ConcussionNCT02696200
Protection Against Potential Brain Injury During Competitive Football
A study testing Q Collar in people with Concussion, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
Significant morbidity, mortality, and related costs are caused by traumatic brain injury (TBI). An externally-worn medical device that applies mild jugular compression according to the principle of the Queckenstedt Maneuver (the Device). Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Concussion
- What is being tested?
- Q Collar
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Jun 2017
- 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 14 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Normal healthy volunteer
- Able to provide written consent
- Must be 14 years or older and a participant on varsity level high school football team
Who cannot join
- Unable to provide written consent
- History of neurological deficits, previous cerebral infarction, or severe head trauma as indicated through pre-season screening:
- Medical contraindications to restriction of venous outflow via the internal jugular veins (known increased intracerebral pressure, metabolic acidosis or alkalosis)
- Glaucoma (Narrow Angle or Normal Tension)
- Hydrocephalus
- Recent penetrating brain trauma (within 6 months)
Show all 11Show fewer
- Known carotid hypersensitivity
- Known increased intracranial pressure
- Central vein thrombosis
- Any known airway obstruction
- Any known seizure disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinanti Childrens Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Novel Protection Against Potential Brain Injury During Competitive Football Head Impacts
Significant morbidity, mortality, and related costs are caused by traumatic brain injury (TBI). An externally-worn medical device that applies mild jugular compression according to the principle of the Queckenstedt Maneuver (the Device). Preliminary research suggests that the Device has the potential to reduce the likelihood of TBI. The currently developed collar has been approved for studies in humans and the results indicate safety for use during high demand and maximal exertion activities, This study will investigate the effectiveness of this device in high school athletes playing a collision sport such as football. The use of helmets during such a high-risk sport will allow for collision measurement devices to be embedded in the helmet and will not affect play or fit of equipment. Athletes participating in this study will be randomly assigned to one of two groups: 1) Device wearing during the season or 2) Non-device wearing during the season. The helmets of all participants will be outfitted with an accelerometer which will measure the magnitude of every impact to the head sustained by the athlete. Effectiveness of the device will be determined via differences in longitudinal brain imaging and functional testing following competitive football participation. A subset of athletes who report a diagnosed concussion will also receive additional brain neuroanatomical and neurophysiological testing within a week following the diagnosed concussive event. The purpose of the study is to monitor longitudinal changes in brain structure and function between the preseason and postseason, in a population of football playing athletes wearing the Device and compared to a similar population not wearing the device. Secondly, the purpose is to determine the protection of the device relative to amount and magnitude of sustained head impacts.
Read the detailed description
The Device has the promise of providing a novel mechanism for reducing or preventing the likelihood of TBI, and may be used in conjunction with other protective equipment. TBI is the leading cause of death in individuals under age 45. The cost of TBI in the U.S. is estimated at anywhere from $50 to $150 billion, annually. The January, 2008 New England Journal of Medicine reports, "Head and neck injuries, including severe brain trauma, have been reported in one quarter of service members who have been evacuated from Iraq and Afghanistan". The vast majority of these injuries have resulted from exposure to improvised explosive device (IED) blast waves. Head injuries, concussions and the resulting trauma have been in public discussion recently as the National Football League (NFL) deals with a lawsuit regarding head injuries by about one-third of living former NFL players.
According to NASA, "The oscillation of a fluid caused by an external force, called sloshing, occurs in moving vehicles containing liquid masses, such as trucks, etc." This oscillation occurs when a vessel is only partially filled. It is hypothesized that the brain faces similar slosh energy absorption during external force impartation. Slosh permits external energies to be absorbed by the contents of a partially filled vessel or container by means of inelastic collisions. Tissues of differing densities can decelerate at different rates creating shear and cavitation. If the collisions between objects or molecules are elastic, the transfer of energies to those objects diminishes, minimizing the energies imparted by slosh.
Woodpeckers, head ramming sheep and all mammals (including humans) have small, little known and misunderstood muscles in their necks called the omohyoid muscles. Highly G-tolerant creatures of the forest have utilized these muscles to gently restrict outflow of the internal jugular veins thereby "taking up" the excess compliance of the cranial space and ultimately protecting themselves from TBI like tiny "airbags" in a motor vehicle. Rat studies by have demonstrated that we can easily and safely facilitate this muscle's actions by a well-engineered gentle compression over those muscles.
The medical Queckenstedt Maneuver devised to detect spinal cord compression, gently places pressure over the external jugular veins to increase cerebral spinal volume and pressure. In this maneuver, the veins are compressed while a lumbar puncture monitors the intracranial pressure. "Normally, the pressure rise to the higher 'plateau' level occurs instantly upon jugular compression to fall again equally fast upon release of the compression". This incredibly simple principle can be employed to protect soldiers and athletes from TBI by safely, and reversibly, increasing intracranial volume and pressure. The neck collar device is made of Outer collar - hytrel (thermoplastic elastomer), Inner collar - TPSiV (thermoplastic elastomer), metal insert (stainless steel), and is fitted to the neck to provide a comfortable and precise jugular compression that potentially mitigates cerebral slosh.
Although the skull, blood, and brain are "almost incompressible," the vasculature tree of the cerebrum is quite reactive and compressible. As volume is added to the cranium, eventually the compensatory reserve volume is surpassed and the intracranial pressure increases slightly. Increasing cerebral blood volume by just 1-3% safely and reversibly reduces compliance of the cerebral vascular tree and diminishes absorption of slosh energies. Jugular compression increases cerebral blood volume almost instantaneously. As mentioned, this degree of increase has significantly mitigated slosh and TBI in laboratory animals and mimics the highly concussion resistant wild animals that are able to reflexively increase cerebral blood volume through natural jugular compression.
A landmark article, published in the Journal of Neurosurgery, used a standard acceleration-deceleration impact laboratory model of mild TBI. The study showed a successful and marked reduction of axonal injury following Internal Jugular Vein (IJV) compression as indicated by immunohistochemical staining of Amyloid Precursor Proteins (APP). It is argued that IJV compression reduces slosh-mediated brain injury by increasing intracranial blood volume and reducing the compliance and potential for brain movement within the confines of the skull. The potential for such technique to mitigate both linear and rotational brain injury in humans by "internal protection" represents the most novel approach to mitigating TBI.
The current project will be designed following a prospective longitudinal study design. All MRI scanning will be performed on a 3 Tesla Philips Achieva MRI scanner located in Imaging Research Center (IRC) in the Cincinnati Children's Hospital Research Foundation (CCHRF). Sedation will not be used for any of the test visits. The entire MRI series, including anatomical imaging, DTI, resting state fMRI, SWI, HARDI, ASL and BOLD will be completed in 65 minutes or less (see Table 1 for detailed specifications). All functional and neurocognitive testing will be performed at the Cincinnati Children's Hospital Human Performance Laboratory.
- Conditions
- Concussion
- Being tested
- Q Collar
- Keywords
- Concussion
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q CollarDevice
The device is fitted to the neck to provide a comfortable and precise jugular compression that potentially mitigates cerebral slosh. The device will be worn inside the collar of an athletic compression shirt.
| Study group | Role | What they receive |
|---|---|---|
| Subjects Wearing the Q Collar | Experimental | Subjects wearing the Q collar throughout the football season Receives: Device: Q Collar |
| Subjects Not Wearing the Q Collar | No intervention | Control group of subjects not wearing the q collar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine Average Number of Hits Between Groups
monitor the differences in average number of hits between the group wearing the collar and the group not wearing the collar
Measured: 5 months
Number of Participants Undergoing EEG Assessment
determine the number of subjects in the collar group and the non collar group that underwent EEG assessment
Measured: 5 months
Change in Fractional Anisotropy (FA)
Change in fractional anisotropy (FA) from Pre to Post season
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study startMay 2015
- Primary completionDec 2016
- Study completionJun 2017
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 ConcussionStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory D Myer, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02696200
- Sponsor's protocol ID
- 2015-2205
- Status last verified
- Nov 2020
- First submitted
- 28 May 2015
- Last updated
- 9 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Results will be published however individual participant data will remain secure.
Publications
Yuan W, Leach J, Maloney T, Altaye M, Smith D, Gubanich PJ, Barber Foss KD, Thomas S, DiCesare CA, Kiefer AW, Myer GD. Neck Collar with Mild Jugular Vein Compression Ameliorates Brain Activation Changes during a Working Memory Task after a Season of High School Football. J Neurotrauma. 2017 Aug 15;34(16):2432-2444. doi: 10.1089/neu.2016.4834. Epub 2017 Jun 8.
PubMed 28437225Myer GD, Yuan W, Barber Foss KD, Thomas S, Smith D, Leach J, Kiefer AW, Dicesare C, Adams J, Gubanich PJ, Kitchen K, Schneider DK, Braswell D, Krueger D, Altaye M. Analysis of head impact exposure and brain microstructure response in a season-long application of a jugular vein compression collar: a prospective, neuroimaging investigation in American football. Br J Sports Med. 2016 Oct;50(20):1276-1285. doi: 10.1136/bjsports-2016-096134. Epub 2016 Jun 15.
PubMed 27307271
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Protection Against Potential Brain Injury During Competitive Football Head Impacts
- ClinicalTrials.gov ID
- NCT02696200
- Acronym / sponsor ID
- 2015-2205
- Conditions
- Concussion
- Keywords
- Concussion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 2 Mar 2016 (estimated)
- Results
- Posted 9 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Significant morbidity, mortality, and related costs are caused by traumatic brain injury (TBI). An externally-worn medical device that applies mild jugular compression according to the principle of the Queckenstedt Maneuver (the Device). Preliminary research suggests that the Device has the potential to reduce the likelihood of TBI. The currently developed collar has been approved for studies in humans and the results indicate safety for use during high demand and maximal exertion activities, This study will investigate the effectiveness of this device in high school athletes playing a collision sport such as football. The use of helmets during such a high-risk sport will allow for collision measurement devices to be embedded in the helmet and will not affect play or fit of equipment. Athletes participating in this study will be randomly assigned to one of two groups: 1) Device wearing during the season or 2) Non-device wearing during the season. The helmets of all participants will be outfitted with an accelerometer which will measure the magnitude of every impact to the head sustained by the athlete. Effectiveness of the device will be determined via differences in longitudinal brain imaging and functional testing following competitive football participation. A subset of athletes who report a diagnosed concussion will also receive additional brain neuroanatomical and neurophysiological testing within a week following the diagnosed concussive event. The purpose of the study is to monitor longitudinal changes in brain structure and function between the preseason and postseason, in a population of football playing athletes wearing the Device and compared to a similar population not wearing the device. Secondly, the purpose is to determine the protection of the device relative to amount and magnitude of sustained head impacts.
Detailed description
The Device has the promise of providing a novel mechanism for reducing or preventing the likelihood of TBI, and may be used in conjunction with other protective equipment. TBI is the leading cause of death in individuals under age 45. The cost of TBI in the U.S. is estimated at anywhere from $50 to $150 billion, annually. The January, 2008 New England Journal of Medicine reports, "Head and neck injuries, including severe brain trauma, have been reported in one quarter of service members who have been evacuated from Iraq and Afghanistan". The vast majority of these injuries have resulted from exposure to improvised explosive device (IED) blast waves. Head injuries, concussions and the resulting trauma have been in public discussion recently as the National Football League (NFL) deals with a lawsuit regarding head injuries by about one-third of living former NFL players.
According to NASA, "The oscillation of a fluid caused by an external force, called sloshing, occurs in moving vehicles containing liquid masses, such as trucks, etc." This oscillation occurs when a vessel is only partially filled. It is hypothesized that the brain faces similar slosh energy absorption during external force impartation. Slosh permits external energies to be absorbed by the contents of a partially filled vessel or container by means of inelastic collisions. Tissues of differing densities can decelerate at different rates creating shear and cavitation. If the collisions between objects or molecules are elastic, the transfer of energies to those objects diminishes, minimizing the energies imparted by slosh.
Woodpeckers, head ramming sheep and all mammals (including humans) have small, little known and misunderstood muscles in their necks called the omohyoid muscles. Highly G-tolerant creatures of the forest have utilized these muscles to gently restrict outflow of the internal jugular veins thereby "taking up" the excess compliance of the cranial space and ultimately protecting themselves from TBI like tiny "airbags" in a motor vehicle. Rat studies by have demonstrated that we can easily and safely facilitate this muscle's actions by a well-engineered gentle compression over those muscles.
The medical Queckenstedt Maneuver devised to detect spinal cord compression, gently places pressure over the external jugular veins to increase cerebral spinal volume and pressure. In this maneuver, the veins are compressed while a lumbar puncture monitors the intracranial pressure. "Normally, the pressure rise to the higher 'plateau' level occurs instantly upon jugular compression to fall again equally fast upon release of the compression". This incredibly simple principle can be employed to protect soldiers and athletes from TBI by safely, and reversibly, increasing intracranial volume and pressure. The neck collar device is made of Outer collar - hytrel (thermoplastic elastomer), Inner collar - TPSiV (thermoplastic elastomer), metal insert (stainless steel), and is fitted to the neck to provide a comfortable and precise jugular compression that potentially mitigates cerebral slosh.
Although the skull, blood, and brain are "almost incompressible," the vasculature tree of the cerebrum is quite reactive and compressible. As volume is added to the cranium, eventually the compensatory reserve volume is surpassed and the intracranial pressure increases slightly. Increasing cerebral blood volume by just 1-3% safely and reversibly reduces compliance of the cerebral vascular tree and diminishes absorption of slosh energies. Jugular compression increases cerebral blood volume almost instantaneously. As mentioned, this degree of increase has significantly mitigated slosh and TBI in laboratory animals and mimics the highly concussion resistant wild animals that are able to reflexively increase cerebral blood volume through natural jugular compression.
A landmark article, published in the Journal of Neurosurgery, used a standard acceleration-deceleration impact laboratory model of mild TBI. The study showed a successful and marked reduction of axonal injury following Internal Jugular Vein (IJV) compression as indicated by immunohistochemical staining of Amyloid Precursor Proteins (APP). It is argued that IJV compression reduces slosh-mediated brain injury by increasing intracranial blood volume and reducing the compliance and potential for brain movement within the confines of the skull. The potential for such technique to mitigate both linear and rotational brain injury in humans by "internal protection" represents the most novel approach to mitigating TBI.
The current project will be designed following a prospective longitudinal study design. All MRI scanning will be performed on a 3 Tesla Philips Achieva MRI scanner located in Imaging Research Center (IRC) in the Cincinnati Children's Hospital Research Foundation (CCHRF). Sedation will not be used for any of the test visits. The entire MRI series, including anatomical imaging, DTI, resting state fMRI, SWI, HARDI, ASL and BOLD will be completed in 65 minutes or less (see Table 1 for detailed specifications). All functional and neurocognitive testing will be performed at the Cincinnati Children's Hospital Human Performance Laboratory.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects Wearing the Q Collar | Experimental | Device: Q CollarSubjects wearing the Q collar throughout the football season |
| Subjects Not Wearing the Q Collar | No intervention | –Control group of subjects not wearing the q collar |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Normal healthy volunteer
- Able to provide written consent
- Must be 14 years or older and a participant on varsity level high school football team
Key exclusion criteria (11 listed)
- Unable to provide written consent
- History of neurological deficits, previous cerebral infarction, or severe head trauma as indicated through pre-season screening:
- Medical contraindications to restriction of venous outflow via the internal jugular veins (known increased intracerebral pressure, metabolic acidosis or alkalosis)
- Glaucoma (Narrow Angle or Normal Tension)
- Hydrocephalus
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 |
|---|---|---|
| Q CollarThe device is fitted to the neck to provide a comfortable and precise jugular compression that potentially mitigates cerebral slosh. The device will be worn inside the collar of an athletic compression shirt. | Device | Subjects Wearing the Q Collar |
Primary outcome
Determine Average Number of Hits Between Groups
Time frame: 5 months
monitor the differences in average number of hits between the group wearing the collar and the group not wearing the collar
Number of Participants Undergoing EEG Assessment
Time frame: 5 months
determine the number of subjects in the collar group and the non collar group that underwent EEG assessment
Change in Fractional Anisotropy (FA)
Time frame: 6 months
Change in fractional anisotropy (FA) from Pre to Post season
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28437225Yuan W, Leach J, Maloney T, Altaye M, Smith D, Gubanich PJ, Barber Foss KD, Thomas S, DiCesare CA, Kiefer AW, Myer GD. Neck Collar with Mild Jugular Vein Compression Ameliorates Brain Activation Changes during a Working Memory Task after a Season of High School Football. J Neurotrauma. 2017 Aug 15;34(16):2432-2444. doi: 10.1089/neu.2016.4834. Epub 2017 Jun 8.
- Derived from this study: PubMed 27307271Myer GD, Yuan W, Barber Foss KD, Thomas S, Smith D, Leach J, Kiefer AW, Dicesare C, Adams J, Gubanich PJ, Kitchen K, Schneider DK, Braswell D, Krueger D, Altaye M. Analysis of head impact exposure and brain microstructure response in a season-long application of a jugular vein compression collar: a prospective, neuroimaging investigation in American football. Br J Sports Med. 2016 Oct;50(20):1276-1285. doi: 10.1136/bjsports-2016-096134. Epub 2016 Jun 15.
- Individual participant dataSharing planned: No. Results will be published however individual participant data will remain secure.
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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.
Gregory D Myer, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Q Collar in people with Concussion, run by Children's Hospital Medical Center, Cincinnati 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 3 inclusion and 11 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 9 Dec 2020. 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 9 Dec 2020). 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?
Determine Average Number of Hits Between Groups (time frame: 5 months). The study lists 3 primary outcomes in all. 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 NCT02696200, 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 9 Dec 2020.