Preventing Cognitive Decline and Dementia Through an Innovative Immersive Virtual Reality and Telemedicine-based Multi-component Intervention: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Cognitive functioning (1): change scores on the Face-Name Associative Memory Exam
研究概览
简要总结
Older adults with subjective cognitive decline (SCD) are at high risk of developing dementia and frequently experience subclinical symptoms (e.g., anxiety, depression) which are themselves associated with dementia and cognitive decline risk. To date, the lack of effective disease-modifying treatments, along with the reliable identification of modifiable lifestyle risk factors (e.g., cognitive activity, dietary habits, physical exercise), have led to growing interest to invest in non-pharmacological interventions that may reduce the prevalence and incidence of dementia and cognitive decline in older adults. In this framework, the aim of this project is to evaluate the efficacy of an Immersive Virtual Reality (IVR) and telemedicine-based multi-component intervention, combining cognitive training and a health and lifestyle education program, for preventing cognitive decline and dementia in at-risk individuals (i.e., SCD). For this purpose, a randomized, double-blinded controlled trial (RCT) will be conducted on seventy-five eligible individuals with SCD, who will be randomly assigned to one of three conditions: (a) multi-component intervention (MC-I), including SCD-tailored cognitive IVR training plus a health and lifestyle education program, (b) cognitive-only intervention (CO-I), including the SCD-tailored cognitive IVR training plus an active control for the education program, and (c) active control intervention (AC-I) for both cognitive training and education program. Intervention will be provided in 20 at-home sessions (4 sessions/week, each lasting about 30 minutes) over a period of 5 weeks. Outcome measures include clinical, neuropsychological, behavioural and neuroimaging data that will be collected before and immediately after intervention in order to detect potentially intervention-induced changes in objective cognitive functioning (primary outcome), subjective cognitive functioning, mood, quality of life and brain connectivity (secondary outcome). Users' compliance with IVR and telemedicine approach will be also evaluated, as well as individuals' factors affecting training efficacy.
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
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Self-perceived decline in cognition compared to five years ago
- •Lack of objective cognitive impairment.
排除标准
- •Clinically significant depression and anxiety;
- •Psychiatric disorders;
- •Unstable medical conditions.
- •Severe visual, auditory, verbal or physical impairments interfere with communication, command compliance, and strategy execution
- •Dizziness or epilepsy history;
结局指标
主要结局
Cognitive functioning (1): change scores on the Face-Name Associative Memory Exam
时间窗: Baseline, post-intervention (around 6 weeks after baseline)
The Face-Name Associative Memory Exam (short form - FNAME12) is an associative long-term memory task that requires the participant to learn and retrieve 12 novel face-name and face-occupation pairs. It consists of two learning phases, followed by an immediate cued recall and a 30-min delayed recall and recognition trial. For each trial, scores range from 0 to 12, where higher scores indicate better memory performance.
Cognitive functioning (2): change scores on the Visual Short-Term Memory Binding Test
时间窗: Baseline, post-intervention (around 6 weeks after baseline)
The Visual Short-Term Memory Binding Test is a recognition task based on a change detection paradigm for arrays of stimuli presented on a computer screen. Two conditions are investigated, that is, a shape-only condition as the first and a shape-color condition as the second. In both conditions, participants are asked to remember visual arrays of two or three black polygons (in the shape-only condition) or colored polygons (in the shape-color condition) presented for 2 s (study phase). For each condition, scores range from 0 to 32, where higher scores indicate better memory performance.
Cognitive functioning (3): change scores on the Spatial pattern separation test
时间窗: Baseline, post-intervention (around 6 weeks after baseline)
The Spatial pattern separation test assesses the ability to differentiate partially overlapping patterns of activation in order to retrieve one pattern as separate from others that are similar. Specifically, it consists of 36 trials, in which the participant is required to learn the location of a grey circle on a sceen; then the participant is required to recognize the position of the previously-learned grey circle with respect to a foil located either to the left or the right of the target. Scores range from 0 to 36, where higher scores indicate better memory performance.
次要结局
- Transfer effect on self-perceived cognitive functioning: change scores on the Subjective Memory Complaints Questionnaire(Baseline, post-intervention (around 6 weeks after baseline))
- Intervention-induced changes in whole-brain functional connectivity(Baseline, post-intervention (around 6 weeks after baseline))
- Transfer effect on mood (1): change scores on the 30-item Geriatric Depression Scale(Baseline, post-intervention (around 6 weeks after baseline))
- Transfer effect on mood (2): change scores on the State-Trait Anxiety Inventory(Baseline, post-intervention (around 6 weeks after baseline))
- Transfer effect on mood (3): change scores on the 18-item Apathy Evaluation Scale (AES)(Baseline, post-intervention (around 6 weeks after baseline))
- Transfer effect on quality of life and health status: Change scores on the Short Form-36 Health Survey(Baseline, post-intervention (around 6 weeks after baseline))
研究者
Maria Stefania De Simone
Principal investigator
I.R.C.C.S. Fondazione Santa Lucia