ImPACT Normative Extension

• Sponsor: ImPACT Applications, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT03180905
• Collaborator: (none)
• Enrollment: 800
• Locations: 3
• Arms: 2
• Anticipated Duration (Months): 68
• Patients Per Site: 266.7
• Patients Per Site Per Month: 3.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Concussion	Device: ImPACT Online/Paper Pencil Tests; Device: ImPACT Online	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 800 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: ImPACT Normative Extension
• Actual Study Start Date: May 1, 2017
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Validity [12 Months]

   ImPACT Online compared to Brief Visuospatial Memory Test

2. Validity [12 Months]

   ImPACT Online compared to Symbol Digit Modalities Test

3. Validity [12 Months]

   ImPACT Online compared to Color Trails

4. Validity [12 Months]

   ImPACT Online compared to Hopkins Verbal Learning Test.

Secondary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Comprehensive Med Psych Systems, Inc.	Sarasota	Florida	United States	34236
2	University of Albany	Albany	New York	United States	12222
3	ImPACT Applications Inc.	Pittsburgh	Pennsylvania	United States	15228

Sponsors and Collaborators

• ImPACT Applications, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ImPACT Applications, Inc.
• ClinicalTrials.gov Identifier: NCT03180905
• Other Study ID Numbers: QPR-17-03
• First Posted: Jun 8, 2017
• Last Update Posted: Mar 31, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Brain Concussion

Study Results

No Results Posted as of Mar 31, 2022