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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 Office of Research and Development
Information provided by (Responsible Party):
Allison Kaup, San Francisco Veterans Affairs Medical Center

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.

Condition or disease Intervention/treatment Phase
TBI (Traumatic Brain Injury) Behavioral: EVO multitask video game Behavioral: EVO words video game Not Applicable

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).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: Cognitive Reserve and Training in Older Veterans With Traumatic Brain Injury: Study 2
Study Start Date : March 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EVO multitask video game Behavioral: EVO multitask video game
Participants will play a multitasking game for 4 weeks

Experimental: EVO words video game Behavioral: EVO words video game
Participants will play a word puzzle game for 4 weeks

No Intervention: Assessment Only



Primary Outcome Measures :
  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 Outcome Measures :
  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) ]


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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02561403


Contacts
Contact: Maria-Paulina Amaya 415-221-4810 ext 25197

Locations
United States, California
San Francisco VA Medical Center Recruiting
San Francisco, California, United States, 94121
Contact: Allison Kaup, PhD       allison.kaup@va.gov   
Veterans Home of California Completed
Yountville, California, United States, 94599
Sponsors and Collaborators
San Francisco Veterans Affairs Medical Center
VA Office of Research and Development
Investigators
Principal Investigator: Allison Kaup, PhD San Francisco Veterans Affairs Medical Center

Responsible Party: Allison Kaup, Clinical Research Psychologist, San Francisco Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT02561403     History of Changes
Other Study ID Numbers: 14-14955
First Posted: September 28, 2015    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017

Keywords provided by Allison Kaup, San Francisco Veterans Affairs Medical Center:
traumatic brain injury (TBI)
aging
cognitive training
Cognitive Aging

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System