Protocol Number: 09-N-0032

Title:

Comprehensive Multimodal Analysis of Patients with Neuroimmunological Diseases of the CNS

Number:

09-N-0032

Summary:

nflammatory 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:

-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.

Sponsoring Institute:

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

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. 18-70 years of age

4. Able to give informed consent

5. Able to undergo complex diagnostic work-up, including lumbar puncture and MRI imaging

6. Able to undergo related research procedures, such as lymphocytapheresis for collection of peripheral blood mononuclear cells (PBMC) samples

Healthy Volunteers

1. Age between 18 and 70

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 or lymphocytapheresis for collection of peripheral blood mononuclear cells (PBMC) samples

EXCLUSION CRITERIA:

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

1. Systemic disorder or central nervous system diseases of any kind or other related risk factors

2. Previous history of alcohol and substances 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. Unable to provide informed consent

7. Any contraindications to having study procedures done

8. History of auditory disorder (i.e. hearing impairment, known impaired acoustic reflex, tinnitus)

Special Instructions:

Currently Not Provided

Keywords:

Inflammation

Multiple Sclerosis

Neuroimmunology

Immune Disorder

Neuroimaging

Recruitment Keyword(s):

Central Nervous System Disease

Multiple Sclerosis

Immune Disorder

Healthy Volunteers

HV

Condition(s):

Central Nervous System Disease

Multiple Sclerosis

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Neurological Disorders and Stroke

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Andrews HE, Nichols PP, Bates D, Turnbull DM. Mitochondrial dysfunction plays a key role in progressive axonal loss in Multiple Sclerosis. Med Hypotheses. 2005; 64(4):669-77.

Arnett HA, Wang Y, Matsushima GK, Suzuki K, Ting JP. Functional genomic analysis of remyelination reveals importance of inflammation in oligodendrocyte regeneration. J Neurosci. 2003 Oct 29;23(30):9824-32.

Astier AL, Meiffren G, Freeman S, Hafler DA. Alterations in CD46-mediated Tr1 regulatory T cells in patients with multiple sclerosis. J Clin Invest. 2006 Dec; 116(12):3252-7. Epub 2006 Nov 9

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

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