Analysis of immune-related diseases affecting the central nervous system
Comprehensive Multimodal Analysis of Patients With Neuroimmunological Diseases of the CNS
This study is trying to see how the immune system affects diseases of the brain and nervous system, like multiple sclerosis, by comparing people with symptoms to healthy volunteers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2400 (estimated) |
| Ages | 1 Month to 99 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT00794352 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the relationship between the immune system and central nervous system (CNS) diseases, particularly focusing on conditions like multiple sclerosis. It will involve two groups: individuals showing symptoms of immune-related CNS damage and healthy volunteers for comparison. Participants will undergo a thorough medical evaluation, including neurological examinations and blood sample collection, to better understand the mechanisms of disability in immune-mediated CNS disorders. The findings may lead to the development of diagnostic tests and new scales for assessing neurological disability and disease severity.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 12 and older with symptoms of immune-mediated CNS disorders or neuroimaging evidence of CNS disease.
Not a fit: Patients without symptoms of immune-related CNS disorders or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of immune-related CNS diseases and improve diagnostic and treatment strategies for patients.
How similar studies have performed: Other studies have shown promise in understanding immune interactions with the CNS, but this specific approach is novel in its comprehensive multimodal analysis.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Bibiana Bielekova, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
- Study coordinator: Amir Moghadam Ahmadi, M.D.
- Email: amir.moghadamahmadi@nih.gov
- Phone: (301) 761-5333
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.