Back to resultsImPACT Online Clinical Study
Primary Purpose
Brain Concussion
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ImPACT Online/Paper Pencil Tests
ImPACT Online
Sponsored by
About this trial
This is an interventional screening trial for Brain Concussion
Eligibility Criteria
Inclusion Criteria:
- Age: 12-59
- 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.
- An average or above average score on the RIST (Reynolds Intellectual Screening 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.
- A below average score on the RIST.
Sites / Locations
- ImPACT Applications Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Validity
Test/Re-Test
Arm Description
ImPACT Online a computerized test will be administered to subjects. They will also receive a battery of paper and pencil neuropsychological tests.
ImPACT Online will be administered at 2 time points.
Outcomes
Primary Outcome Measures
Validity is established through correlation studies with well-known measures of memory and processing speed.
Reliability will be established through a test/re-test to establish results should be stable over time.
Secondary Outcome Measures
Full Information
NCT ID
NCT02701842
First Posted
February 27, 2016
Last Updated
August 22, 2017
Sponsor
ImPACT Applications, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02701842
Brief Title
ImPACT Online Clinical Study
Official Title
ImPACT Online Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
September 2016 (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
The researchers want to find out more about a standalone software application, ImPACT Online and how it relates to other commonly used tests of memory, attention and reaction time. ImPACT Online is a computer-based neurocognitive test for concussion management. The test was designed to help measure the effects of concussion on cognitive processes (for example, 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
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Validity
Arm Type
Experimental
Arm Description
ImPACT Online a computerized test will be administered to subjects. They will also receive a battery of paper and pencil neuropsychological tests.
Arm Title
Test/Re-Test
Arm Type
Active Comparator
Arm Description
ImPACT Online will be administered at 2 time points.
Intervention Type
Device
Intervention Name(s)
ImPACT Online/Paper Pencil Tests
Intervention Type
Device
Intervention Name(s)
ImPACT Online
Primary Outcome Measure Information:
Title
Validity is established through correlation studies with well-known measures of memory and processing speed.
Time Frame
12 Months
Title
Reliability will be established through a test/re-test to establish results should be stable over time.
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age: 12-59
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.
An average or above average score on the RIST (Reynolds Intellectual Screening 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.
A below average score on the RIST.
Facility Information:
Facility Name
ImPACT Applications Inc.
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15228
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ImPACT Online Clinical Study
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