TRAIN-Vets for Traumatic Brain Injury

(TRAIN-Vets Trial)

Recruiting at 1 trial location

Overseen By Julia Cheunkarndee

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northern California Institute of Research and Education

Disqualifiers: Dementia, Delirium, Severe cardiac disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 months

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on helping older veterans with a history of traumatic brain injury (TBI) improve their cognitive abilities. The study compares a special program called TRAIN-Vets, which includes water-based exercise, mental exercises, and lifestyle coaching, to simply receiving information on brain health. It aims to determine if the program can enhance thinking and memory skills over eight months. Veterans who experienced a mild or moderate TBI more than six months ago and feel their cognitive abilities have declined might be a good fit, especially if they are comfortable with water exercises. As an unphased trial, this study offers veterans a unique opportunity to potentially enhance their cognitive health through innovative methods.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the TRAIN-Vets program is safe for older Veterans with TBI?

Research shows that TRAIN-Vets, a program for older Veterans with traumatic brain injury (TBI), has promising results in improving thinking skills like attention and memory. Although specific safety data for TRAIN-Vets isn't available, the program includes activities such as water exercises and brain training, which are generally safe and well-tolerated.

No reports of negative effects specifically for TRAIN-Vets have emerged, but it's important to note that these activities are common in other rehab programs and usually don't cause harm. Veterans with TBI might experience various health issues, often due to their TBI and not necessarily linked to programs like TRAIN-Vets.

In summary, based on similar programs and the activities involved, TRAIN-Vets is likely safe and well-tolerated. Those considering participation should discuss any concerns with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TRAIN-Vets approach to treating traumatic brain injury because it combines physical and cognitive training in a novel way. Unlike standard treatments that might focus solely on medication or physical therapy, TRAIN-Vets incorporates aquatic-based exercises and online cognitive training aimed at improving executive function and attention. Additionally, it includes personalized sessions to address dementia risk factors, providing a comprehensive approach to brain health. This multifaceted intervention offers a unique blend of physical activity and mental exercises, potentially enhancing recovery and reducing future risks for veterans.

What evidence suggests that the TRAIN-Vets program is effective for improving cognitive function in older Veterans with TBI?

Research shows that programs like TRAIN-Vets, a treatment arm in this trial focusing on cognitive rehabilitation, can improve thinking skills in people with traumatic brain injury (TBI). Studies on similar programs suggest that activities such as exercise and brain training enhance mental abilities, especially memory and attention. The aquatic exercise in TRAIN-Vets is gentle on the body and supports overall brain health. Cognitive training, another component of the program, improves skills like planning and focusing. Together, these activities in TRAIN-Vets aim to address the mental challenges many Veterans with TBI face, enhancing their everyday thinking abilities. ^{4 5 6 7 8}

Who Is on the Research Team?

Kristine Yaffe, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for older veterans who have had a traumatic brain injury (TBI) and are experiencing cognitive issues. Participants must be willing to undergo an 8-month program and can't already be involved in another TBI study or have conditions that interfere with the trial.

Inclusion Criteria

My doctor agrees I can join a water-based exercise program.

History (more than 6 months post injury) of mild or moderate TBI defined by the Ohio State University TBI Identification Method and DOD/VA Clinical Practice Guidelines for Definition of TBI

Internet connected device to participate in testing and cognitive training

Exclusion Criteria

Acute illness or unstable chronic illness

I have had a severe traumatic brain injury or an open head injury.

I have had a traumatic brain injury in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phone screening, baseline in-person and virtual visits

Treatment

Participants in the TRAIN-Vets group engage in 6 months of thrice-weekly aquatic-based exercise training and 2 months of weekly structured online cognitive training, along with monthly virtual personalized risk reduction sessions. HEC group receives educational materials and monthly phone calls.

8 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits at approximately 6 and 8 months.

2 months

Follow-up visits with blinded assessors

What Are the Treatments Tested in This Trial?

Interventions

• Health Education Control
• TRAIN-Vets

Trial Overview The study compares TRAIN-Vets, which includes aquatic exercise, cognitive training, and lifestyle coaching, against a control group receiving educational materials on brain health over eight months to see which improves cognitive function in TBI patients more effectively.

How Is the Trial Designed?

Group I: TRAIN-Vets Experimental Treatment 1 Intervention

TRAIN-Vets is an 8-month intervention with aquatic-based exercise training and cognitive training combined with personalized dementia risk factor reduction sessions. This intervention entails 6 months of thrice-weekly aquatic-based exercise training at Veterans Affairs Palo Alto Health Care System (VAPAHCS). After completion of the 6-months of exercise training, Veterans in this condition will participate in 2 months of weekly structured on-line cognitive training focused on improvement of executive function and attention based out of the San Francisco Veterans Affairs Health Care System (SFVAHCS). Concurrently, Veterans in TRAIN-Vets will also participate virtually in personalized risk factor reduction sessions based at SFVAHCS focused on other risk factors and symptoms.

Group II: Health Education Control Experimental Treatment 1 Intervention

The Health Education Control (HEC) receives mailed educational materials about brain health and dementia risk factor reduction over 8 months, as well as regular contact with study staff.

Who Is Running the Clinical Trial?

Northern California Institute of Research and Education

Lead Sponsor

Trials

30

Recruited

10,400+

San Francisco Veterans Affairs Medical Center

Collaborator

Trials

52

Recruited

211,000+

VA Palo Alto Health Care System

Collaborator

Trials

97

Recruited

58,500+

Published Research Related to This Trial

A new movement-discrimination cognitive training method was found to effectively improve both visual timing deficits and high-level cognitive functions in four individuals with mild traumatic brain injury (TBI) over an 8-16 week period.

The training enhanced cognitive skills such as attention, reading fluency, processing speed, and working memory, while brain imaging showed improvements in the brain's dorsal stream and executive control networks, indicating a promising new treatment approach for TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic cognitive remediation for a Traumatic Brain Injury (TBI) significantly improves attention, working memory, processing speed, and reading fluency. Lawton, T., Huang, MX.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06562127

TBI Rehabilitation and Activation in Veterans (TRAIN-Vets) The primary aim of the trial is to evaluate the efficacy of the TRAIN-Vets intervention to improve cognitive function in Veterans with TBI. Secondary aims of ...

2. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06562127

TBI Rehabilitation and Activation in Veterans The primary aim of the trial is to evaluate the efficacy of the TRAIN-Vets intervention to improve cognitive function in Veterans with TBI.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11227399/

Meta-Analysis of Cognitive Rehabilitation Interventions in ... The purpose of the current meta-analysis was to examine the effect of cognitive rehabilitation interventions for V/SMs with history of mild-to-moderate TBI.

4. research.va.gov research.va.gov/topics/tbi.cfm

Traumatic Brain Injury (TBI) More than 185,000 Veterans who use VA for their health care have been diagnosed with at least one TBI. The majority of those TBIs were classified as mild. TBI ...

5. biausa.org biausa.org/public-affairs/media/studying-tbi-in-veteran-populations

Studying TBI in Veteran Populations Approximately 67 percent of veterans have experienced at least one traumatic brain injury ... TBI does not accurately predict long-term outcomes over time.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10728337/

Risk of adverse outcomes among Veterans who screen ... After three years post-TBI screen, the prevalence of documented health issues was 11.5% (cognitive issues) to 76.0% (neck, back, other pain) (Table 3). Among ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2815180

Long-Term Health Outcomes of Traumatic Brain Injury in ... This finding suggests that severe TBI may predispose veterans to brain cancer, whereas mild TBI likely is not associated with heightened risk.

8. withpower.com withpower.com/trial/phase-brain-injuries-10-2024-44f80

TRAIN-Vets for Traumatic Brain Injury The training enhanced cognitive skills such as attention, reading fluency, processing speed, and working memory, while brain imaging showed improvements in the ...