Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001156
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
1999-11-03
Brief Title:
Assessment of Patients With Multiple Sclerosis MS
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Combined Clinical Immunological and Virological Assessment of Patients With Multiple Sclerosis MS
Status:
COMPLETED
Status Verified Date:
2010-02-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 bodys 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 76-N-0021 | None | None | None |