- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04869111
The BrainHealth Project
The BrainHealth Project, a Longitudinal Study in Generally Healthy Adults
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/
Study Overview
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/
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Erin C, MS
- Phone Number: 9728833208
- Email: erin.venza@utdallas.edu
Study Contact Backup
- Name: Margaret Chaplin, MA
- Phone Number: (972) 883-3347
- Email: brainhealthproject@utdallas.edu
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75235
- Recruiting
- The Center for BrainHealth at The University of Texas at Dallas
-
Contact:
- Margaret Chaplin, MA
- Phone Number: (972) 883-3347
- Email: brainhealthproject@utdallas.edu
-
Contact:
- Erin Venza, MS
- Phone Number: 972-883-3208
- Email: brainhealthproject@utdallas.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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/
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Online SMART Intervention & Stress Solutions
Strategic Memory Advanced Reasoning Training (SMART) teaches meta-cognitive strategies for individuals to apply to their daily lives for improved performance
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BrainHealth Index Score
Time Frame: Every 6 months for 10 years
|
We will assess change on a holistic measure of cognitive, social, well-being, and daily life health on the BrainHealth Index (BHI) across multiple timepoints.
Higher score = Better outcome)
|
Every 6 months for 10 years
|
|
Functional Magnetic Resonance Imaging (fMRI) Measure of Neural Correlations
Time Frame: Every 6 months for 10 years
|
We will assess change in regional cerebral brain blood flow (using fMRI) in correlation with gains in complex abstraction across multiple timepoints.
(higher correlation = better outcome)
|
Every 6 months for 10 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sandra B Chapman, PhD, Center for BrainHealth
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Das N, Spence JS, Aslan S, Vanneste S, Mudar R, Rackley A, Quiceno M, Chapman SB. Cognitive Training and Transcranial Direct Current Stimulation in Mild Cognitive Impairment: A Randomized Pilot Trial. Front Neurosci. 2019 Apr 12;13:307. doi: 10.3389/fnins.2019.00307. eCollection 2019.
- Han K, Martinez D, Chapman SB, Krawczyk DC. Neural correlates of reduced depressive symptoms following cognitive training for chronic traumatic brain injury. Hum Brain Mapp. 2018 Jul;39(7):2955-2971. doi: 10.1002/hbm.24052. Epub 2018 Mar 23.
- Venza EE, Chapman SB, Aslan S, Zientz JE, Tyler DL, Spence JS. Enhancing Executive Function and Neural Health in Bipolar Disorder through Reasoning Training. Front Psychol. 2016 Nov 1;7:1676. doi: 10.3389/fpsyg.2016.01676. eCollection 2016.
- Gallen CL, Baniqued PL, Chapman SB, Aslan S, Keebler M, Didehbani N, D'Esposito M. Modular Brain Network Organization Predicts Response to Cognitive Training in Older Adults. PLoS One. 2016 Dec 22;11(12):e0169015. doi: 10.1371/journal.pone.0169015. eCollection 2016.
- Cook LG, Spence JS, Chang Z, Venza EE, Tate A, Robertson IH, D'Esposito M, Ling GSF, Wigginton JG, Chapman SB. Measuring and increasing the brain health span across adulthood: a public health imperative. Sci Rep. 2026 May 2. doi: 10.1038/s41598-026-51403-3. Online ahead of print.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 23-745
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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