CClinicalTrials.gg
TerminatedNCT02597504Updated Sep 29, 2023

Development of a Neurocognitive Screening Test

An interventional study of Pen and paper neuropsychological test and Quick Test in Brain Concussion and Mild Cognitive Impairment, sponsored by ImPACT Applications, Inc.. Terminated at 4 sites in United States. Open to participants aged 6 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-29.

Sponsored by ImPACT Applications, Inc. · Not applicable, Interventional, and Diagnostic

Why this study was terminated
Loss of funding.
Phase
Not applicable
Study type
Interventional
Enrollment
1,600
Allocation
Non-randomized
Ages
6 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Brain Concussion
  • Mild Cognitive Impairment
03

In context

Brain Concussion

530 studies on the registry are indexed under Brain Concussion; 151 are open to participants now.

This study's enrollment of 1,600 is above the median of 64 across 364 interventional studies indexed under Brain Concussion.

Browse Brain Concussion studies →

Lead sponsor

ImPACT Applications, Inc. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,600 participants (actual)

Study arms

  • Active comparator
    Standardization

    individuals assigned to this group will be healthy volunteers and will take the Quick Test.

    Device: Quick Test

  • 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.

    Other: Pen and paper neuropsychological test · Device: Quick Test

Interventions

  • OtherPen and paper neuropsychological test

    Will be administered for Construct Validity to determine agreement with Quick Test

  • DeviceQuick Test

    Quick Test, computerized test will be administered to all subjects.

06

What researchers measure

Primary outcomes

  1. Reliability will be established through a test-retest to establish results should be stable over time

    Time frame: 12 Months

  2. Validity established through correlation studies with well-known measures of memory and processing speed and ANOVA.

    Time frame: 12 Months

07

Study locations

4 sites
  • FastMed Urgent Care
    Scottsdale, Arizona 85254, United States
  • University of Arkansas
    Fayetteville, Arkansas 72701, United States
  • Head First
    Crofton, Maryland 21114, United States
  • Jim Gyurke
    Pittsburgh, Pennsylvania 15288, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02597504
Lead sponsor
ImPACT Applications, Inc.
Responsible party
Sponsor
First posted
Nov 5, 2015
Start date
Oct 2015
Primary completion
Oct 2019
Completion
Oct 2019
Last update
Sep 29, 2023

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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