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Development of a Neurocognitive Screening Test

Primary Purpose

Brain Concussion, Mild Cognitive Impairment

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pen and paper neuropsychological test
Quick Test
Sponsored by
ImPACT Applications, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Concussion

Eligibility Criteria

6 Years - 75 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • FastMed Urgent Care
  • University of Arkansas
  • Head First
  • Jim Gyurke

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standardization

Validity and Reliability

Arm Description

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

Outcomes

Primary Outcome Measures

Reliability will be established through a test-retest to establish results should be stable over time
Validity established through correlation studies with well-known measures of memory and processing speed and ANOVA.

Secondary Outcome Measures

Full Information

First Posted
October 16, 2015
Last Updated
September 27, 2023
Sponsor
ImPACT Applications, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02597504
Brief Title
Development of a Neurocognitive Screening Test
Official Title
Development of a Neurocognitive Screening Test
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
Loss of funding.
Study Start Date
October 2015 (Actual)
Primary Completion Date
October 2019 (Actual)
Study Completion Date
October 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ImPACT Applications, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Concussion, Mild Cognitive Impairment

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standardization
Arm Type
Active Comparator
Arm Description
individuals assigned to this group will be healthy volunteers and will take the Quick Test.
Arm Title
Validity and Reliability
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Pen and paper neuropsychological test
Intervention Description
Will be administered for Construct Validity to determine agreement with Quick Test
Intervention Type
Device
Intervention Name(s)
Quick Test
Intervention Description
Quick Test, computerized test will be administered to all subjects.
Primary Outcome Measure Information:
Title
Reliability will be established through a test-retest to establish results should be stable over time
Time Frame
12 Months
Title
Validity established through correlation studies with well-known measures of memory and processing speed and ANOVA.
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Facility Information:
Facility Name
FastMed Urgent Care
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85254
Country
United States
Facility Name
University of Arkansas
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72701
Country
United States
Facility Name
Head First
City
Crofton
State/Province
Maryland
ZIP/Postal Code
21114
Country
United States
Facility Name
Jim Gyurke
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15288
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Development of a Neurocognitive Screening Test

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