Longitudinal Cortical Demyelination in Multiple Sclerosis and Related Disorders

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT05982925
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
May 6, 2022
Status verified
Jun 2025
Primary completion
Jul 31, 2028
Completion
Jul 31, 2034

Study Design

Enrollment
170 participants (estimated)

Arms

  • Arm: MS Participant
    Adults with multiple sclerosis
  • Arm: Control Participant
    Adults without neurologic disease
  • Arm: 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) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai HospitalNew YorkNew York10029-

Find similar trials in New York, NY

By condition
Multiple sclerosis
By specialty
NeurologyBrain disordersAutoimmune disease
By research site
Mount Sinai Hospital· New York, NY

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