ImPACT Normative Extension

Not Applicable

Recruiting

• Conditions: Brain Concussion

• Registration Number: NCT03180905
• Lead Sponsor: ImPACT Applications, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2017-05-23
• Study First Submitted QC: 2017-06-06
• Study First Posted: 2017-06-08
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-27
• Last Update Posted: 2023-09-29
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Validity	12 Months	ImPACT Online compared to Hopkins Verbal Learning Test.

Secondary Outcome Measures

Name	Time	Method
Reliability	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.

Trial Locations

Locations (3)

Comprehensive Med Psych Systems, Inc.; 🇺🇸 Sarasota, Florida, United States

University of Albany; 🇺🇸 Albany, New York, United States

ImPACT Applications Inc.; 🇺🇸 Pittsburgh, Pennsylvania, United States