Clinical trial NCT02561403: Brain Aging in Veterans (BRAVE) Training: A Cognitive Training Pilot Trial in Older Veterans With Traumatic Brain Injury
Official title: Cognitive Reserve and Training in Older Veterans With Traumatic Brain Injury: Study 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: TBI (Traumatic Brain Injury)
Keywords: traumatic brain injury (TBI)
aging
cognitive training
Cognitive Aging
Lead sponsor: San Francisco Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: VA Office of Research and Development
First posted: 2015-09-28
Enrollment: 89
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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).

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability based on participant ratings
timeFrame: Acceptability ratings assessed post-intervention (1-month after baseline)
measure: Participant adherence to game play
timeFrame: Total adherence over the 4 week intervention phase
measure: Change in cognitive functioning based on neurocognitive test battery
timeFrame: Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline)
Secondary outcomes:
measure: Change in self-reported everyday cognitive functioning [Neuro-QOL (Quality of Life in Neurological Disorders) Cognitive Function inventory]
timeFrame: Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline)
measure: Change in everyday functioning [University of California San Diego (UCSD) Performance Based Skills Assessment (UPSA)]
timeFrame: Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline)
measure: Change in mood symptoms (Geriatric Depression Scale)
timeFrame: Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline)
measure: Change in EVO performance (EVO Monitor)
timeFrame: Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center
state: California
city: Yountville
country: United States
facility: Veterans Home of California
state: California
Study officials:
affiliation: San Francisco Veterans Affairs Medical Center
name: Allison Kaup, PhD
role: PRINCIPAL_INVESTIGATOR
References: