Development of a Neurocognitive Screening Test

September 27, 2023 updated by: ImPACT Applications, Inc.

This research study will evaluate a standalone software application and is designed to standardize and validate new neurocognitive screening testing for children aged 6 through 11, and adolescents and adults ages 12 through 75.

The purpose of this study is to evaluate recently developed computerized tasks sensitive to changes in neurocognitive performance after a concussion. These tests were designed to help measure the effects of concussion on cognitive processes (e.g., memory, attention, brain speed) and visual functioning.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85254
        • FastMed Urgent Care
    • Arkansas
      • Fayetteville, Arkansas, United States, 72701
        • University of Arkansas
    • Maryland
      • Crofton, Maryland, United States, 21114
        • Head First
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15288
        • Jim Gyurke

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age: 12-75 (Adult version), 6-11 (pediatric version)
  • Primary English speaking or fluent in English.
  • No known special education diagnosis excluding a 504 designation.
  • Currently not suffering from a concussion or being treated for a concussion.*
  • No known physical or psychological impairment that would affect their ability to perform the test.

Exclusion Criteria:

  • Documentation of a known special education diagnosis other than a 504 designation.
  • English is not their primary language nor are they proficient in the English language.
  • Currently suffering from a concussion or being treated for a concussion.*

  • Any known physical or psychological impairment that would affect their ability to perform the test.

    • Note: Unless specifically required by the particular study (i.e., a discriminant validity study differentiating concussed versus non-concussed individuals).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standardization
individuals assigned to this group will be healthy volunteers and will take the Quick Test.
Device: Quick Test
Quick Test, computerized test will be administered to all subjects.
Experimental: Validity and Reliability

Reliability:

Test-Retest

Validity:

Concurrent:Quick Test administered with ImPACT online Discriminant: Concussed patient administered Quick Test Construct: Determine agreement between Quick Test and and paper and pencil test.
Device: Quick Test
Quick Test, computerized test will be administered to all subjects.
Other: Pen and paper neuropsychological test
Will be administered for Construct Validity to determine agreement with Quick Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reliability will be established through a test-retest to establish results should be stable over time
Time Frame: 12 Months
12 Months
Validity established through correlation studies with well-known measures of memory and processing speed and ANOVA.
Time Frame: 12 Months
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ImPACT Applications, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

October 16, 2015

First Submitted That Met QC Criteria

November 4, 2015

First Posted (Estimated)

November 5, 2015

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QPR-15-44

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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