Understanding MRI Changes in Multiple Sclerosis

The Pathological Basis of MRI Signal Changes in Multiple Sclerosis: A Longitudinal In Vivo-to-Postmortem Study

This study is trying to see how changes in MRI scans relate to the progression of multiple sclerosis over time by following people with MS and healthy volunteers.

Quick facts

• Study type: Observational
• Enrollment: 250 (estimated)
• Ages: 18 Years to 120 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (nih)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT02659956 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore the relationship between the pathology of multiple sclerosis (MS) and its progression over time through the collection of neuroradiological, clinical, and biological data. Participants, including those diagnosed with MS and control subjects, will undergo annual evaluations that include neurological exams, MRI scans, and blood draws. The study will follow participants longitudinally, with the goal of gathering comprehensive data until the time of their death, allowing researchers to better understand the natural history of MS.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with multiple sclerosis or similar neurological conditions.

Not a fit: Patients who are unable to participate in study procedures or who do not wish to undergo autopsy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the progression of multiple sclerosis, potentially leading to improved treatment strategies.

How similar studies have performed: While this study employs a longitudinal approach to understanding MS, similar studies have shown promise in elucidating disease progression and pathology.

Eligibility criteria

* INCLUSION CRITERIA:
* Diagnosis of MS according to consensus criteria at the time of enrollment OR diagnosis of a disease that shares clinical, imaging, or biological features with MS OR individuals without known CNS disease.
* Age greater than or equal to 18.
* Able to participate in study procedures and provide high-quality clinical research data (for example, prior MRI scans show ability to tolerate the MRI scan with minimal motion artifact).
* Willing to return to NIH for follow-up visits approximately annually (or every 5 years for non-CNS controls) until the time of autopsy. Note: participants who become too sick to return to NIH will not be removed from the study.
* Willing to undergo autopsy with donation of at least the brain, spinal cord, and retinas.
* Able to provide informed consent at the time of initial study enrollment and willing to appoint a Durable Power of Attorney (DPA) if an advanced directive is not already in place.
* Except for non-CNS controls, simultaneously participating in another screening or natural history protocol within the NINDS Neuroimmunology Clinic at the time of study entry.
* Eligible NIH employees and staff may participate.

EXCLUSION CRITERIA:

Unwilling to allow sharing and/or use in future studies of coded samples and data that are collected for this study.

Where this trial is running

Bethesda, Maryland

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (RECRUITING)

Study contacts

• Principal investigator: Daniel S Reich, M.D. — National Institute of Neurological Disorders and Stroke (NINDS)
• Study coordinator: Jenifer E Dwyer

Conditions: Multiple Sclerosis, Longitudinal Prospective Follow-Up, Natural History