Cognitive Enhancement in Healthy Elderly People
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Visual episodic memory of word pairs learning test (Marshall et al., 2004)
研究概览
简要总结
According to the European Commission Special Report, till 2030 it is expected ca. 40% increase of population aged 66-79. Increasing population of elderly people in modern society has suggested that more individuals are expected to suffer from cognitive deficits, as chronological aging is usually accompanied by declined cognition, in particular memory functions.
The cognitive decline reaches medical attention for about 5-25% of the elderly population (over 65 years of age) as they suffer from Mild Cognitive Impairment (MCI). MCI is usually referred to as an intermediate phase between the expected cognitive decline of normal aging and the pathological cognitive decline linked to dementia. In recent years, a new viewpoint argues that substantial improvement in cognitive function may be possible even in older age, using appropriately designed training programs. In the current project the investigators propose a potential intervention that might delay the onset of dementia by maintaining cognitive performance in general and improving in MCI in particular.
The current approach is to employ cognitive enhancement protocols, such as the combination of non-invasive, low intensity electrical stimulation and memory training aiming to preserve and ultimately improve cognitive abilities in MCI and healthy elderly.
详细描述
Aging is associated with several physiological changes that affect global functioning, daily activity and quality of life. For instance, cognitive functions progressively decline during normal aging, as evidenced by decreased episodic memory and working memory (WM) performance.
The above mentioned cognitive decline reaches medical attention for about 5-25% of the elderly population (over 65 years of age) as they suffer from Mild Cognitive Impairment (MCI). MCI is usually referred to as an intermediate phase between the expected cognitive decline of normal aging and the pathological cognitive decline linked to dementia. Around 46% of people with MCI develop dementia within three years, compared to 3% of the age-matched population. According to Peterson's initial definition (Petersen, 2004), The selected technique to improve cognition as the investigators propose here is transcranial non invasive brain stimulation (TES). The investigators will employ a couple of these techniques of neuromodulation that have proven to influence performance in different cognitive domains. Here the investigators propose to combine the investigators' expertise and to investigate the effects on cognition and health of brain stimulation-based treatment in MCI patients compared to matched healthy controls, combine it with cognitive training and explore the longer term effects of the intervention.
Objectives. The main objective of the proposed research is to explore the potential intervention based on non-invasive brain stimulation and cognitive training to improve cognition in the elderly. In particular the investigators aim to explore:
- The immediate efficacy of various stimulation protocols with cognitive training on cognitive improvement in the elderly.
- The long term effect of a selected stimulation protocol on MCI improvement in the elderly.
According to a large controlled study on cognitive stimulation for people with MCI, the treatment proved effective in improving the functioning in several cognitive areas compared to a control group (Ball et al., 2002).The cognitive training in this study included a computerized training, which is more enjoyable and effective than pencil-and paper training due to its immediate feedback and engaging nature. In their systematic review of 26 studies on computerized cognitive training (CCT) for older people with known MCI, Hill et al. (2016) concluded that CCT is an efficient tool for cognitive enhancement in older people with MCI. The overall effect size on cognition score was moderate (Hedges' g=0.35); a large significant effect size on working memory; and there were moderate significant effect sizes for specific cognitive domains, such as verbal memory, non-verbal learning, attention and on psychological functioning measures. In contrast, and consistent with findings of previous CCT meta-analysis (Motter, Pimontel et al., 2016), there were insignificant results regarding executive functions, processing speed and non-verbal memory. The results on dementia patients, as opposed to MCI ones, were less optimistic: there was only a small but statistically significant effect size of the overall efficacy of the CCT on cognition enhancement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants are randomly assigned to one of the four groups and are not aware whether they receive sham or real stimulation.
Data analysis will be conducted with analysts blind to the study condition.
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
- 是
入选标准
- •normal or corrected-to-normal vision good general health independent living MoCa score of at least 24 -
排除标准
- •A history of acute or chronic neurological illness, heart disease, metabolic disorders, vascular disorders psychiatric disorder. epilepsy metal implants
结局指标
主要结局
Visual episodic memory of word pairs learning test (Marshall et al., 2004)
时间窗: Change from baseline (before treatment) to immediately after treatment (6 weeks) and 3 months after end of treatment
Number of correctly recalled word pairs
Ray auditory verbal learning test (episodic memory) includes immediate recall, and after time (Carlesimo et al., 1996),
时间窗: Change from baseline (before treatment) to immediately after treatment (6 weeks) and 3 months after end of treatment
Number of correctly recalled items
次要结局
- Logical Memory Test 1 (Craft et al., 2000; Wechsler, 2008)(Change from baseline (before treatment) to immediately after treatment (6 weeks) and 3 months after end of treatment)
- Montreal questionnaire for Cognitive Assessment (MoCA, Nasreddine et al., 2005)(Change from baseline (before treatment) to immediately after treatment (6 weeks) and 3 months after end of treatment)