NCT05406778已完成不适用
SPARK Neuro Quantitative Resting State EEG Protocol for Assessing Cognitive Impairment and Alzheimer's Disease Status- The REMIND Study
Spark Neuro Inc.14 个研究点 分布在 1 个国家目标入组 185 人开始时间: 2022年5月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 185
- 试验地点
- 14
- 主要终点
- EEG Data collection for AI software development
研究概览
简要总结
The study utilizes investigational software, the SPARK Test, with an FDA-cleared electroencephalography (EEG) amplifier and EEG cap to collect and patient EEG data.
详细描述
The aim of this study is to collect data to support development of an algorithm to determine whether applying machine-learning techniques to eyes open/eyes closed resting-state electroencephalography (EEG) can characterize patient's cognitive status and detect the presence or absence of AD on the basis of the patient's EEG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 55 to 85 at the time of consent
- •Informant available and willing (remotely or in-person) to provide information about sleep patterns and cognitive functioning who spends >8 hours per week with primary subject
- •Subject or Legally Authorized Representative (LAR) has the ability to provide informed consent and comply with the protocol.
排除标准
- •Unable to remain still for up to 30 minutes during EEG data recording
- •Subjects currently on and unable to wash out concomitant medications, including: 1) opiates; 2) benzodiazepines and nonbenzodiazepine hypnotics; 3) sedative antihistamines; 4) tricyclic anti-depressants; 5) skeletal muscle relaxants; 6) antiepileptics; 7) antipsychotics; 8) antimanic agents; 9) THC; 10) anticholinergics
- •Previous history of craniotomy
- •Medical or psychiatric illness that would interfere with study participation
- •History of epilepsy or chronic seizure disorder
- •Presence of non-dental metal in head
- •Currently experiencing a skin disease on scalp that would affect electrode contacts
- •Subject meets at least one of the following criteria:
- •Diagnosis of cognitive impairment from various underlying pathologies as indicated by one of the diagnostic codes listed in Appendix A (protocol)
- •MMSE score of 27 or less
- •Treating physician or PI have documented that the patient is cognitively impaired, with judgment of cognitive impairment having been made within the 6 months prior to enrollment
- •Substance Use Disorder, including Alcohol
结局指标
主要结局
EEG Data collection for AI software development
时间窗: During the diagnostic procedure
Rate of complete software collection per enrolled subjects complete a SPARK Test recording.
次要结局
未报告次要终点
研究者
研究点 (14)
Loading locations...
相似试验
Unknown
不适用
Cardiac Arrest Recovery EEG StudyArrhythmiaCardiac ArrestNCT00483873Infinite Biomedical Technologies100
已完成
不适用
Computational Decision Support in Epilepsy Using Retrospective EEGEpilepsyNCT05384782Cornwall Partnership NHS Foundation Trust825
招募中
不适用
SSVEP Evaluation of Brain Function (PRO)Mild Traumatic Brain InjuryNCT06013566Headsafe MFG1,000
已完成
不适用
SSVEP Evaluation of Brain FunctionMild Traumatic Brain InjuryNCT05614570Headsafe MFG1,300
尚未招募
不适用
EEG in Mild Traumatic Brain InjuryCTRI/2022/03/040847Ajay Hegde