Brain ConcussionNCT02597504
Development of a Neurocognitive Screening Test
A study testing Pen and paper neuropsychological test and Quick Test in people with Brain Concussion and Mild Cognitive Impairment, run by ImPACT Applications, Inc. at 4 sites in United States.
Trial summary
This research study will evaluate a standalone software application and is designed to standardize and validate new neurocognitive screening testing for children aged 6 through 11, and adolescents and adults ages 12 through 75. Read more about this study
- Who is it for?
- Ages 6 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Concussion, Mild Cognitive Impairment
- What is being tested?
- Pen and paper neuropsychological test and Quick Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2015to Oct 2019
- 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 6 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age: 12-75 (Adult version), 6-11 (pediatric version)
- 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.
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.*
- Any known physical or psychological impairment that would affect their ability to perform the test.
- Note: Unless specifically required by the particular study (i.e., a discriminant validity study differentiating concussed versus non-concussed individuals).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Head First
Crofton, Maryland, 21114
University of Arkansas
Fayetteville, Arkansas, 72701
Jim Gyurke
Pittsburgh, Pennsylvania, 15288
FastMed Urgent Care
Scottsdale, Arizona, 85254
About this study
This research study will evaluate a standalone software application and is designed to standardize and validate new neurocognitive screening testing for children aged 6 through 11, and adolescents and adults ages 12 through 75.
The purpose of this study is to evaluate recently developed computerized tasks sensitive to changes in neurocognitive performance after a concussion. These tests were designed to help measure the effects of concussion on cognitive processes (e.g., memory, attention, brain speed) and visual functioning.
- Conditions
- Brain Concussion, Mild Cognitive Impairment
- Being tested
- Pen and paper neuropsychological test, Quick Test
- Medical subject headings
- Brain Concussion, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pen and paper neuropsychological testOther
Will be administered for Construct Validity to determine agreement with Quick Test
Quick TestDevice
Quick Test, computerized test will be administered to all subjects.
| Study group | Role | What they receive |
|---|---|---|
| Standardization | Active comparator | individuals assigned to this group will be healthy volunteers and will take the Quick Test. Receives: Device: Quick Test |
| Validity and Reliability | Experimental | Reliability:
Test-Retest
Validity:
Concurrent:Quick Test administered with ImPACT online Discriminant: Concussed patient administered Quick Test Construct: Determine agreement between Quick Test and and paper and pencil test. Receives: Other: Pen and paper neuropsychological test; Device: Quick Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability will be established through a test-retest to establish results should be stable over time
Measured: 12 Months
Validity established through correlation studies with well-known measures of memory and processing speed and ANOVA.
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 posted5 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2019
- Study completionOct 2019
Why it stopped: Loss of funding.
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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,600 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
- NCT02597504
- Sponsor's protocol ID
- QPR-15-44
- Status last verified
- Sep 2023
- First submitted
- 16 Oct 2015
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- 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
- Development of a Neurocognitive Screening Test
- ClinicalTrials.gov ID
- NCT02597504
- Acronym / sponsor ID
- QPR-15-44
- Conditions
- Brain Concussion, Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Loss of funding.
- Enrolment
- 1,600 participants (actual)
- Lead sponsor
- ImPACT Applications, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2015 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 5 Nov 2015 (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.
This research study will evaluate a standalone software application and is designed to standardize and validate new neurocognitive screening testing for children aged 6 through 11, and adolescents and adults ages 12 through 75.
The purpose of this study is to evaluate recently developed computerized tasks sensitive to changes in neurocognitive performance after a concussion. These tests were designed to help measure the effects of concussion on cognitive processes (e.g., memory, attention, brain speed) and visual functioning.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardization | Active comparator | Device: Quick Testindividuals assigned to this group will be healthy volunteers and will take the Quick Test. |
| Validity and Reliability | Experimental | Other: Pen and paper neuropsychological test, Device: Quick TestReliability: Test-Retest Validity: Concurrent:Quick Test administered with ImPACT online Discriminant: Concussed patient administered Quick Test Construct: Determine agreement between Quick Test and and paper and pencil test. |
Who may qualify
- Ages
- 6 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 12-75 (Adult version), 6-11 (pediatric version)
- 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 (5 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.*
- Any known physical or psychological impairment 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 |
|---|---|---|
| Pen and paper neuropsychological testWill be administered for Construct Validity to determine agreement with Quick Test | Other | Validity and Reliability |
| Quick TestQuick Test, computerized test will be administered to all subjects. | Device | Standardization, Validity and Reliability |
Primary outcome
Reliability will be established through a test-retest to establish results should be stable over time
Time frame: 12 Months
Validity established through correlation studies with well-known measures of memory and processing speed and ANOVA.
Time frame: 12 Months
Results and safety
The study was stopped early (reason given: Loss of funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pen and paper neuropsychological test and Quick Test in people with Brain Concussion and Mild Cognitive Impairment, run by ImPACT Applications, Inc. at 4 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 5 inclusion and 5 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: stopped early, 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 4 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?
The study was stopped early (reason given: Loss of funding.). Results are not available in the source record.
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?
Reliability will be established through a test-retest to establish results should be stable over time (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 29 Sep 2023.