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
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
- 是
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
