Q-Collar jugular compression device to protect from brain injuries in sports 🤯

General
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I am not sure I buy this but time will tell. This is based on imaging study of brain injury pre & post but NOT brain fluid volume measurements to explain the mechanism of protection they hypothesize. Not sure compressing IJVs on upright position increases intercranial pressure significantly (small increases but not significant enough). So I have more questions than answers.

  1. The study wrongly assumes that all drainage are done by the Jugular Veins. It is widely known that on upright position (which players will be unless they are playing football while swimming), Jugular Veins collapse and drainage is partially done by deep collateral veins which I believe this devices can’t compress from the neck area. So this calls into question the amount of brain fluid volume that is restricted while wearing it. This study (Internal jugular vein blood flow in the upright position during external compression and increased central venous pressure: an ultrasound study in healthy volunteers | SpringerLink) concludes “Compression of the internal jugular veins or an increase in intrathoracic pressure does not reduce venous drainage but actually may increase intracranial venous volume”. This means the pressure increases within the veins but does have little to no effect of drainage.

  2. The FDA approval document clearly states that the device has not been proven to prevent concussion or serious brain injury (which is the main reason for wearing it to begin with)

  3. Even if we assume this induces temporary intercranial pressure, there are a lot of studies linking ICP to brain damage in the long term (Increased Intracranial Pressure - StatPearls - NCBI Bookshelf).

LIMITATIONS
• The Q-Collar has not been demonstrated to prevent long-term cognitive function deficits,
and the ultimate impact on clinical outcomes has not been evaluated.
• The use of imaging studies as a future indicator of brain injury has not been validated.
• Data do not demonstrate that the device can prevent concussion or serious brain injury.
• The Q-Collar should not be worn if it interferes with other existing protective equipment.
• Wearers of the device should not depend on the device to protect them from all harmful
effects of head impacts.

BENEFIT-RISK DETERMINATION
The risks of the external compression device for internal jugular vein compression are based on
data collected in the clinical studies described above. Although no adverse events or serious
adverse events (e.g., syncope, loss of consciousness, etc.) were reported during the studies, based
on products with a similar mechanism of action and other clinical knowledge, there are probable
risks to patient health without adequate mitigations in place:
• Small amounts of excessive pressure to the muscles surrounding the IJV could disrupt the
flow of oxygenated blood through the arteries to the brain leading to syncope.
• Use error could cause injury to the user including excessive head impacts caused by a
false sense of protection, use of the device by athletes who should not wear the device, or
interference with existing protective equipment (e.g., helmet). .
Source FDA Approval : https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN200017.pdf

I also agree with the assessment of New York Times writer below.

Concerns About Q-Collar Not Approved By FDA To Prevent Concussion — Concussion Alliance).

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