Actively Recruiting
Effect of Corticosteroids on Inflammation at the Edge of Acute Multiple Sclerosis Plaques
Led by National Institute of Neurological Disorders and Stroke (NINDS) · Updated on 2026-05-12
30
Participants Needed
1
Research Sites
638 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: Multiple sclerosis (MS) affects the brain, spinal cord, and optic nerves. MS lesions can appear on the MRI (magnetic resonance imaging) scans in many ways. Sometimes they light up from the outer edge and fill inward. This is called ring enhancement. Researchers think this type of lesion may not heal as well as others. Corticosteroids are the standard treatment to reduce symptoms of MS relapse. But there is no standard treatment for people with enhancing MS lesions without signs of MS relapse. Researchers want to see if a short-term high-dose course of corticosteroids helps heal those lesions. Objective: To study the effects of short-term high-dose corticosteroids on ring-enhancing MS. Eligibility: Adults ages 18 and older who: * Have MS and a rim-enhancing lesion on a prior brain MRI * Are enrolled in another NINDS protocol Design: Participants will be screened under another protocol Participants will be randomly assigned to get either no treatment or 3 days of treatment with a corticosteroid. Participants will have: * 1 baseline visit * 3 days of high-dose steroids, intravenous or oral. If IV, participants will receive methylprednisolone by IV each day. Participants will also be prescribed medicine to protect their stomach. * Follow-up visits will be at week 13 and week 25 after randomization to treatment or no treatment. Visits include medical history and physical exam. Participants will have blood and urine tests. Participants will also have neurological exams and MRIs. Participants lie on a table that slides into a cylinder. They are in the scanner 1.5-2 hours. They get a dye through a catheter: A needle guides a thin plastic tube into an arm vein. ...
CONDITIONS
Official Title
Effect of Corticosteroids on Inflammation at the Edge of Acute Multiple Sclerosis Plaques
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of multiple sclerosis based on the 2017 Revised McDonald Criteria
- Age 18 years or older
- Ability to provide informed consent
- Able to participate in study procedures and provide quality clinical and imaging data
- Presence of a gadolinium-enhancing lesion on brain MRI with rim or phase rim enhancement
- Participation in another NINDS Neuroimmunology Clinic protocol at study entry
- Willingness to use birth control if able to conceive a child
You will not qualify if you...
- Medical contraindications to MRI such as non-removable metallic implants or devices
- Psychological contraindications to MRI such as claustrophobia
- Use of systemic steroids within the previous 30 days
- Experiencing new neurological symptoms from MS relapse within the past 2 weeks
- Pregnancy or current breastfeeding
- Kidney function below required level if screening labs are done
- Known allergy to gadolinium contrast agents
- Medical contraindications to corticosteroids such as diabetes or gastric ulcer
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
D
Daniel S Reich, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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