Traumatic Brain InjuryBRAIN-SPEEDNCT06217575
Brain Research Assessing Impacts of Neurophysiological Processing Speed Training in Veterans
A study testing Alpha neurofeedback training and Visual Attention Training in people with Traumatic Brain Injury and Mild Traumatic Brain Injury, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Older veterans with a history of mild brain trauma exhibit early cognitive challenges, especially in driving-related tasks. This is attributed to alterations in the brain's excitatory/inhibitory (E/I) balance. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Mild Traumatic Brain Injury, Aging
- What is being tested?
- Alpha neurofeedback training and Visual Attention Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to 1 Apr 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages: 18-35 (Younger Group); Ages 50-80 (Healthy Older Group); Ages 50-85 (persons with a history of mild traumatic brain injury)
- English speaking
- Veterans with mild traumatic brain injury (mTBI):
- A history of mTBI confirmed by the Ohio State University TBI Identification Method-Short Form (including a requirement that the mTBI caused a loss of consciousness lasting less than 30 min).
- An additional note will be made for Veterans with mTBI with a report of objective or subjective cognitive decline not meeting the criteria (i.e.- Montreal Cognitive Assessment (MoCA) >23) for impairment
Who cannot join
- Failure to provide informed consent
- Metal of foreign objects in the body that would interfere with an magnetic resonance imaging (MRI) or transcranial magnetic stimulations (TMS)
- History of penetrating head wounds or a diagnosis of moderate/severe TBI
- Participants with significant visual field deficits were excluded, as were those with active suicidal ideation
- Suicidal ideation will be assessed with the Columbia suicidality scale (C-SSRS)
- Participants with active ideation will be referred to the Veteran Crisis Line (988) (or walked) to the Front Door program at the Birmingham East clinic
Show all 17Show fewer
- Participation in a concurrent clinical trial that could affect study outcome (however, participation in standard treatments e.g. occupational therapy or use of prescribed medications such as antidepressants is acceptable)
- Smoker > 1 pack per day
- Significant cognitive impairment defined as <23 on Montreal Cognitive Assessment (MoCA) or diagnosis of mild cognitive impairment or dementia
- Visual (corrected acuity <20/80) and motor capacity (completion of 9-hole pegboard) to use a computerized intervention
- In-patient status
- Severe visual impairment, which would preclude completion of the assessments
- Progressive, degenerative neurologic disease, e.g., Parkinsons Disease, multiple sclerosis
- Severe rheumatologic or orthopedic diseases, e.g., awaiting joint replacement Actively taking GABAergic agonist/antagonist medication (benzodiazepines, gabapentin, etc.)
- Terminal illness with a life expectancy of less than 12 months, as determined by a physician
- Other significant co-morbid diseases that would impair the ability to participate, e.g. renal failure on hemodialysis, severe psychiatric disorder (e.g. bipolar disorder, schizophrenia), heavy alcohol use (>15 drinks per week); persons with depression will not be excluded
- Unable to communicate because of severe hearing loss, speech disorder or language barrier
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BRAIN-SPEED-VETS: Brain Research Assessing Impacts of Neurophysiological Processing Speed Training in Veterans
Older veterans with a history of mild brain trauma exhibit early cognitive challenges, especially in driving-related tasks. This is attributed to alterations in the brain's excitatory/inhibitory (E/I) balance. This pilot project investigates this phenomenon by leveraging electroencephalography (EEG) to measure parietal lobe alpha rhythms during visual attention tasks. The hypothesis is that targeted visual attention training can modulate these alpha rhythms, improving instrumental activities in daily life. However, outcomes from such training vary, possibly due to individual differences in cortical inhibitory functions. This study will assess the relationship between EEG measures of E/I balance pre- and post-visual attention training and its effects on processing speeds in aging veterans. Our findings aim to provide a foundation for customized therapies and interventions for veterans with and without a history of brain trauma.
Read the detailed description
Veterans aged 50 and above who have suffered mild traumatic brain injury (mTBI) are twice as prone to develop dementia. From 2001, during the Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) campaigns, over 470,000 veterans were diagnosed with TBI. Beyond the prevalence of the signature wound of the OEF and OIF campaigns, the number of mTBI cases within the VA system is believed to be much higher. Disturbingly, an increasing number of veterans, especially those with TBI, are being diagnosed with mild cognitive impairment and frank dementia between ages 50-60. With 72% of veterans (13.2 million, a figure rising yearly) over 50 years old (Vetpop, 2020), the VA needs to implement preventative and rehabilitative interventions to limit the growing impact of cognitive decline in the veteran population.
Cognitive training paradigms have been developed and tested over the past decades, with some controversy over the overall effect10. Programs such as repeated task practice (e.g., list memorization and mnemonics) have shown mixed results in aggregate, primarily due to a lack of training transfer across domains. In contrast, process-based cognitive training has consistently improved general cognitive ability with one program, visual attention training, showing considerable transfer effects. Also known as speed-of-processing training (cf. - useful field-of-view [UFOV]), visual attention training is done on a computer and targets perceptual deficits associated with aging and TBI.
Changes in brain function that reduce the ability for perceptual information to be processed are likely mechanisms of impaired cognition. Visual attention training was developed to increase visual perception directly to counteract deficient visual fields. Previous studies have shown that visual attention training increases instrumental daily activities pertinent to driving performance, resulting in prolonged driving mobility. Unfortunately, visual attention training paradigms have required an extended training duration (months) and tend to show varied outcomes. The identified cognitive mechanism of increased perceptual detail processing is quite powerful, but individual training response may depend on one's ability to apply selective cortical inhibition. Cortical oscillations measured with electroencephalography (EEG) are believed to reflect such inhibition. Recent EEG work during visual attention training has shown that people exhibiting selective engagement of alpha patterns have faster processing speed and better perceptual discrimination.
Our recent VA-funded projects in aging have shown that procedural motor learning performance is related to individual differences in excitatory/inhibitory (E/I balance) assessed with transcranial magnetic stimulation (TMS) (Novak et al., under review). Moreover, recent work has also shown that neurological changes in cortical activity are evident after just 10 hours of visual attention training. The current project will evaluate changes in EEG measures of cortical inhibition in older veterans to improve perceptual processing using an adapted visual attention training program. The present work expands on prior work in neuromodulation using low-cost, nonpharmacological rehabilitation techniques.
- Being tested
- Alpha neurofeedback training, Visual Attention Training
- Keywords
- cognitive decline, visual attention training, useful field of view, mild traumatic brain injury, aging
- Medical subject headings
- Brain Injuries, Traumatic, Brain Concussion, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha neurofeedback trainingBehavioural
Also called alpha modulation, neurofeedback, eeg-nfb
Alpha neurofeedback training affords the participant the ability to monitor cortical EEG waves and entrain to a specific rhythm using visual feedback. Alpha is measured between 8-12Hz and is associated with cortical inhibition. Aging related changes in alpha have been associated with loss of modulation ability. However, alpha training may afford increased perception of visual details.
Visual Attention TrainingBehavioural
Also called Standard Visual Attention Training, dual decision
Visual attention training involves repeated testing on the location and identity of objects in the visual field. Also called the "Dual Decision" task training, objects are briefly presented in a radial field of view surrounding a gaze fixation point. The participant is asked to remember the location and object presented within the field. The test progressively increases in difficulty by limiting the amount of time the object is presented on screen. Accuracy is measured by either a correct or incorrect response (binary response).
| Study group | Role | What they receive |
|---|---|---|
| Visual Attention Training | Active comparator | Visual attention training is at the core of well-known training programs such as useful field of view (UFOV) training. The adapted nature of the computerized training approach affords individual differences in performance at the training outset while evaluating gains using specified performance criteria. Training parameters (duration of stimulus presentation for processing speed) are adjusted based on accuracy. Receives: Behavioral: Visual Attention Training |
| Alpha Neurofeedback training | Experimental | Electroencephalogram (EEG) based neurofeedback (NFB) is a method in which brain activity is modulated via self-induced increases or decreases in the power of selected EEG frequency bands. The subject's control over his or her EEG activity is mediated with visual feedback. We will employ alpha neurofeedback training to examine how this conditioning paradigm may improve visual attention. Receives: Behavioral: Alpha neurofeedback training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific domains of cognitive function
Measured through composite scores: Executive function/mental flexibility will be measured with the Trail Making Tests, Part A and Part B. The results for both TMT-A and TMT-B are reported as the number of seconds required to complete a task. Processing speed (using the Digit Symbol Substitution Test) will be measured as the total correct number-symbol matches achieved in 90 seconds. Verbal fluency (semantic, animal naming, and phonemic) will be measured by using the Controlled Oral Word Association Test and assessed through the total number of words identified by category and letter.
Measured: 6 weeks
Secondary outcomes (2)
General Cognitive function
General cognitive function assessed by the Montreal Cognitive Assessment (MoCA) test on a scale of 0-30 points. Scores are interpreted as follows: >26 indicates no dementia, 18-26 mild cognitive impairment, 6-10 moderate dementia, and <6 severe dementia.
Measured: 6 weeks
Quality of life as measured by SF-12
Older adults' health-related quality of life (QoL) will be measured by the short form (SF-12) of the Medical Outcomes Survey questionnaire, comprised of 12 items. Physical and mental scores will be calculated using an algorithm to convert each item response into standardized values according to specific predetermined weights. Summary scores for each component range from 0-100 and are interpreted as low QoL (close to 0) and high QoL (approaching 100).
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start1 Jul 2025
- Primary completion30 Jan 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Behavioral intervention
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Birmingham VA Health Care System
- Responsible party
- Principal investigator, Keith McGregor, Birmingham VA Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217575
- Sponsor's protocol ID
- IRB-300011767
- Other IDs
- Internally funded
- Acronym
- BRAIN-SPEED
- Status last verified
- Aug 2026
- First submitted
- 14 Dec 2023
- Last updated
- 7 Aug 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 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRAIN-SPEED-VETS: Brain Research Assessing Impacts of Neurophysiological Processing Speed Training in Veterans
- ClinicalTrials.gov ID
- NCT06217575
- Acronym / sponsor ID
- BRAIN-SPEED / IRB-300011767
- Keywords
- cognitive decline, visual attention training, useful field of view, mild traumatic brain injury, aging
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Birmingham VA Health Care System
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Jan 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 22 Jan 2024 (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.
Older veterans with a history of mild brain trauma exhibit early cognitive challenges, especially in driving-related tasks. This is attributed to alterations in the brain's excitatory/inhibitory (E/I) balance. This pilot project investigates this phenomenon by leveraging electroencephalography (EEG) to measure parietal lobe alpha rhythms during visual attention tasks. The hypothesis is that targeted visual attention training can modulate these alpha rhythms, improving instrumental activities in daily life. However, outcomes from such training vary, possibly due to individual differences in cortical inhibitory functions. This study will assess the relationship between EEG measures of E/I balance pre- and post-visual attention training and its effects on processing speeds in aging veterans. Our findings aim to provide a foundation for customized therapies and interventions for veterans with and without a history of brain trauma.
Detailed description
Veterans aged 50 and above who have suffered mild traumatic brain injury (mTBI) are twice as prone to develop dementia. From 2001, during the Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) campaigns, over 470,000 veterans were diagnosed with TBI. Beyond the prevalence of the signature wound of the OEF and OIF campaigns, the number of mTBI cases within the VA system is believed to be much higher. Disturbingly, an increasing number of veterans, especially those with TBI, are being diagnosed with mild cognitive impairment and frank dementia between ages 50-60. With 72% of veterans (13.2 million, a figure rising yearly) over 50 years old (Vetpop, 2020), the VA needs to implement preventative and rehabilitative interventions to limit the growing impact of cognitive decline in the veteran population.
Cognitive training paradigms have been developed and tested over the past decades, with some controversy over the overall effect10. Programs such as repeated task practice (e.g., list memorization and mnemonics) have shown mixed results in aggregate, primarily due to a lack of training transfer across domains. In contrast, process-based cognitive training has consistently improved general cognitive ability with one program, visual attention training, showing considerable transfer effects. Also known as speed-of-processing training (cf. - useful field-of-view [UFOV]), visual attention training is done on a computer and targets perceptual deficits associated with aging and TBI.
Changes in brain function that reduce the ability for perceptual information to be processed are likely mechanisms of impaired cognition. Visual attention training was developed to increase visual perception directly to counteract deficient visual fields. Previous studies have shown that visual attention training increases instrumental daily activities pertinent to driving performance, resulting in prolonged driving mobility. Unfortunately, visual attention training paradigms have required an extended training duration (months) and tend to show varied outcomes. The identified cognitive mechanism of increased perceptual detail processing is quite powerful, but individual training response may depend on one's ability to apply selective cortical inhibition. Cortical oscillations measured with electroencephalography (EEG) are believed to reflect such inhibition. Recent EEG work during visual attention training has shown that people exhibiting selective engagement of alpha patterns have faster processing speed and better perceptual discrimination.
Our recent VA-funded projects in aging have shown that procedural motor learning performance is related to individual differences in excitatory/inhibitory (E/I balance) assessed with transcranial magnetic stimulation (TMS) (Novak et al., under review). Moreover, recent work has also shown that neurological changes in cortical activity are evident after just 10 hours of visual attention training. The current project will evaluate changes in EEG measures of cortical inhibition in older veterans to improve perceptual processing using an adapted visual attention training program. The present work expands on prior work in neuromodulation using low-cost, nonpharmacological rehabilitation techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Behavioral intervention
| Arm | Type | Receives |
|---|---|---|
| Visual Attention Training | Active comparator | Behavioral: Visual Attention TrainingVisual attention training is at the core of well-known training programs such as useful field of view (UFOV) training. The adapted nature of the computerized training approach affords individual differences in performance at the training outset while evaluating gains using specified performance criteria. Training parameters (duration of stimulus presentation for processing speed) are adjusted based on accuracy. |
| Alpha Neurofeedback training | Experimental | Behavioral: Alpha neurofeedback trainingElectroencephalogram (EEG) based neurofeedback (NFB) is a method in which brain activity is modulated via self-induced increases or decreases in the power of selected EEG frequency bands. The subject's control over his or her EEG activity is mediated with visual feedback. We will employ alpha neurofeedback training to examine how this conditioning paradigm may improve visual attention. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ages: 18-35 (Younger Group); Ages 50-80 (Healthy Older Group); Ages 50-85 (persons with a history of mild traumatic brain injury)
- English speaking
- Veterans with mild traumatic brain injury (mTBI):
- A history of mTBI confirmed by the Ohio State University TBI Identification Method-Short Form (including a requirement that the mTBI caused a loss of consciousness lasting less than 30 min).
- An additional note will be made for Veterans with mTBI with a report of objective or subjective cognitive decline not meeting the criteria (i.e.- Montreal Cognitive Assessment (MoCA) >23) for impairment
Key exclusion criteria (17 listed)
- Failure to provide informed consent
- Metal of foreign objects in the body that would interfere with an magnetic resonance imaging (MRI) or transcranial magnetic stimulations (TMS)
- History of penetrating head wounds or a diagnosis of moderate/severe TBI
- Participants with significant visual field deficits were excluded, as were those with active suicidal ideation
- Participation in a concurrent clinical trial that could affect study outcome (however, participation in standard treatments e.g. occupational therapy or use of prescribed medications such as antidepressants is acceptable)
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 |
|---|---|---|
| Alpha neurofeedback trainingAlso: alpha modulation, neurofeedback, eeg-nfbAlpha neurofeedback training affords the participant the ability to monitor cortical EEG waves and entrain to a specific rhythm using visual feedback. Alpha is measured between 8-12Hz and is associated with cortical inhibition. Aging related changes in alpha have been associated with loss of modulation ability. However, alpha training may afford increased perception of visual details. | Behavioural | Alpha Neurofeedback training |
| Visual Attention TrainingAlso: Standard Visual Attention Training, dual decisionVisual attention training involves repeated testing on the location and identity of objects in the visual field. Also called the "Dual Decision" task training, objects are briefly presented in a radial field of view surrounding a gaze fixation point. The participant is asked to remember the location and object presented within the field. The test progressively increases in difficulty by limiting the amount of time the object is presented on screen. Accuracy is measured by either a correct or incorrect response (binary response). | Behavioural | Visual Attention Training |
Primary outcome
Specific domains of cognitive function
Time frame: 6 weeks
Measured through composite scores: Executive function/mental flexibility will be measured with the Trail Making Tests, Part A and Part B. The results for both TMT-A and TMT-B are reported as the number of seconds required to complete a task. Processing speed (using the Digit Symbol Substitution Test) will be measured as the total correct number-symbol matches achieved in 90 seconds. Verbal fluency (semantic, animal naming, and phonemic) will be measured by using the Controlled Oral Word Association Test and assessed through the total number of words identified by category and letter.
2 secondary outcomes
General Cognitive function
Time frame: 6 weeks
Quality of life as measured by SF-12
Time frame: 6 Weeks
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 7 Aug 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alpha neurofeedback training and Visual Attention Training in people with Traumatic Brain Injury and Mild Traumatic Brain Injury, run by University of Alabama at Birmingham 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 5 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 7 Aug 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specific domains of cognitive function (time frame: 6 weeks). 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 7 Aug 2026.