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.
Multiple sclerosis, as defined by the 2017 Revised McDonald Criteria;
Age 18 or older;
Ability to provide informed consent;
Able to participate in study procedures and provide high-quality clinical research and imaging data, based on limited artifacts on prior MRI scans and, when possible to determine;
Medical contraindications for MRI (e.g., any non-organic implant or other device such as a cardiac pacemaker or infusion pump or other metallic implants, objects, or body piercings that are not MRI-compatible or cannot be removed);
Psychological contraindications for MRI (e.g., claustrophobia), to be assessed at the time the medical history is collected;
Treatment with systemic steroids in previous 30 days (non-systemic administration of steroids, such as topical or local injection, is acceptable);
Experiencing new neurological symptoms, with onset in previous 2 weeks, attributable to MS relapse;
Parallel
Methylprednisolone
Drug3 days of corticosteroids (intravenous methylprednisolone at 1000 mg/day
Prednisone
Drug3 days of corticosteroids (oral prednisone at 1250 mg/day
the presence or absence of a hypointense phase rim around each lesion followed over time
At week 13, the presence or absence of a hypointense phase rim around each lesion followed over time.
The change in normalized intralesional proton density-weighted and T1-weighted signal, as well as the R1 relaxation rate, from 3T scan.
From 3-tesla scans, we willmeasure the change in normalized intralesional proton density-weighted and T1-weighted signal, as wellas the R1 relaxation rate, between baseline and week 25.
The presence or absence of a 3T hypointense phase rim around each lesion
The presence or absence of a 3T hypointense phase rim around each lesion at week and 25
The presence or absence of a hypointense phase rim around each lesion followed over time.
At week 25, the presence or absence of a hypointense phase rim around each lesion followed over time.
Lesion volume and intralesional median R1 relaxation rate as determined from the 7T MP2RAGE scan,
Lesion volume and intralesional median R1 relaxation rate at weeks 13 and 25, as determined from the 7T MP2RAGE scan, comparing corticosteroid and no-treatment groups.
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