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Recruiting NCT05982925

Longitudinal Cortical Demyelination in Multiple Sclerosis and Related Disorders

Observational Multiple Sclerosis Neuromyelitis Optica Demyelinating Autoimmune Diseases, CNS

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Multiple Sclerosis, Neuromyelitis Optica, Demyelinating Autoimmune Diseases, CNS. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Longitudinal Investigation of Cortical Demyelination and Meningeal Inflammation in Multiple Sclerosis and Related Disorders

Overview

In this protocol, a combination of MRI, blood, and cerebrospinal fluid (CSF) analysis will be used to understand the natural history, underlying immunologic mechanisms, and clinical implications of central nervous system (CNS) lesions, in particular lesions in the cerebral cortex, in multiple sclerosis (MS) and other inflammatory and autoimmune disorders affecting the CNS. Patients with these disorders, as well as healthy controls, will undergo baseline clinical evaluation and testing, bloodwork, and MRI, with follow up clinical evaluation, bloodwork, and MRI at years 1, 3, and 6. Additional MRIs may be performed in patients with possible new lesion formation or to compare MRI techniques. Lumbar puncture will be performed on participants who are not currently being treated with disease modifying therapies and who are willing to undergo the procedure.

Primary outcome measures

  • Cortical Lesion Number [Time frame: at 6 years (end of study)]

Eligibility criteria

Inclusion criteria

  • 18 years old
  • able to provide consent in English
  • able to undergo MRI

Exclusion criteria

  • contraindication to MRI
  • pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Mount Sinai Hospital — New York

Identifiers

NCT: NCT05982925 · STUDY-21-01855

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗