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Trial record 2 of 4079 for:    Recruiting Studies | NIH

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 : February 14, 2018
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)

Brief Summary:


- 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.


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


  • 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.


  • 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

  Show Detailed Description

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

U.S. FDA Resources

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, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes


  • 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.



  • 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

Contact: Joan M Ohayon, C.R.N.P. (301) 496-0064 eatonj@ninds.nih.gov

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 Institutes of Health Clinical Center (CC)
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Daniel S Reich, M.D. National Institutes of Health Clinical Center (CC)

Additional Information:
Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT02504840     History of Changes
Other Study ID Numbers: 150158
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: June 13, 2017

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:
Multiple Sclerosis
Nervous System Diseases
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases