TBI (Traumatic Brain Injury)NCT02561403
Brain Aging in Veterans (BRAVE) Training: A Cognitive Training Pilot Trial in Older Veterans With Traumatic Brain Injury
A study testing EVO multitask video game and EVO words video game in people with TBI (Traumatic Brain Injury), run by San Francisco Veterans Affairs Medical Center at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- TBI (Traumatic Brain Injury)
- What is being tested?
- EVO multitask video game and EVO words video game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2016to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
San Francisco VA Medical Center
San Francisco, California, 94121
Veterans Home of California
Yountville, California, 94599
About this study
Official title: 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.
Read the 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).
- Conditions
- TBI (Traumatic Brain Injury)
- Being tested
- EVO multitask video game, EVO words video game
- Keywords
- traumatic brain injury (TBI), aging, cognitive training, Cognitive Aging
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVO multitask video gameBehavioural
Participants will play a multitasking game for 4 weeks
EVO words video gameBehavioural
Participants will play a word puzzle game for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| EVO multitask video game | Experimental | Not described Receives: Behavioral: EVO multitask video game |
| EVO words video game | Experimental | Not described Receives: Behavioral: EVO words video game |
| Assessment Only | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability based on participant ratings
Measured: Acceptability ratings assessed post-intervention (1-month after baseline)
Participant adherence to game play
Measured: Total adherence over the 4 week intervention phase
Change in cognitive functioning based on neurocognitive test battery
Measured: 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]
Measured: 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)]
Measured: Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline)
Change in mood symptoms (Geriatric Depression Scale)
Measured: Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline)
Change in EVO performance (EVO Monitor)
Measured: Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2015 (estimated)
- Study startMar 2016
- Primary completionJan 2019
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TBI (Traumatic Brain Injury)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Francisco Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- VA Office of Research and Development
- Responsible party
- Principal investigator, Allison Kaup, San Francisco Veterans Affairs Medical Center
- Investigators
- Allison Kaup, PhD, Principal investigator, San Francisco Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561403
- Sponsor's protocol ID
- 14-14955
- Status last verified
- Apr 2019
- First submitted
- 23 Sep 2015
- Last updated
- 29 Apr 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Reserve and Training in Older Veterans With Traumatic Brain Injury: Study 2
- ClinicalTrials.gov ID
- NCT02561403
- Acronym / sponsor ID
- 14-14955
- Conditions
- TBI (Traumatic Brain Injury)
- Keywords
- traumatic brain injury (TBI), aging, cognitive training, Cognitive Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- San Francisco Veterans Affairs Medical CenterUS federal agency
- Collaborators
- VA Office of Research and Development
- Study start
- Mar 2016 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 28 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EVO multitask video game | Experimental | Behavioral: EVO multitask video game |
| EVO words video game | Experimental | Behavioral: EVO words video game |
| Assessment Only | No intervention | – |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EVO multitask video gameParticipants will play a multitasking game for 4 weeks | Behavioural | EVO multitask video game |
| EVO words video gameParticipants will play a word puzzle game for 4 weeks | Behavioural | EVO words video game |
Primary outcome
Acceptability based on participant ratings
Time frame: Acceptability ratings assessed post-intervention (1-month after baseline)
Participant adherence to game play
Time frame: 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)
4 secondary outcomes
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)
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)
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)
Change in EVO performance (EVO Monitor)
Time frame: Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison Kaup, PhD principal investigator
San Francisco Veterans Affairs Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EVO multitask video game and EVO words video game in people with TBI (Traumatic Brain Injury), run by San Francisco Veterans Affairs Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability based on participant ratings (time frame: Acceptability ratings assessed post-intervention (1-month after baseline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2019.