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

S

San Francisco Veterans Affairs Medical Center

Status

Completed

Conditions

TBI (Traumatic Brain Injury)

Treatments

Behavioral: EVO multitask video game
Behavioral: EVO words video game

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT02561403
14-14955

Details and patient eligibility

About

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.

Full 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).

Enrollment

89 patients

Sex

All

Ages

60 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

89 participants in 3 patient groups

EVO multitask video game
Experimental group
Treatment:
Behavioral: EVO multitask video game
EVO words video game
Experimental group
Treatment:
Behavioral: EVO words video game
Assessment Only
No Intervention group

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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