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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
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Brain injuries affect the lives of numerous Veterans. This study examines how the brain is affected by injury and how rehabilitation training for attention dysfunction may change brain functioning.
Traumatic brain injuries (TBI) are a leading cause of long-term disability among combat Veterans. The most common and persistent sequelae after TBI are cognitive-behavioral deficits in 'executive control' and 'attention' functions. Such abnormalities may directly contribute to poor long-term outcomes as well as impede rehabilitation of dysfunction in other cognitive and motor domains. Effective treatments would potentially make a major impact in improving functional outcomes, but consistently effective treatments are not available. The overall goal of this research is to improve the investigators' understanding of plasticity in brain function after TBI and to develop improved cognitive neurorehabilitation treatments. The intervention involves individual and group-based training in cognitive skills.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Goal-oriented Attention Regulation Training | Experimental | training in goal-directed attention regulation |
|
| Education | Active Comparator | brain health education |
|
| Technology-assisted Goal-directed Self-Regulation Training | Experimental | computer-assisted training in goal-directed attention regulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| training in goal-directed attention regulation | Behavioral | training in goal-directed attention regulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Self-report | Responses to goal processing questionnaire relating to areas of personal goal-based functioning. This scale measured participants self-perceived changes to their cognitive and emotional functioning. Participants indicated the degree to which they perceived changes to 11 questions after receiving trainings in Arm 1 and Arm 3 on a 10-point scale (1=domain became worse, 5 = no change, 10 = domain improved). Participants did not complete this measure after Arm 2. | 5 Weeks (After completion of active trainings in Arm 1 and Arm 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Post-training for Task Errors on a Functional Performance Measure | Participants completed a functional assessment task, the modified Multiple Errands Task (MET). The MET is an unstructured functional task that permits assessment of participants' abilities to follow outlined rules and complete multiple 'real-world' tasks in a limited time period. Participants were provided written instructions and a map of the hospital where the assessment took place, and were instructed to complete 12 subtasks in 40 minutes while following 9 specified rules. Participants completed this at task at baseline and following Training (Arms 1 & 2, but not 3). Outcome measure was computed as post-training - baseline (negative value reflects less errors made post-training). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark D'Esposito, MD | VA Northern California Health Care System, Mather, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Northern California Health Care System, Mather, CA | Sacramento | California | 95655 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21169860 | Background | Novakovic-Agopian T, Chen AJ, Rome S, Abrams G, Castelli H, Rossi A, McKim R, Hills N, D'Esposito M. Rehabilitation of executive functioning with training in attention regulation applied to individually defined goals: a pilot study bridging theory, assessment, and treatment. J Head Trauma Rehabil. 2011 Sep-Oct;26(5):325-38. doi: 10.1097/HTR.0b013e3181f1ead2. | |
| 21515904 |
| Label | URL |
|---|---|
| Northern California Institute for Research and Education | View source |
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Participants were referred for this study by their physicians and treatment providers due to history of acquired brain injury and chronic cognitive complaints involving distractibility and difficulties with problem solving, organization, and multitasking
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| ID | Title | Description |
|---|---|---|
| FG000 | Goal-oriented Attention Regulation Training | Therapist-guided training in goal-oriented attention regulation in a group format |
| FG001 | Education | brain health education brain health education: brain health education workshops |
| FG002 | Technology-assisted Goal-directed Self-Regulation Training | computer-assisted training in goal-directed attention regulation: computer-assisted training in goal-directed attention regulation, with trainer guidance and cognitive games to practice skills |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Goal-oriented Attention Regulation Training | training in goal-directed attention regulation training in goal-directed attention regulation: training in goal-directed attention regulation |
| BG001 | Education |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Self-report | Responses to goal processing questionnaire relating to areas of personal goal-based functioning. This scale measured participants self-perceived changes to their cognitive and emotional functioning. Participants indicated the degree to which they perceived changes to 11 questions after receiving trainings in Arm 1 and Arm 3 on a 10-point scale (1=domain became worse, 5 = no change, 10 = domain improved). Participants did not complete this measure after Arm 2. | Posted | Mean | Standard Deviation | units on a scale | 5 Weeks (After completion of active trainings in Arm 1 and Arm 3) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Goal-oriented Attention Regulation Training | training in goal-directed attention regulation training in goal-directed attention regulation: training in goal-directed attention regulation |
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Overall, recruitment challenges resulted in small numbers.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anthony Chen, MD | VA Northern California | 925-372-2000 | anthony.chen@ucsf.edu |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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The design for Arms 1 and 2 was a cross-over design. Half the participants completed Arm 1 first and then crossed-over to Arm 2; the remaining half completed Arm 2 first and then crossed-over to Arm 1. Thus, all participants completed both Arm 1 and 2.
Arm 3 represented a parallel study. Participants enrolled in this arm did not cross-over to any other condition.
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| brain health education | Behavioral | brain health education workshops |
|
| computer-assisted training in goal-directed attention regulation | Behavioral | computer-assisted training in goal-directed attention regulation, with trainer guidance and cognitive games to practice skills |
|
| 5 weeks (After completion of Arm 1 and Arm 2) |
| Change to Attention and Executive Functioning Composite Scores | Participants completed the following neuropsychological measures of attention and executive functions before and after Arms 1 and 2, but not Arm 3. Letter Number Sequencing from WIAT-III; Auditory Consonant Trigram: 9,18, 36 seconds; Digit Vigilance Test (Time and Errors); DKEFS subtests: Design Fluency, Verbal Fluency Switching, Inhibition (Time and Errors); and Inhibition/Switching (Time and Errors); and Trails B. Performance on these measures were scored based upon age, and when available, educational and repeated administration norms. Resultant scores were transformed into z-scores and aggregated to form a composite measure. Higher z-scores reflect better functioning. The unit of analysis for this outcome was the change score from baseline to post-training. Positive change scores reflect improved performance over time[post-training - baseline], whereas negative change scores reflect worsening performance over time. | 5 weeks (After completion of Arm 1 and Arm 2) |
| Chen AJ, Novakovic-Agopian T, Nycum TJ, Song S, Turner GR, Hills NK, Rome S, Abrams GM, D'Esposito M. Training of goal-directed attention regulation enhances control over neural processing for individuals with brain injury. Brain. 2011 May;134(Pt 5):1541-54. doi: 10.1093/brain/awr067. Epub 2011 Apr 22. |
brain health education
brain health education: brain health education workshops
| BG002 | Technology-assisted Goal-directed Self-Regulation Training | computer-assisted training in goal-directed attention regulation computer-assisted training in goal-directed attention regulation: computer-assisted training in goal-directed attention regulation, with trainer guidance and cognitive games to practice skills |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education |
brain health education brain health education: brain health education workshops |
| OG002 | Technology-assisted Goal-directed Self-Regulation Training | computer-assisted training in goal-directed attention regulation computer-assisted training in goal-directed attention regulation: computer-assisted training in goal-directed attention regulation, with trainer guidance and cognitive games to practice skills |
|
|
| Secondary | Change From Baseline to Post-training for Task Errors on a Functional Performance Measure | Participants completed a functional assessment task, the modified Multiple Errands Task (MET). The MET is an unstructured functional task that permits assessment of participants' abilities to follow outlined rules and complete multiple 'real-world' tasks in a limited time period. Participants were provided written instructions and a map of the hospital where the assessment took place, and were instructed to complete 12 subtasks in 40 minutes while following 9 specified rules. Participants completed this at task at baseline and following Training (Arms 1 & 2, but not 3). Outcome measure was computed as post-training - baseline (negative value reflects less errors made post-training). | Posted | Mean | Standard Deviation | Number of task failures | 5 weeks (After completion of Arm 1 and Arm 2) |
|
|
|
|
| Secondary | Change to Attention and Executive Functioning Composite Scores | Participants completed the following neuropsychological measures of attention and executive functions before and after Arms 1 and 2, but not Arm 3. Letter Number Sequencing from WIAT-III; Auditory Consonant Trigram: 9,18, 36 seconds; Digit Vigilance Test (Time and Errors); DKEFS subtests: Design Fluency, Verbal Fluency Switching, Inhibition (Time and Errors); and Inhibition/Switching (Time and Errors); and Trails B. Performance on these measures were scored based upon age, and when available, educational and repeated administration norms. Resultant scores were transformed into z-scores and aggregated to form a composite measure. Higher z-scores reflect better functioning. The unit of analysis for this outcome was the change score from baseline to post-training. Positive change scores reflect improved performance over time[post-training - baseline], whereas negative change scores reflect worsening performance over time. | Posted | Mean | Standard Deviation | Aggregate Z-scores | 5 weeks (After completion of Arm 1 and Arm 2) |
|
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Education | brain health education brain health education: brain health education workshops | 0 | 19 | 0 | 19 | 0 | 19 |
| EG002 | Technology-assisted Goal-directed Self-Regulation Training | computer-assisted training in goal-directed attention regulation computer-assisted training in goal-directed attention regulation: computer-assisted training in goal-directed attention regulation, with trainer guidance and cognitive games to practice skills | 0 | 11 | 0 | 11 | 0 | 11 |
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| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |