Comprehensive Multimodal Analysis of Neuroimmunological Diseases of the Central Nervous System

Recruiting

• Conditions: Multiple Sclerosis; Central Nervous System Disease

• Registration Number: NCT00794352
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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.

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Detailed Description

The goal of this study is to define the pathophysiological mechanisms underlying the development of disability in immune-mediated disorders of the central nervous system (CNS) and to distinguish these from beneficial responses of the human immune system to CNS injury.

The protocol serves as a screening tool for Neuroimmunological Diseases Section (NDS) of the National Institute of Allergy and Infectious Diseases (NIAID) clinical trials and enables development of clinically-useful tools such as diagnostic tests and new, sensitive scales of neurological disability, disease severity and CNS tissue destruction.

This protocol also serves as a repository to enable prospective institutional review board (IRB) review of research using human samples and data collected under other NDS protocols.

Study Timeline

• Study Start: 2008-10-01
• Study First Submitted: 2008-11-19
• Study First Submitted QC: 2008-11-19
• Study First Posted: 2008-11-20
• Status Verified: 2025-05-08
• Last Update Submitted: 2025-06-13
• Last Update Posted: 2025-06-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease progression as assessed by clinical and MRI criteria.	1-2 years	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
Definite diagnosis of MS or another disorder.	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Immunological biomarkers	Within 1 week of initial CSF	for initial evaluation
MRI measures of lesion load and CNS tissue destruction	within 1 week of first NDS visit	for initial evaluation
Changes in MRI measure of lesion load and CNS tissue destruction from baseline	within 1 week of follow-up visit	for longitudinal evaluation
Clinical measures of disability	within 1 week of follow-up visit	for longitudinal evaluation
Changes in clinical measures of disability from baseline	within 1 week of initial NDS MRI	for initial evaluation

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States