Macromolecular Imaging of White and Gray Matter Pathology in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Measurement of macromolecular proton content (MPC) by Magnetic resonance imaging
研究概览
简要总结
The overall purpose of this research is to determine whether new macromolecular measures optimized for whole brain (gray matter and white matter) magnetic resonance imaging (MRI), predict neuro-cognitive impairment in multiple sclerosis (MS) patients.
详细描述
MRI is a vital component of a MS work-up, providing noninvasive evidence of MS lesions, detecting active inflammatory lesions, and measuring brain atrophy to assess neurodegeneration. Recent years of MRI research have generated strong evidence of gray matter (GM) involvement in MS, resulting in the reclassification of MS as a whole-brain disease. Similar to white matter (WM), a primary target of MS pathology in GM is myelin, the protective sheath insulating the penetrating axons within GM and extending brain connectivity all the way to the neuronal bodies.
This aim of this research is to examine if the associations between imaging measures of GM disease and cognitive performance can establish GM-based imaging correlates predicting the disease course and accurately assessing treatment results.
This observational research will enroll adults diagnosed with MS both with and without cognitive impairment. Subjects will be asked to complete a single research visit that includes the administration of a MRI scan and a neuro-cognitive testing session.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinically definite MS
- •Adult age 18 to 60
排除标准
- •Contraindication to MRI
- •Changes in MS therapy in the last 6 months
- •Less than 6 weeks after relapse or corticosteroid use
- •Currently taking medication that may affect cognition (e.g. donepezil, rivastigmine, adderall)
- •History of significant alcohol or drug abuse
- •Current or recent significant migraines
- •Confounding neurological or cognitive disorders or deficits (stroke, Parkinson's disease, Alzheimer's disease, epilepsy)
- •Sensory or physical impairments that might interfere significantly with cognitive testing
- •History of developmental or learning disability or attention-deficit/hyperactivity disorder.\
- •Exclusion Criteria for Healthy Controls:
- •history of alcohol/drug abuse
- •history of migraines
- •developmental or learning disability/attention-deficit/hyperactivity disorder
- •currently pregnant/breastfeeding
研究组 & 干预措施
Healthy Controls
Healthy adult volunteers will form a control group matched for age, gender, education, handedness
干预措施: MRI (Diagnostic Test)
Cognitive Impairment
Adults diagnosed with MS that have evidence of cognitive decline.
干预措施: MRI (Diagnostic Test)
Cognitive Impairment
Adults diagnosed with MS that have evidence of cognitive decline.
干预措施: Neuropsychological Testing (Diagnostic Test)
No Cognitive Impairment
Adults diagnosed with MS that have no evidence of cognitive decline.
干预措施: MRI (Diagnostic Test)
No Cognitive Impairment
Adults diagnosed with MS that have no evidence of cognitive decline.
干预措施: Neuropsychological Testing (Diagnostic Test)
结局指标
主要结局
Measurement of macromolecular proton content (MPC) by Magnetic resonance imaging
时间窗: 24 hours
Macromolecular Proton Fraction (MPF) is calculated from several specially acquired MR images and is characterized by high degree of sensitivity and specificity to tissue macromolecules, which are the main target of pathological process in neurodegenerative diseases including multiple sclerosis (MS). These properties of MPF are in contrast with standard MR images, which are primarily sensitive to tissue water molecules.
次要结局
- Neurocognitive performance as measured by Minimal Assessment of Cognitive Function in MS (MACFIMS) battery of neuropsychological (NP) tests(24 hours)
- Neurocognitive performance as measured by the Montreal Cognitive Assessment (MoCA) score(24 hours)