Evaluation of a Handheld Evoked Response Potentials (ERP) System as an Effective Method to Diagnose Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Signal to noise ratio (SNR) of ERPs
研究概览
简要总结
This study will evaluate a handheld event-related potential (ERP) testing device from Neuronetrix, Inc. as a method to collect ERP data in an outpatient setting.
An ERP system records electrical signals at the scalp that are produced by the brain when performing cognitive tasks. By doing this study, we hope to evaluate various performance parameters of the COGNISION(TM) system.
详细描述
Patients who have a current diagnosis of mild-moderate dementia and suspected of having Alzheimer's disease (AD) along with cognitively normal age-matched controls will be recruited for this study. The Alzheimer's subjects either will have had a complete clinical and neuropsychiatric workup or will have those tests performed during the study.
Both groups, AD and controls will be asked to listen to a series of sounds and press a button on a handheld control box when a target sound is heard. The COGNISION(TM) headset on each subject's head will then record the electrical signals during this task.
Four important features of the COGNISION(TM) will be investigated:
- Patient tolerance
- Ease of use
- Data quality
- Network architecture
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
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Subjects with advanced AD and severe impairment (CDR > 2, MMSE less than 15)
- •Neurological disorders such as stroke, Parkinson's disease, Huntington's disease, multiple sclerosis, brain tumor, delirium, or psychiatric disorder other than depression (e.g. schizophrenia)
- •Subjects with life threatening illnesses and subjects with significant hearing or visual impairments
- •Subjects with a current prescription for psychoactive pharmaceuticals
结局指标
主要结局
Signal to noise ratio (SNR) of ERPs
时间窗: 9 months
次要结局
- Patient tolerance of the COGNISION(TM) system.(9 months)