Blood Brain Barrier Dysfunction and Postoperative Neurocognitive Disorders in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Postoperative cognitive dysfunction - delayed cognitive recovery II
研究概览
简要总结
Postoperative neurocognitive disorders (PND), which include postoperative delirium and both acute and longlasting neurocognitive deficits, are a significant public health problem, leading to a cascade of deleterious complications. Older adults are particularly at-risk of developing PND both in the short and long term. Although age is consistently reported as an important risk factor, the exact pathophysiology of PND remains poorly understood, but may include postsurgery-compromised blood brain barrier (BBB) function. This project proposes that perioperative BBB dysfunction is associated with measurable brain morphologic findings in cognitive control areas that can be discovered with non-invasive magnetic resonance imaging (MRI). Patients scheduled for surgery with an age range of 65-75 years of age, will participate in brain diffusion-weighted pseudo-continuous arterial spin labeling (DW-pCASL) and diffusion tensor imaging (DTI), cognitive assessments, and evaluation of a BBB marker from blood (at baseline, at two weeks, and at six months after surgery).
All patients will have a brain scan (MRI) within before surgery and two weeks and six months after surgery. During this visit cognitive function will be assessed. Patients will also be asked to participate in a blood draw.
详细描述
The investigators will examine the potential mechanisms contributing to PND in an older surgical population. It is proposed that BBB will be altered contributing to brain tissue changes in cognitive control areas that can be examined with MD measures and blood biomarkers. Therefore, the specific aims are to:
AIM #1: Examine BBB function, using DW-pCASL procedures, and BBB marker (S100β levels), in older adult subjects between pre- ) and post-surgery
AIM #2: Assess brain tissue changes, using DTI-based MD measures, and cognition function, between pre- and post-surgery in older adult subjects.
AIM #3: Examine the relationships between BBB blood biomarker, BBB function index, and MD values from cognitive control areas (prefrontal cortex, caudate, and hippocampus) between pre- and post-surgery in an older surgical population.
A One-group comparative and longitudinal study design will be used in this proposal. A total of 34 older subjects scheduled for surgery will be recruited. Patients of either sex, in the age range 65-75 years scheduled for abdominal, gynecologic or urologic.
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
- 65 Years 至 75 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65-75 years old
- •Scheduled for abdominal, gynecologic or urological surgery
排除标准
- •Subjects undergoing surgery with a previous history of stroke, myocardial infarction, current pregnancy (if female), diagnosed neuropsychological and neuropsychiatric diseases, airway or chest deformities that would interfere with breathing, chronic obstructive pulmonary disease, cystic fibrosis, presence of space-occupying brain lesions, any history of drug abuse (e.g., cocaine or tobacco use), chronic kidney disease requiring dialysis.
- •Body weight >300 pounds (restrictions of MRI scanner table).
- •All subjects with any contraindication to the MRI procedures, such as metallic and electronic implants (phrenic or cardiac pacemakers), claustrophobia, metallic-based tattoos, will also be excluded. Non-english speaking patients will also be excluded as the cognitive tests have not been validated in other languages.
结局指标
主要结局
Postoperative cognitive dysfunction - delayed cognitive recovery II
时间窗: Post-surgery (within two weeks post surgery)
Wide Range Assessment of Memory and Learning (WRAML2)
Postoperative cognitive dysfunction - neurocognitive disorder II
时间窗: Post-surgery (6 months after surgery)
Assessment of Memory and Learning (WRAML2)
Preoperative cognitive function II
时间窗: Pre-surgery (within five days before surgery)
Wide Range Assessment of Memory and Learning (WRAML2)
Postoperative cognitive dysfunction - neurocognitive disorder
时间窗: Post-surgery (6 months after surgery)
Montreal Cognitive Assessment (MoCA) test
Preoperative cognitive function
时间窗: pre-surgery (within five days before)
Montreal Cognitive Assessment (MoCA) test
Postoperative cognitive dysfunction - delayed cognitive recovery
时间窗: Post-surgery (within two weeks post surgery)
Montreal Cognitive Assessment (MoCA) test
次要结局
- Blood Serum anti-inflammatory Biomarkers(pre- (within five days before surgery))
- Brain changes(pre- surgery (within five days before))
- Brain changes II(Post-surgery (within two days post surgery))
- Blood Serum anti-inflammatory Biomarkers II(post-surgery (within two weeks of surgery))
- Brain changes III(Post-surgery (within six months post surgery))
研究者
Rajesh Kumar, PhD
Professor In-Residence
University of California, Los Angeles