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

April 26, 2019 updated by: Allison Kaup, San Francisco Veterans Affairs Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

89

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94121
        • San Francisco VA Medical Center
      • Yountville, California, United States, 94599
        • Veterans Home of California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Assessment Only
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Acceptability based on participant ratings
Time Frame: Acceptability ratings assessed post-intervention (1-month after baseline)
Acceptability ratings assessed post-intervention (1-month after baseline)
Participant adherence to game play
Time Frame: Total adherence over the 4 week intervention phase
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)
Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
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)
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)
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)
Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Francisco Veterans Affairs Medical Center

Collaborators

VA Office of Research and Development

Investigators

  • Principal Investigator: Allison Kaup, PhD, San Francisco Veterans Affairs Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

September 23, 2015

First Submitted That Met QC Criteria

September 24, 2015

First Posted (Estimate)

September 28, 2015

Study Record Updates

Last Update Posted (Actual)

April 29, 2019

Last Update Submitted That Met QC Criteria

April 26, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-14955

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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