Longitudinal Cortical Demyelination in Multiple Sclerosis and Related Disorders

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18 years old

able to provide consent in English

able to undergo MRI

Disqualifiers

contraindication to MRI

pregnancy

Trial population

Adults with MS or other neuroinflammatory diseases and healthy volunteers

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

170 Participants
are grouped into 3 trial groups
Group A: MS Participant
Group B: Control Participant
Group C: Other Neuroinflammatory Participants

Trial outcomes

Primary outcomes

1

Cortical Lesion Number

Lesions in the cerebral cortex

Time frame
at 6 years (end of study)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.