Development of a Neurocognitive Screening Test

Study Overview
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Brief Summary
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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.

Official Title
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Development of a Neurocognitive Screening Test

Conditions
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Brain Concussion, Mild Cognitive Impairment

Intervention / Treatment
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* Other: Pen and paper neuropsychological test
* Device: Quick Test


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standardization<br>individuals assigned to this group will be healthy volunteers and will take the Quick Test. | Device: Quick Test<br>* Quick Test, computerized test will be administered to all subjects.<br>|
| Experimental: Validity and Reliability<br>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<br>* Will be administered for Construct Validity to determine agreement with Quick Test<br>Device: Quick Test<br>* Quick Test, computerized test will be administered to all subjects.<br>|

What is the study measuring?
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Primary Outcome Measures

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