Brain ConcussionNCT02757053
Screening Brain MRI in High School Football: Does the Guardian Cap Reduce the Risk of Traumatic Brain Injury
A study testing Guardian Cap in people with Brain Concussion and Brain Injuries, run by Mosaic Life Care at 1 site in United States.
Trial summary
Screening Brain magnetic resonance imaging (MRI) with Fluid-attenuated Inversion Recovery (FLAIR) and Susceptibility Weighted Imaging (SWI) sequences will be performed pre and post season on high school football players. Read more about this study
- Who is it for?
- Ages 12 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Concussion, Brain Injuries, Diffuse Axonal Injury
- What is being tested?
- Guardian Cap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 14 Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- High school football players willing and able to have a pre and post season Brain MRI with FLAIR and SWI sequences and wear the Guardian Cap on their helmet
Who cannot join
- High school football players unwilling or unable to have an MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Screening Brain MRI in High School Football: What is the Risk of Traumatic Brain Injury and Does the Guardian Cap Reduce the Incidence of Injury as Determined by Fluid-attenuated Inversion Recovery (FLAIR) and Susceptibility Weighted Imaging (SWI) Magnetic Resonance Imaging (MRI) Sequences
Screening Brain magnetic resonance imaging (MRI) with Fluid-attenuated Inversion Recovery (FLAIR) and Susceptibility Weighted Imaging (SWI) sequences will be performed pre and post season on high school football players. One set of players will wear the Guardian Cap on their five star rated helmets and the other will wear five star rated helmets only. The investigators will compare outcomes of ImPACT scores and MRI findings between the two groups to see if there is a statistical difference in reduction of injury and to establish what the baseline level of MRI findings related to injury from high school football is as well as what the baseline level of injury is prior to the start of the season.
Read the detailed description
Screening Brain Magnetic Resonance Imaging (MRI) with Fluid-attenuated Inversion Recovery (FLAIR) and Susceptibility Weighted Imaging (SWI) sequences will be performed pre and post season on high school football players. One set of players will wear the Guardian Cap on their five star rated helmets and the other will wear five star rated helmets only. The investigators will compare outcomes of ImPACT concussion scores and MRI findings on FLAIR and SWI sequences between the two groups to see if there is a statistical difference in reduction of MRI findings on FLAIR and SWI sequences or adverse ImPACT concussion score outcomes and to establish what the baseline level of MRI findings on FLAIR and SWI sequences related to injury from high school football is as well as what the baseline level of MRI findings on FLAIR and SWI is prior to the start of the season.
- Conditions
- Brain Concussion, Brain Injuries, Diffuse Axonal Injury, Athletic Injuries, Injury, Brain, Traumatic
- Being tested
- Guardian Cap
- Keywords
- Brain Concussion, Brain Injuries, Diffuse Axonal Injury, Football, Head Protective Devices, Magnetic Resonance Imaging, Helmet, Third party add-on
- Medical subject headings
- Brain Concussion, Brain Injuries, Diffuse Axonal Injury, Athletic Injuries, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guardian CapDevice
Also called Third party add-on
The Guardian Cap is a third party add-on device attached to the facemask of a football helmet that covers the outside of the helmet with a soft material to reduce the initial impact severity, thus reducing the forces transmitted to the brain
| Study group | Role | What they receive |
|---|---|---|
| Guardian Cap | Experimental | The set of high school football players wearing the Guardian Cap on their helmets Receives: Device: Guardian Cap |
| No Guardian Cap | No intervention | The set of high school football players not wearing the Guardian Cap on their helmets |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI Brain SWI and FLAIR Lesions Pre and Post High School Football Season With and Without the Guardian Cap
MRI Brain SWI Lesions pre and post football season with and without the Guardian Cap
Measured: within the first two months after the high school football season ends
Secondary outcomes (3)
ImPact Concussion Scores Pre and Post High School Football Season With and Without the Guardian Cap
Establish the expected range of ImPact concussion scores pre and post football season with and without the Guardian Cap
Measured: within the first two months after the high school football season ends
Number of MRI Brain SWI and FLAIR Lesions in Preseason High School Football Players
Establish the expected range of MRI Brain SWI and FLAIR lesions in the general high school population at the beginning of a high school football season
Measured: within two months of the start of high school football season
Number of MRI Brain SWI and FLAIR Lesions in Postseason High School Football Players
Establish the incidence of MRI Brain SWI and FLAIR lesions in postseason high school football players
Measured: within two months of the end of high school football season
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startApr 2016
- Primary completion14 Jun 2016
- Study completion14 Jun 2016
Why it stopped: This study was terminated June 28 2016 for low enrollment and PI moving away. No results were obtained
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mosaic Life Care
- Sponsor type
- University, hospital or other
- Collaborators
- Missouri Western State University
- Responsible party
- Principal investigator, Paul Isenbarger, Mosaic Life Care
- Investigators
- Paul A Isenbarger, MD, Principal investigator, Daignostic and Interventional Radiologist at Mosaic Life care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757053
- Sponsor's protocol ID
- MLC002
- Status last verified
- Aug 2016
- First submitted
- 27 Apr 2016
- Last updated
- 14 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Plan to share data with MRI results of individual exams with the patient and plan to publish in peer reviewed journal
Publications
Beauchamp MH, Beare R, Ditchfield M, Coleman L, Babl FE, Kean M, Crossley L, Catroppa C, Yeates KO, Anderson V. Susceptibility weighted imaging and its relationship to outcome after pediatric traumatic brain injury. Cortex. 2013 Feb;49(2):591-8. doi: 10.1016/j.cortex.2012.08.015. Epub 2012 Sep 3.
PubMed 23062584Mittl RL, Grossman RI, Hiehle JF, Hurst RW, Kauder DR, Gennarelli TA, Alburger GW. Prevalence of MR evidence of diffuse axonal injury in patients with mild head injury and normal head CT findings. AJNR Am J Neuroradiol. 1994 Sep;15(8):1583-9.
PubMed 7985582
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Brain MRI in High School Football: What is the Risk of Traumatic Brain Injury and Does the Guardian Cap Reduce the Incidence of Injury as Determined by Fluid-attenuated Inversion Recovery (FLAIR) and Susceptibility Weighted Imaging (SWI) Magnetic Resonance Imaging (MRI) Sequences
- ClinicalTrials.gov ID
- NCT02757053
- Acronym / sponsor ID
- MLC002
- Conditions
- Brain Concussion, Brain Injuries, Diffuse Axonal Injury, Athletic Injuries, Injury, Brain, Traumatic
- Keywords
- Brain Concussion, Brain Injuries, Diffuse Axonal Injury, Football, Head Protective Devices, Magnetic Resonance Imaging, Helmet, Third party add-on
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated June 28 2016 for low enrollment and PI moving away. No results were obtained
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Mosaic Life CareUniversity, hospital or other
- Collaborators
- Missouri Western State University
- Study start
- Apr 2016
- Primary completion
- 14 Jun 2016 (actual)
- Study completion
- 14 Jun 2016 (actual)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Posted 14 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Screening Brain magnetic resonance imaging (MRI) with Fluid-attenuated Inversion Recovery (FLAIR) and Susceptibility Weighted Imaging (SWI) sequences will be performed pre and post season on high school football players. One set of players will wear the Guardian Cap on their five star rated helmets and the other will wear five star rated helmets only. The investigators will compare outcomes of ImPACT scores and MRI findings between the two groups to see if there is a statistical difference in reduction of injury and to establish what the baseline level of MRI findings related to injury from high school football is as well as what the baseline level of injury is prior to the start of the season.
Detailed description
Screening Brain Magnetic Resonance Imaging (MRI) with Fluid-attenuated Inversion Recovery (FLAIR) and Susceptibility Weighted Imaging (SWI) sequences will be performed pre and post season on high school football players. One set of players will wear the Guardian Cap on their five star rated helmets and the other will wear five star rated helmets only. The investigators will compare outcomes of ImPACT concussion scores and MRI findings on FLAIR and SWI sequences between the two groups to see if there is a statistical difference in reduction of MRI findings on FLAIR and SWI sequences or adverse ImPACT concussion score outcomes and to establish what the baseline level of MRI findings on FLAIR and SWI sequences related to injury from high school football is as well as what the baseline level of MRI findings on FLAIR and SWI is prior to the start of the season.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guardian Cap | Experimental | Device: Guardian CapThe set of high school football players wearing the Guardian Cap on their helmets |
| No Guardian Cap | No intervention | –The set of high school football players not wearing the Guardian Cap on their helmets |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- High school football players willing and able to have a pre and post season Brain MRI with FLAIR and SWI sequences and wear the Guardian Cap on their helmet
Key exclusion criteria (1 listed)
- High school football players unwilling or unable to have an MRI
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 |
|---|---|---|
| Guardian CapAlso: Third party add-onThe Guardian Cap is a third party add-on device attached to the facemask of a football helmet that covers the outside of the helmet with a soft material to reduce the initial impact severity, thus reducing the forces transmitted to the brain | Device | Guardian Cap |
Primary outcome
MRI Brain SWI and FLAIR Lesions Pre and Post High School Football Season With and Without the Guardian Cap
Time frame: within the first two months after the high school football season ends
MRI Brain SWI Lesions pre and post football season with and without the Guardian Cap
3 secondary outcomes
ImPact Concussion Scores Pre and Post High School Football Season With and Without the Guardian Cap
Time frame: within the first two months after the high school football season ends
Number of MRI Brain SWI and FLAIR Lesions in Preseason High School Football Players
Time frame: within two months of the start of high school football season
Number of MRI Brain SWI and FLAIR Lesions in Postseason High School Football Players
Time frame: within two months of the end of high school football season
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23062584Beauchamp MH, Beare R, Ditchfield M, Coleman L, Babl FE, Kean M, Crossley L, Catroppa C, Yeates KO, Anderson V. Susceptibility weighted imaging and its relationship to outcome after pediatric traumatic brain injury. Cortex. 2013 Feb;49(2):591-8. doi: 10.1016/j.cortex.2012.08.015. Epub 2012 Sep 3.
- Background: PubMed 7985582Mittl RL, Grossman RI, Hiehle JF, Hurst RW, Kauder DR, Gennarelli TA, Alburger GW. Prevalence of MR evidence of diffuse axonal injury in patients with mild head injury and normal head CT findings. AJNR Am J Neuroradiol. 1994 Sep;15(8):1583-9.
- Individual participant dataSharing planned: Yes. Plan to share data with MRI results of individual exams with the patient and plan to publish in peer reviewed journal
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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.
Paul A Isenbarger, MD principal investigator
Daignostic and Interventional Radiologist at Mosaic Life care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guardian Cap in people with Brain Concussion and Brain Injuries, run by Mosaic Life Care 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 1 inclusion and 1 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 14 May 2018. 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?
Yes. Results are posted in the registry (first posted 14 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
MRI Brain SWI and FLAIR Lesions Pre and Post High School Football Season With and Without the Guardian Cap (time frame: within the first two months after the high school football season ends). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02757053, which also lists 2 linked publications.
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 14 May 2018.