NCT02693275

Brief Summary

This study is being conducted to create a database for the Quotient® System iPad Test. Using community sampling, NCS Pearson will compile the results of this study to create a database against which the results of clinical Quotient tests may be compared to determine patient performance relative to the expected results for developmental age and gender.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,333

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable healthy-volunteers

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 26, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
Last Updated

April 5, 2017

Status Verified

April 1, 2017

Enrollment Period

12 months

First QC Date

February 23, 2016

Last Update Submit

April 3, 2017

Conditions

Healthy Volunteers

Keywords

Community Sampling

Outcome Measures

Primary Outcomes (9)

  • Range of measured head motion of typically developing subjects while taking the attention test as determined on the dimensions of total number of motions >1mm/sec during the 15-minute test

    The result of this primary outcome measure will be analyzed statistically to establish the range of measured values for this assessment parameter and the population distribution of the measurement in typically developing subjects stratified for age, gender and ethnicity.

    12 Months

  • Duration of motion free periods in seconds during the 15-minute test

    The result of this primary outcome measure will be analyzed statistically to establish the range of measured values for this assessment parameter and the population distribution of the measurement in typically developing subjects stratified for age, gender and ethnicity.

    12 Months

  • Area of head motion covered in centimeters during the total 15-minute test.

    The result of this primary outcome measure will be analyzed statistically to establish the range of measured values for this assessment parameter and the population distribution of the measurement in typically developing subjects stratified for age, gender and ethnicity.

    12 Months

  • Total length of movement in meters during the total 15-minute test.

    The result of this primary outcome measure will be analyzed statistically to establish the range of measured values for this assessment parameter and the population distribution of the measurement in typically developing subjects stratified for age, gender and ethnicity.

    12 Months

  • Range of attentive responses to a 15-minute go/no-go attention task (assessed simultaneously with the motion assessment) in terms of accuracy in % correct response during the 15-minute test

    The result of this primary outcome measure will be analyzed statistically to establish the range of measured values for this assessment parameter and the population distribution of the measurement in typically developing subjects stratified for age, gender and ethnicity.

    12 Months

  • Average response time to stimulus items in milliseconds during the 15-minute test

    The result of this primary outcome measure will be analyzed statistically to establish the range of measured values for this assessment parameter and the population distribution of the measurement in typically developing subjects stratified for age, gender and ethnicity.

    12 Months

  • Total errors of omission in % of total targets during the 15-minute test

    The result of this primary outcome measure will be analyzed statistically to establish the range of measured values for this assessment parameter and the population distribution of the measurement in typically developing subjects stratified for age, gender and ethnicity.

    12 Months

  • Total errors of commission in % of total non-targets during the 15-minute test

    The result of this primary outcome measure will be analyzed statistically to establish the range of measured values for this assessment parameter and the population distribution of the measurement in typically developing subjects stratified for age, gender and ethnicity.

    12 Months

  • Variability reported as the standard deviation of all responses from mean response time reported in milliseconds during the 15-minute test

    The result of this primary outcome measure will be analyzed statistically to establish the range of measured values for this assessment parameter and the population distribution of the measurement in typically developing subjects stratified for age, gender and ethnicity.

    12 Months

Study Arms (1)

Quotient® System iPad Test

OTHER

The Quotient® System iPad Test is a test specifically designed to provide clinicians with objective measures in ability to maintain seated stillness, sustained attention to a monotonous task and inhibiting incorrect impulsive responses. The attention task with motion analyses provides a number of objective measures for detailed assessment of the subject's movements and attentiveness.

Device: Quotient® System iPad Test

Interventions

Quotient® System iPad TestDEVICE

See arm/group description

Also known as: Quotient®
Quotient® System iPad Test

Eligibility Criteria

Age6 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female
  • Ages 6 years - 79 years and 11 months (79.11) of age
  • Report of good physical health
  • Able to understand test instructions and comply with testing
  • Willing to give written informed consent and/or assent

You may not qualify if:

  • History of known neurological disease or insult (e.g., head trauma with LOC, skull fracture, seizure disorders). History of febrile seizure does not exclude subject from study participation
  • Major Medical Disorders known to the Investigator that would make it difficult for the participant to complete study requirements
  • Any major medical or neurological condition that could affect motor activity or attention (e.g. Parkinson's, MS, dementia)
  • Currently ill with cold, flu or infections which may compromise their ability to perform the computer task
  • Any condition in which the investigator deems the subject inappropriate for participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Center for Psychiatry and Behavioral Medicine, Inc.

Las Vegas, Nevada, 89128, United States

Location

Growing Child Pediatrics, PA

Raleigh, North Carolina, 27615, United States

Location

Erickson Research and Development

Clinton, Utah, 84015, United States

Location

Tanner Clinic

Layton, Utah, 84041, United States

Location

Study Officials

  • Calvin R Sumner, MD

    Pearson/Clinical Assessment

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Open Label
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2016

First Posted

February 26, 2016

Study Start

April 1, 2016

Primary Completion

March 31, 2017

Study Completion

March 31, 2017

Last Updated

April 5, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(4)