The BrainHealth Project - Pilot Study
Condition: Healthy
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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

        1. 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

             1. Strategic Memory: Visual Selective Learning Task

             2. Integrated Reasoning: Test of Strategic Learning (Test of Strategic Learning, TOSL
                part I)

             3. Innovation: Test of Strategic Learning (TOSL part II)

             4. Memory for Detail: Test of Strategic Learning (TOSL part III)

           Ace Measures of Cognitive Performance - 25 minutes

             1. Basic Response Time

             2. Color Blindness screening (non-editable)

             3. Visual Search, Top-Down Attention, Distraction Cost, Processing Cost

             4. Directed Attention

             5. Selective Attention, Interference Resolution

             6. Working Memory Updating Cognitive Flexibility

           B. EMOTIONAL Well Being (Mood. Centered. Perspective. Rebound.) The EMOTIONAL Well Being
           evaluation taps into an individual's emotional sense of yourself. We will ask how they
           feel about the quality of their life, their level of happiness, their levels of stress
           and sadness, and get a gauge on their emotional resilience. (Completion time: 15 min)

             1. Happiness: Oxford Happiness Questionnaire

             2. Life Satisfaction: Quality of Life Scale

             3. Resilience: Connor-Davidson Resilience Scale

             4. Depression, Anxiety, and Stress Scale (DASS-21)

           C. SOCIAL (Engage. Relate. Connect. Empathize.) The SOCIAL evaluation looks at an
           individual's social vibrancy and quality of relationships. We want to know how they feel
           about their social support networks and the meaningfulness of their social engagements.
           (Completion time: <8 min.)

             1. Amount of Positive Social Support: Social Support Survey Index

             2. Complexity of Social Interactions: Social BrainHealth Scale

           D. DAILY FUNCTION (Strive. Challenge. Habits. Responsibility.) The DAILY FUNCTION
           evaluation monitors the complexity (depth and breadth) of your daily responsibilities,
           habits, and challenges. We are interested in how you strive to optimize your life
           circumstances and habits.

           (Completion time: 20 minutes )

             1. Mindset: BrainHealth Appraisal Questionnaire

             2. Significance of Life Engagement: Engagement in Meaningful Activities Survey

             3. Sleep: Pittsburgh Sleep Quality Index

             4. Occupational Complexity: O*Net Database Census Coding

             5. Physical Exercise: Cardiorespiratory Fitness Estimate Questionnaire

        2. Brain Imaging (2x)(resting state functional MRI), blood flow (Arterial Spin Labeling),
           cerebrovascular reactivity (CVR - with breath hold task) and white matter integrity
           (Diffusion MRI). In this pilot study, as well as the larger BrainHealth Project study,
           the neural data will be analyzed in conjunction with non-neural measures (cognitive,
           well-being, social engagement, sleep, etc.) to support the development of a reliable set
           of metrics to assess brain health.

        3. Brain Gauge by Cortical Metrics (2x) - 15 minutes. The Brain Gauge is a cognitive
           assessment tool that measures brain health by testing sensory perceptions in the
           fingertips. This will be completed at the BrainPerformance Institute prior to imaging at
           the University of Texas (UT) Dallas BrainHealth Imaging Center. During each test, two
           orange tips on the Brain Gauge device will vibrate the pointer and middle finger on a
           participant's non-dominant hand in a specific way. The computer-based application will
           ask questions about what the participant felt. By measuring eight components of brain
           health (speed, focus, fatigue, accuracy, sequencing, timing perception, plasticity, and
           connectivity) the application will then analyze responses using clinically-proven
           neuroscience to provide a comprehensive mental fitness score called the CorticalMetric.

      INTERVENTIONS Online Interventions 1. Strategic Memory Advanced Reasoning Training (SMART) is
      a curriculum that teaches strategies of how to use the brain better, in such a way that may
      improve brain health and performance. SMART strives to achieve optimal cognitive function
      realized by the brain's ability to efficiently manage complex information by abstracting its
      essential meaning rather than attempting to memorize details, and to prioritize the
      information in order to attend to the most relevant parts. Importantly, because this training
      is intended to improve cognition in the healthy population that is being studied in this
      submission, and is NOT treating or preventing a medical condition, it will not be classified
      as a medical device for the purposes of this study. Other similar online strategy-teaching
      curriculum in studies of healthy aging have set a precedent for this position, utilizing this
      rational.

      2. Stress Solutions - provides individuals with practical tools to enhance performance,
      reduce stress, build resilience and improve quality of life. Training will include the
      neurophysiological effects of chronic stress and the neurophysiological impacts of
      mindfulness. Participants will learn and practice skills in awareness, self-regulation, and
      emotion regulation through attentional focus exercises grounded in mindfulness meditation.
      This training enables learners to recognize habitual, conditioned modes of reacting and
      resources the learner with skills to make a shift in their relationship to their thoughts,
      feelings and body sensations within conditions of chronic and acute distress.
    

Intervention name(s): Online SMART & Stress Solutions
Intervention type(s): Behavioral
Intervention description(s): 1. On-line SMART - (Strategic Memory Advanced Reasoning Training) is a curriculum that teaches strategies of how to use the brain better, in such a way that may improve brain health and performance. SMART strives to achieve optimal cognitive function realized by the brain's ability to efficiently manage complex information by abstracting its essential meaning rather than attempting to memorize details, and to prioritize the information in order to attend to the most relevant parts. 2. Stress Solutions - provides individuals with practical tools to enhance performance, reduce stress, build resilience and improve quality of life.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment