Pilot Study of New Computer-based Neuropsychological Tool: Visual Tests, Touch Responses

This study is aimed at investigating three new tests that will form part of a computerized tool designed to test brain/cognitive functioning. The system will be evaluated along with the tests' usability on samples of healthy controls and neurologically impaired patient participants. These new tests will be assessed with regard to reliability and validity. Reliability will be addressed through investigation of internal consistency of the test items. Validity will be evaluated relative to traditional paper-and-pencil tests and differentiation between patient and healthy participants.Each participant will complete both the computerized and paper and pencil-based tests. The results will be analyzed to see how performances on the two test types compare. The overall aim of this project is to determine if these new computerized tasks are an improvement over standard paper and pencil-based neuropsychological measures.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Neurological Illness
• Intervention / Treatment: Diagnostic test: Railroad Test; Diagnostic test: Swamp Test; Diagnostic test: Presidents Recognition Test; Diagnostic test: Judgment of Line Orientation; Diagnostic test: Symbol Span subtest of the Wechsler Memory Scale-IV; Diagnostic test: Information subtest of the Wechsler Adult Intelligence Scale-IV:; Diagnostic test: Digit Span subtest of the Wechsler Adult Intelligence Scale-I; Diagnostic test: Reading subtest of the Wide Range Achievement Test; Diagnostic test: Symbol Digit Modalities Test:; Diagnostic test: Dot Counting Test

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexander Cervinsky, PhD; Phone Number: 718 630 8600; Email: Alexander.Chervinsky@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • New York University School of Medicine
      • Contact: Alexander Chervinsky, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Individuals without positive cerebral findings on neuroimaging (Non-PCF)

• Participants can be male or female and between the ages of 21 and 65 years old.
• Participants will have adequate perceptual and motor capabilities to participate in testing.

Neuroimaging-positive cerebral findings (PCF)

• Patients at NYULMC identified to have significant cerebral findings on neuroimaging.
• Participants will be male or female and between the ages of 21 and 65 years old.
• Participants will have adequate perceptual and motor capabilities to participate in testing.

Exclusion Criteria:

• Participants without adequate perceptual and motor capacities preventing them from participation in the testing.
• Participants with severe dysfunction at the level of dementia that can interfere with informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cerebral neurological illness (CNI) participants; Identified from the department of Rehabilitation, Psychiatry, and Medicine and referred to the research staff via in-person communication, email or staff message	Diagnostic test: Railroad Test; This is a test designed to evaluate visual perception capacities and requires the participant to match photographs with railroads as a central theme. The participant is presented with a photograph image at the top of the screen and is asked to match it to one of the two, three or four choices in the lower portion of the display.; Other Names: 1 Day; Diagnostic test: Swamp Test; This is a test of immediate visual memory/attention for photographs with swamp wetlands as a central theme. The participant is briefly presented with a photograph which is replaced by two, three or four choices, one of which the participant is asked to select as the initially presented image.; Diagnostic test: Presidents Recognition Test; This is a test of history knowledge and facial recognition using pictures of US presidents and non-president distractors. The participant is presented with two photographs and is asked to identify which is the picture of a US president; Diagnostic test: Judgment of Line Orientation; This test requires participants to visually match the orientation of line segments. This is a test of visual perception and was included as a relative equivalent of the Railroad Test.; Diagnostic test: Symbol Span subtest of the Wechsler Memory Scale-IV; This test requires participants to immediately recall a sequence of designs after a brief presentation. This is a test of immediate visual memory/attention and was included as a relative equivalent of the Swamp Test; Diagnostic test: Information subtest of the Wechsler Adult Intelligence Scale-IV: This test requires participants to answer factual knowledge questions. This is a test of fund of knowledge and was included as a verbal equivalent for the non-verbal Presidents Recognition Test.; Diagnostic test: Digit Span subtest of the Wechsler Adult Intelligence Scale-I; This test requires the participant to repeat sets of digits forward, backward, and to sequence digits in ascending order. This is a test of immediate memory/attention and was included to investigate possible attentional correlates of the Swamp Test. This test includes a performance validity indicator that will permit analyses of validity indicators included with the experimental tests; Diagnostic test: Reading subtest of the Wide Range Achievement Test; This test requires participants to read words printed on a card. This is a test of word knowledge/academic achievement and was included to investigate the academic achievement concomitants of the Presidents Recognition Test.; Diagnostic test: Symbol Digit Modalities Test: This test requires participants to visually match abstract symbols with numbers within a certain time period. The participant either verbalizes or writes the response on an answer sheet. This is a test of speed of information processing and was included to assess speed of response factors pertaining to all of the experimental tests as reflecting speed of information processing.; Diagnostic test: Dot Counting Test; This test requires participants to count arrays of dots presented on a card while being timed. This is a performance validity test and was included to ascertain validity factors pertaining to each of the experimental tests.
Active Comparator: Non-CNI participants; Identified from the department of Rehabilitation, Psychiatry, and Medicine and referred to the research staff via in-person communication, email or staff message	Diagnostic test: Railroad Test; This is a test designed to evaluate visual perception capacities and requires the participant to match photographs with railroads as a central theme. The participant is presented with a photograph image at the top of the screen and is asked to match it to one of the two, three or four choices in the lower portion of the display.; Other Names: 1 Day; Diagnostic test: Swamp Test; This is a test of immediate visual memory/attention for photographs with swamp wetlands as a central theme. The participant is briefly presented with a photograph which is replaced by two, three or four choices, one of which the participant is asked to select as the initially presented image.; Diagnostic test: Presidents Recognition Test; This is a test of history knowledge and facial recognition using pictures of US presidents and non-president distractors. The participant is presented with two photographs and is asked to identify which is the picture of a US president; Diagnostic test: Judgment of Line Orientation; This test requires participants to visually match the orientation of line segments. This is a test of visual perception and was included as a relative equivalent of the Railroad Test.; Diagnostic test: Symbol Span subtest of the Wechsler Memory Scale-IV; This test requires participants to immediately recall a sequence of designs after a brief presentation. This is a test of immediate visual memory/attention and was included as a relative equivalent of the Swamp Test; Diagnostic test: Information subtest of the Wechsler Adult Intelligence Scale-IV: This test requires participants to answer factual knowledge questions. This is a test of fund of knowledge and was included as a verbal equivalent for the non-verbal Presidents Recognition Test.; Diagnostic test: Digit Span subtest of the Wechsler Adult Intelligence Scale-I; This test requires the participant to repeat sets of digits forward, backward, and to sequence digits in ascending order. This is a test of immediate memory/attention and was included to investigate possible attentional correlates of the Swamp Test. This test includes a performance validity indicator that will permit analyses of validity indicators included with the experimental tests; Diagnostic test: Reading subtest of the Wide Range Achievement Test; This test requires participants to read words printed on a card. This is a test of word knowledge/academic achievement and was included to investigate the academic achievement concomitants of the Presidents Recognition Test.; Diagnostic test: Symbol Digit Modalities Test: This test requires participants to visually match abstract symbols with numbers within a certain time period. The participant either verbalizes or writes the response on an answer sheet. This is a test of speed of information processing and was included to assess speed of response factors pertaining to all of the experimental tests as reflecting speed of information processing.; Diagnostic test: Dot Counting Test; This test requires participants to count arrays of dots presented on a card while being timed. This is a performance validity test and was included to ascertain validity factors pertaining to each of the experimental tests.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Score on Railroad Test	1 Day
Score on Swamp Test	1 Day
Score on President Recognition Test	1 Day

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Alexander Chervinsky, PhD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2019
• Primary Completion (Estimated): December 16, 2024
• Study Completion (Estimated): December 16, 2024

Study Registration Dates

• First Submitted: April 11, 2018
• First Submitted That Met QC Criteria: April 11, 2018
• First Posted (Actual): April 18, 2018

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 17-01677

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication.
• IPD Sharing Access Criteria: Requests should be directed to alexander.chervinsky@nyulangone.org . To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No