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Assessment of Patients With Multiple Sclerosis (MS)
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), January 2008
Sponsored by: National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001156
  Purpose

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.


Condition
Herpesviridae Infection
HTLV-I Infection
Multiple Sclerosis
Tropical Spastic Paraparesis
Vasculitis

Genetics Home Reference related topics: spastic paraplegia type 4 Troyer syndrome
MedlinePlus related topics: Multiple Sclerosis Neurologic Diseases Vasculitis
U.S. FDA Resources
Study Type: Observational
Official Title: Combined Clinical, Immunological and Virological Assessment of Patients With Multiple Sclerosis (MS)

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 1500
Study Start Date: January 1976
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001156

Contacts
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site

Publications:
Study ID Numbers: 760021, 76-N-0021
Study First Received: November 3, 1999
Last Updated: July 18, 2008
ClinicalTrials.gov Identifier: NCT00001156  
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Immunogenetics
Tropical Spastic Paraplegia
Twins
Epstein-Barr Virus
HTLV-I
Vasculitis
Cerebrospinal Fluid
Immunity to Viruses
Multiple Sclerosis
Magnetic Resonance Imaging

Study placed in the following topic categories:
Spastic paraparesis
Spinal Cord Diseases
Paraplegia
Paraparesis, Tropical Spastic
Demyelinating diseases
Paraparesis, Spastic
Signs and Symptoms
Multiple Sclerosis
Retroviridae Infections
Autoimmune Diseases of the Nervous System
Vasculitis
Autoimmune Diseases
Paresis
Demyelinating Diseases
Vascular Diseases
Central Nervous System Diseases
Sclerosis
Immunologic Deficiency Syndromes
Herpesviridae Infections
Virus Diseases
Central Nervous System Infections
Demyelinating Autoimmune Diseases, CNS
Neurologic Manifestations
DNA Virus Infections
Myelitis
HTLV-I Infections
Paraparesis
Tropical Spastic Paraparesis

Additional relevant MeSH terms:
Communicable Diseases
RNA Virus Infections
Pathologic Processes
Immune System Diseases
Nervous System Diseases
Cardiovascular Diseases
Central Nervous System Viral Diseases
Deltaretrovirus Infections
Infection

ClinicalTrials.gov processed this record on January 15, 2009