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Innovative Concussion Prevention Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02901028
Recruitment Status : Completed
First Posted : September 15, 2016
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief 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 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.

Condition or disease Intervention/treatment Phase
Concussion Other: Laboratory testing Other: Blood and Urine Draws Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Safety Testing of an Innovative Concussion Prevention Device
Study Start Date : April 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : August 2013

Arm Intervention/treatment
Experimental: Collar Device
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.
Other: Laboratory testing
Subjects will visit the Human Performance Laboratory on two separate occasions to perform the testing procedures. testing consists of VO2, strength, biomechanics, dynavision, etc.

Other: Blood and Urine Draws
subjects will have a blood draw and provide a urine sample

Sham Comparator: Arm Device
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)
Other: Laboratory testing
Subjects will visit the Human Performance Laboratory on two separate occasions to perform the testing procedures. testing consists of VO2, strength, biomechanics, dynavision, etc.

Other: Blood and Urine Draws
subjects will have a blood draw and provide a urine sample




Primary Outcome Measures :
  1. Measure any changes in blood physiologies [ Time Frame: 1 week ]
    To monitor changes blood physiologies in a population of athletes wearing the Device.

  2. measure any changes in oxygen consumption [ Time Frame: 1 week ]
    To monitor changes oxygen consumption in a population of athletes wearing the Device.

  3. measure any changes in strength [ Time Frame: 1 week ]
    To monitor changes in strength in a population of athletes wearing the Device.

  4. Measure any changes in biomechanics [ Time Frame: 1 week ]
    To monitor changes in biomechanics balance in a population of athletes wearing the Device.

  5. Measure any changes in neurological capabilities [ Time Frame: 1 week ]
    To monitor changes in neurological capabilities in a population of athletes wearing the Device.

  6. Measure any changes in balance [ Time Frame: 1 week ]
    To monitor changes in and balance in a population of athletes wearing the Device.


Secondary Outcome Measures :
  1. Number of participants with intervention-related adverse events as assessed by participant survey [ Time Frame: 1 week ]
    to determine the tolerance and acceptance of the Device while undergoing exertion.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal healthy volunteer
  • Able to provide written consent
  • Able to tolerate hypercapnia for 1-2 minutes
  • Must be 18 years or older

Exclusion Criteria:

  • 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)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901028


Locations
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United States, Ohio
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: Gregory D Myer, PhD Cincinnati Childrens Hospital

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02901028    
Other Study ID Numbers: 2013-2240
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Results will be published however individual participant data will remain secure