Brain Injuries, TraumaticMTARNCT02920788
Mild TBI Assessment & Rehabilitation
A study testing Goal-Oriented Attentional Self-Regulation (GOALS), Brain Health Education (BHE) and fMRI in people with Brain Injuries, Traumatic, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
One of the most pressing concerns within the VA currently is the provision of interventions that address the cognitive as well as emotional problems faced by Veterans with mild TBI and comorbid conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries, Traumatic
- What is being tested?
- Goal-Oriented Attentional Self-Regulation (GOALS), Brain Health Education (BHE) and fMRI
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Mar 2017to 13 Apr 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For TBI-positive veteran participants, to be randomized to either GOALS or TAU:
- Ages 18+
- A history of mild TBI (as defined by DOD / VA; confirmed by medical records and in person Ohio State University TBI Instrument)
- Chronic, stable phase of recovery (>6 months from last post-concussive event)
- Report of residual cognitive difficulties (1 moderate or severe cognitive symptom(s) on the Neurobehavioral Symptom Inventory (NSI)) that interfere(s) with daily function
- Able and willing to commit to participate in training and assessments
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- If on psychoactive medications, must be stable on medications (> 30 days)
- For the TBI-negative healthy veteran control group:
- Ages 18+
- No history of any (mild to severe) TBI (as defined by DOD / VA; confirmed by medical records and in person Ohio State University TBI Instrument)
- Able and willing to commit to participate in assessments
- If on psychoactive medications, must be stable on medications (> 30 days)
Who cannot join
- For the TBI-positive veteran participants, to be randomized to either GOALS or TAU:
- A history of moderate or severe TBI
- Unstable medical, neurologic, or psychiatric condition, including severe cognitive dysfunction, or other reasons for being unable or unwilling to participate in study procedures (e.g., contraindications to MRI)
- Ongoing illicit drug or alcohol abuse (AUDIT>8)
- Psychosis
- Severe depression, anxiety or PTSD that precludes participation in research activities
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- Poor English comprehension
- Eligible participants may have other co-morbid stable neuropsychiatric disorders, including depression and PTSD
- There will be no restriction in regard to gender, race and socioeconomic status
- For the TBI-negative healthy veteran control group:
- A history of any mild, moderate, or severe TBI
- Unstable medical, neurologic, or psychiatric condition, including severe cognitive dysfunction, or other reasons for being unable or unwilling to participate in study procedures (e.g. contraindications to MRI)
- Ongoing illicit drug or alcohol abuse (AUDIT>8)
- Psychosis
- Severe depression, anxiety or PTSD that precludes participation in research activities
- Poor English comprehension
- Eligible participants may have other co-morbid stable neuropsychiatric disorders, including depression and PTSD.
- There will be no restriction in regard to gender, race and socioeconomic status
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Completed
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121-1563
- Recruiting
University of California, San Francisco
San Francisco, California, 94158
Pratik Mukherjee, MD, 415-353-8972 ext. 23852, pratik.mukherjee@ucsf.edu
Tatjana Novakovic-Agopian, 4157533888, Tatjana.Novakovic-agopian@ucsf.edu
About this study
Official title: Multi-Level Assessment and Rehabilitation of Combat Mild TBI
One of the most pressing concerns within the VA currently is the provision of interventions that address the cognitive as well as emotional problems faced by Veterans with mild TBI and comorbid conditions. When completed, these studies will inform us whether training core attentional self-regulatory control functions via personally-relevant activities will be effective in improving daily life for Veterans with mild TBI and comorbid conditions. The study design will provide a test not only of potential benefits for real life functioning, but also determine to what extent these benefits are related to actual changes in cognitive/behavioral performance and brain networks corresponding to these functions. This project will provide a foundation for future studies to investigate the neural mechanisms that support improvements of cognition and behavior in mTBI.
Read the detailed description
Combat-related mild traumatic brain injury (mTBI) and co-morbid conditions are prevalent in returning Veterans with the reported rates ranging from 14- 22%. Chronic sequela of mTBI can be highly debilitating due to deficits in the cognitive control processes, including attention, executive functions, and memory. In prior studies, individuals with chronic acquired brain injury who participated in a cognitive training program, Goal-Oriented Attentional Self-Regulation (GOALS), which targets executive control functions of applied mindfulness-based attention regulation and goal management, improved cognitive performance in areas of: complex attention/executive function and memory, complex functional task performance, and daily functioning. Furthermore, functional MRI (fMRI) results after training indicated significantly enhanced modulation of neural processing. Preliminary data from recently completed randomized-control GOALS study in 32 Veterans with chronic TBI also show both short and longer term (up to 2 years) improvements in attention and executive function, complex real-life tasks, and emotional regulation.
The primary objectives of this study are to investigate the potential short and longer term effects of GOALS cognitive training program, and to use advanced MRI to investigate changes in brain structure and function in the circuits that regulate attention, memory, executive function and emotion in Veterans with chronic mTBI.
The investigators postulate that 1) GOALS training will improve neurocognitive function in attention and executive function domains, complex functional task performance, and emotional regulation in Veterans with chronic mTBI; 2) improved neurocognitive function will be correlated with macrostructural, microstructural and functional changes in the corresponding brain networks on high field (3T) and ultra-high field (7T) structural MR imaging, diffusion tensor imaging (DTI) and resting state fMRI performed pre- and post-training; 3) Changes in both behavioral function and imaging measures will be maintained at 6 months post-training and be associated with improvements in activities and participation.
AIM 1: To determine the short and long term effects of GOALS training on neuro-cognitive performance and neural plasticity of attention and executive control networks in mTBI.
AIM 2: To determine the short and long term effects of GOALS training on complex functional task performance and daily functioning, and on plasticity in pathways related to memory function, in mTBI.
AIM 3: To determine the short and long term effects of GOALS training on measures of emotional regulation, and on plasticity of frontolimbic networks related to emotion processing, in mTBI In a randomized, controlled interventional study design, 36 Veterans with a history of chronic (> 6 month) mTBI and residual cognitive difficulties will be randomized to participate in 5 weeks of cognitive training (GOALS) or a treatment as usual (TAU) comparison. At baseline, week 5 (post GOALS), and at 6 months, participants will undergo a multi-level assessment battery consisting of: 1) neuroimaging with high field (3T) and ultra-high field (7T) structural MR imaging, diffusion tensor imaging (DTI) and resting state fMRI; 2) neuropsychological assessment focusing on complex attention and executive function; 3) complex 'real life' functional task performance; and 4) self-report measures of daily functioning and emotional regulation/health.
Additionally, the investigators will be recruiting a separate cohort of 15 equally matched healthy veteran volunteers who have no TBI history, for normative comparisons. TBI-negative participants, who will not be participating in training sessions, will have neuroimaging with ultra-high field (7T) structural MR imaging and neuropsychological assessments at baseline and week 5.
When completed, this project will determine whether training core attentional self-regulatory control functions via personally-relevant activities will be effective in improving quality of life and daily functioning for Veterans with mTBI. The study design will provide a test of potential benefits on real-life functioning, and also determine to what extent these benefits are related to actual changes in hypothetically targeted cognitive/behavioral functions and brain networks corresponding to these functions.
Overall recruitment status was changed due to a new study site being added at UCSF. This was made possible by funding recently received from private donation through UCSF's Weill Institute for Neuroscience to study a cohort recruited via physician referral at UCSF.
- Conditions
- Brain Injuries, Traumatic
- Being tested
- Goal-Oriented Attentional Self-Regulation (GOALS), Brain Health Education (BHE), fMRI
- Keywords
- Rehabilitation, Functional Magnetic Resonance Imaging
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal-Oriented Attentional Self-Regulation (GOALS)Behavioural
GOALS is a manualized, therapist-administered cognitive training program that targets executive control functions of applied mindfulness-based attention regulation and goal management strategies and links them to participant-defined real-life goals. In contrast to training via practice on isolated tasks, this training protocol involves application of attention regulation skills and strategies to participant-defined goals in real life, ecologically valid settings. One of the main training aims is to improve self-regulatory control mechanisms as they contribute to goal attainment.
Brain Health Education (BHE)Other
Also called Treatment As Usual (TAU)
BHE group is a formal in-person, active, psycho-educational, control intervention closely matched to GOALS for length, intensity, and contact with a therapist/facilitator. Topics include brain structure, function, sleep, stress, emotion and the brain.
fMRIDevice
Functional Magnetic Resonance Imaging of the Brain
| Study group | Role | What they receive |
|---|---|---|
| Veteran Mild TBI Group - GOALS Intervention | Experimental | Veterans ages 18+ with chronic mild TBI, to undergo GOALS cognitive training as an intervention. Receives: Behavioral: Goal-Oriented Attentional Self-Regulation (GOALS); Device: fMRI |
| Veteran Mild TBI - Treatment as Usual | Active comparator | Veterans ages 18+ with chronic mild TBI, matched by demographic and clinical criteria to the GOALS group, to receive the standard clinical care. Receives: Other: Brain Health Education (BHE); Device: fMRI |
| Veteran Non TBI - No Treatment | No intervention | Veterans ages 18+ with no history of TBI, to undergo Neuropsychologic evaluation and MR Imaging with no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delis-Kaplan Executive Function System (D-KEFS) Stroop Inhibition-Switching Task
Single Test for Attention, Executive Function and Mental Flexibility
Measured: 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study start9 Mar 2017
- Primary completion31 Dec 2026 (estimated)
- Study completion13 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Brain Injuries, TraumaticStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Pratik Mukherjee, MD PhD, Principal investigator, San Francisco VA Medical Center, San Francisco, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920788
- Sponsor's protocol ID
- N2300-R
- Acronym
- MTAR
- Status last verified
- May 2026
- First submitted
- 27 Sep 2016
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Novakovic-Agopian T, Kornblith E, Abrams G, Burciaga-Rosales J, Loya F, D'Esposito M, Chen AJW. Training in Goal-Oriented Attention Self-Regulation Improves Executive Functioning in Veterans with Chronic Traumatic Brain Injury. J Neurotrauma. 2018 Dec 1;35(23):2784-2795. doi: 10.1089/neu.2017.5529. Epub 2018 Jul 23.
PubMed 29717652Kryza-Lacombe M, Santiago R, Hwang A, Raptentsetsang S, Maruyama BA, Chen J, Cassar M, Abrams G, Novakovic-Agopian T, Mukherjee P. Resting-State Connectivity Changes After Goal-Oriented Attentional Self-Regulation Training in Veterans With Mild Traumatic Brain Injury: Preliminary Findings from a Randomized Controlled Trial. Neurotrauma Rep. 2023 Jun 29;4(1):420-432. doi: 10.1089/neur.2022.0074. eCollection 2023.
PubMed 37405257Karbasforoushan H, Wren-Jarvis J, Hwang A, Santiago R, Raptentsetsang S, Cai LT, Xiao J, Maruyama BA, Abrams GM, Novakovic-Agopian T, Mukherjee P. Goal-Oriented Attentional Self-Regulation Training in Chronic Mild Traumatic Brain Injury is Linked to Microstructural Plasticity in Prefrontal White Matter. J Neurotrauma. 2025 Jan;42(1-2):46-56. doi: 10.1089/neu.2023.0229. Epub 2024 Oct 29.
PubMed 39470361Novakovic-Agopian T, Posecion L, Kornblith E, Abrams G, McQuaid JR, Neylan TC, Burciaga J, Joseph J, Carlin G, Groberio J, Maruyama B, Chen AJW. Goal-Oriented Attention Self-Regulation Training Improves Executive Functioning in Veterans with Post-Traumatic Stress Disorder and Mild Traumatic Brain Injury. J Neurotrauma. 2021 Mar;38(5):582-592. doi: 10.1089/neu.2019.6806. Epub 2020 Nov 18.
PubMed 33019861Santiago R, Kryza-Lacombe M, Tessier J, Hwang A, Maruyama BA, Raptentsetsang S, Abrams G, Mukherjee P, Novakovic-Agopian T. Goal-Oriented Attentional Self-Regulation Training Improves Executive Function and Complex Attention in Veterans With mTBI-Randomized-Control Study. Arch Clin Neuropsychol. 2026 Feb 27;41(3):acaf087. doi: 10.1093/arclin/acaf087.
PubMed 41838854
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Level Assessment and Rehabilitation of Combat Mild TBI
- ClinicalTrials.gov ID
- NCT02920788
- Acronym / sponsor ID
- MTAR / N2300-R
- Conditions
- Brain Injuries, Traumatic
- Keywords
- Rehabilitation, Functional Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 13 Apr 2027 (estimated)
- First posted
- 30 Sep 2016 (estimated)
- 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.
One of the most pressing concerns within the VA currently is the provision of interventions that address the cognitive as well as emotional problems faced by Veterans with mild TBI and comorbid conditions. When completed, these studies will inform us whether training core attentional self-regulatory control functions via personally-relevant activities will be effective in improving daily life for Veterans with mild TBI and comorbid conditions. The study design will provide a test not only of potential benefits for real life functioning, but also determine to what extent these benefits are related to actual changes in cognitive/behavioral performance and brain networks corresponding to these functions. This project will provide a foundation for future studies to investigate the neural mechanisms that support improvements of cognition and behavior in mTBI.
Detailed description
Combat-related mild traumatic brain injury (mTBI) and co-morbid conditions are prevalent in returning Veterans with the reported rates ranging from 14- 22%. Chronic sequela of mTBI can be highly debilitating due to deficits in the cognitive control processes, including attention, executive functions, and memory. In prior studies, individuals with chronic acquired brain injury who participated in a cognitive training program, Goal-Oriented Attentional Self-Regulation (GOALS), which targets executive control functions of applied mindfulness-based attention regulation and goal management, improved cognitive performance in areas of: complex attention/executive function and memory, complex functional task performance, and daily functioning. Furthermore, functional MRI (fMRI) results after training indicated significantly enhanced modulation of neural processing. Preliminary data from recently completed randomized-control GOALS study in 32 Veterans with chronic TBI also show both short and longer term (up to 2 years) improvements in attention and executive function, complex real-life tasks, and emotional regulation.
The primary objectives of this study are to investigate the potential short and longer term effects of GOALS cognitive training program, and to use advanced MRI to investigate changes in brain structure and function in the circuits that regulate attention, memory, executive function and emotion in Veterans with chronic mTBI.
The investigators postulate that 1) GOALS training will improve neurocognitive function in attention and executive function domains, complex functional task performance, and emotional regulation in Veterans with chronic mTBI; 2) improved neurocognitive function will be correlated with macrostructural, microstructural and functional changes in the corresponding brain networks on high field (3T) and ultra-high field (7T) structural MR imaging, diffusion tensor imaging (DTI) and resting state fMRI performed pre- and post-training; 3) Changes in both behavioral function and imaging measures will be maintained at 6 months post-training and be associated with improvements in activities and participation.
AIM 1: To determine the short and long term effects of GOALS training on neuro-cognitive performance and neural plasticity of attention and executive control networks in mTBI.
AIM 2: To determine the short and long term effects of GOALS training on complex functional task performance and daily functioning, and on plasticity in pathways related to memory function, in mTBI.
AIM 3: To determine the short and long term effects of GOALS training on measures of emotional regulation, and on plasticity of frontolimbic networks related to emotion processing, in mTBI In a randomized, controlled interventional study design, 36 Veterans with a history of chronic (> 6 month) mTBI and residual cognitive difficulties will be randomized to participate in 5 weeks of cognitive training (GOALS) or a treatment as usual (TAU) comparison. At baseline, week 5 (post GOALS), and at 6 months, participants will undergo a multi-level assessment battery consisting of: 1) neuroimaging with high field (3T) and ultra-high field (7T) structural MR imaging, diffusion tensor imaging (DTI) and resting state fMRI; 2) neuropsychological assessment focusing on complex attention and executive function; 3) complex 'real life' functional task performance; and 4) self-report measures of daily functioning and emotional regulation/health.
Additionally, the investigators will be recruiting a separate cohort of 15 equally matched healthy veteran volunteers who have no TBI history, for normative comparisons. TBI-negative participants, who will not be participating in training sessions, will have neuroimaging with ultra-high field (7T) structural MR imaging and neuropsychological assessments at baseline and week 5.
When completed, this project will determine whether training core attentional self-regulatory control functions via personally-relevant activities will be effective in improving quality of life and daily functioning for Veterans with mTBI. The study design will provide a test of potential benefits on real-life functioning, and also determine to what extent these benefits are related to actual changes in hypothetically targeted cognitive/behavioral functions and brain networks corresponding to these functions.
Overall recruitment status was changed due to a new study site being added at UCSF. This was made possible by funding recently received from private donation through UCSF's Weill Institute for Neuroscience to study a cohort recruited via physician referral at UCSF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Veteran Mild TBI Group - GOALS Intervention | Experimental | Behavioral: Goal-Oriented Attentional Self-Regulation (GOALS), Device: fMRIVeterans ages 18+ with chronic mild TBI, to undergo GOALS cognitive training as an intervention. |
| Veteran Mild TBI - Treatment as Usual | Active comparator | Other: Brain Health Education (BHE), Device: fMRIVeterans ages 18+ with chronic mild TBI, matched by demographic and clinical criteria to the GOALS group, to receive the standard clinical care. |
| Veteran Non TBI - No Treatment | No intervention | –Veterans ages 18+ with no history of TBI, to undergo Neuropsychologic evaluation and MR Imaging with no intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Ages 18+
- A history of mild TBI (as defined by DOD / VA; confirmed by medical records and in person Ohio State University TBI Instrument)
- Chronic, stable phase of recovery (>6 months from last post-concussive event)
- Report of residual cognitive difficulties (1 moderate or severe cognitive symptom(s) on the Neurobehavioral Symptom Inventory (NSI)) that interfere(s) with daily function
- Able and willing to commit to participate in training and assessments
Key exclusion criteria (18 listed)
- A history of moderate or severe TBI
- Unstable medical, neurologic, or psychiatric condition, including severe cognitive dysfunction, or other reasons for being unable or unwilling to participate in study procedures (e.g., contraindications to MRI)
- Ongoing illicit drug or alcohol abuse (AUDIT>8)
- Psychosis
- Severe depression, anxiety or PTSD that precludes participation in research activities
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 |
|---|---|---|
| Goal-Oriented Attentional Self-Regulation (GOALS)GOALS is a manualized, therapist-administered cognitive training program that targets executive control functions of applied mindfulness-based attention regulation and goal management strategies and links them to participant-defined real-life goals. In contrast to training via practice on isolated tasks, this training protocol involves application of attention regulation skills and strategies to participant-defined goals in real life, ecologically valid settings. One of the main training aims is to improve self-regulatory control mechanisms as they contribute to goal attainment. | Behavioural | Veteran Mild TBI Group - GOALS Intervention |
| Brain Health Education (BHE)Also: Treatment As Usual (TAU)BHE group is a formal in-person, active, psycho-educational, control intervention closely matched to GOALS for length, intensity, and contact with a therapist/facilitator. Topics include brain structure, function, sleep, stress, emotion and the brain. | Other | Veteran Mild TBI - Treatment as Usual |
| fMRIFunctional Magnetic Resonance Imaging of the Brain | Device | Veteran Mild TBI - Treatment as Usual, Veteran Mild TBI Group - GOALS Intervention |
Primary outcome
Delis-Kaplan Executive Function System (D-KEFS) Stroop Inhibition-Switching Task
Time frame: 6 months after enrollment
Single Test for Attention, Executive Function and Mental Flexibility
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 6 May 2026.
- Results publication: PubMed 29717652Novakovic-Agopian T, Kornblith E, Abrams G, Burciaga-Rosales J, Loya F, D'Esposito M, Chen AJW. Training in Goal-Oriented Attention Self-Regulation Improves Executive Functioning in Veterans with Chronic Traumatic Brain Injury. J Neurotrauma. 2018 Dec 1;35(23):2784-2795. doi: 10.1089/neu.2017.5529. Epub 2018 Jul 23.
- Results publication: PubMed 37405257Kryza-Lacombe M, Santiago R, Hwang A, Raptentsetsang S, Maruyama BA, Chen J, Cassar M, Abrams G, Novakovic-Agopian T, Mukherjee P. Resting-State Connectivity Changes After Goal-Oriented Attentional Self-Regulation Training in Veterans With Mild Traumatic Brain Injury: Preliminary Findings from a Randomized Controlled Trial. Neurotrauma Rep. 2023 Jun 29;4(1):420-432. doi: 10.1089/neur.2022.0074. eCollection 2023.
- Results publication: PubMed 39470361Karbasforoushan H, Wren-Jarvis J, Hwang A, Santiago R, Raptentsetsang S, Cai LT, Xiao J, Maruyama BA, Abrams GM, Novakovic-Agopian T, Mukherjee P. Goal-Oriented Attentional Self-Regulation Training in Chronic Mild Traumatic Brain Injury is Linked to Microstructural Plasticity in Prefrontal White Matter. J Neurotrauma. 2025 Jan;42(1-2):46-56. doi: 10.1089/neu.2023.0229. Epub 2024 Oct 29.
- Results publication: PubMed 33019861Novakovic-Agopian T, Posecion L, Kornblith E, Abrams G, McQuaid JR, Neylan TC, Burciaga J, Joseph J, Carlin G, Groberio J, Maruyama B, Chen AJW. Goal-Oriented Attention Self-Regulation Training Improves Executive Functioning in Veterans with Post-Traumatic Stress Disorder and Mild Traumatic Brain Injury. J Neurotrauma. 2021 Mar;38(5):582-592. doi: 10.1089/neu.2019.6806. Epub 2020 Nov 18.
- Results publication: PubMed 41838854Santiago R, Kryza-Lacombe M, Tessier J, Hwang A, Maruyama BA, Raptentsetsang S, Abrams G, Mukherjee P, Novakovic-Agopian T. Goal-Oriented Attentional Self-Regulation Training Improves Executive Function and Complex Attention in Veterans With mTBI-Randomized-Control Study. Arch Clin Neuropsychol. 2026 Feb 27;41(3):acaf087. doi: 10.1093/arclin/acaf087.
- 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.
Pratik Mukherjee, MD PhD principal investigator
San Francisco VA Medical Center, San Francisco, CA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal-Oriented Attentional Self-Regulation (GOALS), Brain Health Education (BHE) and fMRI in people with Brain Injuries, Traumatic, run by VA Office of Research and Development at 2 sites 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 12 inclusion and 18 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 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Pratik Mukherjee, MD PhD ((415) 353-9364, pratik.mukherjee@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delis-Kaplan Executive Function System (D-KEFS) Stroop Inhibition-Switching Task (time frame: 6 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02920788, which also lists 5 linked publications.
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 6 May 2026.