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Longitudinal Cortical Demyelination in Multiple Sclerosis and Related Disorders

Sponsor
Icahn School of Medicine at Mount Sinai (Other)
Overall Status
Recruiting
CT.gov ID
NCT05982925
Collaborator
(none)
100
Enrollment
1
Location
95.8
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Longitudinal Investigation of Cortical Demyelination and Meningeal Inflammation in Multiple Sclerosis and Related Disorders
    Actual Study Start Date :
    May 6, 2022
    Anticipated Primary Completion Date :
    May 1, 2030
    Anticipated Study Completion Date :
    May 1, 2030

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Cortical Lesion Number [at 6 years (end of study)]

      Lesions in the cerebral cortex

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 18 years old

    • able to provide consent in English

    • able to undergo MRI

    Exclusion Criteria:

    • contraindication to MRI

    • pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mount Sinai Hospital New York New York United States 10029

    Sponsors and Collaborators

    • Icahn School of Medicine at Mount Sinai

    Investigators

    • Principal Investigator: Erin S Beck, MD, PhD, Icahn School of Medicine at Mount Sinai

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Erin Beck, Assistant Professor of Neurology, Icahn School of Medicine at Mount Sinai
    ClinicalTrials.gov Identifier:
    NCT05982925
    Other Study ID Numbers:
    • STUDY-21-01855
    First Posted:
    Aug 9, 2023
    Last Update Posted:
    Aug 9, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Neuromyelitis Optica
    Demyelinating Diseases
    Demyelinating Autoimmune Diseases, CNS
    Autoimmune Diseases
    Sclerosis

    Study Results

    No Results Posted as of Aug 9, 2023