Brain ConcussionNCT03180905
ImPACT Normative Extension
A study testing ImPACT Online/Paper Pencil Tests and ImPACT Online in people with Brain Concussion, run by ImPACT Applications, Inc. at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Concussion
- What is being tested?
- ImPACT Online/Paper Pencil Tests and ImPACT Online
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 May 2017to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 1 recruiting
- Completed
University of Albany
Albany, New York, 12222
- Recruiting
ImPACT Applications Inc.
Pittsburgh, Pennsylvania, 15228
Jane Luce, 412-567-8400 ext. 938, jluce@impacttest.com
- Completed
Comprehensive Med Psych Systems, Inc.
Sarasota, Florida, 34236
About this study
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
- Brain Concussion
- Being tested
- ImPACT Online/Paper Pencil Tests, ImPACT Online
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImPACT Online/Paper Pencil TestsDevice
Compare ImPACT Online versus Paper and Pencil Neurocognitive Tests
ImPACT OnlineDevice
ImPACT Online will be administered at 2 time points.
| Study group | Role | What they receive |
|---|---|---|
| Validity | Experimental | ImPACT Online a computerized test will be administered to subjects. They will also receive a battery of paper and pencil neuropsychological tests. Receives: Device: ImPACT Online/Paper Pencil Tests |
| Test/Re-Test | Active comparator | ImPACT Online will be administered at 2 time points Receives: Device: ImPACT Online |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity
ImPACT Online compared to Brief Visuospatial Memory Test
Measured: 12 Months
Validity
ImPACT Online compared to Symbol Digit Modalities Test
Measured: 12 Months
Validity
ImPACT Online compared to Color Trails
Measured: 12 Months
Validity
ImPACT Online compared to Hopkins Verbal Learning Test.
Measured: 12 Months
Secondary outcomes (1)
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.
Measured: Baseline Test will be administered at enrollment and re- test will be administered within 30 days of baseline test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start1 May 2017
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain ConcussionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ImPACT Applications, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180905
- Sponsor's protocol ID
- QPR-17-03
- Status last verified
- Sep 2023
- First submitted
- 23 May 2017
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ImPACT Normative Extension
- ClinicalTrials.gov ID
- NCT03180905
- Acronym / sponsor ID
- QPR-17-03
- Conditions
- Brain Concussion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- ImPACT Applications, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Validity | Experimental | Device: ImPACT Online/Paper Pencil TestsImPACT Online a computerized test will be administered to subjects. They will also receive a battery of paper and pencil neuropsychological tests. |
| Test/Re-Test | Active comparator | Device: ImPACT OnlineImPACT Online will be administered at 2 time points |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImPACT Online/Paper Pencil TestsCompare ImPACT Online versus Paper and Pencil Neurocognitive Tests | Device | Validity |
| ImPACT OnlineImPACT Online will be administered at 2 time points. | Device | Test/Re-Test |
Primary outcome
Validity
Time frame: 12 Months
ImPACT Online compared to Brief Visuospatial Memory Test
Validity
Time frame: 12 Months
ImPACT Online compared to Symbol Digit Modalities Test
Validity
Time frame: 12 Months
ImPACT Online compared to Color Trails
Validity
Time frame: 12 Months
ImPACT Online compared to Hopkins Verbal Learning Test.
1 secondary outcome
Reliability
Time frame: Baseline Test will be administered at enrollment and re- test will be administered within 30 days of baseline test.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ImPACT Online/Paper Pencil Tests and ImPACT Online in people with Brain Concussion, run by ImPACT Applications, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jane Luce (412-567-8400 ext. 938, jluce@impacttest.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity (time frame: 12 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.