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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02561403
Other study ID # 14-14955
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2016
Est. completion date January 2019

Study information

Verified date April 2019
Source San Francisco Veterans Affairs Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 89
Est. completion date January 2019
Est. primary completion date January 2019
Accepts healthy volunteers No
Gender All
Age group 60 Years to 85 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
United States San Francisco VA Medical Center San Francisco California
United States Veterans Home of California Yountville California

Sponsors (2)

Lead Sponsor Collaborator
San Francisco Veterans Affairs Medical Center VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acceptability based on participant ratings Acceptability ratings assessed post-intervention (1-month after baseline)
Primary Participant adherence to game play Total adherence over the 4 week intervention phase
Primary 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 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)
Secondary 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)
Secondary Change in mood symptoms (Geriatric Depression Scale) Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline)
Secondary Change in EVO performance (EVO Monitor) Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline)
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