ImPACT Testing for Concussion

Overseen By Jane Luce

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: ImPACT Applications, Inc.

Disqualifiers: Non-English, Skilled nursing, Concussion, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well a computer-based test, ImPACT Online, measures the effects of concussions on thinking and memory compared to traditional paper-and-pencil tests. The test evaluates key areas such as memory, attention, and reaction speed to aid in concussion management. Participants may take part in either a single administration of the test or a comparison between two time points. The trial suits English-speaking individuals aged 60 to 80 who are not currently experiencing a concussion or living in a nursing home. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance concussion management.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this software application is safe for concussion management?

Research shows that ImPACT Online reliably checks brain function after a concussion. Studies have found it effectively measures memory and reaction times, helping to understand how a concussion might affect the brain. As a software program, ImPACT Online is much safer than other clinical trials involving drugs or medical procedures.

When combined with paper-pencil tests, studies suggest both methods are equally effective at detecting concussion effects. This reliability aids in understanding how a concussion impacts thinking skills. Since these are tests and not treatments, there are no major safety concerns.

Overall, both ImPACT Online and its combination with paper-pencil tests are well-tolerated, with no reports of negative effects, as they involve mental testing rather than physical or drug-based treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ImPACT Testing for concussion because it offers a unique approach to assessing brain function after an injury. Unlike traditional methods that rely solely on subjective symptom reporting or basic cognitive tests, ImPACT Online provides a comprehensive, objective assessment through a computerized test. This method is designed to be more precise and can be easily repeated, allowing for better tracking of recovery over time. Additionally, combining it with paper-and-pencil neuropsychological tests enhances the depth of the evaluation, potentially leading to more accurate diagnoses and tailored recovery strategies.

What evidence suggests that ImPACT Online is effective for concussion management?

Research shows that ImPACT Online reliably checks for concussions. Studies indicate it correctly identifies 94.6% of individuals with concussions, demonstrating its effectiveness in detection. It also correctly rules out 97.3% of individuals without concussions, proving its ability to avoid false alarms. In this trial, participants in the "Validity" arm will receive both ImPACT Online and a battery of paper-and-pencil neuropsychological tests. ImPACT accurately measures thinking skills like memory and reaction time after a concussion. When combined with traditional paper-and-pencil tests, it remains a strong tool for managing concussions. Overall, evidence supports ImPACT as a helpful method for tracking the recovery of thinking skills after a head injury. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals aged 60-80 who are not in a nursing facility, have no concussion or related treatment (unless part of a specific subgroup), and no impairments that could affect test performance. They must also score above 23 on the MMSE, indicating normal cognitive function.

Inclusion Criteria

Hearing or vision impairments that have not been corrected within normal limits

I speak English fluently.

Currently does not reside in a skilled nursing facility

Exclusion Criteria

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Test Administration

Participants undergo the ImPACT Online test and a battery of paper and pencil neuropsychological tests

1 day

1 visit (in-person)

Test/Re-Test

ImPACT Online will be administered at 2 time points to establish reliability

30 days

2 visits (in-person)

Follow-up

Participants are monitored for cognitive stability and effectiveness of the test over time

12 months

What Are the Treatments Tested in This Trial?

Interventions

• ImPACT Online
• ImPACT Online/Paper Pencil Tests

Trial Overview The study examines ImPACT Online, a software application designed to assess cognitive processes like memory and attention after concussions. It compares this computer-based neurocognitive test with other standard tests to evaluate its effectiveness.

How Is the Trial Designed?

Group I: Validity Experimental Treatment 1 Intervention

ImPACT Online a computerized test will be administered to subjects. They will also receive a battery of paper and pencil neuropsychological tests.

Group II: Test/Re-Test Active Control 1 Intervention

ImPACT Online will be administered at 2 time points

Who Is Running the Clinical Trial?

ImPACT Applications, Inc.

Lead Sponsor

Trials

4

Recruited

4,200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10784890/

Minimal Detectable Change for the ImPACT Test ... The MDC at the 95% CI was 18.6 for the verbal memory composite score, 24.44 for visual memory, 8.76 for visual motor, 0.14 for reaction time, and 6.13 for ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23144368/

Sensitivity and specificity of the online version of ImPACT ... For asymptomatic athletes suspected of hiding their concussion, data from ImPACT yielded 94.6% sensitivity and 97.3% specificity. Conclusion: The online version ...

3. brainline.org brainline.org/article/testing-test-impact-reliability-study

Testing the Test; Impact Reliability Study Schatz concluded that ImPACT is a reliable measure of cognitive function in assessing sports related concussion. Moreover, another, ...

4. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/0363546512466038

Sensitivity and Specificity of the Online Version of ImPACT ... Results: Data from the ImPACT online version yielded 91.4% sensitivity and 69.1% specificity. For asymptomatic athletes suspected of hiding ...

5. bmcpsychology.biomedcentral.com bmcpsychology.biomedcentral.com/articles/10.1186/s40359-017-0184-1

A case matched study examining the reliability of using ... Results showed no significant between-subjects main effect for verbal memory, visual memory, visual motor, reaction time, or impulse control, or ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2775366/

Immediate Post-Concussion Assessment and Cognitive ... Additional results indicated that both ATs and a physician interpreted the ImPACT results 27.8% (111/399) of the time, followed by interpretation by an AT alone ...

7. impacttest.com impacttest.com/

ImPACT Applications: Concussion Management & Training Our assessment gives healthcare providers data to evaluate a patient's post-injury condition and helps assist recovery decisions for a safe return to activity.

8. thejns.org thejns.org/pediatrics/view/journals/j-neurosurg-pediatr/34/2/article-p121.xml

Effects of hours of sleep on ImPACT concussion testing Our results show that hours of sleep do not seem to affect composite score performance for baseline test takers while there are significant ...