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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment BrainStrong-GSR, BrainStrong-OPT for cognitive rehabilitation in traumatic brain injury?

Research shows that computerized brain training programs can help improve cognitive function in people with traumatic brain injury. Studies found that these programs can lead to small to moderate improvements in thinking skills and daily functioning, suggesting they could be a useful part of rehabilitation. ^{1 2 3 4 5}

Is cognitive rehabilitation for traumatic brain injury safe for humans?

The studies suggest that cognitive rehabilitation tools, including computer-based programs and virtual reality simulations, are generally safe for humans. Participants reported mild fatigue that improved over time, and there were few technical difficulties, indicating that these interventions can be safely used at home with remote support. ^{1 2 6 7 8}

How does the BrainStrong treatment for traumatic brain injury differ from other treatments?

The BrainStrong treatment for traumatic brain injury is unique because it likely incorporates elements of cognitive rehabilitation that may include exercise, virtual reality, and computer-based brain training, which are designed to improve cognitive function and can be administered at home. This approach is different from traditional therapies that often require in-person sessions and may not be as adaptable to mild traumatic brain injuries. ^{1 2 3 4 6}

Research Team

Anthony J. W. Chen, MD MA

Principal Investigator

VA Northern California Health Care System, Mather, CA

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Feasibility of computerized brain plasticity-based cognitive training after traumatic brain injury. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Outcomes from a pilot study using computer-based rehabilitative tools in a military population. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Improving cognitive function after brain injury: the use of exercise and virtual reality. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Use of a randomized clinical trial design to study cognitive rehabilitation approaches to enhance warfighter performance. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Cognitive Training for Post-Acute Traumatic Brain Injury: A Systematic Review and Meta-Analysis. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

A Protocol for Remote Cognitive Training Developed for Use in Clinical Populations During the COVID-19 Pandemic. [2023]

7. United States 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. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Driving rehabilitation for military personnel recovering from traumatic brain injury using virtual reality driving simulation: a feasibility study. [2021]