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

Not Applicable

Completed

• Conditions: TBI (Traumatic Brain Injury)
• Interventions: Behavioral: EVO multitask video game; Behavioral: EVO words video game

• Registration Number: NCT02561403
• Lead Sponsor: San Francisco Veterans Affairs Medical Center

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2015-09-23
• Study First Submitted QC: 2015-09-24
• Study First Posted: 2015-09-28
• Study Start: 2016-03
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-26
• Last Update Posted: 2019-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

1. Ages 60-85
2. Have experienced more than one mild TBI or at least one moderate TBI over their lifetime
3. Have current cognitive problems based on self-report
4. Vision adequate to see test stimuli
5. Hearing adequate to understand the examiner
6. Fluent in English in order to understand task instructions
7. Demonstrate capacity to consent to participate in research
8. Mini-Mental Status Exam (MMSE) score ≥ 25

Exclusion Criteria

1. History of penetrating brain injury
2. Active disabling neurological condition (e.g., stroke, brain tumor, multiple sclerosis)
3. History of severe psychiatric illness (i.e., schizophrenia, bipolar disorder, schizoaffective disorder)
4. Active drug use or active heavy alcohol use
5. History of severe TBI
6. History of a dementia diagnosis
7. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EVO multitask video game	EVO multitask video game	-
EVO words video game	EVO words video game	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (2)

San Francisco VA Medical Center; 🇺🇸 San Francisco, California, United States

Veterans Home of California; 🇺🇸 Yountville, California, United States