Comprehensive Multimodal Analysis of Neuroimmunological Diseases of the Central Nervous System

NCT00794352 | Recruiting

• 2 other identifiers: 09003209-I-0032
• Study Type: observational
• Target: 2,400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis; Central Nervous System Disease

Keywords

Inflammation; Multiple Sclerosis; Neuroimmunology; Immune Disorder; Neuroimaging; Natural History; Central Nervous System Disease; Healthy Volunteers; HV

Outcome Measures

Primary Outcomes (2)

• Disease progression as assessed by clinical and MRI criteria.

  1\. Sustained (i.e. \> 3 months) progression of disability as measured by =\> 0.5 CombiWISE points or 2. Development of new/clearly enlarged distinct lesions on T2WI

  1-2 years

• Definite diagnosis of MS or another disorder.

  To identify MS-specific markers, biomarkers from peripheral blood and CSF will be compared between patients who fulfilled diagnostic criteria for MS versus those who were found to have alternative diagnoses.

  12 weeks

Secondary Outcomes (5)

• MRI measures of lesion load and CNS tissue destruction

  within 1 week of first NDS visit

• Immunological biomarkers

  Within 1 week of initial CSF

• Clinical measures of disability

  within 1 week of follow-up visit

• Changes in MRI measure of lesion load and CNS tissue destruction from baseline

  within 1 week of follow-up visit

• Changes in clinical measures of disability from baseline

  within 1 week of initial NDS MRI

Study Arms (2)

Healthy Volunteer

Healthy patients with NO inflammatory and/or demyelinating/dysmyelinating diseases of the CN

Patient Cohort

Patients who present with CNS white matter injury (including inflammatory and/or demyelinating/dysmyelinating diseases of the CNS)

Eligibility Criteria

• Age: 1 Month - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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
• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (2)

• Kim Y, Varosanec M, Kosa P, Bielekova B. Confounder-adjusted MRI-based predictors of multiple sclerosis disability. Front Radiol. 2022 Sep 13;2:971157. doi: 10.3389/fradi.2022.971157. eCollection 2022.

  PMID: 37492673 DERIVED

• Kosa P, Masvekar R, Komori M, Phillips J, Ramesh V, Varosanec M, Sandford M, Bielekova B. Enhancing the clinical value of serum neurofilament light chain measurement. JCI Insight. 2022 Aug 8;7(15):e161415. doi: 10.1172/jci.insight.161415.

  PMID: 35737460 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Central Nervous System Diseases; Multiple Sclerosis; Inflammation; Immune System Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bibiana Bielekova, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amir Moghadam Ahmadi, M.D.

CONTACT

(301) 761-5333; amir.moghadamahmadi@nih.gov

Bibiana Bielekova, M.D.

CONTACT

(240) 669-2724; bielekovab@mail.nih.gov

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2008
• First Posted: November 20, 2008
• Study Start: October 1, 2008
• Last Updated: April 24, 2026

Record last verified: 2025-12-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)