The #Qcollar is based on the idea that jugular compression increases blood in the brain to create a "bubble wrap" effect, which prevents the it from bouncing around inside the skull.
According to the company, this mechanism is found in Nature. bit.ly/2KqTJvS
Thread/2b
From the company's promotional video, the device is justified based on reducing brain "slosh" by:
1) Replicating the animal adaptations (see 18:00 in video) 3) Replicating effects of "higher altitude" exposure (see 21:57, again at 36:00)
"As we go to higher altitudes, there is less oxygen in the air, so there is more CO2 in the oxygen we are breathing, so the brain senses it needs more oxygen, it naturally pulls more blood, so we have cerebral edema..."
Thread/2d
This thread provides evidence that the very basis they present for the #Qcollar is inherently flawed. Their claims sound scientific, but are not accurate.
Links to the peer-review publications critically evaluating these flaws in greater detail are also provided.
Thread/3a
A patent application for the #Qcollar was first filed in 2010 by Dr. David Smith, focused on reducing brain "slosh"
However, with one exception (a brain tumor report) brain "slosh" does not appear in the scientific literature until 2012, and all articles on the topic have patent-holder Smith as an author.
A financial conflict of interest in "slosh" theory?
In 2012, two studies were published claiming that jugular compression reduced the severity of brain injury in rats that received a single damaging head impact.
This experiment was done using established methods, in which a 450 gram (~1 pound) weight was dropped onto the head of a rat from a height of 2 meters. This produces a 900 G (900 times the force of gravity) impact.
The study classified "higher altitude" as anything greater than the median altitude of the schools examined - 600 feet above sea level.
It hypothesized this elevation would cause physiological responses which would cause a "tighter fit" inside the skull to reduce #TBI
Thread/5c
Conclusion says, "Future research is warranted to test the
hypothesis that mitigating Slosh in the human cranium via
mild jugular vein compression will prevent or diminish severity of concussion."
In other words, "higher altitude" was used to justify #Qcollar
Thread/5d
Decades of altitude research show 600ft elevation is not high enough to cause physiological changes in the brain. Thus, the link between altitude and concussion is implausible.
@zavorsky published a letter to the editor discussing this
The paper makes incorrect statements about altitude physiology.
One example: "Another example would be the actual oxygen concentration of 20.9% at sea level changing to just 20.1% at 1000 ft of altitude."
WRONG: The O2% in the air remains constant at high altitude!
Thread/6c
The paper then links the supposed protective physiology of "higher altitude" to bighorn sheep and woodpeckers protecting themselves, and even mentions "self-altered jugular outflow."
Once again, altitude-concussion link used to justify jugular compression #Qcollar.
Thread/6d
Again, @zavorsky published a letter to the editor, explaining that their physiological explanations did not make scientific sense.
"The authors show a lack of understanding of altitude physiology, while promoting statistical illiteracy"
@zavorsky and I published a paper in @japplphysiol explaining in even greater detail why the low altitudes used in the previous studies and jugular compression could not possibly cause "tighter fit" and reduce #concussion risk.
We compare the ~644 feet elevation (Smith 2013 and Myer 2014) to other altitudes, at which physiological changes actually do occur.
"Tighter fit" only possible >7,000 feet at a minimum!
Too many details to put in a tweet - read full paper if interested (link in 7A)
Thread/7c
We originally submitted the physiology content as part of another paper, which was published in @JAMANeuro
Review below. If the average neurologist may struggle w/some of the physiology data, how is the average parent to know the #Qcollar marketing is #pseudoscience?
Thread/7d
So, we just published a meta-analysis of data comparing concussion risk at higher altitudes.
>5,000,000 data points was not enough to find a significant epidemiologic association between altitude and concussion!
Since "higher altitude" could not plausibly influence concussion, any association must be coincidental and observable with any arbitrary division.
For fun, we showed that @NFL teams w/ animal logos had a ~30% lower risk of concussion than teams w/ non-animal logos!
Thread/8c
It is important to recognize that the supposed link between "higher altitude" and concussion risk was heavily used to justify the #qcollar - jugular compression was claimed to simulate this. They also cited it in some subsequent other papers.
But that is now debunked!
Thread/9a
#Qcollar inventor Smith claims to have studied woodpeckers and that they likely protect themselves by occluding their jugular veins using their omohyoid muscle, and his product replicates that effect.
But, there seems to be no scientific evidence for this claim!
Thread/9b
I read EVERY reference about woodpeckers I could find (including getting full-texts of 300 year old papers! bit.ly/2Ma64Xb)
I contacted ornithologists that studied woodpeckers at @CornellBirds.
Nowhere was there any description of woodpeckers doing this!
Thread/9c
I published a @BJSM_BMJ paper with an engineer who studies woodpecker biomimicry.
We explain how woodpeckers actually do protect their brains - multiple adaptations! Replicating any one mechanism alone could not protect human brains.
We also explain a woodpecker impact is nothing like a sports concussion.
Woodpeckers repeatedly hit objects with their beak and brace their bodies to dissipate force.
Football players get hit directly, unexpectedly, have longer duration impacts, and rotational force.
Thread/9e
The #qcollar is also based on the assumption that woodpeckers don't get brain injuries. However, a @PLOSONE paper called that into question. It isn't clear if they get "injured," but there is evidence of impact-induced changes in their brains.
I put that into the context of the #Qcollar in a paper in @lancetneurology, and concluded "woodpecker biomimicry might be a distraction to more effective strategies for preventing #TBI and chronic traumatic encephalopathy in human beings."
In September 2017, it was announced that @NFL player, Luke Kuechly, would be wearing an woodpecker-inspired "experimental collar" that could help him to prevent concussions - the #Qcollar
According to one coach, "He hopes Kuechly wearing the collar will convince others to give it a try and ultimately lead to the device being passed by the FDA for sale in the U.S."
They suggest stable DTI parameters, such as axial diffusivity (AD) as evidence that jugular compression may protect the brain. However, that is the group AVERAGE.
Of the 21 athletes using #QCollar, 11 decreased AD, 8 increased AD, only 2 showed no AD change!
Thread/11d
These studies involved adolescent athletes. DTI values are meant to change with growth during this time.
It is not clear that the #Qcollar elicits a sufficiently large change in DTI to suggest "brain protection."
Thread/11f
Though the papers attempt to use DTI to demonstrate #Q_collar protects the brain, this data is very nuanced and open to interpretation.
Given the misrepresentation of altitude physiology and woodpeckers used to justify jugular compression, I don't trust the MRI data.
Thread/12a
It must be remembered that the two studies from Smith's group indicated "higher altitude" was associated with a reduced risk of #concussion (i.e. injury from a single large impact).
Authors suggested mimicking the effects of altitude could reduce CONCUSSION risk.
Thread/12b
Indeed, in 2014 the group began conducting clinical trials (on children!) using the #QCollar.
The primary outcome measure was "concussion incidence."
Clearly, it appears that this device was rooted in preventing #concussions from happening, and this was actually being tested in clinical trials.
So, why has company changed its message to one of protecting from "repeated impacts" (in skiers and race-car drivers?)
Thread/12f
It is relatively easy to determine whether a device can prevent single concussive incidents - as the clinical trials show the #Qcollar originally intended to do.
My guess is that it didn't work for this purpose, and thus, the switch to "brain protection."
Thread/13a
Of course, I am not the only skeptic of the #Qcollar.
Accroding to @braindoc172, “In truth, it is my opinion that the way the product is being promoted is potentially misleading.”
This 2013 altitude study is presented in @nytimes by the lead #Qcollar researcher as evidence "slosh mitigation" may create "tighter fit" (Bubble Wrap) to protect from distinct concussive events (no mention of repeated subconcussive impacts).
"We have observed that the woodpecker uses muscles to do this..." This is MISLEADING, since it sounds like they actually have evidence of this, yet none exists!
The @nytimes op ed author (lead #Qcollar researcher) clearly promotes recreating the supposed protective mechanisms of altitude and woodpeckers to defeat #CONCUSSIONS (distinct events from a single impact).
If true, why shift to repeated subconcussive impacts?
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The #Qcollar jugular compression device is "FDA CLEARED" to "protect athletes' brains during head impacts." @US_FDA
Does this mean that it is safe, effective, and based on sound science?
Not quite! Before you believe the company's big claims, read this full thread!
Below is an index to my fully-referenced thread:
2/ A bit about what FDA cleared really means 3/ Critique of the study that got Qcollar FDA cleared 4/ Summary of problems w/ their other studies 5/ Qcollar's continued pattern of false claims 6/ Their plan to profit from taxpayers
2a/
Some semantics, note this isn't "FDA APPROVED" but rather "AUTHORIZED".
QCollar isn't claiming "approval," but many confuse these terms and assume this more stringent standard.
APPROVAL is more appropriate for Class III devices, which undergo more rigorous review.
If you don't understand the highly nuanced #MRI technique known as DTI, these results sound straightforward and convincing.
THEY ARE NOT. Don't be fooled by these numbers!🤔
I will dissect these in the thread below.
3a/
"No significant changes" is based AVERAGE response, not individual.
First, an easy-to-understand analogy below.
If half the sample experiences an increase and half experiences a decrease, they can cancel each other out to falsely suggest "no change" when one does exists!