Brain Aging in Veterans (BRAVE) Training: A Cognitive Training Pilot Trial in Older Veterans With Traumatic Brain Injury

Study Overview
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Brief Summary
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The purpose of this study is to conduct a pilot trial investigating cognitive training in older Veterans with a history of traumatic brain injury (TBI) to assess training effects, acceptability of training to participants, and to explore whether other factors influence training effects.

Detailed Description
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A study of older Veterans (60-85 years old) who have 1) a history of repetitive mild TBI or at least one moderate TBI and 2) subjective cognitive complaints. Participants will be randomized to one of three conditions for 4 weeks: Project:Evolution (EVO) multitask video game, EVO words video game, or an assessment only control condition. Participants will complete assessment visits at baseline, post-intervention (1 month after baseline), and 3 months post-intervention (4 months after baseline).

Official Title
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Cognitive Reserve and Training in Older Veterans With Traumatic Brain Injury: Study 2

Conditions
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TBI (Traumatic Brain Injury)

Intervention / Treatment
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* Behavioral: EVO multitask video game
* Behavioral: EVO words video game


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 60-85 Have experienced more than one mild TBI or at least one moderate TBI over their lifetime Have current cognitive problems based on self-report Vision adequate to see test stimuli Hearing adequate to understand the examiner Fluent in English in order to understand task instructions Demonstrate capacity to consent to participate in research Mini-Mental Status Exam (MMSE) score ≥ 25 Exclusion Criteria: History of penetrating brain injury Active disabling neurological condition (e.g., stroke, brain tumor, multiple sclerosis) History of severe psychiatric illness (i.e., schizophrenia, bipolar disorder, schizoaffective disorder) Active drug use or active heavy alcohol use History of severe TBI History of a dementia diagnosis Individuals who are physically unable to use an iPad for 30 minutes at a time per day will be excluded, such as individuals with debilitating arthritis or tremor

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EVO multitask video game<br> | Behavioral: EVO multitask video game<br>* Participants will play a multitasking game for 4 weeks<br>|
| Experimental: EVO words video game<br> | Behavioral: EVO words video game<br>* Participants will play a word puzzle game for 4 weeks<br>|
| No Intervention: Assessment Only<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability based on participant ratings |  | Acceptability ratings assessed post-intervention (1-month after baseline) | 
| Participant adherence to game play |  | Total adherence over the 4 week intervention phase | 
| Change in cognitive functioning based on neurocognitive test battery |  | Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in self-reported everyday cognitive functioning [Neuro-QOL (Quality of Life in Neurological Disorders) Cognitive Function inventory] |  | Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline) | 
| Change in everyday functioning [University of California San Diego (UCSD) Performance Based Skills Assessment (UPSA)] |  | Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline) | 
| Change in mood symptoms (Geriatric Depression Scale) |  | Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline) | 
| Change in EVO performance (EVO Monitor) |  | Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aging, traumatic brain injury (TBI), cognitive training, Cognitive Aging