The Development of Early-stage Alzheimer's Disease Multimodal Fusion Warning System and Non-invasive Neurostimulation Techniques.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Duration of microstate
研究概览
简要总结
Developing and validating an early digitalized recognition device and multimodal warning model for Alzheimer's disease, and establishing a precision transcranial ultrasound stimulation intervention system.
详细描述
- Establishment of early digitalized recognition devices and multimodal warning models for AD: Participants undergo clinical assessments, and if they meet the inclusion criteria, their gender, age, MMSE, MoCA, CDR, GDS scores, as well as EEG ERP and MR data are collected. Eye-tracking analysis based on human-computer interaction perception technology, limb movement detection, and laser radar depth sensor fusion cognitive assessment are also performed simultaneously. After enrollment, follow-up assessments using scales (MMSE, MoCA, CDR, GDS, ADAS-cog, etc.) are conducted every six months, and EEG ERP and MR data are collected annually.
- Construction of a precision transcranial ultrasound stimulation intervention system: Participants were randomly divided into true stimulation group and false stimulation group: true/false stimulation for 2 weeks, washout for 2 weeks, false/true stimulation for 2 weeks. After treatment, behavioral scale assessment, EEG ERP and multimodal MRI were performed to evaluate the therapeutic effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The study is double-blinded, meaning both participant and Investigator are unaware of the treatment received by the patients.
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with MCI / AD
- •Between the ages of 55 and 80
- •No history of mental illness such as schizophrenia, severe anxiety and depression
排除标准
- •Consistent with Parkinson's disease, frontotemporal dementia, dementia with lewy bodies Or Huntington's disease diagnostic criteria
- •Dementia due to other causes (e.g. cerebrovascular disease, central nervous system trauma, tumors, infections, Metabolic diseases, normal stress hydrocephalus, folic acid or vitamin B12 deficiency, hypothyroidism, etc.)
- •Have aphasia,Disorders that affect cognitive assessment, such as disorders of consciousness
- •Have a history of epilepsy or take antiepileptic drugs
结局指标
主要结局
Duration of microstate
时间窗: 6 months
The investigators refined the microstate method to accurately estimate topographical differences. The calculations were performed for measures of duration (ms). The duration of each microstate were utilized to predict disease classification and prognosis evaluation for patients with Alzheimer's disease.
Montreal Cognitive Assessment (MoCA)
时间窗: 6 months
MoCA is a standardized assessment tool used to evaluate cognitive function, particularly for early cognitive impairment and mild cognitive impairment. It consists of a series of questions and tasks that cover areas such as memory, attention, executive functions, language, and spatial abilities. Test items include naming animals, drawing a clock, recalling a sequence, task guidance, etc., and each item is assigned a different score. The score range is from 0 to 30, with higher scores indicating better cognitive function.
Occurrence of microstate
时间窗: 6 months
The investigators refined the microstate analysis. The calculations were performed for measures of occurrence (times per minute). The occurrence of microstates were utilized to predict disease classification and prognosis evaluation for patients with disturbance of consciousness.
Power spectrum
时间窗: 6 months
The investigators collected EEG data of participants in resting state and listening to music and the absolute power spectral density values (alpha,beta,theta,delta bands dB/Hz) will be calculated using spectral analysis.
Mini-Mental State Examination (MMSE)
时间窗: 6 months
MMSE includes a series of questions and tasks to assess the individual's memory, attention, calculation, language, spatial, and executive functions. The test items include recalling instructions, reproducing patterns, performing mathematical calculations, naming objects, writing sentences, etc. Each item has different scoring criteria, and scores are assigned based on the participant's responses and performance. The total score is 30, with higher scores indicating better cognitive functioning.
次要结局
未报告次要终点