Computerized Attention Training for Individuals With Acquired Brain Injury

Stroke Clinical Trial

Official title:

Computerized Cognitive Treatment of Vigilance Deficits in Individuals With Acquired Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01641432
• Other study ID #: BPI-1002-2011
• Status: Completed
• Phase: Phase 1
• First received: June 25, 2012
• Last updated: July 21, 2014
• Start date: July 2011

Study information

• Verified date: July 2014
• Source: Posit Science Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver)

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Hemispatial Neglect
• Stroke

Intervention

Behavioral:
• Tonic and Phasic Attention Training
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
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.

Locations

Country	Name	City	State
United States	Brain Plasticity Institute	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Posit Science Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months	No