Comprehensive Multimodal Analysis of Neuroimmunological Diseases of the Central Nervous System
|First Received Date ICMJE||November 19, 2008|
|Last Updated Date||June 28, 2014|
|Start Date ICMJE||November 2008|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Diagnostic Study - Definite diagnosis of MS or another disorder. Follow-Up Study - Disease progession as assessed by clinical and MRI criteria.|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00794352 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Clinical measures of disability (EDSS, NRS, MSFC): MRI measures of lesions and CNS tissue destruction (T2LL, T1LL and calculated black hole fraction, measures of atrophy); and immunological biomarkers.|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Comprehensive Multimodal Analysis of Neuroimmunological Diseases of the Central Nervous System|
|Official Title ICMJE||Comprehensive Multimodal Analysis of Neuroimmunological Diseases of the CNS|
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 18 and 70. 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:
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.
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 and clinical measures.
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.
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||1200|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
HEALTHY VOLUNTEER INCLUSION CRITERIA:
PATIENT INCLUSION CRITERIA for processing of collected biological samples:
PATIENT EXCLUSION CRITERIA (for participation in the whole protocol):
HEALTHY VOLUNTEER EXCLUSION CRITERIA:
|Ages||18 Years to 75 Years|
|Accepts Healthy Volunteers||Yes|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00794352|
|Other Study ID Numbers ICMJE||090032, 09-N-0032|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Neurological Disorders and Stroke (NINDS)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||March 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP