Comprehensive Multimodal Analysis of Neuroimmunological Diseases of the Central Nervous System

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Nov 19, 2008

Keywords

ClinConnect Summary

This clinical trial is studying how the immune system may affect diseases of the brain and spinal cord, particularly conditions like multiple sclerosis. Researchers want to better understand how immune cells interact with the central nervous system (CNS) in both healthy individuals and those showing symptoms of immune-related damage. The trial will include two groups: one group of people aged 12 and older who have symptoms related to CNS issues, and another group of healthy volunteers for comparison.

If you or a family member qualifies for the trial, you can expect to visit the NIH Clinical Center for an initial evaluation. This visit will involve sharing your medical history, undergoing a neurological exam, and providing blood samples. Participants with symptoms will have additional tests, including multiple MRIs of the brain and spinal cord, a lumbar puncture (a procedure to collect spinal fluid), and assessments of brain and vision function. Healthy volunteers will also undergo some tests, including an MRI. This study aims to gather important information that could help improve the understanding and treatment of CNS diseases in the future.

Gender

ALL

Eligibility 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 evalautions.
• 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
• 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
• PATIENT EXCLUSION CRITERIA (for in-person and telemedicine subcohorts):
• • Significant medical condition that would make participation in research part of evaluation impossible or risky
• • For in-person sub-cohort: Medical contraindications for MRI (ie- 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
• 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\<TAB\>
• • 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.