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The investigators evaluated whether it was possible to improve the measurement of memory, attention, and executive function in patients who have suffered traumatic brain injury through the use of computer-based testing.
Note: the original design of the study was altered due to failure to recruit sufficient numbers of patients who were willing to undergo prolonged cognitive training.
Here we describe a series of computer-based tests that were used to evaluate memory, attention, and executive function in large groups of control subjects and in patients with chronic mild and moderate/severe TBI. This extensive battery of neuropsychological tests (NPTs) and subjective rating scale measures were obtained at study entry from the TBI cohort. NPT and rating scale data were compared to those obtained from control subjects to characterize the cognitive deficits following mild, moderate and severe TBI. .
Normative data were obtained by regressing the influences of age, education, and computer use on scores to create normed z-scores on different NPTs,. We hypothesized that patient with TBI would show deficits on tests of memory, attention, and executive function relative to their predicted z-scores (based on the aforementioned regression functions) and that deficits would be more pronounced in patients with severe TBI than in patients with mild TBI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control subjects | Control subjects = 237. These subjects underwent extensive testing with computerized neuropsychological tests including digit span testing, spatial span testing, simple reaction time testing, choice reaction time testing, finger tapping, verbal fluency, design fluency, verbal list learning, questionnaire completion, and the trail making test. |
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| TBI patients | TBI patients N = 28. These patients underwent extensive testing with computerized neuropsychological tests including digit span testing, spatial span testing, simple reaction time testing, choice reaction time testing, finger tapping, verbal fluency, design fluency, verbal list learning, questionnaire completion, and the trail making test. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digit span testing | Behavioral | Testing of short-term verbal memory with digit span |
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| Measure | Description | Time Frame |
|---|---|---|
| Performance in TBI Patients and Controls | Subjects were assessed on a set of cognitive tests. Here we describe the results on the simple reaction time test in which subjects respond as rapidly as possible to the computer-controlled occurrence of a visual stimulus by pressing a mouse button. Two control groups were used. One large control group underwent a single test to provide data from subjects with a broad range of age and education. The other, smaller, control group underwent three tests at weekly intervals to evaluate the test-retest reliability of the measure. | Subjects were tested in a single 2-hr session. |
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Inclusion Criteria:
Control subjects were required to meet the following inclusion criteria:
Exclusion criteria:
Exclusion Criteria for TBI patients:
TBI patients had to meet the same inclusion criteria as the controls with the exception that they were required to have a history of TBI. They also had to be in the chronic phase, i.e., 1-4 yrs post-injury.
Exclusion criteria:
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Controls subjects of various ages (approximately 230), and TBI patients (approximately 30).
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| Name | Affiliation | Role |
|---|---|---|
| David L. Woods, PhD | VA Northern California HCS | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23261913 | Background | Atkins Whitmer D, Woods DL. Analysis of the cost effectiveness of a suicide barrier on the Golden Gate Bridge. Crisis. 2013;34(2):98-106. doi: 10.1027/0227-5910/a000179. | |
| 22459048 | Background | Disbrow EA, Russo KA, Higginson CI, Yund EW, Ventura MI, Zhang L, Malhado-Chang N, Woods DL, Sigvardt KA. Efficacy of tailored computer-based neurorehabilitation for improvement of movement initiation in Parkinson's disease. Brain Res. 2012 May 3;1452:151-64. doi: 10.1016/j.brainres.2012.02.073. Epub 2012 Mar 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Subjects | Control subjects = 237. These subjects underwent extensive testing with computerized neuropsychological tests including digit span testing, spatial span testing, simple reaction time testing, choice reaction time testing, finger tapping, verbal fluency, design fluency, verbal list learning, questionnaire completion, and the trail making test. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Spatial span testing | Behavioral | Testing of short-term visuospatial memory with spatial span. |
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| Finger tapping | Behavioral | Testing motor speed with a finger tapping test. |
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| Simple reaction time | Behavioral | Testing the time to respond to the appearance of a visual stimulus. |
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| Choice reaction time | Behavioral | Testing the time needed to discriminate and respond to different visual stimuli. |
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| Verbal fluency | Behavioral | Evaluating how many words are produced in 90s. |
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| Verbal list learning | Behavioral | Evaluating short-term memory, learning, and memory interference in the recall of 12-word lists, presented three times. Evaluating long-term memory and recognition after a 20 min interval. |
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| Trail making test | Behavioral | Evaluating visuomotor speed and executive function in Trail Making Tests, A and B. In the first, subjects connect successive numbers with the mouse. In the second, they connect numbers and letters in alternation. |
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| Design fluency | Behavioral | Subjects create the maximal number of 4-line patterns in 90 s. |
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| Questionnaire completion | Behavioral | Question completion time is measured on each question of the Post-Traumatic Stress Disorder check list (PCL) and on the cognitive failures questionnaire. |
|
| 24406309 | Background | Whitaker KJ, Kang X, Herron TJ, Woods DL, Robertson LC, Alvarez BD. White matter microstructure throughout the brain correlates with visual imagery in grapheme-color synesthesia. Neuroimage. 2014 Apr 15;90:52-9. doi: 10.1016/j.neuroimage.2013.12.054. Epub 2014 Jan 7. |
| 21957866 | Result | Woods DL, Herron TJ, Yund EW, Hink RF, Kishiyama MM, Reed B. Computerized analysis of error patterns in digit span recall. J Clin Exp Neuropsychol. 2011 Aug;33(7):721-34. doi: 10.1080/13803395.2010.550602. |
| 24175464 | Result | Hubel KA, Reed B, Yund EW, Herron TJ, Woods DL. Computerized measures of finger tapping: effects of hand dominance, age, and sex. Percept Mot Skills. 2013 Jun;116(3):929-52. doi: 10.2466/25.29.PMS.116.3.929-952. |
| 23947782 | Result | Hubel KA, Yund EW, Herron TJ, Woods DL. Computerized measures of finger tapping: reliability, malingering and traumatic brain injury. J Clin Exp Neuropsychol. 2013;35(7):745-58. doi: 10.1080/13803395.2013.824070. Epub 2013 Aug 15. |
| 20680884 | Result | Woods DL, Kishiyamaa MM, Lund EW, Herron TJ, Edwards B, Poliva O, Hink RF, Reed B. Improving digit span assessment of short-term verbal memory. J Clin Exp Neuropsychol. 2011 Jan;33(1):101-11. doi: 10.1080/13803395.2010.493149. |
| FG001 |
| TBI Patients |
TBI patients N = 28. These patients underwent extensive testing with computerized neuropsychological tests including digit span testing, spatial span testing, simple reaction time testing, choice reaction time testing, finger tapping, verbal fluency, design fluency, verbal list learning, questionnaire completion, and the trail making test. |
| Cognitive Testing |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Subjects | Control subjects = 230. Normal control subjects of various ages. |
| BG001 | TBI Patients | TBI patients N = 30. Mixed mild and severe TBI group, with most showing PTSD comorbidity. |
| BG002 | Total | Total of all reporting groups |
| 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 | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Subjects from the San Francisco Bay Area | Number | participants |
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| 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 | Performance in TBI Patients and Controls | Subjects were assessed on a set of cognitive tests. Here we describe the results on the simple reaction time test in which subjects respond as rapidly as possible to the computer-controlled occurrence of a visual stimulus by pressing a mouse button. Two control groups were used. One large control group underwent a single test to provide data from subjects with a broad range of age and education. The other, smaller, control group underwent three tests at weekly intervals to evaluate the test-retest reliability of the measure. | Data from two TBI patients were excluded due to suspected suboptimal effort. | Posted | Mean | Standard Deviation | ms | Subjects were tested in a single 2-hr session. |
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Entire study duration (4 years).
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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 | Control Subjects | Control subjects = 237. No adverse events were observed. | 0 | 237 | 0 | 237 | ||
| EG001 | TBI Patients | TBI patients N = 28. No adverse events were observed | 0 | 28 | 0 | 28 |
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Relatively small TBI group limits strength of conclusions. Not all of the results have yet been fully analyzed and subjected to peer-review.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David L. Woods | VANCHCS | 925-372-2571 | dlwoods@ucdavis.edu |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D014145 | Trail Making Test |
| ID | Term |
|---|---|
| D009483 | Neuropsychological Tests |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
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| >=65 years |
|
| Male |
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| Title | Measurements |
|---|---|
|
| Severe TBI, n =4 |
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| The null hypothesis was that the mild TBI group would not differ in age-corrected z-score from that of a control subjects in the large control group. | ANOVA | .50 | The P-value reflects the likelihood of detection a difference of the magnitude observed. | z-score difference between groups | -0.30 | 2-Sided | Yes | Non-Inferiority or Equivalence | Power analysis of controls (i.e., with z-score = 0) showed a 95% chance of detecting a p < 0.05 significance level for z-scores exceeding 0.54 in the mild TBI patient group.. |