Brain ConcussionNCT02701842
ImPACT Online Clinical Study
A study testing ImPACT Online/Paper Pencil Tests and ImPACT Online in people with Brain Concussion, run by ImPACT Applications, Inc. at 1 site 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 12 to 59 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
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Sep 2016
- 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 12 to 59 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age: 12-59
- Primary English speaking or fluent in English.
- No known special education diagnosis excluding a 504 designation.
- Currently not suffering from a concussion or being treated for a concussion.
- No known physical or psychological impairment that would affect their ability to perform the test.
- An average or above average score on the RIST (Reynolds Intellectual Screening Test).
Who cannot join
- Documentation of a known special education diagnosis other than a 504 designation.
- English is not their primary language nor are they proficient in the English language.
- Currently suffering from a concussion or being treated for a concussion.
- A below average score on the RIST.
Trial locations and contacts
1 site in 1 country.
United States1 site
ImPACT Applications Inc.
Pittsburgh, Pennsylvania, 15228
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
ImPACT OnlineDevice
| 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 is established through correlation studies with well-known measures of memory and processing speed.
Measured: 12 Months
Reliability will be established through a test/re-test to establish results should be stable over time.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionJun 2016
- Study completionSep 2016
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
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImPACT Applications, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701842
- Sponsor's protocol ID
- QPR-16-05
- Status last verified
- Aug 2017
- First submitted
- 27 Feb 2016
- Last updated
- 23 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ImPACT Online Clinical Study
- ClinicalTrials.gov ID
- NCT02701842
- Acronym / sponsor ID
- QPR-16-05
- Conditions
- Brain Concussion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- ImPACT Applications, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 8 Mar 2016 (estimated)
- 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
- 12 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age: 12-59
- Primary English speaking or fluent in English.
- No known special education diagnosis excluding a 504 designation.
- Currently not suffering from a concussion or being treated for a concussion.
- No known physical or psychological impairment that would affect their ability to perform the test.
Key exclusion criteria (4 listed)
- Documentation of a known special education diagnosis other than a 504 designation.
- English is not their primary language nor are they proficient in the English language.
- Currently suffering from a concussion or being treated for a concussion.
- A below average score on the RIST.
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 Tests | Device | Validity |
| ImPACT Online | Device | Test/Re-Test |
Primary outcome
Validity is established through correlation studies with well-known measures of memory and processing speed.
Time frame: 12 Months
Reliability will be established through a test/re-test to establish results should be stable over time.
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 1 site 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 23 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity is established through correlation studies with well-known measures of memory and processing speed. (time frame: 12 Months). The study lists 2 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 23 Aug 2017.