EEG-Based Non-Invasive Brain-Computer Interface Combined With 40Hz Audio-Visual Stimulation for Cognitive Function in Patients With Alzheimer's Disease: A Randomized Double-Blind Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
研究概览
简要总结
This study aims to evaluate the efficacy and safety of non-invasive brain-computer interface (BCI) neuromodulation technique combined with 40Hz audio-visual stimulation on cognitive function in patients with Alzheimer's disease (AD). This is a single-center, randomized, double-blind, sham-controlled trial. A total of 90 participants with Aβ-PET positive AD diagnosed according to NIA-AA criteria will be enrolled and randomly assigned to three groups in a 1:1:1 ratio: (1) 40Hz stimulation group (fixed 40Hz audio-visual stimulation, 60 minutes daily for 6 months), (2) individualized stimulation group (closed-loop BCI with real-time EEG feedback to adjust stimulation parameters, 60 minutes daily for 6 months), and (3) sham stimulation group (inactive stimulation, same duration). The primary outcome is the change in MoCA-B score from baseline to 6 months. Secondary outcomes include changes in cognitive domain-specific assessments (AVLT, STT, DST), multimodal brain imaging, EEG parameters, peripheral blood AD biomarkers, safety, tolerability, and comparison of efficacy between open-loop and closed-loop stimulation.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Alzheimer's disease according to the NIA-AA 2018 diagnostic criteria.
- •Age between 50 and 80 years, inclusive.
- •Positive Aβ-PET scan result.
- •Has a stable caregiver who can assist with daily stimulation intervention.
- •Chronic medical conditions stable for at least 30 days.
- •Adequate vision and hearing to perform testing (at minimum, ability to perceive light and communicate in daily conversation).
- •Good mobility (able to walk independently or with assistive devices).
- •Willing and able to provide voluntary signed informed consent.
排除标准
- •History of epilepsy or seizure disorder.
- •Inability to undergo MRI or presence of significant abnormalities on MRI screening.
- •Geriatric Depression Scale (GDS) score >
- •Current suicidal ideation or suicide attempt within the past 6 months.
- •Other major neurological disorders, including but not limited to: dementia with Lewy bodies, frontotemporal dementia, Huntington's disease, Creutzfeldt-Jakob disease, Down syndrome, or mixed dementia; other neurodegenerative diseases (Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis, etc.); history of severe brain infection (meningitis/encephalitis) or multiple concussions; metabolic/systemic diseases causing cognitive impairment (syphilis, vitamin B12 or folate deficiency, etc.).
- •Psychiatric disorders.
- •Severe cardiac disease, chronic liver/kidney/respiratory disease, or uncontrolled diabetes mellitus or thyroid disease.
- •History of drug or alcohol abuse within the past 12 months.
- •Current exposure to anti-Aβ antibody immunotherapies.
- •Current use of memantine within 30 days prior to intervention.
- •Life expectancy < 24 months.
研究者
liu jun
Chief Physician, Chief of Neurology
Ruijin Hospital