Assessment of Patients With Multiple Sclerosis (MS)

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001156
First received: November 3, 1999
Last updated: February 2, 2010
Last verified: February 2010
  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

Study Type: Observational
Official Title: Combined Clinical, Immunological and Virological Assessment of Patients With Multiple Sclerosis (MS)

Resource links provided by NLM:


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

Enrollment: 1388
Study Start Date: January 1976
Estimated Study Completion Date: February 2010
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Publications:
ClinicalTrials.gov Identifier: NCT00001156     History of Changes
Other Study ID Numbers: 760021, 76-N-0021
Study First Received: November 3, 1999
Last Updated: February 2, 2010
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

Additional relevant MeSH terms:
Paraparesis, Tropical Spastic
Paraparesis, Spastic
Paraparesis
Herpesviridae Infections
HTLV-I Infections
Multiple Sclerosis
Sclerosis
Vasculitis
DNA Virus Infections
Virus Diseases
Deltaretrovirus Infections
Retroviridae Infections
RNA Virus Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Myelitis
Central Nervous System Viral Diseases
Central Nervous System Infections
Central Nervous System Diseases
Spinal Cord Diseases
Pathologic Processes
Paresis
Neurologic Manifestations
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on September 14, 2014