A Prospective, Randomized, Double-blind, Controlled Trial of rTMS in the Treatment of Mild Alzheimer's Disease Guided by Personalized Brain Functional Sectors(pBFS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Post-treatment ADAS-Cog change
研究概览
简要总结
This study aims to investigate the effectiveness and safety of rTMS treatment under the guidance of personalized Brain Functional Sectors (pBFS) for the cognitive ability of patients with mild Alzheimer's disease.
详细描述
Alzheimer's Disease (AD) is a neurodegenerative disorder characterized by memory impairment and cognitive decline. Personalized brain functional sectors (pBFS) using resting-state functional MRI scans have shown promise in precisely identifying individualized brain function networks. In this study, we aim to select tailored stimulation sites within the working memory network (WMN) or the default mode network (DMN) as intervention targets for mild AD patients using pBFS.
To evaluate the effectiveness and safety of this intervention, participants will be randomized into four groups: active repetitive transcranial magnetic stimulation (rTMS) to the WMN group, active rTMS to the DMN group, and sham rTMS to either the WMN or DMN group at a ratio of 2:2:1:1. Each participant will receive 3600 pulse active or sham rTMS in each session, consisting of two 1800 pulse treatments with a 50-minute break in between. Two separate treatment sessions will be administered daily, resulting in a sum of 7200 pulses per day. The intervention will be administered for 15 continuous days.
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
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of probable Alzheimer's disease (probable AD) based on the AD diagnostic criteria proposed by NIA-AA.
- •Positive PET or positive cerebrospinal fluid test results for beta-amyloid (Aβ).
- •Elementary school education or higher.
- •MMSE scores between 20 and 26 (including 20 and 26), or 18 and 26 for those with elementary school education.
- •Clinical Dementia Scale (CDR) score of 1, indicating mild dementia.
- •Stable medication for Alzheimer's disease for at least 3 months prior to treatment.
- •Availability of a reliable caregiver who can assist and accompany the patient throughout the study.
- •Voluntary participation with signed informed consent by the patient or legal guardian.
排除标准
- •Patients who have other causes of cognitive decline apart from AD, including but not limited to vascular dementia, Parkinson's disease dementia, dementia with Lewy bodies, frontotemporal dementia, and dementia due to endocrine system lesions or deficiencies of folic acid, vitamin B12 or other causes.
- •Patients with significant focal lesions seen on MRI, including more than two infarct foci larger than 2 cm in diameter, infarct foci in key areas such as the thalamus, hippocampus, internal olfactory cortex, pars oligo-cortical, angular gyrus, cortical and other subcortical gray matter nuclei.
- •Patients with moderate to severe cerebral white matter degeneration ( Fazekas score of 3-6).
- •Patients unable to undergo TMS treatment or MRI scan due to metallic foreign bodies, implanted electronic devices, or claustrophobia.
- •Patients with a history of seizures or epilepsy syndrome, or seizures within the past 12 months.
- •Patients with acute cardiovascular and cerebrovascular events within the 3 months prior to screening.
- •Patients with severe cardiac, pulmonary, hepatic, renal, and other systemic diseases that cannot be controlled with conventional medications.
- •Patients with malignant tumors or a life expectancy of less than 1 year due to reasons other than AD.
- •History of alcohol or drug abuse.
- •Having received other TMS treatments within the past three months.
- •Having participated, or is currently participating in other clinical trial programs within the past three months.
研究组 & 干预措施
WMN group
Active rTMS will be delivered to the tailored stimulation site within the working memory network.
干预措施: active rTMS (Device)
DMN group
Active rTMS will be delivered to the tailored stimulation site within the default mode network.
干预措施: active rTMS (Device)
sham WMN group
Sham rTMS will be delivered to the tailored stimulation site within the working memory network.
干预措施: sham rTMS (Device)
sham DMN group
Sham rTMS will be delivered to the tailored stimulation site within the default mode network.
干预措施: sham rTMS (Device)
结局指标
主要结局
Post-treatment ADAS-Cog change
时间窗: Pretreatment (baseline), Post-treatment (15 days)
The Cognitive Subscale score change of the Alzheimer's Disease Assessment Scale, from baseline to post-treatment.
次要结局
- MMSE change(Pretreatment(baseline), post-treatment(15 days), follow-up (90 days))
- Follow-up ADAS-Cog change(Pretreatment(baseline), follow-up (90 days))