Clinical trial NCT01641432: Computerized Attention Training for Individuals With Acquired Brain Injury
Official title: Computerized Cognitive Treatment of Vigilance Deficits in Individuals With Acquired Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acquired Brain Injury
Stroke
Hemispatial Neglect
Lead sponsor: Posit Science Corporation
Sponsor class: INDUSTRY
First posted: 2012-07-16
Enrollment: 27
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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. 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.

Eligibility criteria: Inclusion:

1. Participants must 21 years or older and not pregnant as indicated by self-report
2. Participant must be fluent in English (indicated by self-report)
3. Participant must be able to engage with computerized cognitive tasks as indicated by investigator's opinion after 30 minutes of computer interaction
4. Participants should have no history of chronic psychiatric or neurological condition (preceding the current insult) as indicated by self-report
5. Normal vision (or corrected to normal vision) as indicated by self-report
6. Participants must be willing to commit to the time requirements of the study as evidenced by written, informed consent.
7. Evidence of hemispatial neglect and/ or vigilance decline on at least one standard measure (e.g., A-SCAN).

Exclusion:

1. 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.
2. Unable to perform neuropsychological evaluations in the opinion of the evaluating Principal or Sub-Investigator.
3. In the opinion of the consenting staff person, the participant cannot comprehend, follow instructions, or is incapable of providing written, informed consent.
4. In the opinion of the consenting staff person, participant is not capable of giving informed consent and does not have a Legal Authorized Representative.
5. History of recurrent psychiatric impairment as indicated by self-report.
6. History of drug or alcohol abuse as indicated by self-report.
7. History of significant medical diseases or multiple neurological events of the head as indicated by self-report.

Primary outcomes:
measure: Attention and Memory
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Brain Plasticity Institute
state: California
Study officials:
References: