Development of a Neurocognitive Screening Test

NCT ID: NCT02597504

Last Updated: 2023-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2019-10-31

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.

Detailed Description

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Conditions

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Brain Concussion Mild Cognitive Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Standardization

individuals assigned to this group will be healthy volunteers and will take the Quick Test.

Group Type ACTIVE_COMPARATOR

Quick Test

Intervention Type DEVICE

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

Validity and Reliability

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.

Group Type EXPERIMENTAL

Pen and paper neuropsychological test

Intervention Type OTHER

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

Quick Test

Intervention Type DEVICE

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

Interventions

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Pen and paper neuropsychological test

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

Intervention Type OTHER

Quick Test

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

Intervention Type DEVICE

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).
Minimum Eligible Age

6 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ImPACT Applications, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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FastMed Urgent Care

Scottsdale, Arizona, United States

Site Status

University of Arkansas

Fayetteville, Arkansas, United States

Site Status

Head First

Crofton, Maryland, United States

Site Status

Jim Gyurke

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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QPR-15-44

Identifier Type: -

Identifier Source: org_study_id

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