40Hz tACS in Treating Cognitive Function and Modulating Neurophysiology of Patients With Alzheimer's Disease: a Triple Blind Randomized Sham-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Alzheimer's Disease Assessment Scale-Cognitive Subscale, ADAS-Cog
研究概览
简要总结
Gamma brain activity is crucial for cognitive function and intra-brain communication. Gamma frequency stimulation via transcranial alternating current stimulation(tACS) might alleviate memory deficits on both animal models of Alzheimer's disease (AD) and clinical trial. The study aims to assess the safety and efficacy of tACS on cognitive function and modulating neurophysiology in patients with AD.
详细描述
Gamma brain activity is crucial for cognitive function and intra-brain communication. Gamma frequency stimulation via transcranial alternating current stimulation(tACS) might alleviate memory deficits on both animal models of Alzheimer's disease (AD) and clinical trial. The study aims to assess the safety and efficacy of tACS on cognitive function and modulating neurophysiology in patients with AD.
40mins 10Hz-tACS for daily consecutive sessions will be given.
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)
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 60- to 90-year-old
- •clinical dementia rating scale (CDR) of 1 or mini-mental state examination (MMSE) score of 18 to
- •Participants were allowed to maintain their anti-dementia medications without changes from at 3 months before and throughout the study.
排除标准
- •having contraindications for tACS, e.g., implanted brain medical devices or mental in the head, having arrhythmia and with pacemaker implantation, having history of seizures, having history of intracranial neoplasms or surgery, or severe head injuries or cerebrovascular diseases
- •clinical depression measured by Hamilton depression rating scale score equal and over 17
结局指标
主要结局
Alzheimer's Disease Assessment Scale-Cognitive Subscale, ADAS-Cog
时间窗: Change from baseline, two weeks, and one months follow-up
The ADAS-Cog consists of items from the following areas chosen for their sensitivity to Alzheimer's disease: language; memory; praxis; and orientation. The test takes 30-35 minutes to administer and the item scores generally range from 1-5.
次要结局
- Wechsler adult intelligence scale, WAIS-IV, digit span(Change from baseline and two weeks)
- peripheral amyloid beta and tau related markers(Change from baseline and two weeks)
- Wechsler adult intelligence scale, WAIS-IV, vocabulary(Change from baseline and two weeks)
- Mini-Mental State Examination, MMSE(Change from baseline and two weeks)
- HRV (heart rate variability)(Change from baseline, after one session, and two weeks)
- Wechsler adult intelligence scale, WAIS-IV, digit symbol coding(Change from baseline and two weeks)
- EEG (electroencephalogram)(Change from baseline, after one session, and two weeks)
- Subjective Cognitive Decline Questionnaire: SCD-QMyCog(Change from baseline and two weeks)
- Neuropsychiatric Inventory (NPI)(Change from baseline and two weeks)
研究者
Che-Sheng Chu
Attending Physician
Kaohsiung Veterans General Hospital.