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

Trial Summary

What is the purpose of this trial?

This trial will evaluate the impact of a multicomponent program (TBI Rehabilitation and Activation in Veterans; TRAIN-Vets) on improving cognitive function over an 8-month trial period in older Veterans with traumatic brain injury (TBI). Older Veterans with a history of TBI and subjective cognitive complaints will be enrolled and randomly assign to either the TRAIN-Vets intervention (consisting of aquatic-based exercise training, cognitive training, and lifestyle coaching) or the Health Education Control, where they will receive educational materials about brain health and healthy lifestyles.

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 data supports the effectiveness of the treatment TRAIN-Vets for Traumatic Brain Injury?

Research shows that dynamic cognitive remediation, which involves brain training exercises, significantly improves attention, working memory, processing speed, and reading fluency in individuals with traumatic brain injury. This suggests that similar approaches, like TRAIN-Vets, could be effective in enhancing cognitive functions in veterans with TBI. ^{1 2 3 4 5}

How is the TRAIN-Vets treatment different from other treatments for traumatic brain injury?

The TRAIN-Vets treatment is unique because it is specifically designed for veterans with traumatic brain injury, taking into account the complex presentations and emotional toll associated with combat-related injuries, which are often different from civilian cases. This treatment is part of a broader program that integrates clinical care with research and education, focusing on the specific needs of military personnel and veterans. ^{2 6 7 8 9}

Research Team

Kristine Yaffe, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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.

Acute illness or unstable chronic illness

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Assessing and treating veterans with traumatic brain injury. [2015]

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

Effects of traumatic brain injury and posttraumatic stress disorder on Alzheimer's disease in veterans, using the Alzheimer's Disease Neuroimaging Initiative. [2021]

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

The Boston Assessment of Traumatic Brain Injury-Lifetime (BAT-L) semistructured interview: evidence of research utility and validity. [2021]

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

Epidemiology, patterns of care and outcomes of traumatic brain injury in deployed military settings: Implications for future military operations. [2022]

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

Defense and Veterans Head Injury Program: background and overview. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Combat blast related traumatic brain injury (TBI): Decade of recognition; promise of progress. [2018]

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

Update on TBI and Cognitive Impairment in Military Veterans. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Defense and Veterans Brain Injury Center: program overview and research initiatives. [2019]