Neurofeedback + Visual Attention Training for Traumatic Brain Injury

(BRAIN-SPEED Trial)

Overseen By Ashton Weber, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: GABAergic medications

Disqualifiers: Severe TBI, Suicidal ideation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help older veterans with a history of mild brain trauma improve cognitive abilities, particularly in driving tasks. It tests two treatments: visual attention training and alpha neurofeedback training, which uses brain wave feedback to enhance focus. The goal is to understand how these treatments affect brain function and daily activities. Veterans who have experienced mild traumatic brain injury and notice cognitive challenges might be suitable candidates for this trial. As an unphased trial, this study offers veterans the chance to contribute to groundbreaking research that could enhance cognitive health and daily functioning.

Do I need to stop taking my current medications to join the trial?

You can continue taking your prescribed medications, such as antidepressants, while participating in the trial. However, you cannot participate if you are actively taking certain medications like benzodiazepines or gabapentin.

What prior data suggests that these methods are safe for older veterans with a history of mild brain trauma?

Past studies have shown that neurofeedback training is safe and possibly helpful for people with brain injuries. One study found that it might improve attention and assist with other cognitive issues. Another study suggested it could be a promising and safe option for addressing symptoms like headaches and sleep problems after a concussion.

Research on visual attention training has shown that it can enhance attention and memory in individuals with moderate to severe brain injuries. This training helps the brain adapt and improve its attention skills.

Both treatments have been used before and are generally well-tolerated, with most people not experiencing serious side effects. While individual experiences may vary, available evidence suggests these treatments are relatively safe and could benefit attention and brain function. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for traumatic brain injury (TBI) because they offer innovative ways to enhance brain function. Alpha neurofeedback training is unique as it allows individuals to modulate their brain activity through visual feedback, potentially improving visual attention by increasing or decreasing specific brainwave patterns. This approach is different from standard TBI treatments, which often focus on managing symptoms rather than directly modifying brain activity. Visual Attention Training, on the other hand, adapts to each person's performance, tailoring the training to improve processing speed and accuracy, unlike traditional methods that may not account for individual differences. Together, these techniques aim to harness the brain's capacity for self-improvement, offering a promising alternative to existing TBI therapies.

What evidence suggests that this trial's treatments could be effective for traumatic brain injury?

Research has shown that neurofeedback training might improve attention in people with traumatic brain injury (TBI). In this trial, participants will receive either Alpha Neurofeedback Training or Visual Attention Training. Some studies suggest that neurofeedback, a type of brain training using EEG to measure brain waves, effectively aids TBI patients with learning and memory. Additionally, visual attention training programs, often utilizing digital tools, have shown promise in enhancing cognitive function in TBI patients. This training typically involves tasks that enhance focus and quick thinking. Both methods aim to boost brain function, offering hope to those dealing with the effects of brain injuries. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for English-speaking veterans aged 18-35 or 50-85 with a history of mild traumatic brain injury (mTBI) confirmed by specific criteria. It includes those who experienced loss of consciousness under 30 minutes and reports cognitive decline without meeting impairment thresholds. Veterans outside these age ranges, without mTBI, or failing to meet the cognitive criteria are excluded.

Inclusion Criteria

You can speak English.

I have had a mild traumatic brain injury with brief unconsciousness.

I am either 18-35, 50-80 without brain injury, or 50-85 with a mild brain injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Visual Attention Training

Participants undergo visual attention training to improve perceptual processing and cognitive function

6 weeks

Weekly sessions (in-person or virtual)

Alpha Neurofeedback Training

Participants engage in EEG-based neurofeedback training to modulate brain activity and enhance visual attention

6 weeks

Weekly sessions (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after training

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Alpha neurofeedback training
• Visual Attention Training

Trial Overview The study tests if visual attention training can improve processing speeds in aging veterans by modulating alpha rhythms in the brain's parietal lobe. Participants will undergo EEG-based neurofeedback training aimed at balancing excitatory/inhibitory functions to enhance daily life activities.

How Is the Trial Designed?

Group I: Alpha Neurofeedback training Experimental Treatment 1 Intervention

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.

Group II: Visual Attention Training Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Birmingham Veterans Affairs Health Care System

Collaborator

Trials

2

Recruited

80+

Birmingham VA Health Care System

Collaborator

Trials

4

Recruited

630+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1008127516301602

Effects of neurofeedback on the short-term memory and ... Discussion. Our results showed that 20 sessions of NFT cannot be effective in rehabilitation of brain function among patients with TBI regarding CA and STM.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03515317

Effects of Neurofeedback in Cognitive Deficit in Patients ... Existing literatures have shown that NF might improve attention performance after TBI.

3. neuroregulation.org neuroregulation.org/article/view/20368

Effect of EEG Neurofeedback Training in Patients with ... Clinical and biochemical outcomes following EEG neurofeedback training in traumatic brain injury in the context of spontaneous recovery.

4. cureus.com cureus.com/articles/252658-longitudinal-outcomes-of-neurofeedback-and-hyperbaric-oxygen-therapy-in-treating-a-traumatic-brain-injury-patient-a-case-report

Longitudinal Outcomes of Neurofeedback and Hyperbaric ... Neurofeedback has proven effective in treating TBIs and strokes. It has been utilized with success in rehabilitating learning and memory [8, 9], ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5580369/

An Overview of the Use of Neurofeedback Biofeedback for the ... Conclusions. Neurofeedback, a type of biofeedback, shows promise in initial research studying its efficacy for treatment of symptoms of TBI.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11332972/

Longitudinal Outcomes of Neurofeedback and Hyperbaric ... Severe Traumatic Brain Injury (TBI) is a significant health issue, with neurofeedback and Hyperbaric Oxygen Therapy (HBOT) as potentially ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S155083072500028X

Infra-low frequency neurofeedback impact on post- ... ILF NFB holds promise to be a safe and effective intervention for those who suffer with post-concussive symptoms of chronic headache, sleep, and attention ...

8. journals.sagepub.com journals.sagepub.com/doi/10.1177/15459683231170539

Effects of Neurofeedback on Cognitive Function ... Cognitive impairment is common in patients with traumatic brain injury (TBI). Studies that have examined the effectiveness of neurofeedback (NFB) ...