ConcussionNCT05551520
ImPACT Version 4-Touchscreen: Normative and Reliability Study
A study testing Normative and Reliability in people with Concussion, run by ImPACT Applications, Inc. at 1 site in United States.
Trial summary
This research study is designed to establish normative database and reliability of ImPACT for adolescents and adults ages 12 through 80 to expand the use of devices to include touchscreen. Read more about this study
- Who is it for?
- Ages 12 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Concussion
- What is being tested?
- Normative and Reliability
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,437 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2022to 1 Oct 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 12 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age 12-80
- Primary English speaking or fluent in English
Who cannot join
- Documentation of a known special education diagnosis other than a 504 designation.
- History of concussion less than 6 months to the study participation
- Known physical (e.g., visual impairment not fixable by usual means, such as glasses) or psychological impairment (ADHD, LDD, etc.) that would affect their ability to perform the test.
Trial locations and contacts
1 site in 1 country.
About this study
This research study is designed to establish normative database and reliability of ImPACT for adolescents and adults ages 12 through 80 to expand the use of devices to include touchscreen.
Read the detailed description
This research study is designed to establish normative database and reliability of ImPACT for adolescents and adults ages 12 through 80 to expand the use of devices to include touchscreen. Enrollment will be 900 participants.
- Conditions
- Concussion
- Being tested
- Normative, Reliability
- Keywords
- Brain
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NormativeDevice
ImPACT will be administered at baseline testing
ReliabilityDevice
ImPACT will be administered again within 60 days of baseline test
| Study group | Role | What they receive |
|---|---|---|
| Normative | Other | ImPACT will be administered to participant's for a baseline test. Receives: Device: Normative |
| Reliability | Other | ImPACT will be administered to participant's within 60 days of baseline test. Receives: Device: Reliability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity
ImPACT Touchscreen performs within normal parameters of ImPACT Online
Measured: 12 months
Secondary outcomes (1)
Reliability
Reliability will be established through a test/re-test. ImPACT Touchscreen 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 60 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 posted22 Sep 2022
- Study start7 Feb 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 1,437 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
- NCT05551520
- Sponsor's protocol ID
- QPR-21-20
- Status last verified
- Jul 2023
- First submitted
- 29 Mar 2022
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ImPACT Version 4-Touchscreen: Normative and Reliability Study
- ClinicalTrials.gov ID
- NCT05551520
- Acronym / sponsor ID
- QPR-21-20
- Conditions
- Concussion
- Keywords
- Brain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,437 participants (actual)
- Lead sponsor
- ImPACT Applications, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 22 Sep 2022 (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.
This research study is designed to establish normative database and reliability of ImPACT for adolescents and adults ages 12 through 80 to expand the use of devices to include touchscreen.
Detailed description
This research study is designed to establish normative database and reliability of ImPACT for adolescents and adults ages 12 through 80 to expand the use of devices to include touchscreen. Enrollment will be 900 participants.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normative | Other | Device: NormativeImPACT will be administered to participant's for a baseline test. |
| Reliability | Other | Device: ReliabilityImPACT will be administered to participant's within 60 days of baseline test. |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age 12-80
- Primary English speaking or fluent in English
Key exclusion criteria (3 listed)
- Documentation of a known special education diagnosis other than a 504 designation.
- History of concussion less than 6 months to the study participation
- Known physical (e.g., visual impairment not fixable by usual means, such as glasses) or psychological impairment (ADHD, LDD, etc.) 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 |
|---|---|---|
| NormativeImPACT will be administered at baseline testing | Device | Normative |
| ReliabilityImPACT will be administered again within 60 days of baseline test | Device | Reliability |
Primary outcome
Validity
Time frame: 12 months
ImPACT Touchscreen performs within normal parameters of ImPACT Online
1 secondary outcome
Reliability
Time frame: Baseline test will be administered at enrollment and re-test will be administered within 60 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 5 Jul 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normative and Reliability in people with 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 2 inclusion and 3 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 5 Jul 2023. 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?
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?
Validity (time frame: 12 months). 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 5 Jul 2023.