TBI (Traumatic Brain Injury)
Conditions
Keywords
traumatic brain injury (TBI), aging, cognitive training, Cognitive Aging
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).
Interventions
BEHAVIORALEVO multitask video game
Participants will play a multitasking game for 4 weeks
BEHAVIORALEVO words video game
Participants will play a word puzzle game for 4 weeks
Sponsors
VA Office of Research and Development
San Francisco Veterans Affairs Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 EVO performance (EVO Monitor) | 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) |
Countries
United States
Outcome results
None listed