Comprehensive Multimodal Analysis of Neuroimmunological Diseases of the Central Nervous System
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 between the ages of 12 and 75. 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
All study participants will return for a followup visit 1 year after the initial evaluation visit. Patients with symptoms of immune-related CNS damage may be offered the opportunity to participate in additional followup tests with NIH researchers.
Central Nervous System Disease
|Study Design:||Time Perspective: Prospective|
|Official Title:||Comprehensive Multimodal Analysis of Neuroimmunological Diseases of the CNS|
- Definite diagnosis of MS or another disorder. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Disease progression as assessed by clinical and MRI criteria. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- MRI measures of lesion load and CNS tissue destruction [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Immunological biomarkers [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Changes in clinical measures of disability from baseline [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Clinical measures of disability [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Changes in MRI measure of lesion load and CNS tissue destruction from baseline [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||November 2008|
Objective: 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 physiological (and often beneficial) responses of the human immune system to CNS injury. The long-term objective of the study is to acquire knowledge that would allow us to therapeutically inhibit the pathogenic mechanisms and enhance repair mechanisms in immune-mediated CNS diseases, thereby minimizing the extent of CNS tissue damage and promoting recovery.
Study Population: Patients with evidence of immune-mediated CNS injury will be enrolled. In addition, healthy volunteers will be included as controls for immunological and neuroimaging biomarkers.
Design: We will collect, in a standardized manner, multimodal data (clinical/functional, neuroimaging and molecular/immunological data) during the diagnostic work-up of untreated patients with varied disorders of the CNS in which immune-mediated processes are expected to play a pathophysiological role.
For the patient cohort, a comprehensive initial evaluation will be performed in order to establish a definitive diagnosis or confirm diagnosis and subtype of multiple sclerosis (MS) as a pre-requisite for enrollment into ongoing clinical trials, but also to collect consistent multimodal research data. This evaluation will include a standardized clinical exam, functional tests quantifying clinical disability, MRI and other neuroimaging modalities, CSF and serological studies, and lymphapheresis. Additional diagnostic tests, tailored to individual patients, may be performed if required for the diagnostic process.
The protocol stipulates a one-year mandatory follow-up for all patients inclusive of clinical and MRI imaging, as well as repetition of any additional imaging or functional testing performed during the initial evaluation. Depending on the specific diagnosis, treatment decisions and clinical/research needs, patients may be offered additional follow-up visits. The maximum frequency of the follow-up visits and research samples to be collected is specified in order to ensure patient safety is not compromised. Patients age 12-17 may also be included in the patient cohort inorder to establish a definitive diagnosis, or to provide non-standard assays to help with diagnostic and therapeutic decisions as part of extraordinary care.
The volunteer cohort will provide sex and age-matched normative values for the immunological and imaging parameters.
Outcome Measures: Clinical, MRI and immunological measures will be the outcome measures. However, no pre-defined research questions will be addressed other than to establish the diagnosis, determine the level of disease activity, and monitor the natural history.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00794352
|Contact: Laura Kannaian, R.N.||(301) firstname.lastname@example.org|
|Contact: Bibiana Bielekova, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Bibiana Bielekova, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|