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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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)
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  • 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

Other trials in United States

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 groups in NCT02901028
Study groupRoleWhat they receive
Collar DeviceExperimentalThe 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 DeviceSham comparatorthe 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.

  1. Measure any changes in blood physiologies

    To monitor changes blood physiologies in a population of athletes wearing the Device.

    Measured: 1 week

  2. measure any changes in oxygen consumption

    To monitor changes oxygen consumption in a population of athletes wearing the Device.

    Measured: 1 week

  3. measure any changes in strength

    To monitor changes in strength in a population of athletes wearing the Device.

    Measured: 1 week

  4. Measure any changes in biomechanics

    To monitor changes in biomechanics balance in a population of athletes wearing the Device.

    Measured: 1 week

  5. Measure any changes in neurological capabilities

    To monitor changes in neurological capabilities in a population of athletes wearing the Device.

    Measured: 1 week

  6. 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)
  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.

  1. First posted15 Sep 2016 (estimated)
  2. Study startApr 2013
  3. Primary completionJul 2013
  4. Study completionAug 2013

Resources

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)
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

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.

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