Speed of Processing (SoP) Training Plus α-tACS in People With Mild Cognitive Impairment: a Double Blind, Parallel, Placebo Controlled Trial Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Useful Field of View Test (UFOV)
研究概览
简要总结
The current proposal aims to assess if the combination of Speed of Processing (SoP) training with alpha tACS (α-tACS) is able to increase brain speed of processing as assessed by the Useful Field of View (UFOV) when comparing to SoP training plus sham α-tACS. Moreover, a second aim is to assess if those changes in speed of processing transfer to other cognitive domains, such as memory, language and executive functioning. Furthermore, the mechanisms underlying these interventions will be tested, namely to assess brain connectivity and coherence as assessed by EEG. To that purpose, the aim of the current proposal is to conduct a double-blind, parallel randomized trial assessing the effects of combining SoP with alpha endogenous tACS (either active or sham) in participants with Mild Cognitive impairment (MCI).
详细描述
Dementia is thought to affect 6.3 million people across Europe and is especially prevalent in people over 85 years old (23.7%). In this sense, several cognitive training programs, alone or in combination with non-invasive brain stimulation have been used in order to ameliorate age-related cognitive impairments, and even to act in a prophylactic manner in order to prevent more extreme deficits, such as the ones presented in mild cognitive impairment, or even dementia.
Despite all these efforts, the effects of CT - combined or not - with several forms of non-invasive brain stimulation have been modest at most.
The current proposal aims to assess if Speed of Processing (SoP) training combined with alpha tACS (α-tACS) increases speed of processing as assessed by the Useful Field of View (UFOV) when comparing to SoP training and sham α-tACS. Furthermore, association betweens changes in speed of processing and changes in other cognitive domains, such as memory, language and executive functioning will be assessed. Finnaly, the current proposal aims at probing the mechanisms underlying these interventions, namely to test brain connectivity and coherence as assessed by EEG.
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, Care Provider, Outcomes Assessor)
盲法说明
Sham tACS and cognitive training
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Community-dwelling adults aged 65 years and older, with cognitive complains in memory or other functions, which have declined over time
排除标准
- •Score in the mini mental examination less than 23 (or over 28);
- •Diagnosis of Alzheimer´s Disease, any other medical condition that may predispose participants for a forthcoming decline in function, or that may increase their risk of mortality during the duration of the study.
- •Any contra-indication to tACS, severe sensory losses or communication difficulties that will prevent them from successfully complete the training.
- •Had any cognitive training in the past.
结局指标
主要结局
Useful Field of View Test (UFOV)
时间窗: Change from baseline to week 3
UFOV is a measure of the speed of visual processing for rapid detection and localization of targets under conditions of divided visual attention and in the presence and absence of visual clutter at an above chance level (i.e. 75%).
Useful Field of View (UFOV)
时间窗: Change from baseline to week 6
UFOV is a measure of the speed of visual processing for rapid detection and localization of targets under conditions of divided visual attention and in the presence and absence of visual clutter at an above chance level (i.e. 75%).
次要结局
- EEG power in the alpha band(Change from baseline to week 6)
- Executive Composite Score from the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (NIH EXAMINER)(Change from baseline to week 6)
- P300 Event related potential - A(Change from baseline to week 6)
- P300 Event related potential - L(Change from baseline to week 6)