Brain Injury
Conditions
Keywords
attention, rehabilitation, training, functional MRI, executive function, brain injury
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALtraining in goal-directed attention regulation
training in goal-directed attention regulation
BEHAVIORALbrain health education
brain health education workshops
BEHAVIORALcomputer-assisted training in goal-directed attention regulation
computer-assisted training in goal-directed attention regulation, with trainer guidance and cognitive games to practice skills
Sponsors
University of California, San Francisco
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* history of traumatic brain injury * greater than 1 week from injury * residual dysfunction related to attention and executive control
Exclusion criteria
* aphasia * active illicit drug use * severe depression * contraindications to MRI scanning
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-report | 5 Weeks (After completion of active trainings in Arm 1 and Arm 3) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Post-training for Task Errors on a Functional Performance Measure | 5 weeks (After completion of Arm 1 and Arm 2) | 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). |
| Change to Attention and Executive Functioning Composite Scores | 5 weeks (After completion of Arm 1 and Arm 2) | 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. |
Countries
United States
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| Goal-oriented Attention Regulation Training training in goal-directed attention regulation
training in goal-directed attention regulation: training in goal-directed attention regulation | 19 |
| Education brain health education
brain health education: brain health education workshops | 19 |
| 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 | 11 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | change in health, job demands,family | 3 | 3 | 4 |
Baseline characteristics
| Characteristic | Education | Technology-assisted Goal-directed Self-Regulation Training | Goal-oriented Attention Regulation Training | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 11 Participants | 19 Participants | 49 Participants |
| Age, Continuous | 50.4 years STANDARD_DEVIATION 12.2 | 51.8 years STANDARD_DEVIATION 12 | 50.4 years STANDARD_DEVIATION 12.2 | 51.1 years STANDARD_DEVIATION 12.1 |
| Region of Enrollment United States | 19 participants | 11 participants | 19 participants | 49 participants |
| Sex: Female, Male Female | 10 Participants | 0 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Male | 9 Participants | 11 Participants | 9 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 | 0 / 11 |
| other Total, other adverse events | 0 / 19 | 0 / 19 | 0 / 11 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 | 0 / 11 |
Outcome results
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.
Time frame: 5 Weeks (After completion of active trainings in Arm 1 and Arm 3)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Goal-oriented Attention Regulation Training | Self-report | Hold information in mind | 7.19 units on a scale | Standard Deviation 1.06 |
| Goal-oriented Attention Regulation Training | Self-report | Choose feasible daily goals to accomplish | 7.07 units on a scale | Standard Deviation 1.07 |
| Goal-oriented Attention Regulation Training | Self-report | Divide a complex task into more manageable tasks | 7.60 units on a scale | Standard Deviation 1.15 |
| Goal-oriented Attention Regulation Training | Self-report | Prioritize | 6.96 units on a scale | Standard Deviation 1.01 |
| Goal-oriented Attention Regulation Training | Self-report | Complete tasks | 7.15 units on a scale | Standard Deviation 1.44 |
| Goal-oriented Attention Regulation Training | Self-report | Manage energy | 6.52 units on a scale | Standard Deviation 1.16 |
| Goal-oriented Attention Regulation Training | Self-report | Stop and Refocus on current goals | 7.61 units on a scale | Standard Deviation 1.36 |
| Goal-oriented Attention Regulation Training | Self-report | Manage distractions | 6.29 units on a scale | Standard Deviation 1.23 |
| Goal-oriented Attention Regulation Training | Self-report | Interact in social settings | 7.08 units on a scale | Standard Deviation 1.25 |
| Goal-oriented Attention Regulation Training | Self-report | Manage anxiety | 6.16 units on a scale | Standard Deviation 1.6 |
| Goal-oriented Attention Regulation Training | Self-report | Stop and Relax during stressful times | 7.79 units on a scale | Standard Deviation 1.39 |
| Technology-assisted Goal-directed Self-Regulation Training | Self-report | Manage anxiety | 5.24 units on a scale | Standard Deviation 1.24 |
| Technology-assisted Goal-directed Self-Regulation Training | Self-report | Stop and Relax during stressful times | 6.49 units on a scale | Standard Deviation 1.38 |
| Technology-assisted Goal-directed Self-Regulation Training | Self-report | Stop and Refocus on current goals | 7.73 units on a scale | Standard Deviation 1.12 |
| Technology-assisted Goal-directed Self-Regulation Training | Self-report | Divide a complex task into more manageable tasks | 6.89 units on a scale | Standard Deviation 1.26 |
| Technology-assisted Goal-directed Self-Regulation Training | Self-report | Hold information in mind | 6.83 units on a scale | Standard Deviation 1.82 |
| Technology-assisted Goal-directed Self-Regulation Training | Self-report | Complete tasks | 7.3 units on a scale | Standard Deviation 1.42 |
| Technology-assisted Goal-directed Self-Regulation Training | Self-report | Interact in social settings | 5.2 units on a scale | Standard Deviation 0.7 |
| Technology-assisted Goal-directed Self-Regulation Training | Self-report | Choose feasible daily goals to accomplish | 6.99 units on a scale | Standard Deviation 1.4 |
| Technology-assisted Goal-directed Self-Regulation Training | Self-report | Prioritize | 7.24 units on a scale | Standard Deviation 1.41 |
| Technology-assisted Goal-directed Self-Regulation Training | Self-report | Manage energy | 6.29 units on a scale | Standard Deviation 1.46 |
| Technology-assisted Goal-directed Self-Regulation Training | Self-report | Manage distractions | 6.47 units on a scale | Standard Deviation 1.32 |
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).
Time frame: 5 weeks (After completion of Arm 1 and Arm 2)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Goal-oriented Attention Regulation Training | Change From Baseline to Post-training for Task Errors on a Functional Performance Measure | -3.7 Number of task failures | Standard Deviation 2.8 |
| Education | Change From Baseline to Post-training for Task Errors on a Functional Performance Measure | -1.8 Number of task failures | Standard Deviation 3.5 |
p-value: <0.01Wilcoxon (Mann-Whitney)
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.
Time frame: 5 weeks (After completion of Arm 1 and Arm 2)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Goal-oriented Attention Regulation Training | Change to Attention and Executive Functioning Composite Scores | 0.82 Aggregate Z-scores | Standard Deviation 0.2 |
| Education | Change to Attention and Executive Functioning Composite Scores | 0.03 Aggregate Z-scores | Standard Deviation 0.11 |
p-value: <0.01t-test, 2 sided