Comprehensive Multimodal Analysis of Neuroimmunological Diseases of the Central Nervous System

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-99
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

2,400 Participants
are grouped into 2 trial groups
Group A: Healthy Volunteer
Group B: Patient Cohort

Trial outcomes

Primary outcomes

1

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

Time frame
1-2 years
2

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.

Time frame
12 weeks

Secondary outcomes

1

MRI measures of lesion load and CNS tissue destruction

for initial evaluation

Time frame
within 1 week of first NDS visit
2

Immunological biomarkers

for initial evaluation

Time frame
Within 1 week of initial CSF
3

Clinical measures of disability

for longitudinal evaluation

Time frame
within 1 week of follow-up visit
4

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

for longitudinal evaluation

Time frame
within 1 week of follow-up visit

Other outcomes

Sponsors and contacts

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