跳至主要内容
临床试验/NCT02426398
NCT02426398招募中不适用

Developing a New EEG Method for the Early Diagnosis of Dementia. Using Novel EEG Analyses to Create a Diagnostic Test and Biomarker for Use With People With Dementia

Sheffield Teaching Hospitals NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
128
试验地点
1
主要终点
Significant spatiotemporal measurements from EEG

研究概览

简要总结

This is a non-invasive study investigating whether EEG, which is used in routine clinical care can be useful in diagnosing dementia. Novel in house developed software will analyse EEG data for this purpose from people with Alzheimer's disease and healthy volunteers.

详细描述

Participant recruitment

15 people with early AD will be recruited from the Sheffield Teaching Hospital and Sheffield Health and Social Care NHS Trusts memory clinics. The STH clinic is neurology led and sees working age (<65 years old) patients while the SHSC clinic sees an older (>65 years old) population. Over 1300 new assessments are conducted every year. Approximately 65-70% are diagnosed with dementia.

Investigators will choose patients with typical neuropsychological profiles of AD. All patients will have previously been recruited to the Virtual Physiological Human: Dementia Research enabled by IT. VPH-DARE@IT is recruiting 30-40 participants in each of the three following groups (mild AD, MCI and normal controls) and thus our participants will be drawn from this group and all will have pre-existing high-resolution 3D structural and volumetric assessment plus resting-state fMRI scans. This resting-state fMRI data will be analysed to examine the DMN, allowing us to directly compare measures of brain-connectivity between EEG and fMRI and contrast the discriminatory ability of the two methodologies.

10 healthy controls will be aged matched and recruited either from Neurology clinics or be spouses of study participants. The investigators will endeavour to recruit normal controls who have undergone fMRI as part of the academic neuroradiology departments control population for VPH-DARE@IT and other studies.

People with AD and 10 healthy controls will have a repeat EEG to assess the reproducibility and robustness of the EEG measures.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of possible or probable AD (according to revised diagnostic criteria (McKhann et al., 2011, Dubois et al., 2007)

排除标准

  • Significant vascular change on neuro-imaging (Fazekas grading of white matter change >2) (Fazekas et al., 2002).
  • Clinical history of stroke, Parkinsonism, epilepsy or other neurological disorder. (e.g. severe auditory, visual, language or motor impairment)
  • Moderate to severe dementia (defined by research team but we wouldn't expect those with a mini mental state exam [MMSE] ≤ 18 to be able to participate)
  • Severe current mental health disorder (depression, psychosis).
  • Patients on sedating or antiepileptic medication

结局指标

主要结局

Significant spatiotemporal measurements from EEG

时间窗: 12 months

EEG data analysis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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