- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01641432
Computerized Attention Training for Individuals With Acquired Brain Injury
Computerized Cognitive Treatment of Vigilance Deficits in Individuals With Acquired Brain Injury
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94104
- Brain Plasticity Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion:
- 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).
Exclusion:
- 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.
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TAPAT
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).
|
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 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).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BPI-1002-2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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