ConcussionNCT02901028
Innovative Concussion Prevention Device
A study testing Laboratory testing and Blood and Urine Draws 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). A simple, effective, and lightweight device worn by athletes or war fighters in the field, designed to mitigate TBI resulting from blast trauma or concussive events, would save lives, and the huge costs currently being… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Concussion
- What is being tested?
- Laboratory testing and Blood and Urine Draws
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Aug 2013
- 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal healthy volunteer
- Able to provide written consent
- Able to tolerate hypercapnia for 1-2 minutes
- Must be 18 years or older
Who cannot join
- Unable to provide written consent
- History of neurological deficits, previous cerebral infarction, or head trauma
- Medical contraindications to limited hypercapnia or 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 22Show fewer
- Known carotid hypersensitivity
- Known increased intracranial pressure
- Central vein thrombosis
- Known open eye injuries
- Neck injuries
- Any known airway obstruction
- Any known seizure disorder
- Any altered level of consciousness
- Have suffered an injury to a lower extremity in the past 6 months
- Have undergone ACL reconstruction less than 2 years ago
- Cardiovascular/Respiratory issues
- Known untreated hypertension
- Known cardiomyopathy
- Known exercise intolerance
- Any indication of cardiovascular risk by the Physical Activity Readiness Questionnaire (PAR-Q)
- Under the age of 18 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Safety Testing of an Innovative Concussion Prevention Device
Significant morbidity, mortality, and related costs are caused by traumatic brain injury (TBI). A simple, effective, and lightweight device worn by athletes or war fighters in the field, designed to mitigate TBI resulting from blast trauma or concussive events, would save lives, and the huge costs currently being experienced for life-treatment of surviving victims. An externally-worn medical device that applies mild jugular compression according to the principle of the Queckenstedt Maneuver. PURPOSE: To monitor changes in vital signs, blood physiologies, oxygen consumption, biomechanics, strength, neurological capabilities, and balance in a population of athletes wearing the Device. Secondly, to determine the tolerance and acceptance of the Device while undergoing exertion.
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"[1-3]. 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 and are also a concern for athletes who participate in a wide range of sports, including hockey, rugby and soccer.
According to NASA, "The oscillation of a fluid caused by 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. Similarly, the brain faces slosh peril 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 mankind) have small, little known and misunderstood muscles in their necks called the omo-hyoid 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.
This study utilizes a randomized cross over study design. Subjects will visit the Human Performance Laboratory on two separate occasions to perform the testing procedures listed in the table below. During one testing session, the subject will perform the testing procedures while wearing the Device under investigation while the other testing session will be completed while the subject is wearing a sham arm device, which will be placed on the upper arm and not cause venous engorgement. The order of the testing sessions will be randomized prior to the subject's arrival for the first session. The Device is a standard hockey neck guard, adapted for the purposes of this study. The Device incorporates two bulges localized over the site of the internal jugular veins bilaterally. Experiments performed with jugular Doppler ultrasound demonstrate that while wearing the Device, flows within the jugular veins are reduced, while flow within the carotid arteries and all portions of the cerebrum are preserved (JA Fisher, unpublished data). Thus, application of the Device to the subject will not cause any untoward health risks. The pressure exerted by the Device on the region of the neck superficial to the internal jugular vein is akin to the pressure felt when a person yawns or wears a snugly fitting necktie.
- Conditions
- Concussion
- Being tested
- Laboratory testing, Blood and Urine Draws
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory testingOther
Subjects will visit the Human Performance Laboratory on two separate occasions to perform the testing procedures. testing consists of VO2, strength, biomechanics, dynavision, etc.
Blood and Urine DrawsOther
subjects will have a blood draw and provide a urine sample
| Study group | Role | What they receive |
|---|---|---|
| Collar Device | Experimental | The Device is a standard hockey neck guard, adapted for the purposes of this study. The Device incorporates two bulges localized over the site of the internal jugular veins bilaterally. Experiments performed with jugular Doppler ultrasound demonstrate that while wearing the Device, flows within the jugular veins are reduced, while flow within the carotid arteries and all portions of the cerebrum are preserved (JA Fisher, unpublished data). Thus, application of the Device to the subject will not cause any untoward health risks. The pressure exerted by the Device on the region of the neck superficial to the internal jugular vein is akin to the pressure felt when a person yawns or wears a snugly fitting necktie. Receives: Other: Laboratory testing; Other: Blood and Urine Draws |
| Arm Device | Sham comparator | the subject is wearing a sham arm device, which will be placed on the upper arm and not cause venous engorgement. The subject will undergo the same testing as when wearing the collar device (strength, Vo2, vision, blood, urine, etc) Receives: Other: Laboratory testing; Other: Blood and Urine Draws |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure any changes in blood physiologies
To monitor changes blood physiologies in a population of athletes wearing the Device.
Measured: 1 week
measure any changes in oxygen consumption
To monitor changes oxygen consumption in a population of athletes wearing the Device.
Measured: 1 week
measure any changes in strength
To monitor changes in strength in a population of athletes wearing the Device.
Measured: 1 week
Measure any changes in biomechanics
To monitor changes in biomechanics balance in a population of athletes wearing the Device.
Measured: 1 week
Measure any changes in neurological capabilities
To monitor changes in neurological capabilities in a population of athletes wearing the Device.
Measured: 1 week
Measure any changes in balance
To monitor changes in and balance in a population of athletes wearing the Device.
Measured: 1 week
Secondary outcomes (1)
Number of participants with intervention-related adverse events as assessed by participant survey
to determine the tolerance and acceptance of the Device while undergoing exertion.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study startApr 2013
- Primary completionJul 2013
- Study completionAug 2013
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 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, Cincinnati Childrens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02901028
- Sponsor's protocol ID
- 2013-2240
- Status last verified
- Sep 2016
- First submitted
- 20 Oct 2015
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Results will be published however individual participant data will remain secure
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Testing of an Innovative Concussion Prevention Device
- ClinicalTrials.gov ID
- NCT02901028
- Acronym / sponsor ID
- 2013-2240
- Conditions
- Concussion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 15 Sep 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.
Significant morbidity, mortality, and related costs are caused by traumatic brain injury (TBI). A simple, effective, and lightweight device worn by athletes or war fighters in the field, designed to mitigate TBI resulting from blast trauma or concussive events, would save lives, and the huge costs currently being experienced for life-treatment of surviving victims. An externally-worn medical device that applies mild jugular compression according to the principle of the Queckenstedt Maneuver. PURPOSE: To monitor changes in vital signs, blood physiologies, oxygen consumption, biomechanics, strength, neurological capabilities, and balance in a population of athletes wearing the Device. Secondly, to determine the tolerance and acceptance of the Device while undergoing exertion.
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"[1-3]. 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 and are also a concern for athletes who participate in a wide range of sports, including hockey, rugby and soccer.
According to NASA, "The oscillation of a fluid caused by 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. Similarly, the brain faces slosh peril 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 mankind) have small, little known and misunderstood muscles in their necks called the omo-hyoid 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.
This study utilizes a randomized cross over study design. Subjects will visit the Human Performance Laboratory on two separate occasions to perform the testing procedures listed in the table below. During one testing session, the subject will perform the testing procedures while wearing the Device under investigation while the other testing session will be completed while the subject is wearing a sham arm device, which will be placed on the upper arm and not cause venous engorgement. The order of the testing sessions will be randomized prior to the subject's arrival for the first session. The Device is a standard hockey neck guard, adapted for the purposes of this study. The Device incorporates two bulges localized over the site of the internal jugular veins bilaterally. Experiments performed with jugular Doppler ultrasound demonstrate that while wearing the Device, flows within the jugular veins are reduced, while flow within the carotid arteries and all portions of the cerebrum are preserved (JA Fisher, unpublished data). Thus, application of the Device to the subject will not cause any untoward health risks. The pressure exerted by the Device on the region of the neck superficial to the internal jugular vein is akin to the pressure felt when a person yawns or wears a snugly fitting necktie.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collar Device | Experimental | Other: Laboratory testing, Other: Blood and Urine DrawsThe Device is a standard hockey neck guard, adapted for the purposes of this study. The Device incorporates two bulges localized over the site of the internal jugular veins bilaterally. Experiments performed with jugular Doppler ultrasound demonstrate that while wearing the Device, flows within the jugular veins are reduced, while flow within the carotid arteries and all portions of the cerebrum are preserved (JA Fisher, unpublished data). Thus, application of the Device to the subject will not cause any untoward health risks. The pressure exerted by the Device on the region of the neck superficial to the internal jugular vein is akin to the pressure felt when a person yawns or wears a snugly fitting necktie. |
| Arm Device | Sham comparator | Other: Laboratory testing, Other: Blood and Urine Drawsthe subject is wearing a sham arm device, which will be placed on the upper arm and not cause venous engorgement. The subject will undergo the same testing as when wearing the collar device (strength, Vo2, vision, blood, urine, etc) |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Normal healthy volunteer
- Able to provide written consent
- Able to tolerate hypercapnia for 1-2 minutes
- Must be 18 years or older
Key exclusion criteria (22 listed)
- Unable to provide written consent
- History of neurological deficits, previous cerebral infarction, or head trauma
- Medical contraindications to limited hypercapnia or 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 |
|---|---|---|
| Laboratory testingSubjects will visit the Human Performance Laboratory on two separate occasions to perform the testing procedures. testing consists of VO2, strength, biomechanics, dynavision, etc. | Other | Arm Device, Collar Device |
| Blood and Urine Drawssubjects will have a blood draw and provide a urine sample | Other | Arm Device, Collar Device |
Primary outcome
Measure any changes in blood physiologies
Time frame: 1 week
To monitor changes blood physiologies in a population of athletes wearing the Device.
measure any changes in oxygen consumption
Time frame: 1 week
To monitor changes oxygen consumption in a population of athletes wearing the Device.
measure any changes in strength
Time frame: 1 week
To monitor changes in strength in a population of athletes wearing the Device.
Measure any changes in biomechanics
Time frame: 1 week
To monitor changes in biomechanics balance in a population of athletes wearing the Device.
Measure any changes in neurological capabilities
Time frame: 1 week
To monitor changes in neurological capabilities in a population of athletes wearing the Device.
Measure any changes in balance
Time frame: 1 week
To monitor changes in and balance in a population of athletes wearing the Device.
1 secondary outcome
Number of participants with intervention-related adverse events as assessed by participant survey
Time frame: 1 week
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 15 Sep 2016.
- 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
Cincinnati Childrens Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laboratory testing and Blood and Urine Draws 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 4 inclusion and 22 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 15 Sep 2016. 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. Some participants in this study may receive a placebo. 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?
Measure any changes in blood physiologies (time frame: 1 week). The study lists 6 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 15 Sep 2016.