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

• ClinicalTrials.gov Identifier: NCT03502603
• Recruitment Status: Recruiting
• First Posted: April 18, 2018
• Last Update Posted: October 6, 2021
• Sponsor: NYU Langone Health
• Information provided by (Responsible Party): NYU Langone Health

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Cerebral Neurological Illness	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	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Pilot Study of New Computer-based Neuropsychological Tool: Visual Tests, Touch Responses
• Actual Study Start Date: May 10, 2019
• Estimated Primary Completion Date: December 1, 2022
• Estimated Study Completion Date: December 1, 2022

Arms and Interventions

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 Name: 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 Name: 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.

Outcome Measures

Primary Outcome Measures :

1. Score on Railroad Test [ Time Frame: 1 Day ]
2. Score on Swamp Test [ Time Frame: 1 Day ]
3. Score on President Recognition Test [ Time Frame: 1 Day ]

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Contacts

Contact: Alexander Cervinsky, PhD; 718 630 8600; Alexander.Chervinsky@nyulangone.org

Locations

United States, New York

New York University School of Medicine; Recruiting

New York, New York, United States, 10016

Contact: Alexander Chervinsky, PhD

Sponsors and Collaborators

NYU Langone Health

Investigators

• Principal Investigator: Alexander Chervinsky, PhD; NYU Langone Health

More Information

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT03502603
• Other Study ID Numbers: 17-01677
• First Posted: April 18, 2018
• Last Update Posted: October 6, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

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

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No