TBINCT04109027
Strengthening Neuro-Cognitive Skills for Success in School, Work and Beyond
A study testing BrainStrong-BSR and BrainStrong-OPT in people with TBI and Cognitive Dysfunction, run by VA Office of Research and Development at 1 site in United States.
Trial summary
For many Veterans, success in achieving goals at work, school and in other aspects of life are top priorities. The abilities to regulate attention, remember key information, and stay calm and on track are fundamental to this success. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- TBI, Cognitive Dysfunction
- What is being tested?
- BrainStrong-BSR and BrainStrong-OPT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2024to 5 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Post 9/11 Veterans
- history of mild-moderate traumatic brain injury (including reported mechanism of head injury and alteration of consciousness)
- in the chronic, stable phase of recovery (>6 months from injury); with at least 1 self-reported cognitive symptom --including difficulties with working memory; and interested in goal-setting and intensive training
Who cannot join
- Severely apathetic/abulic, aphasic, or other reasons for being unable or unwilling to participate in training
- severe cognitive dysfunction (below 2 standard deviations on two composite cognitive domains)
- schizophrenia
- bipolar disorder
- history of other neurological disorders
- current medical illnesses that may alter mental status or disrupt participation in the study
- active psychotropic medication changes
- symptom magnification or malingering
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Northern California Health Care System, Mather, CA
Sacramento, California, 95655-4200
Jefferson Lee, (916) 843-2769, Jefferson.Lee2@va.gov
Lucita E Echaluse, BSN, (916) 843-7195, lucita.echaluse@va.gov
About this study
For many Veterans, success in achieving goals at work, school and in other aspects of life are top priorities. The abilities to regulate attention, remember key information, and stay calm and on track are fundamental to this success. Unfortunately, Veterans who have experienced a traumatic brain injury (TBI) often struggle with these very abilities, and a number of barriers can make it difficult for them to access the help Veterans need. Tele-rehabilitation has the potential to overcome some of these barriers and increase access to care, enabling providers to better reach Veterans 'where they are' in their communities. This project will assess two different approaches to brain injury rehabilitation that seek to help Veterans build personal strengths to better accomplish their goals. Both approaches will be delivered remotely via tele-rehabilitation and augmented by digital apps to best support Veterans' learning in community settings outside the VA.
Read the detailed description
This project will offer two training approaches targeting difficulties with goal-directed functioning associated with traumatic brain injury. Both approaches will be delivered remotely via tele-rehabilitation and augmented by digital apps - an intervention framework that addresses known barriers to engagement (e.g., convenience and access) and provides tools to intensify training. The study will be open to eligible Veterans (ages 21-60 years old) with history of mild-to-moderate TBI who experience difficulties with cognitive-emotional regulation and goal-directed functioning. After screening for eligibility and providing informed consent, participants will be allocated by permuted block randomization into one of two treatments: Education to optimize brain functioning (OPT), which will teach Veterans about brain health, brain injury and factors that affect brain functioning, or training in goal-directed state regulation skills (GSR), which will teach Veterans skills for regulating cognitive-emotional functioning during goal pursuit. A special emphasis on outreach will be to recruit student Veterans with TBI.
Each intervention will be matched for delivery method, expectation of benefit, workload and attention, and overall duration. Training will last approximately five weeks, accommodating typical academic schedules. Participants will undergo multi-level assessments at baseline (prior to interventions), immediately after training, and at 3 months follow-up, administered in-person by staff at study sites. In order to investigate effects on goal-directed functioning at multiple levels, assessments will include (1) measures of performance on neurocognitive tasks; (2) functional performance on complex, goal-based tasks; (3) ratings of changes in functioning in personal life, and (4) progress toward personal goals as measured with goal attainment scaling procedures. Data will be analyzed to assess immediate and long term changes associated with each intervention; immediate and long-term differences between the interventions; and moderators and mediators of intervention effects.
- Conditions
- TBI, Cognitive Dysfunction
- Being tested
- BrainStrong-BSR, BrainStrong-OPT
- Keywords
- attention, working memory, executive functioning
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrainStrong-BSRBehavioural
Also called Goal-integrated Brain State Regulation Training (BSR)
Training in Goal-integrated Brain State Regulation Skills
BrainStrong-OPTBehavioural
Also called Optimization of Brain Functioning (OPT)
Education on Optimization of Brain Functioning (OPT)
| Study group | Role | What they receive |
|---|---|---|
| BrainStrong-BSR | Experimental | Goal-integerated Brain State Regulation Training (BSR) Receives: Behavioral: BrainStrong-BSR |
| BrainStrong-OPT | Active comparator | Education on Optimization of Brain Functioning (OPT) Receives: Behavioral: BrainStrong-OPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Selective Information Processing
In order to test a primary hypothesis related to potential intervention mechanisms, the investigators will use the well-established Automated Operation Span Task (OSPAN) to measure working memory in the presence of distractions. Specifically, the OSPAN sums correctly recalled and ordered items from a memory set in the presence of distractors. The investigators elected to use this psychometric measure due to its sensitivity, precision, and test-retest stability in order to maximize the ability to detect longitudinal changes on the primary outcome of interest.
Measured: Change from baseline to 2 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start10 Jun 2024
- Primary completion13 Mar 2028 (estimated)
- Study completion5 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TBIStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized trial with active comparison interventions
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Anthony J. W. Chen, MD MA, Principal investigator, VA Northern California Health Care System, Mather, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109027
- Sponsor's protocol ID
- N3141-R
- Other IDs
- 1I01RX003141-01A1
- Status last verified
- Oct 2026
- First submitted
- 26 Sep 2019
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening Neuro-Cognitive Skills for Success in School, Work and Beyond
- ClinicalTrials.gov ID
- NCT04109027
- Acronym / sponsor ID
- N3141-R
- Conditions
- TBI, Cognitive Dysfunction
- Keywords
- attention, working memory, executive functioning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 13 Mar 2028 (estimated)
- Study completion
- 5 Jun 2028 (estimated)
- First posted
- 30 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For many Veterans, success in achieving goals at work, school and in other aspects of life are top priorities. The abilities to regulate attention, remember key information, and stay calm and on track are fundamental to this success. Unfortunately, Veterans who have experienced a traumatic brain injury (TBI) often struggle with these very abilities, and a number of barriers can make it difficult for them to access the help Veterans need. Tele-rehabilitation has the potential to overcome some of these barriers and increase access to care, enabling providers to better reach Veterans 'where they are' in their communities. This project will assess two different approaches to brain injury rehabilitation that seek to help Veterans build personal strengths to better accomplish their goals. Both approaches will be delivered remotely via tele-rehabilitation and augmented by digital apps to best support Veterans' learning in community settings outside the VA.
Detailed description
This project will offer two training approaches targeting difficulties with goal-directed functioning associated with traumatic brain injury. Both approaches will be delivered remotely via tele-rehabilitation and augmented by digital apps - an intervention framework that addresses known barriers to engagement (e.g., convenience and access) and provides tools to intensify training. The study will be open to eligible Veterans (ages 21-60 years old) with history of mild-to-moderate TBI who experience difficulties with cognitive-emotional regulation and goal-directed functioning. After screening for eligibility and providing informed consent, participants will be allocated by permuted block randomization into one of two treatments: Education to optimize brain functioning (OPT), which will teach Veterans about brain health, brain injury and factors that affect brain functioning, or training in goal-directed state regulation skills (GSR), which will teach Veterans skills for regulating cognitive-emotional functioning during goal pursuit. A special emphasis on outreach will be to recruit student Veterans with TBI.
Each intervention will be matched for delivery method, expectation of benefit, workload and attention, and overall duration. Training will last approximately five weeks, accommodating typical academic schedules. Participants will undergo multi-level assessments at baseline (prior to interventions), immediately after training, and at 3 months follow-up, administered in-person by staff at study sites. In order to investigate effects on goal-directed functioning at multiple levels, assessments will include (1) measures of performance on neurocognitive tasks; (2) functional performance on complex, goal-based tasks; (3) ratings of changes in functioning in personal life, and (4) progress toward personal goals as measured with goal attainment scaling procedures. Data will be analyzed to assess immediate and long term changes associated with each intervention; immediate and long-term differences between the interventions; and moderators and mediators of intervention effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized trial with active comparison interventions
| Arm | Type | Receives |
|---|---|---|
| BrainStrong-BSR | Experimental | Behavioral: BrainStrong-BSRGoal-integerated Brain State Regulation Training (BSR) |
| BrainStrong-OPT | Active comparator | Behavioral: BrainStrong-OPTEducation on Optimization of Brain Functioning (OPT) |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Post 9/11 Veterans
- history of mild-moderate traumatic brain injury (including reported mechanism of head injury and alteration of consciousness)
- in the chronic, stable phase of recovery (>6 months from injury); with at least 1 self-reported cognitive symptom --including difficulties with working memory; and interested in goal-setting and intensive training
Key exclusion criteria (8 listed)
- Severely apathetic/abulic, aphasic, or other reasons for being unable or unwilling to participate in training
- severe cognitive dysfunction (below 2 standard deviations on two composite cognitive domains)
- schizophrenia
- bipolar disorder
- history of other neurological disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrainStrong-BSRAlso: Goal-integrated Brain State Regulation Training (BSR)Training in Goal-integrated Brain State Regulation Skills | Behavioural | BrainStrong-BSR |
| BrainStrong-OPTAlso: Optimization of Brain Functioning (OPT)Education on Optimization of Brain Functioning (OPT) | Behavioural | BrainStrong-OPT |
Primary outcome
Selective Information Processing
Time frame: Change from baseline to 2 weeks post-intervention
In order to test a primary hypothesis related to potential intervention mechanisms, the investigators will use the well-established Automated Operation Span Task (OSPAN) to measure working memory in the presence of distractions. Specifically, the OSPAN sums correctly recalled and ordered items from a memory set in the presence of distractors. The investigators elected to use this psychometric measure due to its sensitivity, precision, and test-retest stability in order to maximize the ability to detect longitudinal changes on the primary outcome of interest.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anthony J. W. Chen, MD MA principal investigator
VA Northern California Health Care System, Mather, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BrainStrong-BSR and BrainStrong-OPT in people with TBI and Cognitive Dysfunction, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeanette M Cope ((916) 843-7512, Jeanette.Cope@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Selective Information Processing (time frame: Change from baseline to 2 weeks post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.