ImPACT Normative Extension

September 27, 2023 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

800

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 Contact

Study Locations

  • United States
    • Florida
      • Sarasota, Florida, United States, 34236
        • Completed
        • Comprehensive Med Psych Systems, Inc.
    • New York
      • Albany, New York, United States, 12222
        • Completed
        • University of Albany
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15228
        • Recruiting
        • ImPACT Applications Inc.
        • Contact:

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

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age: 60-80
  2. Primary English speaking or fluent in English.
  3. Currently does not reside in a skilled nursing facility.
  4. Currently not suffering from a concussion or being treated for a concussion, unless enrolled in the subgroup Discriminative Validity.
  5. No known physical, neurological, behavioral or psychological impairment that would affect their ability to perform the test.
  6. Hearing or vision impairments that have not been corrected within normal limits.
  7. A score of 24 or greater on the MMSE (Mini-Mental State Examination).

Exclusion Criteria:

  1. English is not their primary language nor are they proficient in the English language.
  2. Currently resides in a skilled nursing facility.
  3. Currently suffering from a concussion or being treated for a concussion, unless enrolled in the subgroup Discriminative Validity.
  4. Known physical, neurological, behavioral, or psychological impairment that would affect their ability to take or complete the test.
  5. Hearing or vision impairments that would affect their ability to perform the test.
  6. Score of 23 or below on the MMSE(Mini-Mental State Examination).

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 Assignment
  • Masking: None (Open Label)

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
Compare ImPACT Online versus Paper and Pencil Neurocognitive Tests
Active Comparator: Test/Re-Test
ImPACT Online will be administered at 2 time points
Device: ImPACT Online
ImPACT Online will be administered at 2 time points.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validity
Time Frame: 12 Months
ImPACT Online compared to Brief Visuospatial Memory Test
12 Months
Validity
Time Frame: 12 Months
ImPACT Online compared to Symbol Digit Modalities Test
12 Months
Validity
Time Frame: 12 Months
ImPACT Online compared to Color Trails
12 Months
Validity
Time Frame: 12 Months
ImPACT Online compared to Hopkins Verbal Learning Test.
12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reliability
Time Frame: Baseline Test will be administered at enrollment and re- test will be administered within 30 days of baseline test.
Reliability will be established through a test/re-test. Online ImPACT will be administered at 2 time points to establish results should be stable over time.
Baseline Test will be administered at enrollment and re- test will be administered within 30 days of baseline test.

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 (Actual)

May 1, 2017

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

May 23, 2017

First Submitted That Met QC Criteria

June 6, 2017

First Posted (Actual)

June 8, 2017

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QPR-17-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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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