Comprehensive Multimodal Analysis of Neuroimmunological Diseases of the Central Nervous System (NCT00794352) | Clinical Trial Compass
RecruitingNot Applicable
Comprehensive Multimodal Analysis of Neuroimmunological Diseases of the Central Nervous System
United States2,400 participantsStarted 2008-10-01
Plain-language summary
Inflammatory or degenerative diseases of the brain and spinal cord, such as multiple sclerosis, may be related to problems with an individual s immune system. However, more information is needed on the ways in which the cells of the immune system interact with the central nervous system (CNS). This study will compare tests performed on both healthy volunteers and individuals who have signs or symptoms of immune-related damage to their CNS.
This study will include two groups of subjects at least 12 years old. Subjects will either have symptoms of immune-related CNS damage, or will be healthy volunteers selected for comparison purposes.
Study participants will visit the NIH Clinical Center on an outpatient basis for an initial evaluation visit. During the visit, patients will provide a comprehensive medical history and undergo a neurological examination, and will provide blood samples for research purposes. The healthy volunteers will be asked to schedule a return visit for a magnetic resonance imaging (MRI) procedure, and may be asked to undergo other tests requested by the study researchers on an as-needed basis. The group of patients with symptoms of immune-related CNS damage will be asked to undergo a series of tests, including the following:
* MRI procedures, with a minimum of three brain MRIs and one spinal cord MRI taken approximately 4 weeks apart
* A diagnostic lumbar puncture, performed on an outpatient basis
* Tests of brain and vision activity
* Additional blood and tissue samples
Patients with symptoms of immune-related CNS damage may be offered the opportunity to participate in additional followup tests with NIH researchers.
Who can participate
Age range
1 Month – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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 an…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Disease progression as assessed by clinical and MRI criteria.
Timeframe: 1-2 years
2
Definite diagnosis of MS or another disorder.
Timeframe: 12 weeks
Trial details
NCT IDNCT00794352
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)