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临床试验/NCT07196592
NCT07196592尚未招募不适用

AD New Multi-Dimensional Therapy Device Development - Microcurrent Brain Stimulation Device and Virtual Reality Therapy Equipment

Yuan Shen0 个研究点目标入组 300 人开始时间: 2025年10月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
300
主要终点
Change in Olfactory Sensitivity (TDI score)

研究概览

简要总结

As populations age, Alzheimer's disease (AD) is increasing while disease-modifying drugs remain elusive, making early diagnosis and intervention essential. Building on advances in neuromodulation and virtual reality (VR), we target amnestic mild cognitive impairment (aMCI)-the prodromal stage of AD-as a key window for prevention. Preliminary evidence shows disrupted theta-delta phase-amplitude coupling in prefrontal and temporal cortices in aMCI, whereas olfactory enrichment can enhance hippocampal synaptic function, improve cognition, and potentially lower AD risk. We will conduct a large-scale clinical cohort study to test the neural mechanisms and clinical efficacy of multi-site, cross-frequency transcranial alternating current stimulation (tACS) combined with multisensory (visual-olfactory-auditory) VR. A comprehensive database spanning demographic, neuropsychological, biochemical, neuroimaging, and neuromodulation parameters will guide optimal protocols and provide objective evidence for non-pharmacological interventions, informing development of a microcurrent brain stimulator and a portable VR device.

详细描述

With the accelerating pace of population aging, the prevalence of Alzheimer's disease (AD) continues to rise, yet effective disease-modifying pharmacotherapies remain unavailable. Early diagnosis and intervention are critical to slowing cognitive decline and reducing disease burden. In recent years, rapid advances in neuromodulation and virtual reality (VR) have opened new avenues for mechanistic studies and functional brain rehabilitation in AD and other neurodegenerative disorders. Amnestic mild cognitive impairment (aMCI) is widely regarded as the prodromal stage of AD and represents a key window for prevention and treatment. Developing innovative non-pharmacological therapies for individuals at this early stage has therefore become an urgent clinical priority. Preliminary studies indicate that people with aMCI exhibit a significant loss of phase-amplitude coupling (PAC) between theta and delta rhythms in the prefrontal cortex and temporal lobe, whereas olfactory-enriched environmental stimulation can enhance hippocampal synaptic function, improve cognition, and lower AD risk. Accordingly, we propose a large-scale clinical cohort study to investigate the neural-circuit mechanisms and clinical efficacy of multi-site, cross-frequency transcranial alternating current stimulation (tACS) and multisensory VR integrating visual, olfactory, and auditory inputs for the treatment of aMCI. We will establish a comprehensive database encompassing demographic, neuropsychological, biochemical, neuroimaging, and neuromodulation parameters. Ultimately, this work will provide optimal theoretical parameters and objective evidence to guide the development of non-pharmacological interventions for AD-specifically, a microcurrent brain stimulator and a portable VR device.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Baseline screening inclusion criteria: a) Age ≤ 65 years and ≤ 85 years; b) Education duration ≥ 1 year; c) Normal cognitive function at enrollment: MMSE total score: non-illiterate (primary school or below) ≥ 20 points, primary school or above ≥ 24 points; d) Corrected vision and hearing are basically normal, and able to complete cognitive assessment.

排除标准

  • Baseline screening exclusion criteria: a) Neurological/psychiatric disorders affecting cognitive function: depression, schizophrenia, mental retardation, Parkinson's disease, etc.; b) Severe physical illnesses: cardiovascular disease, cerebrovascular disease, tumors, diabetes, kidney disease, and hypertension stage III or above; c) Autoimmune inflammatory diseases such as rheumatoid arthritis, lupus erythematosus, osteoarthritis, and multiple sclerosis.

研究组 & 干预措施

Olfactory Stimulation Group

Experimental

干预措施: Olfactory stimulation (Behavioral)

TI Stimulation Group

Experimental

干预措施: Temporal Interference,TI (Biological)

Olfactory-TI Stimulation Group

Experimental

干预措施: Olfactory-TI Stimulation (Combination Product)

Sham Control Group

Sham Comparator

干预措施: Sham Control (Combination Product)

结局指标

主要结局

Change in Olfactory Sensitivity (TDI score)

时间窗: Baseline; 30 minutes after Session 1; 30 minutes after Session 5; 30 minutes after Session 10; 1 week after Session 10.

Change in olfactory function measured with the Sniffin' Sticks Threshold-Discrimination-Identification (TDI) composite score. Unit of Measure: TDI score, 1-48 (higher scores indicate better olfactory function).

Path Integration - Angle Deviation

时间窗: Baseline; 5 minutes after Session 1; 5 minutes after Session 5; 5 minutes after Session 10.

Absolute angular error during the path-integration task. Lower values indicate better performance. Unit of Measure: Degrees (°); lower is better.

Path Integration - Distance Deviation

时间窗: Baseline; 5 minutes after Session 1; 5 minutes after Session 5; 5 minutes after Session 10.

Difference between actual and ideal path length during the path-integration task. Lower values indicate better performance. Unit of Measure: Meters (m); lower is better.

Path Integration - Composite Accuracy (M_ROC_AUC)

时间窗: Baseline; 5 minutes after Session 1; 5 minutes after Session 5; 5 minutes after Session 10.

Area under the ROC curve computed from multivariate PI features to quantify task accuracy/reliability across sessions. Unit Measure: AUC, 0.00-1.00 (higher values indicate better accuracy/stability).

Change in Cognitive Performance (MoCA-B)

时间窗: Baseline; 5 minutes after Session 10.

Change in global cognition using the Montreal Cognitive Assessment-Basic (MoCA-B). Unit of Measure: MoCA-B score, 0-30 (higher scores indicate better cognition).

次要结局

  • Activities of Daily Living (ADL - Barthel Index)(Baseline; 30 minutes after Session 1; 30 minutes after Session 5; 30 minutes after Session 10; 1 week after Session 10.)
  • Adverse Events Related to Intervention(Baseline; 5 minutes after Session 1; 5 minutes after Session 5; 5 minutes after Session 10.)

研究者

发起方
Yuan Shen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yuan Shen

MD., Ph.D.

Tongji University

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