RecruitingNCT03180905Updated Sep 29, 2023

ImPACT Normative Extension

An interventional study of ImPACT Online/Paper Pencil Tests and ImPACT Online in Brain Concussion, sponsored by ImPACT Applications, Inc.. Recruiting at 3 sites in United States. Open to participants aged 60 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-29.

Sponsored by ImPACT Applications, Inc. · Not applicable, Interventional, and Screening

From the registry’s dates

Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
Started May 2017; still recruiting 9 years 5 months later.

Phase: Not applicable
Study type: Interventional
Enrollment: 800
Allocation: Non-randomized
Ages: 60 Years to 80 Years
Sex: All

Study 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.

Conditions studied

Brain Concussion

Browse trials for

Brain Concussion 530

In context

Brain Concussion

530 studies on the registry are indexed under Brain Concussion; 151 are open to participants now.

This study's planned enrollment of 800 is above the median of 64 across 364 interventional studies indexed under Brain Concussion.

Browse Brain Concussion studies →

Lead sponsor

ImPACT Applications, Inc. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 60 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Not applicable
Primary purpose: Screening
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 800 participants (estimated)

Study arms

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
Active comparator
Test/Re-Test
ImPACT Online will be administered at 2 time points
Device: ImPACT Online

Interventions

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

What researchers measure

Primary outcomes

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

Secondary outcomes

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.
Time frame: Baseline Test will be administered at enrollment and re- test will be administered within 30 days of baseline test.

Study locations

1 of 3 sites recruiting

Comprehensive Med Psych Systems, Inc.
Sarasota, Florida 34236, United States
Completed
University of Albany
Albany, New York 12222, United States
Completed
ImPACT Applications Inc.
Pittsburgh, Pennsylvania 15228, United States
- Jane Luce · Contact · jluce@impacttest.com · 412-567-8400
Recruiting

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03180905
Lead sponsor: ImPACT Applications, Inc.
Responsible party: Sponsor
First posted: Jun 8, 2017
Start date: May 1, 2017
Primary completion: Dec 31, 2024 (estimated)
Completion: Dec 31, 2024 (estimated)
Last update: Sep 29, 2023

Study contacts

Jane Luce

Contact

jluce@impacttest.com

412-567-8400 ext. 938

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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