A Randomized, Controlled Clinical Study on Cerebellar ITBS Mode Transcranial Magnetic Stimulation for the Treatment of Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The changes in CDR（Clinical Dementia Rating）
研究概览
简要总结
Study the therapeutic effect and potential neural mechanisms of cerebellar iTBS mode transcranial magnetic stimulation on Alzheimer's disease patients through MRI and EEG.
详细描述
This study intends to apply intermittent therapy for the first time θ The Outbreak Stimulation (iTBS) mode was used for rTMS treatment in the cerebellum of Alzheimer's disease (AD). This was a randomized, double-blind, parallel, and sham stimulation controlled clinical trial, which included 28 AD patients. All patients were randomly divided into the iTBS group and the sham stimulation group. Collect clinical information, scales, magnetic resonance imaging, TMS synchronous electroencephalography, polysomnography monitoring, etc., and then perform TMS/false stimulation treatment on subjects for 4 weeks (a total of 20 times); After treatment and one month follow-up, relevant scales, magnetic resonance imaging, TMS synchronous electroencephalogram and other data were collected again, and appropriate statistical methods were used to analyze 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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Alzheimer's disease patients were enrolled by expert neurol ogists who were blinded to treatment allocation. rTMS sessions were performed by dedicated technicians. The Cognitive evaluations and analysis of neuro physiological data were performed by expert neurophysiologists blinded to treatment allocation.
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 45-80 years old;
- •Meets the NIA-AA standards established by the National Institute on Aging in the United States; Cerebrospinal fluid presents as A β decrease and increase tau protein.
- •3 The MMSE score ranges from 18 to 26, and the Clinical Dementia Rating (CDR) score is 0.5 to 1 4 At least one adult caregiver 5 patients have received treatment with acetylcholinesterase inhibitors (AChEI) or memantine, such as donepezil, galantamine, or gabalin
- •Medication for at least 3 months
- •The current dosing regimen remains stable for 8 weeks
- •The medication plan remains stable throughout the entire process
- •At least 8 years of educational experience 7 Patients and their families voluntarily sign informed consent forms
排除标准
- •Central nervous system degenerative diseases other than Alzheimer's disease
- •Previous history of epilepsy (excluding febrile seizures in childhood)
- •According to the Diagnostic and Statistical Manual of Mental Disorders, the Fourth Edition - Text Revised Edition (DSM IV-TR) standard meets any of the following:
- •Depression (currently)
- •Schizophrenia
- •Other psychiatric disorders, bipolar disorder, or substance dependence (including alcohol) (within the past 5 years)
- •Cerebrovascular disease (excluding lacunar infarction), severe infection, malignant tumor, accompanied by severe dysfunction of organs such as heart, liver, and kidney
- •There are contraindications for transcranial magnetic stimulation and MRI, or there are metal or implanted devices in the body, such as pacemakers, deep brain stimulators, etc; 6 Use any of the following medications for treatment within the past 3 months:
- •Typical and atypical antipsychotic drugs (such as clozapine, olanzapine)
- •Antiepileptic drugs (such as carbamazepine, topiramate, sodium valproate) 7 has received TMS treatment in the past 8 Participate in clinical trials of any drug within 6 months prior to study registration
结局指标
主要结局
The changes in CDR（Clinical Dementia Rating）
时间窗: baseline, 4 weeks after start of the treatment
The changes in CDR-SB will constitute the major research outcome measure used to assess response to rTMS.There are two scoring methods for the CDR scale, namely Total Score Calculation (CDR-GS) and Sum of Six Content Calculation (CDR-SB). The scoring method used in this study is CDR-SB, with a total score of 18 points. The lower the score, the milder the symptoms
次要结局
- The changes in MMSE(Mini Mental State Examination)(baseline, 4 weeks and 4 weeks after treatment)
- EEG（electroencephalogram）(baseline, 4 weeks and 4 weeks after treatment)
- ADL( Lawton-Brody Activities of Daily Living)(baseline, 4 weeks and 4 weeks after treatment)
- MEP（Motor evoked potential）(baseline, 4 weeks and 4 weeks after treatment)
- NPI (Neuropsychiatric Inventory)(baseline, 4 weeks and 4 weeks after treatment)
- DST (Digital Span Test; Forward and Backward)(baseline, 4 weeks and 4 weeks after treatment)
- ADAS-cog（Alzheimer's disease assessment scale)(baseline, 4 weeks and 4 weeks after treatment)
- DMS(Delayed matching-to-sample task)(baseline, 4 weeks and 4 weeks after treatment)
- MRI measures(baseline, 4 weeks and 4 weeks after treatment)