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Protocol Details

Evaluation of Progression in Multiple Sclerosis by Magnetic Resonance Imaging (MRI)

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

89-N-0045

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Multiple Sclerosis;
MRI (Magnetic Resonance Imaging)

Recruitment Keyword(s)

None

Condition(s)

Multiple Sclerosis

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Neurological Disorders and Stroke

Studies performed under 89-N-0045 are designed to examine the natural history of multiple sclerosis (MS) using MRI and immunological measures. In addition to studying the natural history of untreated patients, the natural history of patients receiving approved disease-modifying therapies of MS will be examined. In both cohorts of patients levels of disease activity on MRI will be compared with immunological characteristics in order to help identify disease mechanism. Patients with either definite MS (based either on clinical or combined clinical and MRI criteria) or with an initial presentation of neurological dysfunction consistent with MS will be studied longitudinally by MRI. Disease activity on MRI will be assessed using several MRI measures of disease activity including the number of contrast enhancing lesions, the overall burden of disease, brain atrophy and measures to assess axonal damage. Patients will be assessed clinically and correlations between immunological and genetic factors and disease activity as seen clinically or by MRI will be studied.

A second cohort of patients starting the use of approved therapy will also be examined. Patients referred to NIH prior to beginning approved therapy will be assessed with a series of three monthly MRIs to determine the level of pretreatment disease activity. After beginning approved therapy under the direction of their private physician, patients will be followed similarly to the natural history cohort. Immunological and genetic findings will be accessed before and during therapy in order to help establish the mechanisms of action of the therapies and to identify mechanisms accounting for either a response or lack of response to therapy. Part of the collected samples willl be cryopreserved to provide respository for further studies focusing on detection of biomarkers indicative of disease state, disease stage or repsonse to therapies.

Additionally, a cohort of normal volunteers will be studied. The studies in the normal volunteers will be used to establish the most appropriate imaging sequences for studying normal white matter in MS patients using magnetization transfer (MT) imaging sequences for studying normal white matter in MS patients using magnetization transfer (MT) imaging and to provide normative immunological measures.

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Eligibility

INCLUSION CRITERIA:

Inclusion criteria for all populations:

-Diagnosis of MS based on combined MRI and clinical criteria (Polman et al., 2005) OR presentation with a clinically isolated syndrome consistent with MS and at least two abnormalities on MRI consistent with MS OR diagnosis of another neurological disease of the CNS (see Section 6.1.2) OR patients with other diseases who are receiving identical DMTs as the MS cohort OR patients who acquire an MS-like disease while receiving immunomodulatory agents for a different indication.

-For patients with neuroimmunological disorders, treatment with any available immunomodulatory therapy.

-Age greater than or equal to 18.

-Able to give informed consent.

-NIH Employees are eligibile to participate.

EXCLUSION CRITERIA:

Exclusion criteria for all cohorts:

-Contraindication to MRI.

-Fulfills inclusion criteria for 09-N-0032 protocol, i.e. any untreated neuroimmunological or CNS white matter disease that requires diagnostic work-up.

-Pregnancy.

-Unwilling to allow coded samples to be processed offsite or unwilling to have coded samples used in other studies.


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Citations:

Clinical safety of serial monthly administrations of gadopentetate dimeglumine in patients with multiple sclerosis: implications for natural history and early-phase treatment trials

Interferon beta results in immediate reduction of contrast-enhanced MRI lesions in multiple sclerosis patients followed by weekly MRI

Increases insoluble VCAM-1 correlate with a decrease in MRI lesions in multiple sclerosis treated with interferon beta-1b

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Contacts:

Principal Investigator

Referral Contact

For more information:

Daniel S. Reich, M.D.
National Institutes of Health Clinical Center (CC)
BG 10 RM 5C103
10 CENTER DR
BETHESDA MD 20814
(301) 496-1801
reichds@ninds.nih.gov

Joan M. Ohayon, C.R.N.P.
National Institutes of Health Clinical Center (CC)
BG 10 RM 5C442
10 CENTER DR
BETHESDA MD 20814
(301) 496-3825
eatonj@ninds.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT00001248

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