Massive study aims to unlock secrets of Brain's immune attacks
NCT ID NCT00794352
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 23 times
Summary
This observational study is recruiting 2400 people with immune-related central nervous system diseases, such as multiple sclerosis, along with healthy volunteers for comparison. Researchers will use MRI scans, lumbar punctures, blood tests, and neurological exams to track disease progression and identify biomarkers. The goal is to better understand how the immune system damages the brain and spinal cord, which could inform future diagnostic and treatment strategies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could identify new biomarkers and improve understanding of immune-related brain diseases, potentially guiding future treatments.
- What could go wrong
- This is an observational study, not a treatment trial. It may not directly lead to new therapies, and results may take years to translate into clinical practice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 2,400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2008
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with evidence, or suspicion of immune-mediated CNS injury will be enrolled. In addition, healthy volunteers will be included as controls for immunological and imaging biomarkers and to obtain normative data for development of new clinical scales and smartphone apps.
- Ages
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1 month to 99 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* PATIENT INCLUSION CRITERIA (for in-person and telemedicine sub-cohorts): Presentation with a clinical syndrome consistent with immune-mediated CNS disorder and/or Neuroimaging evidence of inflammatory and/or demyelinating/dysmyelinating CNS disease At least 12 years old at the time of enrollment Willing to share medical records (including past MRI results) with the study team. Adults: Able to give informed consent on their own or via a Legally Authorized Representative (LAR) or Durable Power of Attorney (DPA); or Minors: parent or legal guardian able to give consent, with child willing to give assent, if reasonable based on their age and assent capacity For in-person sub-cohort: Able to undergo the required procedures, including LP, MRI and clinical/functional evaluations PATIENT EXCLUSION CRITERIA (for in-person and telemedicine sub-cohorts): Significant medical condition that would make participation in research part of evaluation impossible or risky For in-person sub-cohort: Medical contraindications for MRI (i.e. any non-organic implant or other device such as a cardiac pacemaker or infusion pump or other metallic implants, objects or body piercings that cannot be removed) Unwilling to consent for collection of biological samples or their cryopreservation PATIENT INCLUSION CRITERIA for processing of collected biological samples: Presentation with a clinical syndrome consistent with immune-mediated CNS disorder and/or Neuroimaging evidence of inflammatory and/or demyelinating/ dysmyelinating CNS disease Ability to obtain either direct or surrogate informed consent for sample processing and storage Aged 0+ years HEALTHY VOLUNTEER (in person) INCLUSION CRITERIA: At least 18 years old at the time of enrollment Vital signs are found within normal range at the time of the screening visit Able to give informed consent Able and willing to undergo related research procedures, such as blood draw, LP HEALTHY VOLUNTEER (in person) EXCLUSION CRITERIA: Systemic inflammatory disorder, or inflammatory or non-inflammatory neurological diseases Previous or current history of alcohol and substance abuse Medical contraindications for MRI (i.e. any non-organic implant or other device such as a cardiac pacemaker or infusion pump or other metallic implants, objects or body piercings that cannot be removed) Medical contraindication for LP Psychological contraindications for MRI (i.e. claustrophobia). This will be assessed at the time the medical history is collected Pregnancy or current breastfeeding Any contraindications to having study procedures done History of auditory disorder (i.e. hearing impairment, known impaired acoustic reflex, tinnitus) HEALTHY VOLUNTEER SUB-STUDY TO OBTAIN NORMATIVE DATA FOR THE SMARTPHONE APPS: Because this sub-study collects no personal identifiable information (PII), there are no inclusion/exclusion criteria. Participating subjects are self-declared as not having any neurological deficit, which would be the same population that would provide normative data if the apps were freely available via App store.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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