Recruiting

Observational Study

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT05982925

Conditions

Multiple Sclerosis

Neuromyelitis Optica

Demyelinating Autoimmune Diseases, CNS

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

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 ID

NCT05982925

Start date

May 6, 2022

Status verified date

Jun, 2026

Completion date

Jul 31, 2034

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • contraindication to MRI
  • pregnancy

Study Design

Enrollment

170 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • Cortical Lesion Number [ Time Frame: at 6 years (end of study) ]

Central Contacts and Locations

Central contacts

Locations

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Principal Investigator:

Erin S Beck

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-06-15.