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

NCT ID: NCT02561403

Last Updated: 2019-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2019-01-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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TBI (Traumatic Brain Injury)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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EVO multitask video game

Group Type EXPERIMENTAL

EVO multitask video game

Intervention Type BEHAVIORAL

Participants will play a multitasking game for 4 weeks

EVO words video game

Group Type EXPERIMENTAL

EVO words video game

Intervention Type BEHAVIORAL

Participants will play a word puzzle game for 4 weeks

Assessment Only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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EVO multitask video game

Participants will play a multitasking game for 4 weeks

Intervention Type BEHAVIORAL

EVO words video game

Participants will play a word puzzle game for 4 weeks

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role collaborator

San Francisco Veterans Affairs Medical Center

FED

Sponsor Role lead

Responsible Party

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Allison Kaup

Clinical Research Psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Allison Kaup, PhD

Role: PRINCIPAL_INVESTIGATOR

San Francisco Veterans Affairs Medical Center

Locations

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San Francisco VA Medical Center

San Francisco, California, United States

Site Status

Veterans Home of California

Yountville, California, United States

Site Status

Countries

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United States

Other Identifiers

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14-14955

Identifier Type: -

Identifier Source: org_study_id

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