Dr. Kevin Tracey

So are you stimulating the vagus nerve when you put electricity on your...

Yes, and there's some really interesting, and I'm a fan of it, right?

There's some really interesting science that's been done with brain imaging, fMRIs, far-field evoke responses, and you can connect all kinds of dots, but you can't say it's the same thing that Setpoint is doing as putting a device on the vagus nerve to specifically activate vagus nerve fibers.

So what does that mean?

It means if you look at the typical study of an externally used device, whether it's on the neck or the ear,

What you see are relatively small numbers of subjects, usually 20 or 50, usually open label, usually not well controlled, and usually measuring some clinical effect, which often reaches statistical significance, decreased inflammation, increased heart rate variability.

This is interesting stuff, Eric, but it doesn't prove the mechanism.

It doesn't prove the mechanism and almost none of it, even some of the trials that have led to FDA approvals for various devices, almost none of those have been replicated in a way that would make you comfortable to recommend these things for your practice or would make your professional societies comfortable.

Recommending it as a broad scale thing, meaning they have not been subjected to large, randomized, well-controlled, statistically rigorous clinical trials.

I'm not opposed to these things.

Yeah.

I do it.

I use a TENS unit in my ear most days because it might work, but I don't recommend it to people as a therapy because I'm not sure it does work.

How's that?

Yeah, so there's two or three interesting stories here.

Like you, I'm a fan of medical history, but the story begins at the end of the 19th century when a New York physician started treating his patients with epilepsy, serious seizure disorders, started treating them with like a dog collar-like device that he would put around the neck of his patients connected to a Faraday charging coil.

And so he was shocking these people.

They had to be tied down on his exam table.

So that's when it all started.

And there's some great treatises of those stories that are out there.