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

TBI (Traumatic Brain Injury) Clinical Trial

Official title:

Cognitive Reserve and Training in Older Veterans With Traumatic Brain Injury: Study 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02561403
• Other study ID #: 14-14955
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• TBI (Traumatic Brain Injury)
• Wounds and Injuries

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)