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NCT05982925 Clinical Trial

Longitudinal Cortical Demyelination in Multiple Sclerosis and Related Disorders

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05982925
Other study ID # STUDY-21-01855
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 6, 2022
Est. completion date May 1, 2030

Study information
Verified date August 2023
Source Icahn School of Medicine at Mount Sinai
Contact Erin S Beck, MD, PhD
Phone 212-241-2474
Email erin.beck@mssm.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date May 1, 2030
Est. primary completion date May 1, 2030
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years old - able to provide consent in English - able to undergo MRI Exclusion Criteria: - contraindication to MRI - pregnancy

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Mount Sinai Hospital New York New York

Sponsors (1)
Lead Sponsor Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cortical Lesion Number Lesions in the cerebral cortex at 6 years (end of study)
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