Assessment of Patients With Multiple Sclerosis (MS)
Primary Purpose
Herpesviridae Infection, HTLV-I Infection, Multiple Sclerosis
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Herpesviridae Infection focused on measuring Immunogenetics, Tropical Spastic Paraplegia, Twins, Epstein-Barr Virus, HTLV-I, Vasculitis, Cerebrospinal Fluid, Immunity to Viruses, Multiple Sclerosis, Magnetic Resonance Imaging
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.
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001156
First Posted
November 3, 1999
Last Updated
June 30, 2017
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
1. Study Identification
Unique Protocol Identification Number
NCT00001156
Brief Title
Assessment of Patients With Multiple Sclerosis (MS)
Official Title
Combined Clinical, Immunological and Virological Assessment of Patients With Multiple Sclerosis (MS)
Study Type
Observational
2. Study Status
Record Verification Date
February 1, 2010
Overall Recruitment Status
Completed
Study Start Date
January 23, 1976 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 1, 2010 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpesviridae Infection, HTLV-I Infection, Multiple Sclerosis, Tropical Spastic Paraparesis, Vasculitis
Keywords
Immunogenetics, Tropical Spastic Paraplegia, Twins, Epstein-Barr Virus, HTLV-I, Vasculitis, Cerebrospinal Fluid, Immunity to Viruses, Multiple Sclerosis, Magnetic Resonance Imaging
7. Study Design
Enrollment
1388 (Actual)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
1375472
Citation
Martin R, McFarland HF, McFarlin DE. Immunological aspects of demyelinating diseases. Annu Rev Immunol. 1992;10:153-87. doi: 10.1146/annurev.iy.10.040192.001101.
Results Reference
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PubMed Identifier
3369771
Citation
Alexander EL, Beall SS, Gordon B, Selnes OA, Yannakakis GD, Patronas N, Provost TT, McFarland HF. Magnetic resonance imaging of cerebral lesions in patients with the Sjogren syndrome. Ann Intern Med. 1988 Jun;108(6):815-23. doi: 10.7326/0003-4819-108-6-815.
Results Reference
background
PubMed Identifier
2562801
Citation
Beall SS, Concannon P, Charmley P, McFarland HF, Gatti RA, Hood LE, McFarlin DE, Biddison WE. The germline repertoire of T cell receptor beta-chain genes in patients with chronic progressive multiple sclerosis. J Neuroimmunol. 1989 Jan;21(1):59-66. doi: 10.1016/0165-5728(89)90159-8.
Results Reference
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Assessment of Patients With Multiple Sclerosis (MS)
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