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Sclerosis clinical trials

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NCT ID: NCT06291142 Enrolling by invitation - Systemic Sclerosis Clinical Trials

Early Diagnosis of SSc in the General Rheumatology Clinic - Pilot

Start date: November 22, 2023
Phase:
Study type: Observational

The goal of this observational pilot data acquisition study is to establish if target users can obtain diagnostic quality images in the clinic, from participants with Systemic Sclerosis (SSc), and SSc spectrum conditions. The main questions it aims to answer are: - Can a range of healthcare professionals, including non-specialists, use the capillaroscopy image acquisition system to take high quality images that can be used to create a clinical report? - Can the investigators collect user and patient feedback on the usability of the capillaroscopy system, to help develop the software and to develop the clinical report - Which microscope light source, from four different light wavelengths is better to see the blood vessels in skin with more melanin content. Participants will be asked to attend a single clinic visit where they will undergo a brief, non-invasive nailfold capillaroscopy examination, using the software-guided capillaroscopy system. Participants and rheumatology healthcare professionals will be invited to take part in one or more focus groups and interviews, to collect feedback and to contribute to the development of the image acquisition software and the clinical report.

NCT ID: NCT06223074 Enrolling by invitation - Methylprednisolone Clinical Trials

Improving the Treatment of Acute Relapses in Multiple Sclerosis Through Intranasal Methylprednisolone Administration

IN-DXM-EMRR
Start date: January 9, 2023
Phase: Phase 2
Study type: Interventional

This Clinical Trial evaluates the nasal administration of Methylprednisolone as a treatment strategy for Acute Relapses in Multiple Sclerosis

NCT ID: NCT06219291 Enrolling by invitation - Multiple Sclerosis Clinical Trials

Preventing the Progression of Multiple Sclerosis: Early Rehabilitative Treatment and Multimodal Assessment - Part A

Start date: July 1, 2022
Phase:
Study type: Observational

Motor performance of people with Multiple Sclerosis (PwMS) can decline since the onset of the disease. Longitudinal studies are needed to detect early worsening in mobility and balance using wearable devices for activity tracking and neurophysiological techniques for investigating brain functional adaptation. Similarly, neurophysiological assessment can provide evidences on the integrity of brain motor networks and mechanisms underlying cortical plasticity in the early disease phase, potentially providing a set of reliable prognostic factors of disease progression in early diagnosed PwMS. Furthermore, disease progression might be delayed using physical activity, which is effective in PwMS with moderate disability to ameliorate mobility and promoting brain reorganization and seems promising also for PwMS in the early stages of the disease. Functional Near-Infrared Spectroscopy (fNIRS) measures blood flow which accompanies neuronal activity, thus, it can provide spatial information about changes in cortical activation patterns and it could represent a useful tool for studying the effect of exercise on cortical plasticity. The aims of the study in non-disabled PwMS are: 1) a) to assess the presence of subclinical balance and walking impairments using wearable devices and multimodal gait analysis and b) to investigate cortical activity during exercise, 2) to define prognostic factors associated to disease progression and 3) to study the efficacy of physical activity in preventing the worsening of mobility and stimulating brain functional adaptation.

NCT ID: NCT06197841 Enrolling by invitation - Clinical trials for Role of Neurofilment in Diagnosis of Multiple Sclerosis

Neurofilament Light Chain as Diagnostic and Prognostic Marker in naïve Multiple Sclerosis Patients

NFLMS
Start date: December 1, 2023
Phase:
Study type: Observational

Neurofilament protein detected in the serum appears to be a good marker for the extent of active neurodegeneration. Chitinase may also be a good marker reflecting the degree of astrocyte activation, or damage in active lesions (Paul et al, 2018).These markers have some clinical value for diagnosis and monitoring of disease activity. NfL can be objectively measured and quantified, it is highly sensitive to neurodegenerative processes and its concentration changes as the disease worsens or improves (Disanto et al., 2017). Numerous studies have shown that NfL levels increase during MS relapses and correlate with MRI lesion development (Disanto et al., 2016, 2017; Novakova et al., 2017), disease activity, (Thebault et al., 2020). Cognitive impairment is common in the early stages of multiple sclerosis, mainly affecting attention, working memory, and information processing speed, but also memory, inhibition, and conceptualisation. Poor performance is common but remains subtle and does not significantly affect the quality of life at this stage. However, many studies shows that these deficits reflect the destruction both within and outside lesions, and that they may therefore be considered as a severity marker in the early stages of multiple sclerosis. (Lengenfelder et al., 2005). The aim of the work is to detect the role of serum NFL and chitinase as biomarkers in the diagnosis and prognosis of newly diagnosed multiple sclerosis patients, and to estimate the incidence of cognitive impairment and their relationship with the NFL in newly diagnosed MS patients.

NCT ID: NCT06167642 Enrolling by invitation - Multiple Sclerosis Clinical Trials

Retinal Atrophy and Neurofilament Light Chain in People With Multiple Sclerosis Taking Ofatumumab

Start date: May 22, 2023
Phase:
Study type: Observational

This study aims to assess whether, and the degree to which, ofatumumab modulates or reduces rates of retinal atrophy in people with relapsing-remitting MS (RMS), according to baseline serum neurofilament light chain (sNfL) levels.

NCT ID: NCT06056960 Enrolling by invitation - Multiple Sclerosis Clinical Trials

Preventing the Progression of Multiple Sclerosis: Early Rehabilitative Treatment and Multimodal Assessment - Part B

Start date: July 15, 2024
Phase: N/A
Study type: Interventional

It is widely recognized that physical exercise is safe and people with moderate Multiple Sclerosis (MS) are encouraged to train regularly to improve their skills in motor task execution. Several studies demonstrated that these activities represent an effective low-cost therapy which leads to significant and clinically meaningful improvements in gait and balance in people with MS (PwMS) with mild to moderate walking dysfunction, possibly also by promoting brain plasticity. There is general agreement within the scientific community on the importance of timing intervention also during the early stages of MS to preserve or improve walking and balance abilities and fostering brain functional adaptation, thus slowing down the disease progression. Previous studies highlighted the need to early identify and manage gait disorders using a multimodal approach tailored on individual's need. Moreover, Functional Near-Infrared Spectroscopy (fNIRS) measures blood flow which accompanies neuronal activity and thus, it can provide spatial information about changes in cortical activation patterns due to the possible effects of exercise on cortical plasticity. To the best of the investigators knowledge, no published studies have assessed the effect of exercise on mobility and brain activity in PwMS with minimal or clinically undetectable disability. This emphasizes the need of trials investigating the effect of walking exercise as preventive strategy on MS clinical worsening.

NCT ID: NCT06001138 Enrolling by invitation - Multiple Sclerosis Clinical Trials

Multiple Sclerosis: FutureMS-2 - an Observational Cohort and Scottish Precision Medicine Study

Start date: October 7, 2021
Phase:
Study type: Observational

FutureMS is a project created in direct response to frequent questions people with MS ask their doctors. Every person newly diagnosed wants to know how MS will affect them over their life and what can be done to stop the disease progressing and improve their quality of life. FutureMS aims to help answer those questions. The original FutureMS study provided a snapshot of the impact of MS within a year of diagnosis. However, MS is a long-term condition and so the investigators now want to better understand the impact of MS, on the same individuals, after approximately 5 and 10 years of living with MS. This is the purpose of FutureMS-2.

NCT ID: NCT05903690 Enrolling by invitation - Gene Mutation Clinical Trials

Safety and Tolerability of RAG-17 in the Treatment of Amyotrophic Lateral Sclerosis Patients With SOD1 Gene Mutation

Start date: May 22, 2023
Phase: Early Phase 1
Study type: Interventional

The goal of this clinical trial is to evaluate the safety, tolerability and pharmacokinetics of RAG-17 in adult amyotrophic lateral sclerosis (ALS) patients with SOD1 mutation. Patients will receive drug treamtent via dose escalation which ranging from minimum of 60 mg to the maximum tolerated dose (MTD), after reaching the tolerated dose, a fixed dose of the drug is given once every two months for continuous treatment, and the total treatment cycle is 8 months. The duration of this study is two years.

NCT ID: NCT05725759 Enrolling by invitation - Clinical trials for Amyotrophic Lateral Sclerosis

Rehabilitation in SOD1 ALS Treated With Tofersen

Start date: November 8, 2022
Phase:
Study type: Observational

The primary objective of this study is to document and describe the effects of a personalized rehabilitation program for patients with SOD1 ALS participating in the tofersen expanded access program. Participants currently receiving tofersen treatment will be referred to outpatient physical and/or occupational therapy. Participants will have an initial assessment performed and an individualized rehabilitation program will be prescribed. Each participant is encouraged to follow the prescribed recommendations that will include scheduled outpatient therapy sessions, functional assessments, and/or a home-based rehabilitation program. Functional assessments will be done at a minimum of every three months.

NCT ID: NCT05706220 Enrolling by invitation - Multiple Sclerosis Clinical Trials

Visual Processing Speed and Objective Analysis of Ocular Movements in Multiple Sclerosis

Start date: June 13, 2022
Phase:
Study type: Observational

This project aims to analyze ocular motility problems, visual processing speed and microperimetry, and their relationship with consolidated retinal structural biomarkers (optical coherence tomography, OCT) in patients with Multiple Sclerosis w/w reading complaints comparing with healthy subjects.