Comprehensive Multimodal Analysis of Neuroimmunological Diseases of the Central Nervous System
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|ClinicalTrials.gov Identifier: NCT00794352|
Recruitment Status : Recruiting
First Posted : November 20, 2008
Last Update Posted : October 26, 2020
|First Submitted Date||November 19, 2008|
|First Posted Date||November 20, 2008|
|Last Update Posted Date||October 26, 2020|
|Actual Study Start Date||October 1, 2008|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
|Original Primary Outcome Measures||Not Provided|
|Current Secondary Outcome Measures
|Original Secondary Outcome Measures||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title||Comprehensive Multimodal Analysis of Neuroimmunological Diseases of the Central Nervous System|
|Official Title||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 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:
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.
The protocol also serves as a screening tool for NDU 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.
Study 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 and biomarkers and to obtain normative data for development of new clinical scales and smartphone apps.
Design: We will collect, in a standardized manner, multimodal data (standardized clinical/functional, neuroimaging and molecular/immunological data) during the diagnostic work-up of patients with varied disorders of the CNS in which immunemediated
processes are expected to play a pathophysiological role.
For the patient cohort, a comprehensive initial evaluation will be performed to establish a definitive diagnosis or confirm diagnosis and subtype of multiple sclerosis (MS) as a pre-requisite for enrollment into NDU clinical trials, but also to collect consistent multimodal research data. Additional diagnostic tests, tailored to individual patients, may be performed if required for the diagnostic process. The protocol stipulates a mandatory follow-up visit for all adult patients inclusive of clinical, functional and MRI examinations. 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 to ensure patient safety is not compromised. Patients age 12-17 may also be included in the patient cohort to establish a definitive diagnosis, or to provide non-standard assays to help with diagnostic and therapeutic decisions as part of extraordinary clinical care.
The volunteer cohort will provide sex and age-matched (to adult patients) normative values.
Additionally, we will also enroll patients from whom only biological samples collected by outside clinicians will be processed. This will be done to provide non-standard assays to help with diagnostic and therapeutic decisions as a part of extraordinary clinical care.
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 Design||Observational Model: Case-Control
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
|Study 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.|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
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:
HEALTHY VOLUNTEER SUB STUDY TO OBTAIN NORMATIVE DATA FOR THE SMARTPHONE APPS:
|Ages||12 Years to 99 Years (Child, Adult, Older Adult)|
|Accepts Healthy Volunteers||Yes|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||090032
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )|
|Study Sponsor||National Institute of Allergy and Infectious Diseases (NIAID)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||February 18, 2020|