269 — Multiple Sclerosis, Relapsing-Remitting
Status: Active, not recruiting
http://inclinicaltrials.com/multiple-sclerosis-relapsing-remitting/NCT05417269/
"Outwalk MS" - Benefits of Outdoor Walking Exercise Therapy on Walking Capacity and Well-being in Multiple Sclerosis
Deterioration of walking capacity is a common symptom in persons with multiple sclerosis (pwMS), furthermore having a negative influence on well-being. Studies have nevertheless shown that walking exercise therapy can improve walking capacity in pwMS. This may be particularly potent if occurring outdoors due to the varying stimuli it can provide (different surfaces and terrain etc.), and if the intensity and duration is adequate. Furthermore, outdoor walking is (1) suitable as a group intervention facilitating interaction between pwMS and (2) advantageous due to the health benefits offered through the interaction with nature itself. Both these aspects are also relevant for well-being. Few studies have nevertheless examined the effects of outdoor walking exercise therapy in pwMS. The purpose of the present study is therefore to examine the effects of 7 weeks of moderate-to-high intensity outdoor walking exercise therapy on walking capacity (primary outcome: 6-minute walk test) and well-being in pwMS.
NCT05415956 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT05415956/