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临床试验/NCT05460143
NCT05460143招募中不适用

Wearable Optical Monitoring of Brain Function in Healthy Adults and People With Dementia

University of Cambridge1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Cognitive behavioural data

研究概览

简要总结

Dementia is associated with a variety of neurovascular and neurometabolic abnormalities. Traditional imaging techniques used to investigate such abnormalities, such as Positron Emission Tomography and functional Magnetic Resonance Imaging, are not always well tolerated, have expensive start up and running costs, and are limited with regards to the types of experiments that can be performed as they can be highly sensitive to movement, are noisy, and have physical restrictions.

Near-infrared spectroscopy (NIRS) is a non-invasive neuroimaging technique which uses light in the near-infrared spectrum to detect relative changes in concentration of oxygenated and deoxygenated haemoglobin, and the oxidation state of Cytochrome C Oxidase. As such, NIRS can provide measures of brain oxygenation and metabolism. NIRS is less sensitive to movement, is well tolerated and has few contraindications. It is thus a promising candidate for use in clinics or in peoples' homes for monitoring dementia.

In the present study, the investigators aim to use both dual-wavelength and broadband NIRS in a range of dementia subtypes, including Alzheimer's Disease and Dementia with Lewy Bodies, and severities, including Mild Cognitive Impairment, to identify how brain oxygenation and metabolism is altered in dementia and across various clinical subgroups. The investigators also aim to determine the relationship between brain oxygenation and metabolism in dementia, and use machine learning approaches to identify optical biomarkers for dementia.

详细描述

There are several different types of dementia including Alzheimer's Disease (AD) and Dementia with Lewy Bodies (DLB). Due to the overlapping symptomatology across types of dementia and the lack of objective biomarkers currently available for dementia, misdiagnosis rates are high. Additionally, the transition from what is commonly thought to be an intermediate stage, termed Mild Cognitive Impairment (MCI), to dementia, is not well defined. Neurovascular and metabolic dysfunction has been strongly linked to neurodegeneration and dementia, however, a mechanistic understanding of this link has not been fully developed.

Near-Infrared Spectroscopy (NIRS) is a non-invasive, non-ionising and portable neuroimaging technique which uses light to quantify changes in concentration of oxygenated and deoxygenated haemoglobin in the brain. As such, it is a highly attractive alternative to functional Magnetic Resonance Imaging as it allows access to a larger variety of individuals, can be used at the bedside or in patients' own homes, and is significantly less intrusive.

To identify how the brain's haemodynamics and metabolism is altered in dementia, this study will use NIRS in 25 patients with AD, 25 patients with DLB, 50 patients with MCI and 100 age-matched healthy controls. This study will be conducted by the School of Technology and the School of Clinical Medicine at the University of Cambridge.

Firstly, the investigators will perform several cognitive tests in these patient groups whilst measuring brain activity using a state-of-the-art, dual-wavelength, high-density NIRS device to map how the brain's haemodynamics are altered in dementia. Secondly, the investigators will perform further cognitive tests using broadband NIRS to measure how neurometabolism is altered across the patient groups. The investigators will also relate the optical data to several facets of cognition that these cognitive tests will measure including memory, attention, and motor function. Several questionnaires will also be administered to assess non-cognitive symptoms such as depression and sleep disturbances. If participants in the patient groups have not had a Magnetic Resonance Imaging (MRI) scan, or did one over two years ago, they will also undertake an MRI scan to enable the localisation of brain activity, measured by NIRS, accounting for individual differences in brain structure and atrophy patterns.

The investigators shall compare all patient groups (AD, DLB, MCI) with healthy controls to determine how the brain's haemodynamics and metabolism are altered in dementia, as well as how this relates to both behavioural scores (collected during cognitive testing) and clinical scores (using either data collected from questionnaires or patient's own clinical history). Through combining the two NIRS techniques, the investigators shall also determine the nature of the relationship between the blood oxygenation in the surrounding vasculature and the intra-neuronal metabolic activity, and how this relationship may be altered in dementia and across different types of dementia. Additionally, the investigators shall apply computational methods, such as machine learning, to identify haemodynamic and/or metabolic signatures for use as biomarkers in the clinic.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A diagnosis of probable:
  • Lewy Body Dementia
  • Alzheimer's Disease
  • Mild Cognitive Impairment (MCI-LB or MCI-AD) OR
  • Cognitively normal for their education and age, with a MMSE score above 26 AND
  • A good grasp of the English language
  • An informant (either a carer or family member) who will be available throughout testing (only relevant if in a patient group)

排除标准

  • Severe dementia
  • Unable to participate
  • A MMSE score below 12
  • A condition which influences metabolism or haemodynamics
  • Such as metabolic or respiratory disorders
  • A significant mental illness
  • Such as rheumatoid arthritis, systemic lupus erythematosus
  • Oral steroid use
  • A significant psychiatric disorder
  • MCI due to other causes such as traumatic brain injury, vascular dementia, or fronto-temporal dementia
  • A history of excessive drug or alcohol use
  • Contraindications to MRI (only for patient groups undertaking the MRI scan: AD/MCI/DLB)
  • Surgical implants e.g. pacemakers

结局指标

主要结局

Cognitive behavioural data

时间窗: Within the study session (1 hour)

Behavioural scores collected through the cognitive testing performed during NIRS scans. These include scores of memory function and word retrieval, e.g., accuracy of words recalled, reaction times.

Brain metabolism

时间窗: Within the study session (1hour)

As measured with broadband NIRS. We will measure task-related changes in oxidation state of Cytochrome C Oxidase(µmol).

Brain oxygenation

时间窗: Within the study session (1 hour)

As measured with dual-wavelength NIRS. We will measure task-related relative changes in concentration in oxygenated and deoxygenated haemoglobin (µmol).

次要结局

  • Geriatric depression scale(Within the study session (maximum 1 hour))
  • Rey Auditory Verbal learning test(Within the study session (maximum 1 hour))
  • ACE-R score(Within the study session (maximum 1 hour))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gemma Bale

Assistant professor

University of Cambridge

研究点 (1)

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