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Longitudinal Cortical Demyelination in Multiple Sclerosis and Related Disorders

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Mount Sinai Health System

Status

Invitation-only

Conditions

Demyelinating Autoimmune Diseases, CNS
Neuromyelitis Optica
Multiple Sclerosis

Study type

Observational

Funder types

Other

Identifiers

NCT05982925
STUDY-21-01855

Details and patient eligibility

About

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.

Enrollment

170 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • contraindication to MRI
  • pregnancy

Trial design

170 participants in 3 patient groups

MS Participant
Description:
Adults with multiple sclerosis
Control Participant
Description:
Adults without neurologic disease
Other Neuroinflammatory Participants
Description:
Adults with a neuroinflammatory disease that is not multiple sclerosis

Trial contacts and locations

1

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Central trial contact

Erin S Beck, MD, PhD; Julia L Galasso, BS

Data sourced from clinicaltrials.gov

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