Longitudinal Cortical Demyelination in Multiple Sclerosis and Related Disorders

NCT05982925 | Enrolling By Invitation

• 1 other identifier: STUDY-21-01855
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Neuromyelitis Optica; Demyelinating Autoimmune Diseases, CNS

Outcome Measures

Primary Outcomes (1)

• Cortical Lesion Number

  Lesions in the cerebral cortex

  at 6 years (end of study)

Study Arms (3)

MS Participant

Adults with multiple sclerosis

Control Participant

Adults without neurologic disease

Other Neuroinflammatory Participants

Adults with a neuroinflammatory disease that is not multiple sclerosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with MS or other neuroinflammatory diseases and healthy volunteers

You may qualify if:

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

You may not qualify if:

• contraindication to MRI
• pregnancy

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and cerebrospinal fluid

MeSH Terms

Conditions

Multiple Sclerosis; Neuromyelitis Optica; Demyelinating Autoimmune Diseases, CNS

Condition Hierarchy (Ancestors)

Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Myelitis, Transverse; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Eye Diseases; Leukoencephalopathies; Brain Diseases; Central Nervous System Diseases

Study Officials

• Erin S Beck, MD, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 9, 2023
• Study Start: May 6, 2022
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2034
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal. Any purpose. Specify Other Mechanism Proposals should be directed to erin.beck@mssm.edu To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)