In 1992, doctors told Sana Health founder and CEO Richard Hanbury that he had just five years to live.
A Jeep accident in Yemen at age 19 left him in a wheelchair and in such intense pain that he was rarely able to sleep, he recalls. Prescription drugs, even morphine, lost their effectiveness and the chronic pain from nerve damage only got worse, to the point that it threatened to kill him.
It was a 1990’s movie — « Hudson Hawk » — that led Hanbury to develop a cure. In the film, Hawk, played by Bruce Willis, is just out of prison and gets pulled back into a series of heists, including stealing famous works of art.
« Bruce Willis did literally save my life with that film, » Hanbury said in an interview. « The film went from good and bad to good and bad the whole way through. As I was watching, I realized that had changed my pain levels more than morphine. That’s where the whole idea of using a visual stimulus to create a different state of consciousness came from. »
Sana pain management mask
Hanbury created Sana. The company now makes a mask that users wear over their eyes for 15 minutes before bed, or in 15 minute intervals throughout the day as needed, to put them into a relaxed, lower-pain state. The Sana mask measures minute changes between each heartbeat, and administers precisely timed pulses of light and sound to stimulate the audio and visual cortex of the user’s brain.
Some 50 million people in the U.S. experience chronic pain daily or almost daily. But Sana is also attacking the crisis caused by opioids, which many people turned to for help in dealing with their pain. That led to an addiction epidemic that’s now killing 130 Americans every day from overdoses, according to estimates from the Centers for Disease Control and Prevention.
Sana is currently only available for people in clinical trials. It’s seeking classification as a medical device, and Hanbury is aiming for approval from the U.S. Food and Drug Administration by October. Along with other companies in the field like Bioness and Cefaly, Sana is developing neuromodulation devices that have the potential to reduce or completely eliminate pain, as well as over-reliance on opioids to treat it.
Wearable migraine management device Cefaly is placed on the forehead, calming the trigeminal nerve with a sedative effect.
In 2017, the FDA approved a wearable device from Cefaly for acute treatment of migraines. It’s placed on the forehead for one or two hours during a headache and sends electric pulses through the skin into the trigeminal nerve in the face, calming the main culprit for pain with a sedative effect.
Other pain relieving devices need to be implanted. Bioness’s StimRouter, which is FDA approved, is comprised of small wire-like electrodes that are inserted under a patient’s skin in a simple surgery, right next to a nerve. An external device can then stimulate that nerve by sending electrical pulses through the electrodes.
Bioness CEO Todd Cushman said the company recently had a study published by the University of California, San Diego, with 39 patients. The treatment targeted 11 different nerves.
« The results were very very good, » Cushman said. « Over 90 percent of the patients had a reduction of 50 percent in their opioid usage and their pain scores went down significantly. »
Cushman said that 71 percent of people in the study « had a big improvement in their pain scores. »
Many devices, and their long-term effects, are still unproven and not totally understood. Scientists warn the placebo effect is significant with new treatments, because measuring pain is so subjective.
The components of a StimRouter neuromodulation device by Bioness for pain management in San Francisco on February 26, 2019.
« Who doesn’t want to believe that something is going to help their pain? » said Indre Viskontas, who teaches learning and memory and science communication at the University of San Francisco. « 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. And I think this is a ripe, vulnerable population. »
Regulators and health-care providers also want to understand how effective technological approaches are compared to pharmaceutical treatments over the long term.
Devices vs. pills
« The thing that’s going to be really interesting is the longevity of a lot of these devices, » Viskontas said. « You know, whether the pain relief is going to last or if it is just going to be taken over by the next thing, when the person realizes that their pain hasn’t gone away. »
Jennifer Hah, a pain management specialist at Stanford University Medical Center, is optimistic about technology, even if there’s a placebo effect on patients.
« There potentially could be a mechanism behind how that is actually helping patients, whether it’s just a 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, » Hah said.
Neuromodulation devices and other technology can potentially offer other advantages over pills, she said.
Parents may be more comfortable with doctors prescribing devices for children, and the cost of a device can also be far lower over time than prescription drugs that need to be refilled consistently by a pharmacy.
« It’s such a large number of people that we need to have practical cost-effective solutions that can get to every corner of the country, » Hah said.