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Natural History of Multiple Sclerosis and Its Mimickers

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ClinicalTrials.gov Identifier: NCT02504840
Recruitment Status : Recruiting
First Posted : July 22, 2015
Last Update Posted : August 16, 2018
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)

Brief Summary:

Background:

- Magnetic resonance imaging (MRI) has been used for decades to help diagnose and monitor neurological disorders like multiple sclerosis (MS). Researchers want to improve how MRI pictures are taken. They also want to learn more about using newer MRIs with stronger magnets to get better pictures than standard MRIs provide.

Objectives:

- To collect data that will help researchers better understand MS and related diseases.

Eligibility:

  • Adults 18 and older with MS or MRI findings that appear similar to MS, or with other neurological diseases that may look or act like MS.
  • Healthy adult volunteers.

Design:

  • Participants will be screened with a review of their medical records.
  • Participants will have a baseline visit. It will include a physical exam, medical history, and neurological exam. They may have blood tests.
  • The study will last indefinitely.
  • Participants may have MRIs. Some MRIs may include a contrast dye. For this, a needle will be used to guide a thin plastic tube into an arm vein.
  • Participants may have up to 2 lumbar punctures per year. Skin will be numbed and a needle inserted between back bones will remove fluid.
  • Participants may give saliva samples and have an eye exam.
  • Participants may have evoked potential tests. These measure how the nervous system responds to different types of stimulation. Participants may sit in front of a TV and watch pictures on the screen. Or they may wear earphones that make a clicking noise or static. Or they may get a small electrical shock that may tingle and cause a hand or foot twitch.
  • Participants may have tests of strength, spasticity, sensations, balance, and/or walking.

Condition or disease
Neurologic Disorders Healthy Volunteers Multiple Sclerosis

Detailed Description:

Objectives.

The goals of this protocol are to study the pathophysiology of multiple sclerosis (MS), primarily through small studies that utilize magnetic resonance imaging (MRI), and to correlate the results with clinical and biological measures. The protocol includes only techniques with minimal risk (standard and quantitative clinical evaluation, MRI, blood draws, saliva testing, urine and stool collection, visual evoked potentials, ophthalmologic evaluation) or more-than-minimal risk (injection of approved gadolinium-based contrast agents, lumbar punctures) that are appropriate and common in this study population. Under this protocol, we will conduct:

  • Pilot substudies. These studies are exploratory and hypothesis generating. Once sufficient data are collected to justify a hypothesis-driven study and a formal power analysis, further work will continue under either a dedicated protocol or, if appropriate, a hypothesis-testing substudy. There are no enrollment limitations for pilot substudies.
  • Hypothesis-testing substudy. These studies have a specific hypothesis that can be tested with at most 6 participants per arm. If additional participants are required, a memo will be sent to the Protocol Review Committee (PIRC) and its statistical reviewer to request review of a hypothesis-testing substudy for possible additional enrollment.The memo will also be forwarded to the IRB.
  • Individual patient substudies. These studies seek to increase knowledge of a disease process or to assist in the diagnosis of an individual patient.
  • Technique development substudies. These studies will lay the groundwork for new experimental paradigms, using the methods approved under this protocol, which can be further tested in the substudies listed above.
  • Training of investigators. These studies will be done to train new investigators in techniques relevant to the studies under this protocol.

Study Population

Three groups of study participants will be enrolled:

  • MS patients. Participants with definite, probable, or possible MS.
  • Patient controls. Participants with diseases that share features with MS.
  • Healthy volunteers.

Design

We will design small substudies as ideas arise in the course of our work that are pertinent to the theme of the pathophysiology of MS (or of diseases that share features with MS). If a hypothesis testing sub-study leads to results of interest and if a larger population is necessary to reach statistical significance, a separate protocol will be submitted with a priori hypotheses, specific study design and power analysis adapted from the pilot or exploratory substudies performed in the present protocol.

Outcome Measures

These will include MRI, clinical, and biological outcome measures consistent with the objectives of the study and its investigators. Imaging measures will focus on features related to the central nervous system (CNS), particularly focal lesions. Clinical measures will include standard and established MS disability scales as well as quantitative measures related to function. Biological measures will include genotype, gene expression, proteomics, virological studies, and immunological profiling.


Study Type : Observational
Estimated Enrollment : 1300 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Thematic Studies of Multiple Sclerosis and Related Diseases
Study Start Date : July 21, 2015
Estimated Primary Completion Date : February 26, 2041
Estimated Study Completion Date : August 26, 2041

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Association between MRI findings and clinical status [ Time Frame: 25 Years ]

Secondary Outcome Measures :
  1. Focal brain lesions: presence, extent, imaging characteristics, distribution, and changes over time [ Time Frame: 25 Years ]
  2. Brain volume, brain-substructure, and spinal-cord volumes [ Time Frame: 25 Years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

<TAB>

  • One or more of the following:

    • Diagnosis of MS, clinically isolated syndrome, or radiologically isolated syndrome.
    • Presentation with clinical or neuroimaging findings that, in the best judgment of the investigators, are possibly consistent with central nervous system inflammatory demyelination.
    • Healthy volunteer.
  • Age greater than or equal to18.
  • Able to participate in study procedures and provide high-quality clinical research data, in the best judgment of the investigators.
  • Interest of the study investigators in performing one or more procedures under one or more of the substudies.

EXCLUSION CRITERIA:

<TAB>

  • Unwilling to allow sharing and/or use in future studies of coded samples and data that are collected for this study.
  • Inability to provide informed consent.

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): NCT02504840


Contacts
Contact: Joan M Ohayon, C.R.N.P. (301) 496-0064 eatonj@ninds.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 Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Daniel S Reich, M.D. National Institutes of Health Clinical Center (CC)

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT02504840     History of Changes
Other Study ID Numbers: 150158
15-N-0158
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 13, 2018

Keywords provided by National Institutes of Health Clinical Center (CC):
Multiple Sclerosis
Clinically Isolated Syndrome
CNS Inflammatory Demyellnation
Radiologically Isolated Syndrome

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