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Development of a Neurocognitive Screening Test

Development of a Neurocognitive Screening Test

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02597504
Enrollment
1600
Registered
2015-11-05
Start date
2015-10-31
Completion date
2019-10-31
Last updated
2023-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Concussion, Mild Cognitive Impairment

Brief 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.

Interventions

OTHERPen and paper neuropsychological test

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

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

Sponsors

ImPACT Applications, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 75 Years
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

* 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).

Design outcomes

Primary

MeasureTime frame
Reliability will be established through a test-retest to establish results should be stable over time12 Months
Validity established through correlation studies with well-known measures of memory and processing speed and ANOVA.12 Months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026