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Sclerosis clinical trials

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NCT ID: NCT05002764 Recruiting - Multiple Sclerosis Clinical Trials

Thalamic Nuclei Volumes in Multiple Sclerosis

THALNUC-MS
Start date: July 1, 2021
Phase:
Study type: Observational [Patient Registry]

The thalamus is composed of several nuclei interlocked in a complex anatomy. In multiple sclerosis (MS), the thalamus can be altered due to disconnection by white matter lesions and due to direct damages that could be partly mediated by CSF. Due to such pathophysiology and complex anatomy, some nuclei could be more vulnerable to multiple sclerosis than others. We will test this hypothesis by using a new algorithm to automatically segment several nuclei that we will be applied to the French national MS database

NCT ID: NCT04998305 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

TJ-68 Clinical Trial in Patients With Amyotrophic Lateral Sclerosis (ALS) and Muscle Cramps

Start date: September 30, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objective of the study is to demonstrate the safety and potential efficacy of TJ-68 for improving muscle cramps in participants with ALS based on a two-site, randomized, placebo-controlled double-blind multi-period crossover (N-of-1) study design.

NCT ID: NCT04995588 Recruiting - Systemic Sclerosis Clinical Trials

Systemic Sclerosis and Innate T Cells

Start date: February 28, 2022
Phase: N/A
Study type: Interventional

Innate T cells (ITC) are decreased in systemic sclerosis (SS) and an early lymphocyte innateness has been reported. In the other part, ITC are implicated on inflammatory process, including the IL-33/ST2 axis, which is also involved in ScS endotheliopathy. Data are however scarce and physiopathological mechanisms have not been assessed to date. The investigators hypothesize a global lymphocyte innateness in SSc, linked to a chronic ITC stimulation by innate signals leading to ITC exhaustion, and their potential role in endotheliopathy and fibroblast activation in SSc.

NCT ID: NCT04987463 Recruiting - Clinical trials for Tuberous Sclerosis Complex

Efficacy and Safety of Rapamycin Versus Vigabatrin in the Prevention of Tuberous Sclerosis Complex Symptoms in Infants

ViRap
Start date: May 7, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of the study is to evaluate the efficacy, tolerability, and safety of vigabatrin versus rapamycin as a preventive treatment in infants with Tuberous Sclerosis Complex (TSC).

NCT ID: NCT04979845 Recruiting - Multiple Sclerosis Clinical Trials

Telerehabilitation in Multiple Sclerosis

Start date: July 1, 2021
Phase: N/A
Study type: Interventional

Patients with multiple sclerosis will be randomized into two groups. One group will receive live telerehabilitation sessions 3 times a week over a course of three months. The other group will receive video instructions for aerobic and strengthening exercises. Patients fatigue, sleep quality and quality of life will be measured.

NCT ID: NCT04979819 Recruiting - Multiple Sclerosis Clinical Trials

The Validity and Reliability of the Upper Extremity Exercise Testing (UULEX) in Patients With Multiple Sclerosis

Start date: July 1, 2021
Phase: N/A
Study type: Interventional

Multiple sclerosis negatively affects the endurance and functionality in the upper extremities. 20 female patients aged 18-70 years who were diagnosed with MS will be included in the study. Demographic, family, cigarette alcohol use, etc. information will be obtained from the patients and the study will begin. Timed 25-Step Walking Test, upper extremity endurance with UULEX, Hand-Shoulder and Arm Problems Questionnaire (DASH) and Nine-hole Board Test (DDTT) evaluation were performed on the patients. Manual muscle test for muscle strength, handheld dynamometer handheld Grip strength will be measured with a dynamometer and spasticity will be measured with the Ashworth scale. Depression status of the patients will be determined by the Beck depression scale, and the presence of dyspnea will be determined by the dyspnea scale. The validity and reliability of the Unsupported Upper Extremity Exercise Test (UULEX) will be investigated with the obtained data. In order to give the most accurate result of the test in adults over 65 years of age, 3 repetitions will be performed with a resting period of half an hour. Limitation of activities of daily living will be evaluated with MSQOL-54 specific to Multiple Sclerosis. Intraclass correlation coefficient (ICC) will be used to determine test-retest reliability.

NCT ID: NCT04977622 Recruiting - Clinical trials for Primary Progressive Multiple Sclerosis

Gray Matter Demyelination in Primary Progressive MS at 7T

Start date: November 30, 2021
Phase:
Study type: Observational

Progressive-onset multiple sclerosis (PPMS) occurs in about 15% of all people living with MS. PPMS remains understudied, and most disease-modifying treatments are ineffective for PPMS. To date, it is unknown why some people progress immediately from MS onset. The present study will assess the role of gray matter in PPMS by characterizing it with ultra-high field magnetic resonance imaging (MRI). While both white and gray matter are affected in relapsing MS, in PPMS tissue damage is primarily in the cortex. Cortical gray matter consists largely of neuronal cell bodies, which send electrical signals to create a functional response, such as arm or leg movement. While white matter damage slows the signal response, cortical damage inhibits the initial creation of electrical signals. There is a great need to research and develop scientific biomarkers to identify and monitor progression and repair in PPMS. In this project, 7 Tesla MRI is used to investigate the cortical gray matter in people with PPMS. 7 Tesla MRI is the safest and most detailed way to study the brain. Because the cortex is only a few millimeters thick, it has been traditionally difficult to investigate. At 7 Tesla, different layers and lesions within the cortex can be seen. In addition, this project will use myelin-sensitive MRI to determine the biological underpinnings of both cortical lesions and the 'normal appearing' cortical damage in PPMS. This will answer relevant questions about the brain's capacity for repair, the extent of demyelination and the occurrence of inherent cortical remyelination and provides an avenue for the development of novel clinical MR biomarkers tailored to PPMS.

NCT ID: NCT04975685 Recruiting - Multiple Sclerosis Clinical Trials

Strengthening Mental Abilities With Relational Training (SMART) in Multiple Sclerosis (MS): A Feasibility Trial

SMART_MS
Start date: February 7, 2022
Phase: N/A
Study type: Interventional

Background: Multiple Sclerosis (MS) is a chronic condition of the central nervous system; around 1 in 600 people in the United Kingdom have MS. Many people with MS (70%) have cognitive difficulties, which they experience as distressing and disabling, and there is currently a lack of treatment options to improve these difficulties. SMART (Strengthening Mental Abilities with Relational Training) - a theory-based online cognitive training programme, which has been shown to improve general cognitive abilities - has not been tested with people who have MS. Aims: To conduct a feasibility study to inform development of a definitive trial of SMART for improving cognitive functioning in people with MS. The investigators will assess: 1. Acceptability to participants of the intervention, delivery format, inclusion/exclusion criteria, baseline and outcome measures, randomisation protocol, and study procedures 2. The framework for a cost-effectiveness analysis alongside a definitive trial 3. Participant recruitment and retention rates 4. Sample-size needed for fully powered trial 5. Signal of efficacy Plan: To address Aims 1-5, the investigators will recruit 60 adults with MS who are experiencing cognitive difficulties, identified from MS clinics. Participants will complete baseline assessments of their cognitive abilities and answer questionnaires about their cognitive difficulties, personal priorities, mood, fatigue, self-efficacy, quality of life, and healthcare services used. Assessments will be administered by a researcher, face-to-face or remotely. Participants will be randomly allocated to one of three arms (20 per group): Group 1: Receives SMART intervention online - plus usual care (MS Nurse support). SMART intervention involves completing a series of logic problems, which are designed to train skills that scaffold complex cognition. Group 2: Receives usual care alone. Group 3: Receives a 'control' intervention online - plus usual care. Baseline measures will be re-administered at three- and six-months post-randomisation. Researchers and patient-partners (people with personal experience of MS, who will act as co-researchers) will also interview 30 participants about their experience of the study and treatment. All qualitative data will be transcribed and thematically analysed in terms of a priori feasibility aims. Quantitative data will enable sample-size calculation for a definitive study and determine signal of efficacy.

NCT ID: NCT04972929 Recruiting - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

Effects of Chiropractic Care on Cytokine Levels in Multiple Sclerosis

Start date: December 15, 2022
Phase: N/A
Study type: Interventional

Multiple sclerosis (MS) is an inflammatory autoimmune disease associated with an imbalance between pro- and anti-inflammatory markers (cytokines) resulting in a demyelinating and neurodegenerative disease. There is early evidence that spinal manipulation (chiropractic care) is better than control in influencing immune (cytokine) activity in asymptomatic participants, but few studies have been completed in participants with chronic inflammatory conditions, such as MS. The purpose of this project is to examine the immediate (after a single thoracic spinal manipulation treatment) and summative impact (after 8 thoracic spinal manipulation treatments occurring over 4 weeks) on pro-inflammatory (interleukin (IL) IL-1ß, IL-2, IL-6, Tumor necrosis factor-alpha) and anti-inflammatory (IL-4, IL-10) plasma cytokines 20 minutes and 2 hours after thoracic spinal manipulation in participants diagnosed with neuroinflammatory relapsing-remitting MS (RR-MS). Spinal manipulation treatment will be limited to the thoracic spine. Secondary outcomes will include determining the impact of 8 thoracic spinal manipulations on fatigue, cognitive processing speed, pain, depression, sleep, and motor function through questionnaires and performance of various in assessments such as the timed 25 foot walk test.

NCT ID: NCT04971018 Recruiting - Systemic Sclerosis Clinical Trials

Impact of Transcutaneous Auricular Vagus Nerve Stimulation on Digestive Symptoms in Systemic Sclerosis Systemic Sclerosis

AVADIS
Start date: November 9, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the effect of transcutaneous auricular vagus nerve stimulation (ta-VNS) on gastrointestinal symptoms and quality of life in systemic sclerosis (SSc) patients.