An observational study in Traumatic Brain Injury, sponsored by US Department of Veterans Affairs. Completed. Open to participants aged 18 Years to 78 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-07-31.
Sponsored by US Department of Veterans Affairs · Observational
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.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's enrollment of 265 is above the median of 100 across 690 observational studies indexed under Brain Injuries.
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Controls subjects of various ages (approximately 230), and TBI patients (approximately 30).
Inclusion Criteria:
Control subjects were required to meet the following inclusion criteria:
Exclusion criteria:
Exclusion Criteria for TBI patients:
Exclusion criteria:
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.
Behavioral: Digit span testing · Behavioral: Spatial span testing · Behavioral: Finger tapping · Behavioral: Simple reaction time · Behavioral: Choice reaction time · Behavioral: Verbal fluency · Behavioral: Verbal list learning · Behavioral: Trail making test · Behavioral: Design fluency · Behavioral: Questionnaire completion
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.
Behavioral: Digit span testing · Behavioral: Spatial span testing · Behavioral: Finger tapping · Behavioral: Simple reaction time · Behavioral: Choice reaction time · Behavioral: Verbal fluency · Behavioral: Verbal list learning · Behavioral: Trail making test · Behavioral: Design fluency · Behavioral: Questionnaire completion
Testing of short-term verbal memory with digit span
Testing of short-term visuospatial memory with spatial span.
Testing motor speed with a finger tapping test.
Testing the time to respond to the appearance of a visual stimulus.
Testing the time needed to discriminate and respond to different visual stimuli.
Evaluating how many words are produced in 90s.
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.
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.
Subjects create the maximal number of 4-line patterns in 90 s.
Question completion time is measured on each question of the Post-Traumatic Stress Disorder check list (PCL) and on the cognitive failures questionnaire.
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.
Time frame: Subjects were tested in a single 2-hr session.
| Milestone | Control Subjects | TBI Patients |
|---|---|---|
| Started | 237 | 28 |
| Cognitive testing | 237 | 28 |
| Completed | 237 | 28 |
| Not completed | 0 | 0 |
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.
| ms | Simple Reaction Time Test |
|---|---|
| Control group 1, n=189 | 237.8 ± 27.8 |
| Control group 2, n =48 | 231.5 ± 17.72 |
| Mild TBI, n =22 | 228.0 ± 34.6 |
| Severe TBI, n =4 | 280.0 ± 42.4 |
Collected over Entire study duration (4 years).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Subjects | — | 0/237 (0%) | 0/237 (0%) |
| TBI Patients | — | 0/28 (0%) | 0/28 (0%) |
| Age, Categorical(Participants) | Control Subjects | TBI Patients | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 222 | 28 | 250 |
| >=65 years | 15 | 0 | 15 |
| Age, Continuous(years) | Control Subjects | TBI Patients | Total |
|---|---|---|---|
| Mean | 41.0 ± 21.3 | 42.4 ± 10.3 | 41.8 ± 14.4 |
| Sex: Female, Male(Participants) | Control Subjects | TBI Patients | Total |
|---|---|---|---|
| Female | 107 | 1 | 108 |
| Male | 130 | 27 | 157 |
| Region of Enrollment(participants) | Control Subjects | TBI Patients | Total |
|---|---|---|---|
| United States | 237 | 28 | 265 |
No study locations are listed for this record.
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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US Department of Veterans Affairs