Effect and Safety of Non-invasive Electrical Stimulation in Improving Cognitive and Depressive Symptoms in Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Alzheimer Disease Assessment Scale-Cognitive(ADAS-Cog)
研究概览
简要总结
Alzheimer's disease (AD) is the most common neurodegenerative disorder, characterized primarily by cognitive impairment as its main clinical symptom, often accompanied by emotional disturbances such as depression and anxiety, imposing a significant disease burden. Temporal Interference Stimulation (TIS) is an emerging non-invasive electrical stimulation technique that precisely targets deep structures within the hippocampus through interference of multiple electric fields. This study will administer a two-week TIS treatment to patients with AD co-occurring depression, targeting the hippocampus, and compare changes in patients' cognitive function, scores on depression and anxiety scales, and functional magnetic resonance imaging (fMRI) data before and after treatment. An emotional word recall task will be administered during fMRI scans. The aim of this study is to investigate the efficacy, safety, and neural mechanisms of TIS-mediated modulation of hippocampal circuits in improving cognitive and emotional functioning in patients with AD and comorbid depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Right-handed, Han ethnicity; (2) Meet the clinical diagnostic criteria for Alzheimer's disease as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); (3) Age ≥60 years, with at least primary school education, and capable of cooperating during testing; (4) Mini-Mental State Examination (MMSE) score <24; (5) Clinical Dementia Rating (CDR) score of 0.5 or 1; (6) The 24-item Hamilton Depression Scale (HAMD-24) score ≥20.
排除标准
- •(1) Systemic diseases causing cognitive impairment, such as hypothyroidism, vitamin B12 or folic acid deficiency, and acquired immunodeficiency syndrome; (2) Comorbid neurological disorders including epilepsy, Parkinson's disease, normal-pressure hydrocephalus, and brain tumors; (3) Comorbid mental illnesses such as schizophrenia, bipolar disorder, or psychiatric disorders due to alcohol or drug abuse; (4) History of post-traumatic loss of consciousness, intracranial infection, or cerebrovascular disease; (5) A Hachinski Ischemic Scale (HIS) score ≥4; (6) Cranial MRI revealing ischemic lesions involving critical brain regions like the hippocampus, thalamus, basal ganglia, or angular gyrus, or multiple ischemic lesions in deep gray matter of the cerebral hemispheres; (7) Inability to undergo MRI due to special conditions such as internal metal implants or pacemakers.
研究组 & 干预措施
Temporal Interference Stimulation
Specific electrode sites are customized for the subject through magnetic resonance scanning, the Hippocampal region to be stimulated is calibrated through electric field simulation before treatment, and the stimulation target can be accurately positioned by stimulating the specific electrode sites of the subject during treatment.
干预措施: Temporal Interference Stimulation (Device)
结局指标
主要结局
Alzheimer Disease Assessment Scale-Cognitive(ADAS-Cog)
时间窗: From enrollment to the end of treatment at 2 weeks
The Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) is a brief, standardized, and widely used neuropsychological assessment designed to measure the severity of cognitive impairment, specifically the core symptoms of Alzheimer's disease (AD).Total Score Range:0 to 80. The higher scores mean a worse outcome.
The 24-item Hamilton Depression Scale (HAMD-24)
时间窗: From enrollment to the end of treatment at 2 weeks
The 24-item Hamilton Depression Scale (HAMD-24) is one of the most widely used clinician-administered questionnaires in psychiatry to assess the severity of depression.The total score ranges from 0 to 76, and higher scores mean a worse outcome.
次要结局
- Mini-Mental State Examination (MMSE)(From enrollment to the end of treatment at 2 weeks)
- Clinical Dementia Rating (CDR)(From enrollment to the end of treatment at 2 weeks)
- Hamilton anxiety scale (HAMA)(From enrollment to the end of treatment at 2 weeks)