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Magnetic Resonance Imaging (MRI) to Evaluate Activity of Multiple Sclerosis (MS)

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 405 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor

    Eligibility criteria expanded, about 8 words

    Publications: details revised at 6 of 6 entries

    Show what changed: Eligibility criteria
    * INCLUSION CRITERIA: In order to be eligible to participate i [...] udy, 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 [...] a, or imaging or clinical abnormalities associated with MS. 2. Healthy volunteer. 2. Age \>=18 3. Able to give informed consent. EXCLUSION CRITERIA: An indivi [...] 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 [...]
  2. Minor

    38 amendments

    38 re-verifications since 2025-08-09, no change to tracked fields

    v367-v404

  3. Notable

    Enrollment target: 2500 to 3750

    Study Status, Study Description, Study Designv366

  4. Minor

    10 amendments

    10 re-verifications since 2025-04-18, no change to tracked fields

    v356-v365

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00001248
Lead Sponsor National Institute of Neurological Disorders and Stroke (NINDS)
Conditions Multiple Sclerosis
Enrollment 3,750 participants
Start Date
Updated on ClinicalTrials.gov