Validation of the Consecutive-Letter Substitution Task (CST)

NCT06066281 | Unknown DMC

• 1 other identifier: VAL-CST
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

Processing Speed; Neuropsychological Tests; Reference Standards

Outcome Measures

Primary Outcomes (3)

• Test-retest reliability

  CST intra-class correlation coefficients will be calculated on total CST scores which are expected to remain stable

  15 days

• Construct validity

  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.

  2 years

• Italian normative data

  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.

  2 years

Study Arms (1)

Healthy volunteers

480 healthy subjects between the ages of 18 and 75, Italian native speakers, willing and able to comply with study procedures.

Behavioral: Neuropsychological assessment

Interventions

Neuropsychological assessment BEHAVIORAL

All participants who will meet the inclusion criteria will be adminstered a pencil-paper neuropsychological tests battery including: the Digit Span Backward Task, the Brief Repeatable Battery of Neuropsychological Tests and the CST. After 15 days from the baseline evaluation the CST will be re-administrated to all subjects.

Healthy volunteers

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Four hundred and eighty healthy subjects will be recruited, in order to have a sample wide enough to represent the Italian population

You may qualify if:

• Italian native speaker;
• No neurological and/or psychiatric diseases;
• Willing and able to comply with study procedures.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS San Raffaele

Milan, 20132, Italy

RECRUITING

Related Publications (10)

• Costa SL, Genova HM, DeLuca J, Chiaravalloti ND. Information processing speed in multiple sclerosis: Past, present, and future. Mult Scler. 2017 May;23(6):772-789. doi: 10.1177/1352458516645869. Epub 2016 May 9.

  PMID: 27207446 BACKGROUND

• Benedict RH, DeLuca J, Phillips G, LaRocca N, Hudson LD, Rudick R; Multiple Sclerosis Outcome Assessments Consortium. Validity of the Symbol Digit Modalities Test as a cognition performance outcome measure for multiple sclerosis. Mult Scler. 2017 Apr;23(5):721-733. doi: 10.1177/1352458517690821. Epub 2017 Feb 16.

  PMID: 28206827 BACKGROUND

• Monaco M, Costa A, Caltagirone C, Carlesimo GA. Forward and backward span for verbal and visuo-spatial data: standardization and normative data from an Italian adult population. Neurol Sci. 2013 May;34(5):749-54. doi: 10.1007/s10072-012-1130-x. Epub 2012 Jun 12.

  PMID: 22689311 BACKGROUND

• Amato MP, Portaccio E, Goretti B, Zipoli V, Ricchiuti L, De Caro MF, Patti F, Vecchio R, Sorbi S, Trojano M. The Rao's Brief Repeatable Battery and Stroop Test: normative values with age, education and gender corrections in an Italian population. Mult Scler. 2006 Dec;12(6):787-93. doi: 10.1177/1352458506070933.

  PMID: 17263008 BACKGROUND

• Zimmerman M, Chelminski I, Posternak M. A review of studies of the Hamilton depression rating scale in healthy controls: implications for the definition of remission in treatment studies of depression. J Nerv Ment Dis. 2004 Sep;192(9):595-601. doi: 10.1097/01.nmd.0000138226.22761.39.

  PMID: 15348975 BACKGROUND

• MacCallum RC, Widaman KF, Preacher KJ, Hong S. Sample Size in Factor Analysis: The Role of Model Error. Multivariate Behav Res. 2001 Oct 1;36(4):611-37. doi: 10.1207/S15327906MBR3604_06.

  PMID: 26822184 BACKGROUND

• Charter RA. Sample size requirements for precise estimates of reliability, generalizability, and validity coefficients. J Clin Exp Neuropsychol. 1999 Aug;21(4):559-66. doi: 10.1076/jcen.21.4.559.889.

  PMID: 10550813 BACKGROUND

• Gigantesco A, Ferrante G, Baldissera S, Masocco M; PASSI coordinating group. Depressive Symptoms and Behavior-Related Risk Factors, Italian Population-Based Surveillance System, 2013. Prev Chronic Dis. 2015 Oct 29;12:E183. doi: 10.5888/pcd12.150154.

  PMID: 26513439 BACKGROUND

• Sakpal TV. Sample size estimation in clinical trial. Perspect Clin Res. 2010 Apr;1(2):67-9.

  PMID: 21829786 BACKGROUND

• Galinowski A, Lehert P. Structural validity of MADRS during antidepressant treatment. Int Clin Psychopharmacol. 1995 Sep;10(3):157-61. doi: 10.1097/00004850-199510030-00004.

  PMID: 8675968 BACKGROUND

MeSH Terms

Interventions

Neuropsychological Tests

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Massimo Filippi, MD

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Massimo Filippi, MD

CONTACT

00390226433054; filippi.massimo@hsr.it

Maria A. Rocca, MD

CONTACT

00390226433019; rocca.mara@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neurology

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 4, 2023
• Study Start: January 3, 2023
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The dataset including all the data obtained from this study will be available 6 months after the publication of the results.
• Access Criteria: The dataset including all the data obtained from this study will be available from the Principal Investigator upon reasonable request.

Locations

IT (1)