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Demyelinating Diseases clinical trials

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NCT ID: NCT05415579 Not yet recruiting - Clinical trials for Demyelinating Diseases of the Central Nervous System (DDC)

Demyelinating Diseases of the Central Nervous System Registry for Patients With Traditional Chinese Medicine (DATE-TCM)

Start date: June 20, 2022
Phase:
Study type: Observational [Patient Registry]

Demyelinating Diseases of the Central Nervous System Registry for Patients with Traditional Chinese Medicine (DATE-TCM) is an observational study aiming to better define the multidimensional (epidemiologic, demographic and clinical) characteristics of Demyelinating Diseases of the Central Nervous System (DDC) patients receiving Traditional Chinese medicine (TCM) treatment, the type and long-term safety and effectiveness of TCM in DDC populations, as well as the interaction of TCM treatment and disease-modifying therapy in the management of DDC.

NCT ID: NCT05414487 Recruiting - Multiple Sclerosis Clinical Trials

Effects of Ofatumumab Treatment on Immune Cells and Meningeal Lymphatic Drainage in Patients With Demyelinating Diseases

OMNISCIENCE
Start date: October 15, 2022
Phase:
Study type: Observational

This is an uncontrolled, prospective, observational cohort study to assess the function of meningeal lymphatic drainage and dynamics of immune cells in patients with relapsing multiple sclerosis (RMS) or Neuromyelitis optica spectrum disorder (NMOSD) after receiving ofatumumab treatment over an observational period of 12 months.

NCT ID: NCT05347277 Completed - Multiple Sclerosis Clinical Trials

CSF Free Kappa Light Chain for The Diagnosis of Demyelinating Disorders

Start date: June 1, 2021
Phase:
Study type: Observational

Multiple sclerosis (MS) is a demyelinating disease of the central nervous system (CNS) which commonly leads to disability. The current preferred clinical laboratory test for the diagnosis is the detection of oligoclonal bands (OCBs) in the cerebrospinal fluid (CSF) by isoelectric focusing electrophoresis (IEF) followed by immunoblotting.Measuring the levels of Kappa Free Light Chain (K-FLC) in CSF has been proposed as a potential alternative to the qualitative assessment of OCBs. The aim of this study is to validate and determine the diagnostic yield of K-FLC in CSF against OCBs via IEF as gold standard.

NCT ID: NCT05199363 Recruiting - Clinical trials for Urinary Incontinence

Pediatric Patient Experience on a Diagnostic Path

Start date: October 15, 2021
Phase: N/A
Study type: Interventional

The trial will determine the impact of an information- and education-focused interventions on the anxiety levels, and patients' experiences as well as satisfaction of patients aged 10-14 and their caregivers during the MR examination.

NCT ID: NCT04997343 Not yet recruiting - Multiple Sclerosis Clinical Trials

Neurophysiological Assessment in Patients With Multiple Sclerosis

Start date: October 2021
Phase: N/A
Study type: Interventional

Main aim of this study will be the evaluation of the neurophysiological techniques of Transcranial Magnetic Stimulation (TMS) via electroencephalography (EEG) co-registration (TMS-EEG) with the study of TEPs (TEP: transcranial evoked potentials) as surrogates of white matter and grey matter functional integrity in patients with Multiple Sclerosis (MS). Data will be compared with those obtained from a group of healthy control subjects. Secondary aim will be the longitudinal evaluation of these neurophysiological parameters in MS patients during routine clinical and radiological evaluations, performed according to clinical practice, for 12 months. To this aim a longitudinal multicenter study will be carried out, interventional (for neurophysiological techniques) and observational (for clinical and radiological evaluations), which involves the enrollment of 64 patients diagnosed with MS. Patients will keep their usual therapeutic regimen and their usual clinical-radiological checks according to clinical practice. The control group will consist of 64 healthy subjects, enrolled with prior written informed consent, age and sex-matched with MS patients and selected among the caregivers of the patients. Healthy subjects will only undergo neurophysiological assessment at baseline. The neurophysiological evaluation will include the study of the propagation of potentials induced by stimulation. This method allows the study of cortical responses in terms of time domain and frequency, obtaining a measurement of interhemispheric connectivity and of microstructural and functional integrity of white matter. In the same way, these methods allow the assessment of grey matter integrity through the study of intracortical excitability.

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: NCT04837651 Completed - Multiple Sclerosis Clinical Trials

Humoral and T-Cell Responses to COVID-19 Vaccination in Multiple Sclerosis Patients Treated With Ocrelizumab Treated With Ocrelizumab or Natalizumab

OCR-VAX
Start date: March 2, 2021
Phase:
Study type: Observational

The primary goal of this study is to provide additional data regarding B and T-cell mediated responses to COVID-19 vaccines in MS patients treated with OCR and to determine which clinical and paraclinical variables correlating with vaccine immunogenicity. B-cell mediated humoral responses and adaptive T-cell mediated cellular responses were measured in patients treated with OCR who received any of the available SARS-CoV-2 vaccines, 3-4 weeks after completion of vaccination.

NCT ID: NCT04762342 Recruiting - Multiple Sclerosis Clinical Trials

Power Training in Older Multiple Sclerosis Patients

POTOMS
Start date: December 7, 2020
Phase: N/A
Study type: Interventional

The study seeks to investigate whether 24 weeks of power training has neuroprotective effects in older PwMS. Additional purposes are to examine the effects of 24 weeks power training on physical function, cognitive function and neuromuscular function. Further, it is investigated whether the potential effects of power training are maintained after 24 weeks of follow-up.

NCT ID: NCT04762017 Recruiting - Optic Neuritis Clinical Trials

OCS-05 in Patients With Acute Optic Neuritis

ACUITY
Start date: February 11, 2021
Phase: Phase 2
Study type: Interventional

To evaluate the safety and tolerability of OCS-05 compared to placebo in patients with acute optic neuritis (AON) receiving the standard of care

NCT ID: NCT04710550 Active, not recruiting - Alzheimer Disease Clinical Trials

Exploring the Utility of [18F]3F4AP for Demyelination Imaging in Controls, Neurodegeneration and Traumatic Brian Injury

Start date: January 25, 2021
Phase: Phase 1
Study type: Interventional

The overall objective is to obtain an initial assessment of the value of using [18F]3F4AP for imaging demyelinating diseases such as traumatic brain injury (TBI), neurodegenerative diseases such as mild cognitive impairment (MCI) and Alzheimer's Disease (AD): - Aim 1) Assess the safety of [18F]3F4AP in healthy volunteers and subjects with traumatic brain injury (TBI) and neurocognitive impaired subjects (AD/MCI). Hypothesis 1: Administration of [18F]3F4AP will result in no changes in vitals or other adverse events. - Aim 2) Assess the radiation doses to the main organs in healthy volunteers. Hypothesis 2: the radiation doses to each organ will be comparable in all subjects and within the acceptable limits. - Aim 3) Assess the pharmacokinetics of a bolus infusion of [18F]3F4AP in humans including healthy volunteers and patients. Hypothesis 3: the pharmacokinetics of [18F]3F4AP at the whole brain level will be similar in controls, TBI and AD/MCI subjects. The kinetics in demyelinated lesions will be slower than in healthy areas. - Aim 4) Correlate MR images with [18F]3F4AP PET images. Hypothesis 4A: all the lesions seen on the MRI will show increased signal (VT or SUV) on the PET images. Hypothesis 4B: some of the lesions on the MRI will show increased signal (VT or SUV) on the PET but not all. - Aim 5) Correlate [18F]3F4AP PET signal with neuropsychological testing in people with TBI and AD/MCI. Hypothesis 5A: increased PET signal (VT or SUV) will correlate with impaired Mini Mental State Examination (MMSE).