N/A
N=180
The BrainHealth Project - Pilot Study
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT04621240 ↗Enrolled (actual)
180
Serious AEs
—
Results posted
Sep 2024
Primary outcome: Primary: The BrainHealth Index — 54 score on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Online SMART & Stress Solutions (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas at Dallas
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The BrainHealth Index |
54 | <0.001 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Minimum age of 18
- internet access and device
- fluent English speaker
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT04621240). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.