Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04621240 |
| Other study ID # |
20-32 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2020 |
| Est. completion date |
March 31, 2021 |
Study information
| Verified date |
April 2021 |
| Source |
The University of Texas at Dallas |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
