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Clinical Trials/NCT05982925
NCT05982925
Enrolling By Invitation
Not Applicable

Longitudinal Investigation of Cortical Demyelination and Meningeal Inflammation in Multiple Sclerosis and Related Disorders

Icahn School of Medicine at Mount Sinai1 site in 1 country170 target enrollmentMay 6, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Icahn School of Medicine at Mount Sinai
Enrollment
170
Locations
1
Primary Endpoint
Cortical Lesion Number
Status
Enrolling By Invitation
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 6, 2022
End Date
July 31, 2034
Last Updated
10 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Erin Beck

Assistant Professor of Neurology

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • contraindication to MRI
  • pregnancy

Outcomes

Primary Outcomes

Cortical Lesion Number

Time Frame: at 6 years (end of study)

Lesions in the cerebral cortex

Study Sites (1)

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