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Comprehensive Multimodal Analysis of Neuroimmunological Diseases of the Central Nervous System

This study is currently recruiting participants.
Verified July 17, 2017 by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT00794352
First Posted: November 20, 2008
Last Update Posted: July 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
  Purpose

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.


Condition
Central Nervous System Disease Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Comprehensive Multimodal Analysis of Neuroimmunological Diseases of the CNS

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):

Primary Outcome Measures:
  • Definite diagnosis of MS or another disorder. [ Time Frame: 12 weeks ]
  • Disease progression as assessed by clinical and MRI criteria. [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • MRI measures of lesion load and CNS tissue destruction [ Time Frame: 12 weeks ]
  • Immunological biomarkers [ Time Frame: 12 weeks ]
  • Changes in clinical measures of disability from baseline [ Time Frame: 1 year ]
  • Clinical measures of disability [ Time Frame: 12 weeks ]
  • Changes in MRI measure of lesion load and CNS tissue destruction from baseline [ Time Frame: 1 year ]

Estimated Enrollment: 1200
Study Start Date: November 17, 2008
Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • PATIENT INCLUSION CRITERIA (for participation in the whole protocol):

    1. Presentation with a clinical syndrome consistent with immune-mediated CNS disorder and/or
    2. Neuroimaging evidence of inflammatory and/or demyelinating/ dysmyelinating CNS disease
    3. 12-75 years of age, at the time of enrollment
    4. Able to give informed consent, or for minors, able to give assent with consent given by their parent or legal guardian
    5. Able to undergo the required procedures for diagnostic work-up, including lumbar puncture and MRI
    6. Adults must be able to undergo related research procedures, such as lymphocytapheresis or repeated collection of 120cc of whole blood for collection of peripheral blood mononuclear cells (PBMC) samples

HEALTHY VOLUNTEER INCLUSION CRITERIA:

  1. Age between 18 and 75, at the time of enrollment
  2. Vital signs are found within normal range at the time of the screening visit
  3. Able to give informed consent
  4. Able to undergo related research procedures, such as blood draw, lumbar puncture or lymphocytapheresis for collection of peripheral blood mononuclear cells (PBMC) samples

PATIENT INCLUSION CRITERIA for processing of collected biological samples:

  1. Presentation with a clinical syndrome consistent with immune-mediated CNS disorder and/or
  2. Neuroimaging evidence of inflammatory and/or demyelinating/ dysmyelinating CNS disease
  3. Ability to obtain either direct or surrogate informed consent for sample processing and storage

PATIENT EXCLUSION CRITERIA (for participation in the whole protocol):

  1. Significant medical condition that would make participation in diagnostic and research part of evaluation impossible or risky
  2. Medical contraindications for MRI (ie- any non-organic implant or other device such as a cardiac pacemaker or infusion pump or other metallic implants, objects or body piercings that cannot be removed)
  3. Unable to provide informed consent
  4. Unwilling to consent for collection of biological samples or their cryopreservation

HEALTHY VOLUNTEER EXCLUSION CRITERIA:

  1. Systemic disorder or central nervous system diseases of any kind or other related risk factors
  2. Previous history of alcohol and substance abuse
  3. Medical contraindications for MRI (i.e. any non-organic implant or other device such as a cardiac pacemaker or infusion pump or other metallic implants, objects or body piercings that cannot be removed)
  4. Psychological contraindications for MRI (i.e. claustrophobia). This will be assessed at the time the medical history is collected.
  5. Pregnancy or current breastfeeding
  6. Any contraindications to having study procedures done<TAB>
  7. History of auditory disorder (i.e. hearing impairment, known impaired acoustic reflex, tinnitus)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00794352


Contacts
Contact: Laura Kannaian, R.N. (301) 496-1801 neesel@mail.nih.gov
Contact: Bibiana Bielekova, M.D. (301) 402-4488 bielekovab@mail.nih.gov

Locations
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    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Bibiana Bielekova, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT00794352     History of Changes
Other Study ID Numbers: 090032
09-N-0032
First Submitted: November 19, 2008
First Posted: November 20, 2008
Last Update Posted: July 27, 2017
Last Verified: July 17, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
Inflammation
Multiple Sclerosis
Neuroimmunology
Immune Disorder
Neuroimaging
Central Nervous System Disease
Healthy Volunteers
HV

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Nervous System Diseases
Central Nervous System Diseases
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases


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