RightFit
RecruitingPhase 2

Effect of Corticosteroids on Inflammation at the Edge of Acute Multiple Sclerosis Plaques

The Effect of Corticosteroids on Inflammation at the Edge of Acute Multiple Sclerosis Plaques: An Investigator-Blinded Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 120 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 1 visit
  • Procedures mentioned: MRI scans, Physical exams, Urine samples

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "MS lesions can appear on the MRI (magnetic resonance imaging) scans in many ways."
  • "Participants will have: * 1 baseline visit * 3 days of high-dose steroids, intravenous or oral."
  • "Visits include medical history and physical exam."
  • "Participants will have blood and urine tests."
  • "Participants will also have neurological exams and MRIs."
  • "Objectives: The primary aim of this pilot study is to assess the effects of short-term, high-dose corticosteroid administration on the 12-week evolution of multiple sclerosis lesions with centripetal enhancement pattern on magnetic resonance imaging (MRI), in particular with respect to the development of a hypointense rim on 7-tesla phase images."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether 3 days of high-dose corticosteroids, medicines that reduce swelling, help heal certain areas of MS damage in the brain. It is for adults with multiple sclerosis (MS) who have a certain ring or rim pattern on a brain MRI scan and are in another NINDS study. Participants are assigned by chance to get steroids or no treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are age 18 or older.
  • Have MS diagnosed using the study’s required standards.
  • Can understand the study and agree to join.
  • Can complete study tests and provide clear MRI pictures and other study information.
  • Have an area of MS damage on the screening brain MRI that lights up with dye and shows the required ring or rim pattern.
  • Are also in a screening or long-term study at the NINDS Neuroimmunology Clinic when joining.
  • Are willing to use birth control if able to conceive a child.

Who can't join

  • Have metal, an implant, or a device that is unsafe for MRI and cannot be removed.
  • Cannot have an MRI because of fear of small, closed spaces or another mental health reason.
  • Used steroids that affect the whole body in the past 30 days. Skin treatments or local steroid shots are allowed.
  • Have new nerve-related symptoms from an MS flare-up that started in the past 2 weeks.
  • Are pregnant or breastfeeding.
  • Have a kidney filtering rate below 60 mL/min, if kidney testing is required before MRI dye is given.
  • Have a known allergy to gadolinium, the MRI dye.
  • Have a condition that makes steroids unsafe, such as diabetes or a stomach ulcer.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

* 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)

Study sites (1)

MD