Longitudinal Cortical Demyelination in Multiple Sclerosis and Related Disorders

Recruiting

• Conditions: Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Neuromyelitis Optica

• Registration Number: NCT05982925
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-06
• Study First Submitted: 2023-08-01
• Study First Submitted QC: 2023-08-08
• Study First Posted: 2023-08-09
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-07-01
• Primary Completion: 2030-05-01
• Study Completion: 2030-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• contraindication to MRI
• pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cortical Lesion Number	at 6 years (end of study)	Lesions in the cerebral cortex

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇺🇸 New York, New York, United States