Development of a Neurocognitive Screening Test

Mild Cognitive Impairment Clinical Trial

Official title:

Development of a Neurocognitive Screening Test

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02597504
• Other study ID #: QPR-15-44
• Status: Terminated
• Phase: N/A
• Start date: October 2015
• Est. completion date: October 2019

Study information

• Verified date: September 2023
• Source: ImPACT Applications, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1600
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Brain Concussion
• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Other:
• Pen and paper neuropsychological test
Will be administered for Construct Validity to determine agreement with Quick Test

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

Locations

Country	Name	City	State
United States	Head First	Crofton	Maryland
United States	University of Arkansas	Fayetteville	Arkansas
United States	Jim Gyurke	Pittsburgh	Pennsylvania
United States	FastMed Urgent Care	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
ImPACT Applications, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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