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โ† Trials
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Effect of Corticosteroids on Inflammation at the Edge of Acute Multiple Sclerosis Plaques

RecruitingPhase 2Ages 18 Years - 120 YearsAllNational Institute of Neurological Disorders and โ€ฆ
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
* INCLUSION CRITERIA: * 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; * Presence of a gadolinium enhancing lesion on the screening (3T or 7T) brain MRI that demonstrates either centripetal/rim enhancement or a phase rim, or both; * Simultaneously participates in another screening or natural history protocol within the NINDS Neuroimmunology Clinic at the time of study entry. * Willing to use birth control if able to conceive a child EXCLUSION CRITERIA: * 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; * Pregnancy or current breastfeeding; * Screening labs, only if required per current NIH Clinical Center guidelines for kidney-function screening before gadolinium-based MRI contrast, demonstrating estimated glomerular filtration rate \<60 mL/min; * Known hypersensitivity to gadolinium-based contrast agents; * Medical contraindications to corticosteroid administration (e.g., diabetes, gastric ulcer)
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What it tests

  • Methylprednisolone
  • Prednisone
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Where

1 site
National Institutes of Health Clinical Center
Bethesda, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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