Protocol Number: 09-N-0032
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, 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. 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.
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 05/05/2009
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