The Underlying Neural Mechanism of TMS in Improving the Imbalance of "Microbiota-brain-gut Axis" in Alzheimer 's Disease Population
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 主要终点
- MoCA score
研究概览
简要总结
What is this study about? This study focuses on Alzheimer's Disease (AD), a common neurodegenerative disease that affects memory, thinking, and daily life. We aim to explore whether a non-invasive treatment called Repetitive Transcranial Magnetic Stimulation (rTMS) can improve AD symptoms by regulating the "gut-brain-intestine axis" - a connection between gut bacteria, the brain, and the intestines.
Who can participate?
- **AD patients**: Aged 50-80, diagnosed with mild to moderate AD (MMSE score 18-27, MoCA score 10-26), with stable condition for at least 6 months, and able to cooperate with tests and treatment.
- **Healthy controls**: Aged 50-80, with normal cognitive function (MMSE ≥28, MoCA ≥27), no AD family history, and matched in age and gender with AD patients.
Those with epilepsy, severe mental illness, recent use of antibiotics/probiotics, or inability to complete MRI scans are not eligible.
What will participants experience?
- **AD patients**: Will be randomly divided into two groups. Both groups will receive 4 weeks of treatment (5 days/week) with a helmet-like device. One group gets real rTMS (safe magnetic stimulation to the brain), and the other gets sham stimulation (no effective magnetic field, but same sound/feel).
- **Healthy controls**: No treatment, but will complete the same tests as AD patients.
- **Tests during the study**: Cognitive assessments (memory, thinking skills via questionnaires), stool/blood sample collection (to check gut bacteria and body markers), and MRI scans (to look at brain structure/function) at baseline, 1 month, 3 months, 6 months, and 1 year.
What are the potential benefits?
- Free rTMS treatment (for AD patients), free MRI scans (valued at 700 RMB), and a 200 RMB subsidy.
- Free health checks (gut bacteria analysis, metabolic tests) and cognitive evaluations to understand personal health status.
- Contribution to developing new AD treatments that may help future patients.
Is it safe? rTMS is a clinically proven safe technique. Possible mild side effects (headache, scalp irritation) usually go away on their own. Sample collection (stool/blood) and MRI scans are non-invasive or minimally invasive. A professional team will monitor participants throughout to handle any issues.
For healthcare providers This is a multicenter, randomized, double-blind sham-controlled study (200 AD patients, 200 healthy controls). The primary goal is to explore rTMS's mechanism via the gut-brain-intestine axis, with MoCA score changes (6 months post-treatment) as the main outcome. It integrates multi-omics and neuroimaging data to provide evidence for AD's non-drug treatment.
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
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Dementia Patients: Conformed to internationally recognized diagnostic criteria for dementia (e.g., DSM-5, NINCDS-ADRDA)
- •Diagnosed through clinical evaluation, neuropsychological scale assessments, and relevant examinations
- •Aged ≥50 years and residing in Nanchang, Jiangxi
- •With dementia-negative family history, no severe psychiatric or neurological disorders
- •No history of major systemic diseases.
排除标准
- •Unable to cooperate with all required examinations, intervention procedures, and sample collection during the study.
研究组 & 干预措施
Patients undergoing treatment
干预措施: TMS (Procedure)
No treatment
The sham DLPFC-rTMS group will receive stimulation via a single helmet equipped with a sham coil, which is designed to induce similar noise and scalp sensations under the same parameters as the active stimulation group.
结局指标
主要结局
MoCA score
时间窗: Pre-intervention, Periprocedural, and Post-intervention at 1/3/6/12 months
The Montreal Cognitive Assessment (MoCA) is a widely used tool for screening mild cognitive impairment (MCI), and its scoring reflects an individual's performance in cognitive domains such as attention, memory, and language. The total score is 30; a score of ≥26 is generally considered normal, 18-25 indicates mild cognitive impairment, and ≤17 may indicate moderate to severe impairment. Higher scores in the intervention group indicate better intervention effects.
次要结局
未报告次要终点