The BrainHealth Project

Official title

The BrainHealth Project, a Longitudinal Study in Generally Healthy Adults

Overview

The BrainHealth Project is a longitudinal study designed to identify factors associated with brain health and cognitive performance across the lifespan. Participants complete online assessments approximately twice per year to measure changes in cognitive, behavioral, and lifestyle-related domains. Between assessments, participants have access to digital training modules, educational resources, and optional coaching sessions. A subset of participants may be invited to participate in additional components, including neuroimaging. For an overview of the study and link TO REGISTER please go to -- https://brainhealth.utdallas.edu/programs/the-brainhealth-project/

Detailed description

Description of Study:

The BrainHealth Project is a longitudinal study designed to examine factors associated with brain health, including both maintenance and changes in cognitive function across the lifespan. Additionally, researchers aim to identify more personalized practices for promoting brain health.

The study design is informed by prior longitudinal research, namely the Framingham study, demonstrating the value of large-scale, repeated assessments in identifying modifiable factors associated with health outcomes. The goal of this study is to characterize determinants of brain health and support future research on prevention and intervention strategies.

Participants complete online assessments approximately twice per year to measure changes in cognitive performance and related domains over time. Between assessment time points, participants may engage in digital training modules, educational resources, and optional coaching sessions.

Assessments:

BrainHealth Index (\~70 min) - An online battery of cognitive measures and questionnaires. The Clarity section looks at complex thinking capacities such as reasoning, flexibility and strategy. In this section, you will be asked to complete different cognitive tasks. The questionnaires measure other aspects of life that relate to brain health, such as emotional well-being, quality of life, happiness, social support systems, and sleep. In this section, you will rate these aspects of your own life. Participants will also complete a 5 minute assessment with BrainHQ to measure processing speed.

The small group of participants who are invited to complete the brain imaging portion of the study will undergo annual brain imaging and will also complete brain gauge (in-person computer assessment). We will offer participants additional sub-studies, and they will have the opportunity to participate or not.

Additional and Exploratory Assessments:

Participants may be invited to complete additional optional surveys or behavioral tasks administered online to further characterize brain health and related behavioral, lifestyle, and biological domains. These additional assessments are exploratory in nature and are not designated as primary or secondary outcome measures.

Online Trainings, habits, and resources:

Trainings can be accessed through the online dashboard and include videos, exercises, and application opportunities. Trainings include strategies to efficiently manage complex information by abstracting its essential meaning rather than attempting to memorize Training will also include strategies for stress management and healthy sleep routines, as well as other brain health education and resources. Most trainings are no more than 10 minutes a day.

Online Coaching:

Online coaching sessions will be offered to participants. Participants can elect to take advantage of this offer to the extent they chose.

For an overview of the study and LINK TO REGISTER please go to -- https://brainhealth.utdallas.edu/programs/the-brainhealth-project/

Interventions

• Behavioral BrainHealth App-Based Program
  Participants will engage in a BrainHealth app-based program tailored for this study. The program includes ongoing microlearning modules focused on supporting brain health through evidence-informed approaches, such as thinking strategies, cognitive exercises, lifestyle practices, stress management techniques, and other brain-healthy behaviors. Participants can access educational resources on the broad topic of brain health and can utilize tools to support habit formation. Participants can comple

Primary outcome measures

• BrainHealth Index (BHI) [Time frame: Every 6 months until end of study]

Secondary outcome measures (2)

• Neural and Physiological Markers of Brain Health [Time frame: baseline, 6 months, then annually until study end]
• Engagement in Intervention [Time frame: From enrollment through study completion]

Eligibility criteria

Inclusion criteria

• English-speaking
• Access to an internet connect and device
• Able to read information and hear sounds

Exclusion criteria

• Diagnosed neurodegenerative disease
• History of stroke, concussion, or brain injury that currently hinders you from functioning at your prior level
• Diagnosed with Autism Spectrum Disorder and not functioning independently

For an overview of the study and LINK TO REGISTER please go to -- https://brainhealth.utdallas.edu/programs/the-brainhealth-project/

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• The Center for BrainHealth at The University of Texas at Dallas — Dallas

Publications

• Chapman SB, Aslan S, Spence JS, Hart JJ Jr, Bartz EK, Didehbani N, Keebler MW, Gardner CM, Strain JF, DeFina LF, Lu H. Neural mechanisms of brain plasticity with complex cognitive training in healthy seniors. Cereb Cortex. 2015 Feb;25(2):396-405. doi: 10.1093/cercor/bht234. Epub 2013 Aug 28. PMID 23985135
• Chapman SB, Fratantoni JM, Robertson IH, D'Esposito M, Ling GSF, Zientz J, Vernon S, Venza E, Cook LG, Tate A, Spence JS. A Novel BrainHealth Index Prototype Improved by Telehealth-Delivered Training During COVID-19. Front Public Health. 2021 Mar 16;9:641754. doi: 10.3389/fpubh.2021.641754. eCollection 2021. PMID 33796498
• Chapman SB, Mudar RA. Enhancement of cognitive and neural functions through complex reasoning training: evidence from normal and clinical populations. Front Syst Neurosci. 2014 Apr 28;8:69. doi: 10.3389/fnsys.2014.00069. eCollection 2014. PMID 24808834
• Chapman SB, Aslan S, Spence JS, Keebler MW, DeFina LF, Didehbani N, Perez AM, Lu H, D'Esposito M. Distinct Brain and Behavioral Benefits from Cognitive vs. Physical Training: A Randomized Trial in Aging Adults. Front Hum Neurosci. 2016 Jul 18;10:338. doi: 10.3389/fnhum.2016.00338. eCollection 2016. PMID 27462210
• Chapman SB, Spence JS, Aslan S, Keebler MW. Enhancing Innovation and Underlying Neural Mechanisms Via Cognitive Training in Healthy Older Adults. Front Aging Neurosci. 2017 Oct 9;9:314. doi: 10.3389/fnagi.2017.00314. eCollection 2017. PMID 29062276
• Motes MA, Yezhuvath US, Aslan S, Spence JS, Rypma B, Chapman SB. Higher-order cognitive training effects on processing speed-related neural activity: a randomized trial. Neurobiol Aging. 2018 Feb;62:72-81. doi: 10.1016/j.neurobiolaging.2017.10.003. Epub 2017 Oct 12. PMID 29121545
• Han K, Davis RA, Chapman SB, Krawczyk DC. Strategy-based reasoning training modulates cortical thickness and resting-state functional connectivity in adults with chronic traumatic brain injury. Brain Behav. 2017 Apr 10;7(5):e00687. doi: 10.1002/brb3.687. eCollection 2017 May. PMID 28523229
• Vas A, Chapman S, Aslan S, Spence J, Keebler M, Rodriguez-Larrain G, Rodgers B, Jantz T, Martinez D, Rakic J, Krawczyk D. Reasoning training in veteran and civilian traumatic brain injury with persistent mild impairment. Neuropsychol Rehabil. 2016 Aug;26(4):502-31. doi: 10.1080/09602011.2015.1044013. Epub 2015 May 27. PMID 26018041

Identifiers

NCT: NCT04869111 · 23-745

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗