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

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ClinicalTrials.gov Identifier: NCT02561403
Recruitment Status : Recruiting
First Posted : September 28, 2015
Last Update Posted : December 8, 2017
Sponsor:
Collaborator:
VA Rehabilitation Research and Development Service (RR&D)
Information provided by (Responsible Party):
Allison Kaup, San Francisco Veterans Affairs Medical Center

September 23, 2015
September 28, 2015
December 8, 2017
March 2016
June 2019   (Final data collection date for primary outcome measure)
  • Acceptability based on participant ratings [ Time Frame: Acceptability ratings assessed post-intervention (1-month after baseline) ]
  • Participant adherence to game play [ Time Frame: Total adherence over the 4 week intervention phase ]
  • 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) ]
Same as current
Complete list of historical versions of study NCT02561403 on ClinicalTrials.gov Archive Site
  • 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) ]
  • 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) ]
  • 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) ]
  • Change in EVO performance (EVO Monitor) [ Time Frame: Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • Change in health-related quality of life [Short Form-36 (SF-36)] [ Time Frame: Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline) ]
  • Change in EVO performance (EVO Monitor) [ Time Frame: Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline) ]
Not Provided
Not Provided
 
Brain Aging in Veterans (BRAVE) Training: A Cognitive Training Pilot Trial in Older Veterans With Traumatic Brain Injury
Cognitive Reserve and Training in Older Veterans With Traumatic Brain Injury: Study 2
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.
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).
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
TBI (Traumatic Brain Injury)
  • Behavioral: EVO multitask video game
    Participants will play a multitasking game for 4 weeks
  • Behavioral: EVO words video game
    Participants will play a word puzzle game for 4 weeks
  • Experimental: EVO multitask video game
    Intervention: Behavioral: EVO multitask video game
  • Experimental: EVO words video game
    Intervention: Behavioral: EVO words video game
  • No Intervention: Assessment Only
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
Same as current
December 2019
June 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
60 Years to 85 Years   (Adult, Senior)
No
Contact: Maria-Paulina Amaya 415-221-4810 ext 25197
United States
 
 
NCT02561403
14-14955
Not Provided
Not Provided
Not Provided
Allison Kaup, San Francisco Veterans Affairs Medical Center
San Francisco Veterans Affairs Medical Center
VA Rehabilitation Research and Development Service (RR&D)
Principal Investigator: Allison Kaup, PhD San Francisco Veterans Affairs Medical Center
San Francisco Veterans Affairs Medical Center
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP