Evaluation of Progression in Multiple Sclerosis by Magnetic Resonance Imaging (MRI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,750
- 试验地点
- 1
- 主要终点
- the rate of change in the number of new white matter lesions per participant
研究概览
简要总结
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.
详细描述
Study Description:
This study is primarily designed to examine the evolving natural history of multiple sclerosis (MS) and its mimickers, viewed through the window of neuroimaging (especially magnetic resonance imaging or MRI). After required baseline evaluation, follow-up study timepoints are driven by clinical standard-of-care, and data from clinically driven procedures may be analyzed for research. Optional research procedures may also be performed during these visits. Optional research-only visits may be scheduled to further investigate findings from the clinical visits. The same research procedures may be performed in healthy volunteers to assess whether the research findings are specific to the affected participant group.
Objectives:
To describe the evolving natural history of MS, viewed clinically, radiologically, and biologically, both prior to and after the introduction of increasingly effective disease modifying therapies (DMT). The protocol has three other important objectives: (1) screening prospective participants for selected NINDS Neuroimmunology Clinic trials; (2) studying healthy volunteers for comparison with affected participants and for development of new experimental technologies; and (3) comparing MS to other neurological diseases that share imaging or clinical features.
Endpoints:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •INCLUSION CRITERIA:
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •One of the following:
- •Affected participant with either a diagnosis of MS based on currently accepted diagnostic criteria, or imaging or clinical abnormalities associated with MS.
- •Healthy volunteer.
- •Able to give informed consent.
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Contraindication to MRI at the time of initial enrollment (with the exception of pregnancy).
- •Unwilling to allow coded samples to be processed offsite or unwilling to have coded samples used in other studies.
研究组 & 干预措施
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
healthy volunteers
Healthy volunteers for technique development and comparison with the patient populations.
结局指标
主要结局
the rate of change in the number of new white matter lesions per participant
时间窗: baseline vs. follow up visits
The primary outcome, which is designed to determine how MS disease activity has changed with the advent of ever-more-effective disease-modifying therapy, is the rate of change in the number of new white matter lesions per participant, indexed by the date of baseline evaluation.
次要结局
未报告次要终点