Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02696200 |
| Other study ID # |
2015-2205 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 2015 |
| Est. completion date |
June 2017 |
Study information
| Verified date |
November 2020 |
| Source |
Children's Hospital Medical Center, Cincinnati |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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). 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.
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.
