Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
California Verbal Learning Test-II (CLVT-II) |
The CLVT-II is an assessment of verbal learning and memory which measures recall and recognition scores, encoding strategies, learning rates and error types. A list learning task with 16 words from 4 semantic categories are read over a series of 5 list presentations. Recall is assessed after learning and at a 20-minute delay. Software produces a report that computes raw and standardized scores. Our dependent variable was the age adjusted t-score for total number of words recalled after 5 trials. A higher score indicated better recall. The maximum possible score was 80 and a minimum was 0. |
Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without patient follow up. Scores for the experimental and control group were compared. |
|
| Secondary |
Continuous Performance Test |
Sustained attention was assessed using the Penn version of the Continuous Performance Test. During the CPT the participant responds to a target stimulus (e.g., the letter "A"), while inhibiting responding to distractor stimuli. Reaction time to correct targets (true positives) was used as the dependent variable. Faster reaction times indicate better performance. |
Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up |
|
| Secondary |
Controlled Oral Word Association Test |
The Controlled Oral Word Association Test is a measure of the ability to orally generate words to a phonemic cue within a 60-second time interval. Age and education-adjusted t-scores were used as the dependent variable. A T-score of 50 is equal to the mean, with a standard deviation of 10 points. A higher T-score is a more favorable outcome. |
Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up |
|
| Secondary |
Wisconsin Card Sort Test |
The Wisconsin Card Sorting Test is a test of rule-learning and conceptual flexibility. The participant is required to learn to sort a series of cards according to one of three principles (color, form or number) based on response feedback. The age-adjusted t-score for total number of errors was used as a dependent variable. A T-score of 50 is equal to the mean, with a standard deviation of 10 points. A higher T-score is a more favorable outcome. |
Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up |
|
| Secondary |
Trails B |
Trails B is a measure of cognitive flexibility. The participant alternates sequencing between numbers and letters. An age and education-adjusted t-score for time to complete the exercise was used as the dependent variable. A T-score of 50 is equal to the mean, with a standard deviation of 10 points. A higher T-score is a more favorable outcome. |
Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up |
|
| Secondary |
Stroop |
The Stroop Color Word Test is a measure of selective attention and cognitive flexibility. This measure consists of three conditions: word reading, color naming and color-word naming. The interference score (t-score) was used as the dependent variable. A T-score of 50 is equal to the mean, with a standard deviation of 10 points. Higher t-scores represent a more favorable outcome. |
Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up |
|
| Secondary |
Implicit Memory Task |
Participants were presented with 32 stimulus words: 16 neutral and 16 threatening words. After a filler task (crossing out 8's on a sheet of randomized numbers) participants completed a response sheet including the stems for the 32 words presented to participants (primed words) along with stems for the 32 unprimed words. Participants were instructed to write down the first word that came to mind that completes each word stem. The priming effect was determined using the difference score between the correct number of stem completions for primed versus unprimed words. This is a value determined for each participant using the following equation: correct number of stem completions for primed word minus the correct number of stem completions for unprimed words. A larger difference score indicates a stronger implicit memory. |
Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up |
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