ImPACT Normative Extension

Brain Concussion Clinical Trial

Official title:

ImPACT Normative Extension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03180905
• Other study ID #: QPR-17-03
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: ImPACT Applications, Inc.
• Contact: Jane Luce
• Phone: 412-567-8400
• Email: jluce[@]impacttest.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Brain Concussion

Intervention

Device:
• ImPACT Online/Paper Pencil Tests
Compare ImPACT Online versus Paper and Pencil Neurocognitive Tests
• ImPACT Online
ImPACT Online will be administered at 2 time points.

Locations

Country	Name	City	State
United States	University of Albany	Albany	New York
United States	ImPACT Applications Inc.	Pittsburgh	Pennsylvania
United States	Comprehensive Med Psych Systems, Inc.	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
ImPACT Applications, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validity	ImPACT Online compared to Brief Visuospatial Memory Test	12 Months
Primary	Validity	ImPACT Online compared to Symbol Digit Modalities Test	12 Months
Primary	Validity	ImPACT Online compared to Color Trails	12 Months
Primary	Validity	ImPACT Online compared to Hopkins Verbal Learning Test.	12 Months
Secondary	Reliability	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.