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Completed

NCT Number: NCT02561403

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

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.

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Key information

Conditions

TBI (Traumatic Brain Injury) Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco VA Medical Center, San Francisco, California, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EVO multitask video game

Behavioral

Participants will play a multitasking game for 4 weeks

EVO words video game

Behavioral

Participants will play a word puzzle game for 4 weeks

Primary outcomes

  1. Acceptability based on participant ratings

    Time frame: Acceptability ratings assessed post-intervention (1-month after baseline)

  2. Participant adherence to game play

    Time frame: Total adherence over the 4 week intervention phase

  3. Change in cognitive functioning based on neurocognitive test battery

    Time frame: Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline)

Secondary outcomes

  1. Change in self-reported everyday cognitive functioning [Neuro-QOL (Quality of Life in Neurological Disorders) Cognitive Function inventory]

    Time frame: Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline)

  2. Change in everyday functioning [University of California San Diego (UCSD) Performance Based Skills Assessment (UPSA)]

    Time frame: Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline)

  3. Change in mood symptoms (Geriatric Depression Scale)

    Time frame: Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline)

  4. Change in EVO performance (EVO Monitor)

    Time frame: Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline)

Sponsors and collaborators

Lead sponsor

San Francisco Veterans Affairs Medical Center

Fed

Collaborators

  • VA Office of Research and Development

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Sep 28, 2015
Registry last updated
Apr 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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