Assessing Cognitive Deterioration in COVID-19 (ACDC) Cognitive Impairment After COVID-19 - Inflammatory and Neural Correlates: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- NHS Grampian
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Primary Endpoint The primary endpoint is MR imaging and spectroscopy associations with measured cognitive performance.
研究概览
简要总结
The long-term impact and effects of COVID-19 are still being determined. However, what is clear, is that some people are still struggling following a period of illness with COVID-19. Now known as 'long covid' or 'post covid-19 syndrome', people are not only experiencing physical symptoms like fatigue and breathlessness, but also psychological difficulties, as well as cognitive changes often referred to as 'brain fog'. This can include symptoms, such as changes in memory, difficulties with organisation and problem solving, as well as the ability to concentrate.
Evidence from other research areas suggest that these changes could be due to shrinkage in areas of the brain that control functions like memory and concentration. There are also connections between different brain areas that work together to perform tasks such as remembering and concentrating, and these areas may also be affected by COVID-19.
The purpose of this study is to scan the brains of patients reporting cognitive changes having been hospitalised with COVID-19 infection to see if any of these areas or connections have changed after infection and whether this might explain these cognitive changes.
详细描述
BACKGROUND OF PROPOSED INVESTIGATION
Overview
A heterogenous cohort of patients, who have been variably denoted as suffering from "Long COVID" or the Post COVID-19 Syndrome, will have persistent cognitive and affective symptoms. A recent large systematic review found that fatigue and objective cognitive impairment were common and persistent after COVID-19 disease with a prevalence of 24.4% and 20.2% respectively (Badenoch et al., 2022). The severity of physical illness associated with SARS-CoV2 infection does not correlate with the likelihood of these symptoms developing or persisting, raising the questions as to the nature of the processes driving post COVID-19 cognitive symptoms.
The effects of COVID-19 disease on the brain and the link to cognitive impairment has been emphasised as an area of priority research (Samkaria and Mandal, 2021). There have been proposed mechanistic explanations from case studies (Yesilkaya et al., 2021) as well as more general commentaries on the neuroimmune correlates of COVID-19 disease, (Yesilkaya and Balcioglu, 2020) but as yet no high-quality evidence exists.
It is suggested that COVID-19 disease may lead to pathologically identifiable brain changes. A large study evaluating structural brain imaging of patients before and after SARS-CoV2 infection using United Kingdom (UK) Biobank data found evidence of grey matter volume reduction compared with controls (Douaud et al., 2022). This mainly involved olfactory areas but wider limbic involvement was discussed in the context of memory impairment and reported cognitive change. A much smaller study (Hosp et al., 2021) correlated functional imaging changes, Fluoro-Deoxy-Glucose Positron Emission Tomography (FDG-PET), with cognitive impairment in patients hospitalised with COVID-19 disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PARTICIPANTS:
- •Inclusion Criteria
- •A patient who has been hospitalised with COVID-19 disease (with a positive Polymerase Chain Reaction (PCR) result for SARS-CoV2 infection) within NHS Grampian hospitals with subsequent subjective reporting and objective evidence of cognitive change.
- •Patients aged over
- •Patient has completed neuropsychometric testing protocol as described above.
- •Participant who is willing and able to give informed consent for participation in the study.
排除标准
- •Any patient whose physical condition will preclude them from lying still for the duration of the brain scan.
- •Contraindication to magnetic resonance scanning such as an implantable cardiac device.
- •Patients who required intensive care treatment for SARS-CoV2 infection.
- •Patients with a pre-existing diagnosis of a Neurodegenerative disease (eg. Dementia), Intellectual Disability, previous moderate/severe brain injury or previous brain injury with noted cognitive change.
- •Patients with a pre-existing neuro-inflammatory disorder (eg. Multiple Sclerosis).
- •Patients under investigation for, or with a history of, cognitive change prior to hospitalisation with COVID-19 disease.
- •Patients with a dependency on alcohol or recreational drugs.
结局指标
主要结局
Primary Endpoint The primary endpoint is MR imaging and spectroscopy associations with measured cognitive performance.
时间窗: June 2024
To report the association (present or not) between MR imaging and spectroscopy measures and cognitive performance following hospitalisation for COVID-19 disease.
次要结局
- Metabolic profile of selected brain regions via MRS(June 2024)
- Brain iron levels(June 2024)
- White matter assessment via Tract Based Spatial Statistics (TBSS)(June 2024)