Cognitive Rehabilitation for Traumatic Brain Injury

Overseen By Juliana V Baldo, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Psychotropics

Disqualifiers: Severe cognitive dysfunction, Schizophrenia, Bipolar, Neurological disorders, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Veterans with a history of mild to moderate traumatic brain injury (TBI) improve attention, memory, and emotional control, which are vital for success in daily life. It will test two remote rehabilitation approaches—BrainStrong-GSR and BrainStrong-OPT—delivered via tele-rehabilitation and supported by digital apps. Veterans who have had a TBI, experience issues like trouble with working memory, and are interested in setting personal goals and intensive training might be a good fit. This unphased trial offers Veterans the opportunity to explore innovative rehabilitation methods tailored to their needs.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that participants should not have active changes in psychotropic medications (drugs affecting mood, perception, or behavior). It's best to discuss your specific medications with the trial coordinators.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have examined the treatments BrainStrong-GSR and BrainStrong-OPT for aiding individuals with traumatic brain injury (TBI). These treatments aim to enhance skills such as attention and memory. Research has shown that both treatments are designed to be safe and manageable.

For BrainStrong-GSR, studies have not identified any major safety concerns. This treatment improves focus and task completion. Although specific side effects are not detailed, the absence of reported issues suggests it is likely well-tolerated.

Similarly, BrainStrong-OPT seeks to enhance brain function. While research on brain injury has tested various methods, no specific evidence indicates harmful effects from BrainStrong-OPT itself. This implies it may be safe to use, though detailed safety information remains limited.

With the trial phase marked as "Not Applicable," these treatments might be considered non-invasive or low-risk. This generally indicates they are expected to be safe, but consulting a healthcare provider is essential to understand any personal risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because BrainStrong-GSR and BrainStrong-OPT offer new approaches to cognitive rehabilitation for traumatic brain injury (TBI). Unlike traditional therapies like cognitive behavioral therapy or medication, BrainStrong-GSR uses Goal-directed State Regulation Training, which focuses on helping patients control their cognitive states. Meanwhile, BrainStrong-OPT aims to enhance brain functioning by optimizing neural pathways. These methods provide innovative ways to tackle TBI symptoms, potentially offering more personalized and effective rehabilitation options.

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

Research has shown that after a traumatic brain injury (TBI), the brain can heal by forming new connections, a process called neuroplasticity. In this trial, participants will join one of two treatment arms. The BrainStrong-GSR method, one treatment being tested, focuses on improving metacognitive skills, helping individuals think about their own thinking. Studies have found that this can lead to better outcomes in daily life for those with TBI. Meanwhile, the BrainStrong-OPT method, another treatment option in this trial, may enhance brain function by addressing heart-related issues linked to the severity of TBI. Both methods aim to improve goal-directed activities, which are essential for enhancing quality of life after a TBI. ^{1 6 7 8 9}

Who Is on the Research Team?

Anthony J. W. Chen, MD MA

Principal Investigator

VA Northern California Health Care System, Mather, CA

Are You a Good Fit for This Trial?

This trial is for post-9/11 Veterans aged 21-60 who have had a mild to moderate traumatic brain injury and are at least six months into recovery. They should experience cognitive symptoms like memory issues and be interested in goal-setting and training. It's not suitable for those with severe mental health conditions, other neurological disorders, or ongoing medical issues that could affect participation.

Inclusion Criteria

I have had a mild to moderate traumatic brain injury.

I am between 21 and 60 years old and have had a mild to moderate traumatic brain injury.

I am over 6 months post-injury, have memory issues, and am open to intensive training.

Exclusion Criteria

Severe cognitive dysfunction (below 2 standard deviations on two composite cognitive domains)

Current medical illnesses that may alter mental status or disrupt participation in the study

Symptom magnification or malingering

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Goal-directed State Regulation Training (GSR) or Optimization of Brain Functioning (OPT) via tele-rehabilitation, augmented by digital apps

5 weeks

Remote sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3 months post-intervention

3 months

In-person assessments

What Are the Treatments Tested in This Trial?

Interventions

• BrainStrong-GSR
• BrainStrong-OPT

Trial Overview The study tests two remote rehabilitation methods delivered via tele-rehabilitation supported by digital apps: BrainStrong-OPT and BrainStrong-GSR. These interventions aim to help Veterans improve attention regulation, memory retention, and emotional control to achieve their life goals.

How Is the Trial Designed?

Group I: BrainStrong-GSR Experimental Treatment 1 Intervention

Goal-directed State Regulation Training (GSR)

Group II: BrainStrong-OPT Active Control 1 Intervention

Optimization of Brain Functioning (OPT)

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

A 4-week program of nonimmersive virtual reality (VR) exercise significantly improved cognitive functions, such as attention and memory, in 13 adults with traumatic brain injury (TBI) compared to control groups.

A single session of VR exercise also led to notable improvements in reaction and movement times, suggesting that even short bouts of exercise in a virtual environment can enhance cognitive performance in TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving cognitive function after brain injury: the use of exercise and virtual reality. Grealy, MA., Johnson, DA., Rushton, SK.[2022]

A pilot study involving 10 individuals with traumatic brain injury (TBI) showed that a computerized brain plasticity-based cognitive training (BPCT) program can be effectively used at home to improve cognitive functioning, with participants reporting subjective improvements and small to large effect sizes on cognitive measures.

The BPCT program was well-received, with minimal technical difficulties and only mild fatigue reported, suggesting it could serve as a beneficial adjunct to traditional neurorehabilitation for TBI patients, even years after their injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of computerized brain plasticity-based cognitive training after traumatic brain injury. Lebowitz, MS., Dams-O'Connor, K., Cantor, JB.[2019]

Virtual reality driving simulation rehabilitation training (VRDSRT) was well-received by military personnel recovering from traumatic brain injury (TBI), with no reported side effects like simulation sickness.

Participants in the VRDSRT group showed significant improvements in driving performance and reduced instances of road rage and risky driving behaviors, indicating its effectiveness as a rehabilitation tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Driving rehabilitation for military personnel recovering from traumatic brain injury using virtual reality driving simulation: a feasibility study. Cox, DJ., Davis, M., Singh, H., et al.[2021]

Over 220,000 service members have experienced traumatic brain injuries (TBI) in recent military operations, leading to cognitive and sensorimotor deficits that can impact their performance and readiness to return to duty.

Current assessment methods for determining readiness to return to duty after TBI are limited and often do not reflect the unique demands of military tasks; new complex, task-oriented approaches, including virtual reality and dual-task assessments, are being developed to better evaluate functional performance in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Returning service members to duty following mild traumatic brain injury: exploring the use of dual-task and multitask assessment methods. Scherer, MR., Weightman, MM., Radomski, MV., et al.[2022]

Cognitive training (CT) has a small but statistically significant effect on overall cognition in patients with traumatic brain injury (TBI) more than 12 months post-injury, based on a meta-analysis of 14 studies involving 575 patients.

CT shows a moderate effect on overall functional outcomes and is particularly effective in improving executive function and verbal memory, suggesting it should be more widely integrated into TBI rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Training for Post-Acute Traumatic Brain Injury: A Systematic Review and Meta-Analysis. Hallock, H., Collins, D., Lampit, A., et al.[2020]

Current cognitive rehabilitation methods for military personnel with mild traumatic brain injury (mTBI) are largely based on civilian therapies, which may not effectively address the subtle impairments faced by warfighters.

The proposed Strategic Memory Advanced Reasoning Training (SMART) offers a novel approach to cognitive rehabilitation that will be tested in a randomized clinical trial, aiming to improve cognitive readiness in military settings by using ecologically valid outcome metrics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a randomized clinical trial design to study cognitive rehabilitation approaches to enhance warfighter performance. Babakhanyan, I., Jensen, M., Remigio-Baker, RA., et al.[2020]

The study demonstrated that the at-home cognitive training tool NeuroTrackerX is feasible for use among cognitively healthy adults, with high recruitment and retention rates, and 90% adherence to the program over 10 sessions in 5 weeks.

Both the at-home group and the control group showed significant improvements in task performance, indicating that NeuroTrackerX could be an effective therapeutic option for cognitive training, particularly for traumatic brain injury survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Protocol for Remote Cognitive Training Developed for Use in Clinical Populations During the COVID-19 Pandemic. Snowden, T., Ohlhauser, L., Morrison, J., et al.[2023]

The Brain Fitness Center (BFC) at Walter Reed National Military Medical Center has provided brain-training programs to over 250 military Service Members, showing promising results in reducing cognitive and functional symptoms after traumatic brain injury, as indicated by significant improvements in the Mayo-Portland Adaptability Inventory and Neurobehavioral Symptom Inventory scores.

Preliminary data from the first 29 participants suggest that while there was a notable reduction in symptom severity, there were no significant changes in overall life satisfaction, highlighting the need for further research to fully understand the efficacy of computer-based cognitive rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes from a pilot study using computer-based rehabilitative tools in a military population. Sullivan, KW., Quinn, JE., Pramuka, M., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04109027

Strengthening Neuro-Cognitive Skills for Success in ... This project will offer two training approaches targeting difficulties with goal-directed functioning associated with traumatic brain injury. Both approaches ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11244718/

Strategies and Outcomes for Traumatic Brain Injury Recovery Results indicate that rehabilitation after TBI happens through neuroplasticity, which combines neural regeneration and functional reorganization.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03169647

Evaluating the Effectiveness of Treatment for Metacognition ... Metacognitive deficits can greatly reduce quality of life for individuals with TBI as functioning in this domain has been closely linked with successful ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8261688/

Functional Outcomes Over the First Year After Moderate to ... By 12 months postinjury, 142 of 271 with severe TBI (52.4%) and 54 of 72 with moderate TBI (75%) achieved favorable outcomes. Nearly 1 in 5 ...

5. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2022.870190/full

The Outcome of Neurorehabilitation Efficacy and ... In Japan, TBI accounted for only 9.3% of 1,160,000 traffic accident injuries. However, of the 9,000 deaths in these data, 50.3% of them were in fact due to TBI ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7601591/

Traumatic Brain Injury: Oxidative Stress and Novel Anti- ... Accordingly, available research data indicate that decreased mitochondrial oxidative stress can suppress or delay the progression of TBI [95]. The first study ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10858774/

Neuroprotection strategies in traumatic brain injury This review delves into clinical strategies aimed at addressing the complexities of traumatic brain injury (TBI), specifically focusing on pharmaceutical ...

8. mdpi.com mdpi.com/1422-0067/25/4/2372

Innovative Insights into Traumatic Brain Injuries In CENTER-TBI's extensive study with 2869 patients, six serum biomarkers (GFAP, NF-L, NSE, S100B, total Tau, and UCHL1) were tested within 24 h of an injury.

9. clinicalcasereportsint.com clinicalcasereportsint.com/open-access/pathological-aspects-of-traumatic-brain-injury-role-of-biomarkers-and-9389.pdf

Pathological Aspects of Traumatic Brain Injury: Role of ... When CsA is taken early after a severe TBI, it has an excellent activity and safety profile, and it also reduces lesion volume. CsA injection ...