ImPACT Online Clinical Study

August 22, 2017 updated by: ImPACT Applications, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15228
        • ImPACT Applications Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 59 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Validity
ImPACT Online a computerized test will be administered to subjects. They will also receive a battery of paper and pencil neuropsychological tests.
Device: ImPACT Online/Paper Pencil Tests
ACTIVE_COMPARATOR: Test/Re-Test
ImPACT Online will be administered at 2 time points.
Device: ImPACT Online

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Validity is established through correlation studies with well-known measures of memory and processing speed.
Time Frame: 12 Months
12 Months
Reliability will be established through a test/re-test to establish results should be stable over time.
Time Frame: 12 Months
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ImPACT Applications, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

February 27, 2016

First Submitted That Met QC Criteria

March 2, 2016

First Posted (ESTIMATE)

March 8, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 23, 2017

Last Update Submitted That Met QC Criteria

August 22, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QPR-16-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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