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| Name | Class |
|---|---|
| Washington University School of Medicine | OTHER |
| VA Boston Healthcare System | FED |
| Spaulding Rehabilitation Hospital | OTHER |
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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. 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. The study aims to understand how our computer program can affect cognition and attention in those with acquired brain injury.
Following consent, participants will engage in an assessment process to determine eligibility. Once eligibility is confirmed, participants will be scheduled for another assessment session 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 an Internet browser-delivered training sessions conducted on any internet-accessible computer. The computerized training sessions can be done up to 7 times a week (once a day) or at participant's convenience (we recommend 5 times a week). Following the completion of training, the participant's cognitive function will be re-assessed and again after 3-month no-contact period. Participation is voluntary and participants may withdraw from the study at any time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Treatment | Experimental | Computerized Plasticity-based Adaptive Cognitive Training requiring a total maximum of 39 treatment sessions, 4-5 times weekly, ~30 mins each session. |
|
| Active Comparator | Active Comparator | Commercially available computerized training requiring a total maximum of 39 treatment sessions, 4-5 times weekly, ~30 mins each session. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computerized Plasticity-based Adaptive Cognitive Training | Other | Computerized Plasticity-based Adaptive Cognitive Training requiring a total maximum of 39 treatment sessions, 4-5 times weekly, ~30 mins each session. |
| Measure | Description | Time Frame |
|---|---|---|
| Performance on Posner Cueing Task | Between-group magnitude of change in reaction time (RT) for RT detecting targets appearing on the left side of the display minus the RT for detecting targets appearing on the right side of the display as measured by Posner Cueing Task. Positive reaction time difference scores indicate a rightward bias; whereas, negative reaction time difference scores indicate a leftward bias in spatial attention. | At 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Spatial Cognition (Multiple scores are aggregated to arrive at a single composite score) | Between-group magnitude of change in composite score with the measure constructed from Greyscales Task (perceptual bias score) and Spatial Working Memory Task (percent accuracy for targets). The composite is composed of the individual measures combined as follows: i. For each included variable convert the distribution of raw scores in the Intent-to-Treat population at baseline to z-scores (with a mean of 0 and a standard deviation of 1). ii. Compute the average of all z-scores to create a single score for the composite measure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Van Vleet, PhD | Posit Science Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9556766 | Background | Friedrich FJ, Egly R, Rafal RD, Beck D. Spatial attention deficits in humans: a comparison of superior parietal and temporal-parietal junction lesions. Neuropsychology. 1998 Apr;12(2):193-207. doi: 10.1037//0894-4105.12.2.193. | |
| 8892067 | Background | Husain M, Kennard C. Visual neglect associated with frontal lobe infarction. J Neurol. 1996 Sep;243(9):652-7. doi: 10.1007/BF00878662. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 6, 2018 | Jun 6, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D001930 | Brain Injuries |
| D010468 | Perceptual Disorders |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Commercially available computerized training | Other | Commercially available computerized training requiring a total maximum of 39 treatment sessions, 4-5 times weekly, ~30 mins each session. |
|
| At 3 months and at 6 months |
| Change in Cognitive Performance (Multiple scores are aggregated to arrive at a single composite score) | Between-group magnitude of change in composite score with the measure constructed from Delis-Kaplan Executive Function System Verbal Fluency (Letter Fluency, raw scores; Category Fluency total, raw scores; Category Switching total, raw scores; Category Switching, switching Accuracy total, raw scores), Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span total (sum of forward, backward, sequencing raw scores), WAIS-IV Digit Span (Forward total, raw scores; Backward total, raw scores; Sequencing total, raw scores), and Gradual Continuous Performance Task (percent accuracy for targets and standard deviation (SD) of average reaction time for non-targets). The composite is composed of the individual measures combined as follows: i. For each included variable convert the distribution of raw scores in the Intent-to-Treat population at baseline to z-scores (with a mean of 0 and a SD of 1). ii. Compute the average of all z-scores to create a single score for the composite measure. | At 3 months and at 6 months |
| Change in Functional Ability (Multiple scores are aggregated to arrive at a single composite score) | Between-group magnitude of change in composite score with the measure constructed from Catherine Bergego Scale total (raw score) and Barthel Index total (raw score). The composite is composed of the individual measures combined as follows: i. For each included variable convert the distribution of raw scores in the Intent-to-Treat population at baseline to z-scores (with a mean of 0 and a standard deviation of 1). ii. Compute the average of all z-scores to create a single score for the composite measure. | At 3 months and at 6 months |
| Change in Quality of Life (Multiple scores are aggregated to arrive at a single composite score) | Between-group magnitude of change in composite score with the measure constructed from SF-12v2 Health Survey Physical and Mental Component Scores. The composite is composed of the individual measures combined as follows: i. For each included variable convert the distribution of raw scores in the Intent-to-Treat population at baseline to z-scores (with a mean of 0 and a standard deviation of 1). ii. Compute the average of all z-scores to create a single score for the composite measure. | At 3 months and at 6 months |
| Change in Quality of Sleep: Pittsburgh Sleep Quality Index (Multiple scores are aggregated to arrive at a single composite score) | Between-group magnitude of change in composite score with the measure constructed from Pittsburgh Sleep Quality Index (PSQI, sum of component scores), PSQI Sleep Efficiency (raw score), and PSQI Component scores. The composite is composed of the individual measures combined as follows: i. For each included variable convert the distribution of raw scores in the Intent-to-Treat population at baseline to z-scores (with a mean of 0 and a standard deviation of 1). ii. Compute the average of all z-scores to create a single score for the composite measure. | At 3 months and at 6 months |
| Performance on Posner Cueing Task | Between-group magnitude of change in reaction time (RT) for RT detecting targets appearing on the left side of the display minus the RT for detecting targets appearing on the right side of the display as measured by Posner Cueing Task. Positive reaction time difference scores indicate a rightward bias; whereas, negative reaction time difference scores indicate a leftward bias in spatial attention. | At 6 months |
| 8137006 | Background | Heilman KM, Bowers D, Valenstein E, Watson RT. Disorders of visual attention. Baillieres Clin Neurol. 1993 Aug;2(2):389-413. No abstract available. |
| 12821519 | Background | Mort DJ, Malhotra P, Mannan SK, Rorden C, Pambakian A, Kennard C, Husain M. The anatomy of visual neglect. Brain. 2003 Sep;126(Pt 9):1986-97. doi: 10.1093/brain/awg200. Epub 2003 Jun 23. |
| 6737043 | Background | Posner MI, Walker JA, Friedrich FJ, Rafal RD. Effects of parietal injury on covert orienting of attention. J Neurosci. 1984 Jul;4(7):1863-74. doi: 10.1523/JNEUROSCI.04-07-01863.1984. |
| 24502769 | Derived | Vleet TV, DeGutis J, Dabit S, Chiu C. Randomized control trial of computer-based rehabilitation of spatial neglect syndrome: the RESPONSE trial protocol. BMC Neurol. 2014 Feb 7;14:25. doi: 10.1186/1471-2377-14-25. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |