Acquired Brain InjuryPhase 1NCT01641432
Computerized Attention Training for Individuals With Acquired Brain Injury
A Phase 1 study testing Tonic and Phasic Attention Training and Active Comparator in people with Acquired Brain Injury and Stroke, run by Posit Science Corporation at 1 site in United States.
Trial summary
Problems with attention are a common and debilitating consequence of brain injury. Studies show that poor attention is the number one predictor of poor cognitive functioning one year post-injury. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Acquired Brain Injury, Stroke, Hemispatial Neglect
- What is being tested?
- Tonic and Phasic Attention Training and Active Comparator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Jul 2013
- Phase
- Phase 1
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must 21 years or older and not pregnant as indicated by self-report
- Participant must be fluent in English (indicated by self-report)
- Participant must be able to engage with computerized cognitive tasks as indicated by investigator's opinion after 30 minutes of computer interaction
- Participants should have no history of chronic psychiatric or neurological condition (preceding the current insult) as indicated by self-report
- Normal vision (or corrected to normal vision) as indicated by self-report
- Participants must be willing to commit to the time requirements of the study as evidenced by written, informed consent.
- Evidence of hemispatial neglect and/ or vigilance decline on at least one standard measure (e.g., A-SCAN).
Who cannot join
- Participants report or present a hand tremor that prevents the use of a computer mouse or keyboard, in the opinion of the evaluating Principal or Sub-Investigator.
- Unable to perform neuropsychological evaluations in the opinion of the evaluating Principal or Sub-Investigator.
- In the opinion of the consenting staff person, the participant cannot comprehend, follow instructions, or is incapable of providing written, informed consent.
- In the opinion of the consenting staff person, participant is not capable of giving informed consent and does not have a Legal Authorized Representative.
- History of recurrent psychiatric impairment as indicated by self-report.
- History of drug or alcohol abuse as indicated by self-report.
- History of significant medical diseases or multiple neurological events of the head as indicated by self-report.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brain Plasticity Institute
San Francisco, California, 94104
About this study
Official title: Computerized Cognitive Treatment of Vigilance Deficits in Individuals With Acquired Brain Injury
Problems with attention are a common and debilitating consequence of brain injury. Studies show that poor attention is the number one predictor of poor cognitive functioning one year post-injury. This is due to the fact that attention is a necessary component of more complex cognitive functions such as learning \& memory, multi-tasking and problem solving. In many cases, individuals may exhibit problems with spatial attention known as 'hemi-spatial neglect syndrome' or simply 'neglect'. Many studies now show that the processing machinery of the brain is plastic and remodeled throughout life by learning and experience, enabling the strengthening of cognitive skills or abilities. The investigators own research has shown that brief, daily computerized cognitive training that is sufficiently challenging, goal-directed and adaptive enables intact brain structures to restore balance in attention and compensate for disruptions in cognitive functioning.
Read the detailed description
Participants will first engage in an assessment process to determine current level of cognitive function. This process consists of paper-pencil surveys and computerized tests. Following the assessment process, participants will engage in Internet browser-delivered training sessions conducted on any internet-accessible computer. These trainings can be done up to 7 times a week (once a day) or at participant's convenience (the investigators recommend 4-5 times a week). Following the completion of training, participant's cognitive function will be re-assessed. Participation is voluntary and participants may withdraw from the study at any time.
- Conditions
- Acquired Brain Injury, Stroke, Hemispatial Neglect
- Being tested
- Tonic and Phasic Attention Training, Active Comparator
- Medical subject headings
- Brain Injuries, Stroke, Perceptual Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tonic and Phasic Attention TrainingBehavioural
The Tonic and Phasic Alertness treatment task (TAPAT) consist of two consecutive rounds of a 12-minute continuous performance task in which continually varying, rich visual (e.g., scenes, objects, faces) or auditory stimuli (tones or complex sounds) are briefly displayed and participants are required to respond via a button press when they see a non-target item (90% of trials) or withhold button-press responding when the item is a pre-determined target item (10% of trials). Presentation of the target item is non-predictive and infrequent, disallowing the development of an executive strategy. Participants simply sustain attention to the task over a prolonged period of time (tonic attention), ignoring distractions, and inhibiting the pre-potent motor response when they see a target item (phasic attention).
Following the 24 minutes of TAPAT treatment participants will undergo one additional computer-based cognitive exercise, Multiple Object Tracking (MOT), for an additional 12 minutes.
Active ComparatorBehavioural
Computer games chosen from a list of progressive visual/audiovisual games from the top-100 game list: sporcle.com. Training duration will be similar to that of experimental training.
| Study group | Role | What they receive |
|---|---|---|
| TAPAT | Experimental | Computerized Tonic and Phasic Attention training consisting of visual, auditory, and spatial stimuli that requires sustained attention (24 minutes). Training is followed by a computerized cognitive exercise (12 minutes). Receives: Behavioral: Tonic and Phasic Attention Training |
| Active Comparator | Active comparator | Computerized conventional board-games that lack the therapeutic effect of the TAPAT exercises. Active control has stimulus parameters similar to the TAPAT exercises (eg. stimuli is presented on the computer, participant responses are collected, session time and improvement is measured). Receives: Behavioral: Active Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attention and Memory
Percent change on standardized measures of attention and executive function (all participants) using the ASCAN, Attentional Blink, Attention Capture Task, Landmark task, Conjunction Search task, SART, Verbal Fluency, CVLT-II, D-KEFS Stroop, and LNS assessments.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study startJul 2011
- Primary completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies 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 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Posit Science Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01641432
- Sponsor's protocol ID
- BPI-1002-2011
- Status last verified
- Jul 2014
- First submitted
- 25 Jun 2012
- Last updated
- 22 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Cognitive Treatment of Vigilance Deficits in Individuals With Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT01641432
- Acronym / sponsor ID
- BPI-1002-2011
- Conditions
- Acquired Brain Injury, Stroke, Hemispatial Neglect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Posit Science CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Jul 2013 (actual)
- First posted
- 16 Jul 2012 (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.
Problems with attention are a common and debilitating consequence of brain injury. Studies show that poor attention is the number one predictor of poor cognitive functioning one year post-injury. This is due to the fact that attention is a necessary component of more complex cognitive functions such as learning \& memory, multi-tasking and problem solving. In many cases, individuals may exhibit problems with spatial attention known as 'hemi-spatial neglect syndrome' or simply 'neglect'. Many studies now show that the processing machinery of the brain is plastic and remodeled throughout life by learning and experience, enabling the strengthening of cognitive skills or abilities. The investigators own research has shown that brief, daily computerized cognitive training that is sufficiently challenging, goal-directed and adaptive enables intact brain structures to restore balance in attention and compensate for disruptions in cognitive functioning.
Detailed description
Participants will first engage in an assessment process to determine current level of cognitive function. This process consists of paper-pencil surveys and computerized tests. Following the assessment process, participants will engage in Internet browser-delivered training sessions conducted on any internet-accessible computer. These trainings can be done up to 7 times a week (once a day) or at participant's convenience (the investigators recommend 4-5 times a week). Following the completion of training, participant's cognitive function will be re-assessed. Participation is voluntary and participants may withdraw from the study at any time.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAPAT | Experimental | Behavioral: Tonic and Phasic Attention TrainingComputerized Tonic and Phasic Attention training consisting of visual, auditory, and spatial stimuli that requires sustained attention (24 minutes). Training is followed by a computerized cognitive exercise (12 minutes). |
| Active Comparator | Active comparator | Behavioral: Active ComparatorComputerized conventional board-games that lack the therapeutic effect of the TAPAT exercises. Active control has stimulus parameters similar to the TAPAT exercises (eg. stimuli is presented on the computer, participant responses are collected, session time and improvement is measured). |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants must 21 years or older and not pregnant as indicated by self-report
- Participant must be fluent in English (indicated by self-report)
- Participant must be able to engage with computerized cognitive tasks as indicated by investigator's opinion after 30 minutes of computer interaction
- Participants should have no history of chronic psychiatric or neurological condition (preceding the current insult) as indicated by self-report
- Normal vision (or corrected to normal vision) as indicated by self-report
Key exclusion criteria (7 listed)
- Participants report or present a hand tremor that prevents the use of a computer mouse or keyboard, in the opinion of the evaluating Principal or Sub-Investigator.
- Unable to perform neuropsychological evaluations in the opinion of the evaluating Principal or Sub-Investigator.
- In the opinion of the consenting staff person, the participant cannot comprehend, follow instructions, or is incapable of providing written, informed consent.
- In the opinion of the consenting staff person, participant is not capable of giving informed consent and does not have a Legal Authorized Representative.
- History of recurrent psychiatric impairment as indicated by self-report.
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 |
|---|---|---|
| Tonic and Phasic Attention TrainingThe Tonic and Phasic Alertness treatment task (TAPAT) consist of two consecutive rounds of a 12-minute continuous performance task in which continually varying, rich visual (e.g., scenes, objects, faces) or auditory stimuli (tones or complex sounds) are briefly displayed and participants are required to respond via a button press when they see a non-target item (90% of trials) or withhold button-press responding when the item is a pre-determined target item (10% of trials). Presentation of the target item is non-predictive and infrequent, disallowing the development of an executive strategy. Participants simply sustain attention to the task over a prolonged period of time (tonic attention), ignoring distractions, and inhibiting the pre-potent motor response when they see a target item (phasic attention). Following the 24 minutes of TAPAT treatment participants will undergo one additional computer-based cognitive exercise, Multiple Object Tracking (MOT), for an additional 12 minutes. | Behavioural | TAPAT |
| Active ComparatorComputer games chosen from a list of progressive visual/audiovisual games from the top-100 game list: sporcle.com. Training duration will be similar to that of experimental training. | Behavioural | Active Comparator |
Primary outcome
Attention and Memory
Time frame: 6 months
Percent change on standardized measures of attention and executive function (all participants) using the ASCAN, Attentional Blink, Attention Capture Task, Landmark task, Conjunction Search task, SART, Verbal Fluency, CVLT-II, D-KEFS Stroop, and LNS assessments.
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 22 Jul 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tonic and Phasic Attention Training and Active Comparator in people with Acquired Brain Injury and Stroke, run by Posit Science Corporation at 1 site 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 7 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 22 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Attention and Memory (time frame: 6 months). 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 22 Jul 2014.