Longitudinal Cortical Demyelination in Multiple Sclerosis and Related Disorders

NCT ID: NCT05982925

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 170 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-06
• Study Completion Date: 2034-07-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

MS Participant

Adults with multiple sclerosis

No interventions assigned to this group

Control Participant

Adults without neurologic disease

No interventions assigned to this group

Other Neuroinflammatory Participants

Adults with a neuroinflammatory disease that is not multiple sclerosis

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• contraindication to MRI
• pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Erin Beck

Assistant Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erin S Beck, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai Hospital

New York, New York, United States

Countries

United States

Other Identifiers

STUDY-21-01855

Identifier Type: -

Identifier Source: org_study_id