Validation and Standardization of the Consecutive-Letter Substitution Task (CST) Test in an Italian Population Sample
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Test-retest reliability
研究概览
简要总结
The CST is a new neuropsychological test created to measure information processing speed, which is frequently impaired in patients with multiple sclerosis. The aim of the study is to validate the CST through the administration on a representative sample of healthy subjects of the Italian population. Each subject will be administered a standardized battery of neuropsychological tests (Digit Span Task and Brief Repeatable Battery of Neuropsychological Tests which includes Selective Reminding Test, Spatial Recall Test, Symbol Digit Modalities Test, Paced Auditory Serial Addition Test and Word List Generation), and the CST in order to verify its validity. After 15 days from the baseline, the CST will be re-administrated to all subjects to assess the reliability of the test.
详细描述
STUDY DESIGN: This is a monocentric, observational study with low-risk intervention.
STUDY PROCEDURES: The CST consists of a standard A4 sheet of paper that shows 135 items within a table of nine rows by fifteen columns. The subject is timed to determine how many correct responses can be made in 90 seconds. The first ten items are administered without a time limit for familiarizing examinee with the task before proceeding with the actual test. The study will involve two evaluations:
- Baseline, in which CST, the Digit Span Backward Task and the Brief Repeatable Battery of Neuropsychological Tests ([BRB-N] including Selective Reminding Test [SRT], Spatial Recall Test [SPART], Symbol Digit Modalities Test [SDMT], Paced Auditory Serial Addition Test [PASAT] and Word List Generation [WLG]) will be administered in order to perform a comparison between these tools useful for the validation analysis. Moreover, the Montgomery-Åsberg Depression Rating Scale (MADRS) will be administered to detect the presence of depressive symptoms which could affect cognitive performance;
- Follow-up, after 15 days from the baseline, in which CST will be re-administrated to all subjects to assess the reliability of the test.
At baseline, all participants will be informed of the project purpose and will be asked whether they agree to participate signing the consent form, then the tests will be administered. The first evaluation will require approximately 45 minutes, whereas the second one will take around 5 minutes. The CST, BRB-N, Digit Span Backward Task and MADRS will be administered by trained psychologists.
COLLECTED VARABLES:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Italian native speaker;
- •No neurological and/or psychiatric diseases;
- •Willing and able to comply with study procedures.
排除标准
- •History of drug, alcohol or substance abuse;
- •A score > 9 on the Montgomery-Åsberg Depression Rating Scale (MADRS), which is the lower limit for mild depressive symptoms;
- •Any person unable to understand and follow the instructions of the investigators.
结局指标
主要结局
Test-retest reliability
时间窗: 15 days
CST intra-class correlation coefficients will be calculated on total CST scores which are expected to remain stable
Italian normative data
时间窗: 2 years
Multivariable hierarchical linear models will be performed to identify possible predictors (among demographic variables) of information processing speed assessed with the CST in healthy adults. A p-value \<0.05 will be considered as significant. When a significant relationship between test scores and the variables is found, the regression coefficients will be used to adjust raw data. After correcting for the relevant demographic factors, the fifth percentile of CST scores distribution will be calculated to determine the cut-off value.
Construct validity
时间窗: 2 years
CST covergent and discriminant construct validity: neuropsychological tests scores comparisons will be performed to investigate the concurrent convergent validity of the CST. Pearson correlation coefficients will be calculated to explore the association between CST scores and Selective Reminding Test (SRT), Spatial Recall Test (SPART), Symbol Digit Modalities Test (SDMT), Paced Auditory Serial Addition Test (PASAT) and Word List Generation (WLG) and Digit Span Backward Task scores. Exploratory and confirmatory factor analysis will be performed to determine latent variables.
次要结局
未报告次要终点
研究者
Prof. Massimo Filippi
Head of Neurology
IRCCS San Raffaele