Recruiting

MRI

Sponsor:

National Institute of Neurological Disorders and Stroke (NINDS)

Code:

NCT00001248

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Study Details

Brief summary:

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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Conditions

Multiple Sclerosis

Study ID

NCT00001248

Start date

Jul 23, 1992

Status verified date

Jun 4, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

  • INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. One of the following:

1. Affected participant with either a diagnosis of MS based on currently accepted diagnostic criteria, or imaging or clinical abnormalities associated with MS.
2. Healthy volunteer.
2. Age >=18
3. Able to give informed consent.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Contraindication to MRI at the time of initial enrollment (with the exception of pregnancy).
2. Unwilling to allow coded samples to be processed offsite or unwilling to have coded samples used in other studies.

Study Design

Enrollment

3750 participants

Anticipated

Interventions and Outcome Measures

Arms

healthy volunteers

Healthy volunteers for technique development and comparison with the patient populations.

MS/CIS/RIS population

Patients with a diagnosis of MS or who have typical imaging abnormalities associated with MS.

Non-MS comparison population

Patients with disorders of the CNS, to include patients with diseases that share mechanisms of tissue damage with MS

Primary outcome measure

  • the rate of change in the number of new white matter lesions per participant [ Time Frame: baseline vs. follow up visits ]

Central Contacts and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Last update posted

Sep 8, 2026

Last verified

Jun 4, 2026

Keywords

  • Multiple Sclerosis
  • MRI (Magnetic Resonance Imaging)
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of Neurological Disorders and Stroke (NINDS) on 2026-09-08.