Neural and Cognitive Consequences of COVID-19 Survival
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Number of Participants with Blood Biomarkers
研究概览
简要总结
The novel coronavirus SARS-CoV-2 infection, COVID, continues to rage throughout the world with 115,000,000 confirmed cases and over 2,500,000 deaths (as of Mar 3, 2021). This translates to millions of people surviving COVID19 infection. While the lungs are ground zero, COVID tears through organ systems from brain to blood vessels. We are now beginning to see people recover but complain of ongoing problems, including lingering cognitive problems, depression, and anxiety. We have brought together 2 laboratories with complementary techniques including psychological testing and neuroimaging methods togethers with markers in the blood that may signal damage in the brain. A close look at these problems is timely and imperative if we are to understand the pathophysiology of 'COVID brain' and prepare for downstream problems.
详细描述
The SARS-CoV-2 pandemic has been going on for over a year worldwide, with 115,000,000 confirmed cases and over 2,500,000 deaths (as of Mar 3, 2021). We are seeing people recover from the initial COVID infection with complaints of ongoing problems. An increasing number of people are complaining of cognitive deficits and depression/anxiety.
Methodologically, we have brought together two laboratories studying neurocognitive impairment using an EEG, MRI, and behavioral approach as well as laboratory-based data. This study queries neuropsychological functions in individuals using a neuropsychological battery, EEG-based measures, functional MRI (connectivity) and structural MRI (gray and white matter volumes, myelin, micro-bleeds). In addition, we have preliminary data to show a continued increase in plasma cytokines in COVID survivors. Plasma isolated neuronal enriched extracellular vesicles (nEVs) showed an increase in amyloid beta, neurofilament light and pT181-Tau, all proteins associated with neurodegeneration.
The overall aim is to determine the extent of cognitive, clinical, and neurological damage in people recovered from COVID.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Our studies require some in-person visits to our research lab, located at 42nd Ave and Clement St in San Francisco.
- •Because this study includes an MRI, part of the screening process will be to ensure you don't have any metal in your body, you do not have head or neck tattoos, and you are comfortable inside the MRI scanner.
- •18-70 years with a confirmed COVID infection at least 3 months ago.
- •Negative metal screen for MRI safety
- •Normal (or corrected to normal) vision
排除标准
- •Past or present neurological problems (including seizures and head trauma resulting in neurological or cognitive symptoms)
- •Loss of consciousness (LOC) greater than 30 minutes or any LOC with neurologic symptoms
- •Major medical conditions (e.g., seizures disorders, treatment with anticonvulsant medication, endocrine disorders, significant cardiac pathology)
- •Substance dependence, within the past year, or failed urine toxicology on the day of neuroimaging sessions
- •Known claustrophobia
- •Current pregnancy
- •IQ estimate < 70
结局指标
主要结局
Number of Participants with Blood Biomarkers
时间窗: 1 month
We will correlate blood biomarkers of inflammation and NP test performance, thalamo-cortical connectivity, and measures of neural speed.
Number of Participants with MRI Functional Disconnectivity
时间窗: 1 month
We will compare thalamo-cortical connectivity in people with Covid-related worsening of attention, memory, anxiety, and/or depression to people who do not endorse worsening in those domains.
Change of Neuropsychological Test Performance
时间窗: 1 month
We will compare NP test performance in people with Covid-related worsening of attention, memory, anxiety, and/or depression to people who do not endorse worsening in those domains.
Number of Participants with EEG Latency & Amplitude
时间窗: 1 month
We will compare EEG-derived event related potential measures of neural speed in people with Covid-related worsening of attention, memory, anxiety, and/or depression to people who do not endorse worsening in those domains.
次要结局
未报告次要终点
研究者
Judith Ford
Staff Neuroscientist/Clinician Investigator
San Francisco Veterans Affairs Medical Center