Effects of a Computer-based Cognitive Stimulation on the Verbal Learning and the Progression of White Matter Hyperintensities in Mild Cognitive Impairment: A Protocol for a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 主要终点
- Change on Rey Auditory Verbal Learning test
研究概览
简要总结
This is a non-pharmacological study evaluating the impact of a computerized cognitive stimulation program on verbal learning and on the progression white matter hyperintensities in elderly with mild cognitive impairment.
详细描述
White matter hyperintensities (WMH) can appear in Mild Cognitive Impairment (MCI) and have been associated to executive, attention and processing speed deficits. Some findings indicate that the presence of WMH may contribute to Alzheimer's disease (AD) in addition to ß-amyloid, suggesting a greater vulnerability of MCI. One important challenge is to prevent or slowing down the progression of WMH. Few studies investigated the effects of computerized cognitive interventions in MCI with WMH, which deserve special attention. This study aim to investigate the effects of an intensive computer-based cognitive stimulation (CCS) program on the verbal learning in episodic memory in MCI with WMH and to explore the effects on the progression of WMH at 1-year interval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Mild Cognitive Impairment
- •With and without with matter hyperintensities
- •MRI data available or accept to perform one
- •No engagement in other cognitive intervention program
排除标准
- •Psychiatric and neurological disorders
- •History of alcohol or other substance consumption
- •Sensory and or motor deficit that could interfere with the use of computer tool
- •Refusal MRI.
结局指标
主要结局
Change on Rey Auditory Verbal Learning test
时间窗: Baseline assessment in 3-weeks period before intervention, change from baseline at 6-months immediately after the end intervention, and after 3-months follow-up
Assessment of verbal learning in episodic memory
次要结局
- Change on Fazekas scale(Baseline assessment of WMH severity and evolution at 12 months immediately after intervention)
研究者
Leila DJABELKHIR
PhD candidate
Broca Hospital