NCT05982925

Longitudinal Cortical Demyelination in Multiple Sclerosis and Related Disorders

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 170 (estimated)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Multiple Sclerosis
• Neuromyelitis Optica
• Demyelinating Autoimmune Diseases, CNS

Timeline

• Start date: 2022-05-06
• Primary completion: 2028-07-31
• Completion: 2034-07-31
• First posted: 2023-08-09
• Last updated: 2025-06-18

Locations

1 site across 1 country: United States