NCT02561403

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 28, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

April 29, 2019

Status Verified

April 1, 2019

Enrollment Period

2.8 years

First QC Date

September 23, 2015

Last Update Submit

April 26, 2019

Conditions

TBI (Traumatic Brain Injury)

Keywords

traumatic brain injury (TBI)agingcognitive trainingCognitive Aging

Outcome Measures

Primary Outcomes (3)

  • Acceptability based on participant ratings

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

  • Participant adherence to game play

    Total adherence over the 4 week intervention phase

  • Change in cognitive functioning based on neurocognitive test battery

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

Secondary Outcomes (4)

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

    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)]

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

  • Change in mood symptoms (Geriatric Depression Scale)

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

  • Change in EVO performance (EVO Monitor)

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

Study Arms (3)

EVO multitask video game

EXPERIMENTAL
Behavioral: EVO multitask video game

EVO words video game

EXPERIMENTAL
Behavioral: EVO words video game

Assessment Only

NO INTERVENTION

Interventions

EVO multitask video gameBEHAVIORAL

Participants will play a multitasking game for 4 weeks

EVO multitask video game
EVO words video gameBEHAVIORAL

Participants will play a word puzzle game for 4 weeks

EVO words video game

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

San Francisco VA Medical Center

San Francisco, California, 94121, United States

Location

Veterans Home of California

Yountville, California, 94599, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Allison Kaup, PhD

    San Francisco Veterans Affairs Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Psychologist

Study Record Dates

First Submitted

September 23, 2015

First Posted

September 28, 2015

Study Start

March 1, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

April 29, 2019

Record last verified: 2019-04

Locations

US(2)