Here is what the device looks like when it's pulsing.
Richard Hanbury got the idea for this pulsing pain control mask called
Sana when his own doses of morphine and opioids stopped working in 1992.
When I was 19, I was driving down a road in the Yemen and I had a choice of
a head-on collision next to a petrol truck or to go off a bridge.
I went off the bridge because I figured we were dead either way and I
wanted to leave some remains behind. And that
resulted in a spinal injury from T8 to T10, and that resulted in
a nerve damage pain problem that was so severe I was given a five-year life expectancy.
Twenty-six years later, Hanbury isn't just pain free.
He's presenting his solution at Stanford.
This is our first device.
We are neuromodulation for the management of pain and I made the early
device to be a better painkiller so I didn't to take opioids.
And it wiped out all of my underlying pain.
Hanbury says the masks coordinated pulses of light and sound calm pain by
stimulating the audio and visual cortex of the brain.
He originally set out to help people sleep.
He then realized he could solve a bigger problem with the technology.
Chronic pain: it affects about 100 million Americans across the U.S.
and it's a number that's greater than those combined suffering from heart
disease cancer diabetes.
In five years time there's no reason why anybody should suffer chronic pain anymore.
Sana got him off opioids.
Now he hopes it could help stop America's deadly dependence on the painkillers.
About 130 Americans are dying from opioid overdoses every single day.
This is a big public health crisis and a lot of people want the non-opioid options.
Sana is part of a rapidly growing field of non-opioid medical technology called neuromodulation.
Specific neurological sites in the body are electrically or chemically
stimulated in order to alter how we feel pain.
Anecdotally in the tests we've done so far, on average people are taking
between 30 and 50 percent less opioids when they have a choice of using the Sana device.
Last year, the National Institutes of Health announced a $500 million
pain research initiative that will include more clinical trials for
non-opioid alternatives, all aimed at ending addiction long-term.
Hanbury says Sana will be a powerful alternative to opioids, more than just
distraction therapy like virtual reality pain treatments.
We're aiming for two things with this device: to get that immediate
relaxation effect which reduces pain and also to change the underlying
base level of pain by increasing neuroplasticity to undo the chronic nature of the pain.
So VR is great for the short-term one-off uses, two-off uses.
We're aiming to be something that actually works longer term.
As with many new med tech devices, Sana's long-term effectiveness remains unproven.
I think the thing that's going to be really interesting is the longevity of
a lot of these devices, whether the pain relief is going to last.
Or is it just going to be taken over by the next thing when the person
realizes that their pain hasn't gone away?
Sana is meant to be used for the 15 minutes before sleep or for 15-minute bursts throughout the day.
As you go to sleep, your brain goes through a series of cycles of brainwave
activity and that's one of the critical parts of getting good deep sleep.
And it is also true that if you don't have good deep sleep because you're
in pain, that's going to make your pain worse. You're
gonna be more sensitized to pain the next day.
So I can see how this mechanism would work, but I think what bothered me
about their website was that it wasn't clear that that was the mechanism they were going after.
An initial 75-person clinical trial last year showed people using Sana as
designed had three times the amount of pain reduction as those who used it in a placebo mode.
Scientists warn the placebo effect is strong because measuring pain is so subjective.
Just because someone else had a pain reduction by using a particular device
doesn't mean it's going to work for you.
Who doesn't want to believe that something's going to help their pain?
And as a result they're going to pay a lot of money for it, they're going
to have this expectancy, and so I think the placebo effect is really
strong for a lot of these devices.
Sana is currently in clinical trials for classification as a medical
device. Hanbury is hoping for FDA approval by October.
I'm optimistic even if it's a placebo, hopefully there potentially could be
a mechanism behind how that is actually helping patients.
Whether it's just even reduction in anxiety or depressed mood symptoms,
that's going to have a positive effect on how well patients respond to our
other pain treatments.
Neuromodulation devices are already approved to treat one of the most
common causes of pain: migraines.
These severe headaches can last up to 72 hours and affect one in seven Americans every year.
Migraines are often treated with expensive drugs called Triptans.
And in 35 percent of migraines visits to emergency departments, doctors still prescribe opioids.
But using opioids to treat migraines is nonsense.
In 2017 the FDA approved a wearable device, Cefaly, for acute treatment of
migraines. It's placed on the forehead for one or two hours during a
migraine, where it sends electric pulses through the skin into the
trigeminal nerve, calming the main culprit for migraine pain with a
sedative effect.
Cefaly's these latest clinical trial in 2018 on 600 patients showed that
after two hours of using the device, 30 to 35 percent are free from
migraine attacks and 72 percent get significant pain relief.
It costs $500 and is not covered by insurance.
Another type of neuromodulation device is called peripheral nerve stimulation, or PNS.
The concept of these peripheral nerve stimulation devices is to generate an
electrical field around the nerves.
So the nerves are the way we sense pain in our periphery in our hands or
our feet. And what that electrical field does is to block the pain signals
coming back to the spinal cord and the brain.
The technology isn't new.
It's similar to what's found in pacemakers, but it only recently started
being used to treat pain.
We go right to the site of where the pain is rather than trying to treat it
systemically like spinal cord stimulators do and opioids do.
Bioness' Stimrouter is implanted through one or two incisions in a simple
surgery. Small wire-like electrodes are inserted next to a nerve. An
external device can then stimulate the nerve by sending electrical pulses
through the electrodes.
And the results are striking.
Over 90 percent of the patients had a reduction of 50 percent in their
opioid usage, and 71 percent of them had a big improvement in their pain scores.
Last year the FDA approved a less permanent PNS device that's even easier
to implant, with a single needle through the skin.
It's called Sprint.
It's placed on the back or limbs for up to 60 days to treat pain in one or even two different areas.
Stimrouter and Sprint are both covered by Medicare and most insurance plans.
We want to make sure that whatever cutting edge technology or new devices
or new interventions, that they're widely available to all patients
suffering with chronic pain.
Because it's such a large number of people than we need to have practical
cost-effective solutions that can get to every corner of the country.
There's one over-the-counter neuromodulation device that requires no
incisions. It's called Quell.
It's a battery-powered device worn below the knee that sends electric
stimulation through the nerves in the leg, reducing the pain signals sent up to the brain.
Eighty one percent of patients reported a reduction in their chronic pain
and 67 percent reduced their opioid usage.
It's not covered by insurance, but you can get it on Amazon or in drugstores for $300.
With a sleek IDEO-designed sports band and a mobile app that lets users
adjust the intensity and track their sleep and gait, Quell is meant to
appeal to the masses.
The dream seven years from now is that chronic pain is no longer a thing.
That there is a toolkit that everyone knows that can go into that toolkit
and some of the things are going to help you and you figure out how to
remove chronic pain.
And that in turn would then wipe out the opioid crisis.
Richard Hanbury is also aiming for accessibility with Sana.
He hopes to make it available over-the-counter by the end of the year with an eventual price around $400.
We're not going to be the entire solution.
We're going to be part of it. There will
be better drugs, there will be digital solutions, there will be VR, and there will be us.
My hope is that all together, between us all, we eradicate chronic pain.