ImPACT Version 4-Touchscreen: Normative and Reliability Study

Overview

This research study is designed to establish normative database and reliability of ImPACT for adolescents and adults ages 12 through 80 to expand the use of devices to include touchscreen.

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Screening
  • Masking: None (Open Label)
• Study Primary Completion Date: June 1, 2024

Detailed Description

This research study is designed to establish normative database and reliability of ImPACT for adolescents and adults ages 12 through 80 to expand the use of devices to include touchscreen. Enrollment will be 900 participants.

Interventions

• Device: Normative
  • ImPACT will be administered at baseline testing
• Device: Reliability
  • ImPACT will be administered again within 60 days of baseline test

Arms, Groups and Cohorts

• Other: Normative
  • ImPACT will be administered to participant’s for a baseline test.
• Other: Reliability
  • ImPACT will be administered to participant’s within 60 days of baseline test.

Clinical Trial Outcome Measures

Primary Measures

• Validity
  • Time Frame: 12 months
  • ImPACT Touchscreen performs within normal parameters of ImPACT Online

Secondary Measures

• Reliability
  • Time Frame: Baseline test will be administered at enrollment and re-test will be administered within 60 days of baseline test.
  • Reliability will be established through a test/re-test. ImPACT Touchscreen will be administered at 2 time points to establish results should be stable over time.

Participating in This Clinical Trial

Inclusion Criteria

1. Age 12-80 2. Primary English speaking or fluent in English Exclusion Criteria:

1. Documentation of a known special education diagnosis other than a 504 designation. 2. History of concussion less than 6 months to the study participation 3. Known physical (e.g., visual impairment not fixable by usual means, such as glasses) or psychological impairment (ADHD, LDD, etc.) that would affect their ability to perform the test.

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • ImPACT Applications, Inc.
• Provider of Information About this Clinical Study
  • Sponsor