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Computerized Attention Training for Individuals With Acquired Brain Injury

This study is currently recruiting participants.
Verified May 2013 by Posit Science Corporation
Sponsor:
Information provided by (Responsible Party):
Posit Science Corporation
ClinicalTrials.gov Identifier:
NCT01641432
First received: June 25, 2012
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Acquired Brain Injury
Stroke
Hemispatial Neglect
 Behavioral: Tonic and Phasic Attention Training
Behavioral: Active Comparator
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Official Title: Computerized Cognitive Treatment of Vigilance Deficits in Individuals With Acquired Brain Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Posit Science Corporation:

Primary Outcome Measures:
  • Attention and Memory [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 24
Study Start Date: July 2011
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
 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: 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).
 Behavioral: 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.

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

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01641432

Contacts
Contact: Christina Marini, BA 415-230-3741 christina.marini@brainplasticity.com

Locations
United States, California
Brain Plasticity Institute Recruiting
San Francisco, California, United States, 94104
Sponsors and Collaborators
Posit Science Corporation
  More Information

No publications provided

Responsible Party: Posit Science Corporation
ClinicalTrials.gov Identifier: NCT01641432     History of Changes
Other Study ID Numbers: BPI-1002-2011
Study First Received: June 25, 2012
Last Updated: May 13, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Stroke
Brain Injuries
Perceptual Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
 Cardiovascular Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013