Development of a Neurocognitive Screening Test

Not Applicable

Terminated

• Conditions: Brain Concussion; Mild Cognitive Impairment

• 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

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)

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

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

Head First; 🇺🇸 Crofton, Maryland, United States

Jim Gyurke; 🇺🇸 Pittsburgh, Pennsylvania, United States