Assessment of Patients With Multiple Sclerosis (MS)

Brief Title

Assessment of Patients With Multiple Sclerosis (MS)

Official Title

Combined Clinical, Immunological and Virological Assessment of Patients With Multiple Sclerosis (MS)

Brief Summary

      Multiple sclerosis (MS) is a disease of the nervous system. The exact cause of MS is unknown,
      but it is believed to be an autoimmune condition. Autoimmune conditions are diseases that
      cause the body's immune system and natural defenses to attack healthy cells. In the case of
      MS, the immune system begins attacking myelin, the cells that make up the sheath covering
      nerves. Without myelin, nerves are unable to transmit signals effectively and symptoms occur.

      This study is directed toward a better understanding of the cause of Multiple Sclerosis (MS).
      Researchers will evaluate patients with a tentative diagnosis of MS or other neurological
      diseases possibly caused by a immunological reaction. Patients will undergo a series of three
      MRIs, taken once a month for three months and submit blood samples for immunological studies.
    

Detailed Description

      The Neuroimmunology Branch (NIB) conducts research into the cause of immunologically mediated
      diseases of the nervous system such as multiple sclerosis (MS). The studies in the NIB range
      for studies of the natural history of MS to trials of new experimental therapies. In order to
      recruit patients into the various NIB research studies, patients with a tentative diagnosis
      are initially seen by the NIB to assess the accuracy of the diagnosis and to assess the level
      of disease activity occurring in the patient. Patients seen under the NIB screening protocol
      are evaluated in clinic with a complete neurological examination. Blood studies necessary to
      eliminate the possibility of many other causes of disease that may resemble MS are performed.
      Spinal fluid examination may be preformed if uncertainty exists with respect to the
      diagnosis. Finally, patients will have at least one MRI preformed to assess the consistency
      with MRI findings expected in MS. Most patients will have a series of three MRIs done
      approximately one month apart in order to assess the frequency of new contrast enhancing
      lesions occurring in the patient. The level of disease on MRI is important both from the
      standpoint of diagnosis as well as determining if the patient may be eligible for any other
      NIB protocols. To assess the patient's eligibility for other NIB studies, the NIB may
      periodically follow patients in whom the diagnosis is uncertain or in whom the level of
      disease activity is not clear for the initial evaluation.
    


Study Type

Observational




Condition

Herpesviridae Infection



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

1388

Start Date

January 23, 1976

Completion Date

February 1, 2010


Eligibility Criteria

        -  INCLUSION CRITERIA:

        Diagnosis of possible MS.

        Age between 18 and 75.

        EXCLUSION CRITERIA:

        Clinically significant medical condition other than MS that could cause neurological
        dysfunction.

        Currently enrolled in an experimental study.

        Medical contraindication for MRI.

        Psychological contraindications for MRI.

        Unable to provide informed consent.
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

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Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00001156

Organization ID

760021

Secondary IDs

76-N-0021


Study Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)


Study Sponsor

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Verification Date

February 1, 2010