The Pathological Basis of MRI Signal Changes in Multiple Sclerosis: A Longitudinal In Vivo-to-Postmortem Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Correlation among in vivo imaging, postmortem imaging, and pathological characteristics of individual areas of tissue damage ("lesions") in the brain, spinal cord, and retinas.
研究概览
简要总结
Background:
Multiple sclerosis (MS) is a disease that damages the central nervous system (brain and spinal cord). This leads to increased physical disability over time. The disease is lifelong once it begins. Researchers want to learn more about MS s stages and follow them until a person s death.
Objective:
To understand how the physical and clinical signs of MS relate to its changes over time.
Eligibility:
Adults age 18 or older with MS or a disease of the brain and spinal cord that may act like MS.
Design:
Participants will have a medical history and a complete neurological exam. They may have timed tests of neurological function, such as a 25-foot walk and a 9-hole peg test.
Participants will have multi-day visits about once a year.
Participants will have blood drawn.
Participants may have a brain magnetic resonance imaging (MRI) scan. They may also have an MRI of the spinal cord. They may get a contrast agent (dye) injected into a tube in an arm vein. During the MRI, participants will lie on a table that slides in and out of a metal cylinder.
Participants will have the thickness of their retina measured using optical coherence tomography. A camera on top of a table uses lasers. Participants will look through a lens and follow instructions. Eye drops may be used to dilate the pupils.
Participants will chew on a piece of sterile cotton for 1 minute to collect saliva.
Participants agree to have an autopsy at the time of their death and to donate some of their organs to research, such as the brain and spinal cord.
详细描述
Objective.
The goal of this protocol is to understand how the pathology of multiple sclerosis (MS) relates to its evolution over time as observed through neuroradiological, clinical, and biological data collection in vivo.
Study population.
This study will enroll up to 200 individuals with MS, targeting 100 study completers, across various ages and stages of the disease, as well as up to 50 appropriate disease and non-neurological control participants, for a total of 250 participants.
Design.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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:
- •Diagnosis of MS according to consensus criteria at the time of enrollment OR diagnosis of a disease that shares clinical, imaging, or biological features with MS OR individuals without known CNS disease.
- •Age greater than or equal to
- •Able to participate in study procedures and provide high-quality clinical research data (for example, prior MRI scans show ability to tolerate the MRI scan with minimal motion artifact).
- •Willing to return to NIH for follow-up visits approximately annually (or every 5 years for non-CNS controls) until the time of autopsy. Note: participants who become too sick to return to NIH will not be removed from the study.
- •Willing to undergo autopsy with donation of at least the brain, spinal cord, and retinas.
- •Able to provide informed consent at the time of initial study enrollment and willing to appoint a Durable Power of Attorney (DPA) if an advanced directive is not already in place.
- •Except for non-CNS controls, simultaneously participating in another screening or natural history protocol within the NINDS Neuroimmunology Clinic at the time of study entry.
- •Eligible NIH employees and staff may participate.
排除标准
- •Unwilling to allow sharing and/or use in future studies of coded samples and data that are collected for this study.
研究组 & 干预措施
Patients with multiple sclerosis
Up to 250 adults (age >= 18) with MS, diagnosed by applicable consensus criteria and by the best judgment of the investigators at the time of enrollment.
Individuals without known CNS disease
Family members of patient participants
Patient controls
A target population of 100 patient controls will also be enrolled. These individuals will have diseases that share clinical, imaging, or biological features with MS.
结局指标
主要结局
Correlation among in vivo imaging, postmortem imaging, and pathological characteristics of individual areas of tissue damage ("lesions") in the brain, spinal cord, and retinas.
时间窗: annual visits
Correlation among in vivo imaging, postmortem imaging, and pathological characteristics of individual areas of tissue damage ( lesions ) in the brain, spinal cord, and retinas. Priority will be given to measures of myelination, axonal preservation, inflammation, and astrogliosis, as judged primarily by histological stains and immunohistochemistry.
次要结局
未报告次要终点