Completed

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

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What is being collected

Data Collection

Who is being recruted

Neuroinflammatory Diseases+24

+ Autoimmune Diseases

+ Cardiovascular Diseases

From 18 to 75 Years
See all eligibility criteria
How is the trial designed

Observational
Study Start: January 1976
See protocol details

Summary

Principal SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Last updated: July 2, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: January 23, 1976

Actual date on which the first participant was enrolled.

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.

NCT00001156
Principal SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Last updated: July 2, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1388 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neuroinflammatory DiseasesAutoimmune DiseasesCardiovascular DiseasesCentral Nervous System DiseasesCentral Nervous System InfectionsDemyelinating DiseasesDNA Virus InfectionsDeltaretrovirus InfectionsImmunologic Deficiency SyndromesImmune System DiseasesInfectionsMyelitisNervous System DiseasesRetroviridae InfectionsRNA Virus InfectionsSpinal Cord DiseasesTumor Virus InfectionsVascular DiseasesVirus DiseasesAutoimmune Diseases of the Nervous SystemDemyelinating Autoimmune Diseases, CNSHerpesviridae InfectionsMultiple SclerosisVasculitisHTLV-I InfectionsParaparesis, Tropical SpasticEpstein-Barr Virus Infections

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, United StatesOpen National Institutes of Health Clinical Center, 9000 Rockville Pike in Google Maps
CompletedOne Study Center