Evaluating a software application for concussion management
ImPACT Normative Extension
This study is testing a new online concussion management tool to see if it works better than other common tests for older adults aged 60-80.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 800 (estimated) |
| Ages | 60 Years to 80 Years |
| Sex | All |
| Sponsor | ImPACT Applications, Inc. Industry-sponsored |
| Locations | 3 sites (Sarasota, Florida and 2 other locations) |
| Trial ID | NCT03180905 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of ImPACT Online, a computer-based neurocognitive test designed for concussion management. It will compare ImPACT Online with other commonly used tests that measure cognitive functions such as memory, attention, and reaction time. Participants will be evaluated to determine how well the software performs in assessing the effects of concussion on cognitive processes. The study focuses on older adults aged 60-80 who meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are English-speaking adults aged 60-80 without any significant cognitive impairments.
Not a fit: Patients currently residing in skilled nursing facilities or those suffering from a concussion may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance concussion management by providing a reliable tool for assessing cognitive impairment.
How similar studies have performed: Other studies have shown promise in using neurocognitive tests for concussion management, suggesting that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Sarasota, Florida and 2 other locations
- Comprehensive Med Psych Systems, Inc. — Sarasota, Florida, United States (Completed)
- University of Albany — Albany, New York, United States (Completed)
- ImPACT Applications Inc. — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Jane Luce
- Email: jluce@impacttest.com
- Phone: 412-567-8400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.