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NCT Number: NCT05982925

Longitudinal Cortical Demyelination in Multiple Sclerosis and Related Disorders

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Central Nervous System Diseases Cranial Nerve Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Eye Diseases Immune System Diseases Leukoencephalopathies Myelitis, Transverse Nervous System Diseases Neuromyelitis Optica Optic Nerve Diseases Optic Neuritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • contraindication to MRI
  • pregnancy

Treatment and study plan

Primary outcomes

  1. Cortical Lesion Number

    Time frame: at 6 years (end of study)

    Lesions in the cerebral cortex

Study contacts

Contact information is provided by the study sponsor or research team.

Erin S Beck, MD, PhD

CONTACT

[email protected]

212-241-2474

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2028
Study completion
2034
First posted
Aug 9, 2023
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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