Development of a Neurocognitive Screening Test

Not Applicable

Terminated

• Conditions: Brain Concussion; Mild Cognitive Impairment
• Interventions: Device: Quick Test; Other: Pen and paper neuropsychological test

• Registration Number: NCT02597504
• Lead Sponsor: ImPACT Applications, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-16
• Study First Submitted QC: 2015-11-04
• Study First Posted: 2015-11-05
• Primary Completion: 2019-10
• Study Completion: 2019-10
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-27
• Last Update Posted: 2023-09-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1600

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standardization	Quick Test	individuals assigned to this group will be healthy volunteers and will take the Quick Test.
Validity and Reliability	Pen and paper neuropsychological test	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.
Validity and Reliability	Quick Test	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

University of Arkansas; 🇺🇸 Fayetteville, Arkansas, United States

Jim Gyurke; 🇺🇸 Pittsburgh, Pennsylvania, United States

Head First; 🇺🇸 Crofton, Maryland, United States

FastMed Urgent Care; 🇺🇸 Scottsdale, Arizona, United States