The BrainHealth Project - Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- The BrainHealth Index
研究概览
简要总结
The proposed project is a pilot study in preparation for a larger study called The BrainHealth Project. The BrainHealth Project will be a prospective, longitudinal (10 yr) study focused on identifying determinants of brain health. Over the 4-month time commitment of this pilot study, 200 participants will complete online cognitive testing & functional magnetic resonance imaging (fMRI) at 2 time points (pre- and post-intervention). Up to 200 participants will complete online cognitive testing at 2 time points (pre- and post-intervention) and no fMRI. In between those time points, all participants will participate in online training and education regarding ways to optimize brain health, as well as overall health. Online training that will be recommended to participants include the following: (1) Strategic Memory Advanced Reasoning Training (SMART) teaches meta-cognitive strategies for individuals to apply to their daily lives for improved performance; and (2) Stress Solutions provides individuals with practical tools to reduce stress, build resilience and improve quality of life.
The main objectives are: (i) to characterize lifestyle, cognitive, and behavioral markers related to an individual's cognitive function from adolescent to elderly ages, (ii) to assess the neural/biological determinants predictive of maintenance of brain health, and (iii) to evaluate the impact of available cognitive and lifestyle interventions on improving and maintaining brain health.
详细描述
The Center for BrainHealth and Brain Performance Institute have years of experience working as a translational research facility with the mission of delivering evidence-based BrainHealth services to the public. However, as the goal of the larger project is to reach 120,000 individuals, this is only feasible through the use of online, remote interactions. Historically, the preponderance of experience at the Center for BrainHealth and Brain Performance Institute has been through face-to-face interactions. In order to make this shift to remote assessments, training, and interactions, we propose a pilot study of up to 400 healthy adults aimed at informing and perfecting the protocols for the larger study. In order to better understand any modifications or enhancements that may be required to the current online assessments and training, these pilot study participants will be selected from the local population, and will complete their BrainHealth Assessment, as well as complete online training.
The assessments and training included in this protocol consist of:
ASSESSMENTS
- Online BrainHealth Index (2x) - a battery of measures of connected language, which have been found to be preserved in normal aging (see list of previous studies in the next section), combined with standardized neuropsychological measures that assess other areas of cognition such as attention, memory, visuospatial, executive and psychomotor functions.
A. COGNITIVE (Recall. Learn. Solve. Innovate.) The COGNITIVE evaluation looks at how an individual thinks. We will look at complex thinking capacities - such as reasoning, flexibility, and strategy - and specific thinking components, such as processing speed, attention, and memory. (Completion time ~ 1 hour) BrainHealth Measures of Cognitive Performance - 30 minutes
- Strategic Memory: Visual Selective Learning Task
- Integrated Reasoning: Test of Strategic Learning (Test of Strategic Learning, TOSL part I)
- Innovation: Test of Strategic Learning (TOSL part II)
- Memory for Detail: Test of Strategic Learning (TOSL part III)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Minimum age of 18
- •internet access and device
- •fluent English speaker
排除标准
- •Children are excluded from this study
- •Individuals who do not speak or read English
- •If individuals have undergone an in-person BrainHealth Index (previously BrainHealth Physical), they will need to wait 6 months have passed to participate.
- •Individuals who will complete the imaging component must pass an fMRI screener and score a 26 or above on the TICS (Telephone Interview Cognitive Status)-M.
- •A history of neurological disorders, injuries or disabilities (dementia, multiple sclerosis, Parkinson's, traumatic brain injury, stroke)
- •A history of psychiatric disorders (schizophrenia, bipolar disorder, or others related to anxiety, depression, panic)
- •A history of uncontrolled health issues (substance abuse, hypertension, hypo- or hyper-thyroidism)
结局指标
主要结局
The BrainHealth Index
时间窗: 3 months
The BrainHealth Index is a composite score of 22 individual measures encompassing four components of brain health, including (1) cognitive performance, (2) mental well-being, (3) daily life functioning (e.g., sleep, fitness, activities), and (4) social interactions/engagement. \[Composite score min value = 30, Composite score max value = 82, higher composite score = better outcome\]
次要结局
未报告次要终点