The Efficacy and Neural Mechanism of Acupuncture Treatment in Older Adults With Subjective Cognitive Decline: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in cognitive function
研究概览
简要总结
This study evaluates the efficacy and mechanism of acupuncture treatment in patients with subjective cognitive decline. Half of patients will receive acupuncture treatment for 12 weeks, while the other half will receive sham acupuncture treatment for 12 weeks .
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female adults aged 55-75;
- •Native Chinese speakers with right-handed and at least a primary school education;
- •Self-reported persistent memory decline, which was confirmed by caregivers;
- •Normal general cognitive function and not meeting the criterion of mild cognitive impairment, as defined by performance within the normal range on both measures within at least one cognitive domain or in each of the three cognitive domains sampled (adjusted for age and education);
- •No or minimal impairment in activities of daily living;
排除标准
- •Presence of positive neurologic history (e.g., traumatic brain injury, stroke, Parkinson's disease, multiple sclerosis, etc.) ;
- •treatments that would affect cognitive function;
- •Presence of significant psychiatric history (e.g., bipolar disorder, schizophrenia, etc.) and/or severe anxiety and depression;
- •Presence of serious heart, kidney, liver, gastrointestinal, infectious, endocrine disease or cancer;
- •History of alcohol or drug abuse/addiction in nearly two years;
- •Any contraindications for magnetic resonance imaging (MRI) scans (e.g., aneurysm clip pacemaker, etc.);
- •Significant visual and/or auditory impairment uncorrected by aids, and unable to perform neuropsychological evaluations;
- •Currently enrolled in another research study;
- •Received acupuncture treatment in the preceding month.
研究组 & 干预措施
Acupuncture group
干预措施: Acupuncture group (Device)
Sham acupuncture group
干预措施: Sham acupuncture group (Device)
结局指标
主要结局
Change in cognitive function
时间窗: Changes from baseline at 12 weeks
A composite score will be computed by averaging z-scores from Animal Fluency Test, Digit Symbol Substitution Test, Trail-Making Test Parts A and B, Stroop Color Word Test C, Digit Span Test, Boston Naming Test, Clock Drawing Test and Auditory Verbal Learning Test delayed recall and delayed recognition.
次要结局
- Neuroplasticity outcome(baseline and 12 weeks)
研究者
Ping Zhou
doctor
Beijing Hospital of Traditional Chinese Medicine