Effects of Cognitive Training and Brain Stimulation in Prodromal Alzheimer's Disease - Randomised, Sham Controlled, Interventional Study
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
- Working memory training performance (Letter Updating task)
研究概览
简要总结
The aim of this study is to investigate whether a tDCS-accompanied intensive cognitive training of working memory leads to performance improvement in individuals with prodromal Alzheimer's disease.
详细描述
The goal of the present study is to assess behavioral (primary) effects of a multi-session cognitive training combined with transcranial direct current stimulation (tDCS). Many studies to date have found tDCS to be an efficient method to enhance various cognitive functions by modulating cortical excitability in young adults, but its behavioral impact and underlying mechanisms in pathological aging still need to be elucidated. Individuals with prodromal Alzheimer's disease, will participate in a three-week cognitive training with concurrent online tDCS application. Cognitive performance (primary) will be examined before, during and after the intervention, in order to draw conclusions about the effect of tDCS. In addition to cognitive training, a control group, receiving sham stimulation during training, will be assessed. Follow-up sessions to assess long-term effects are planned four weeks and seven months after the post assessment. Furthermore, to assess potential predictors of tDCS effects, functional and structural parameters will be measured with MRI. The results of the study will offer valuable insights into efficacy of combined tDCS and cognitive training, as compared to training alone, in individuals with prodromal stages of Alzheimer's disease. Moreover, improved understanding of tDCS effects on cognitive training performance and underlying neural correlates may help to develop novel approaches for modulating cognitive decline in healthy and pathological aging.
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, Investigator)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older adults (60 - 80 years);
- •Right handedness;
- •subjective cognitive decline (SCD) or mild cognitive impairment (MCI)
排除标准
- •Dementia or other neurodegenerative neurological disorders; epilepsy or history of seizures; close relatives with epilepsy or history of seizures; previous stroke;
- •Severe and untreated medical conditions that precludes participation in the training, as determined by responsible physician;
- •History of severe alcoholism or use of drugs;
- •Severe psychiatric disorders such as depression (if not in remission) or psychosis
结局指标
主要结局
Working memory training performance (Letter Updating task)
时间窗: 3 weeks
Performance in a memory training task (Letter updating) under anodal tDCS compared to sham condition; operationalized by working Memory Updating performance assessed with number of correctly recalled letter lists in the letter updating task, analyzed immediately after training period (anodal condition versus sham)
次要结局
- Transfer outcomes: Wiener Matrices Test (no. correct)(3 weeks)
- Long-term outcomes: Markov decision making task (% optimal actions)(4 weeks and 7 months after training)
- Long-term outcomes: numerical n-back task (% correct)(4 weeks and 7 months after training)
- Transfer outcomes: AVLT (auditory verbal learning test) (sum of correctly recalled items trials 1-5)(3 weeks)
- Long-term outcomes: Wiener Matrices Test (no. correct)(4 weeks and 7 months after training)
- Transfer outcomes: numerical n-back task (% correct)(3 weeks)
- Long-term outcomes: Letter Updating task (no. of correctly recalled lists)(4 weeks and 7 months after training)
- Working memory training performance (Markov task)(3 weeks)
- Long-term outcomes: AVLT (auditory verbal learning test) (sum of correctly recalled items trials 1-5)(4 weeks and 7 months after training)
- Neural correlates: Structural neural correlates of tDCS effect(before training; 7 months after training)
- Neural correlates: Functional neural correlates of tDCS effect(before training; 7 months after training)