As opioids continue to take a toll on Americans, public health officials are looking for alternatives. One avenue of exploration, especially for chronic pain, is stimulating parts of the brain with electricity.
A company called Nēsos is exploring the use of an earbud that would send an electrical current through the inner ear in an effort to reduce inflammation and pain associated with rheumatoid arthritis, an autoimmune disease that causes joints to swell and bones to wear down. An electrical current travels through the auricular branch of the vagus nerve and ultimately targets a pathway in the brain that controls inflammation. The results of its first feasibility study are being published later this year in a leading medical journal.
“We do know through published research over the years that this [neural] pathway atrophies or kind of gets a little bit out of whack early in the disease process,” says Nēsos founder Konstantinos Alataris. “So the brain stops sending the signal to control inflammation and what we’re trying to do is retune or restore that system.”
Between 2018 and 2020, the company sponsored a 30-person safety and efficacy study that showed promising reductions in disease severity. Patients were directed to use the Nēsos device, earbuds that look like any old pair of headphones, for roughly a half-hour per day over the course of 12 weeks. While it didn’t perform quite as well as some of the existing pharmaceuticals used to treat rheumatoid arthritis, the device seems to come with significantly fewer side affects. For example, a set of drugs known as janus kinases inhibitors have been shown to reduce symptoms of rheumatoid arthritis by interrupting certain immune and inflammation responses. However, they also leave patients more vulnerable to infection. By contrast, side effects associated with vagus nerve stimulation are minor, including headache, dizziness, and skin irritation. In Nēsos study, only one person developed an abrasion from the headset.
The study was small and Nēsos is still figuring out the optimal electrical signal to send through the earbuds and whether that signal ultimately needs to be tailored to individual patients. In addition to conducting ongoing research into the device’s effects on rheumatoid arthritis, Nēsos is looking at whether the device might also have an impact on depression and migraines.
The technology is part of a current research trend investigating whether brain stimulation can treat pain. The federal government is keen to find alternatives to opioid prescriptions, going so far as to bring alternative medicine like acupuncture under Medicare coverage for lower back pain. Earlier this year, the National Institutes of Health granted researchers at the University of California San Francisco $7.5 million to understand how deep brain stimulation can be used to treat chronic pain. The funding is part of a larger initiative aimed at quelling opioid addiction called Helping End Addiction Long-term. For deep brain stimulation, doctors implant electrodes that give off a constant electrical current directly into a patient’s brain. This technique is already used to treat Parkinson’s disease, but early research shows it could be used to treat pain as well. Researchers at the University of San Francisco are developing a system that will deliver electrical pulses based on feedback from the patient’s device.
Conceptually, UCSF’s initiative is similar to the work Nēsos is doing. Alataris says his company is developing a software system that can record patient response to stimulation and make adjustments accordingly. At his last company, Nevro, he lead research on an implantable device that controls chronic lower back and leg pain. In that case, the device needed to be used on a continuing basis. Alataris is now investigating whether Nēsos needs to be used in perpetuity or if patients can use it less over time based on data about the patient’s condition. The big difference between the Nēsos method and UCSF’s deep brain stimulation is that the former is not invasive.
Alataris says he is seeking federal approval for the Nēsos earpod to become a prescription medical device, which means that any data collected from a patient’s brain will be protected under HIPAA privacy protections. However, the law wasn’t designed for medical data generated from such technologically advanced devices or the internet-connected world we live in. In a 2018 report, cybersecurity outfit Kaspersky Lab raised concerns about remote tampering with brain implants after it found potential vulnerabilities. While the report focused on implants rather than wearable devices, it noted that if a device is connecting with another piece of external equipment—like a database—companies must ensure the communication between the two is secure.
“All of these protections that the FDA require are already [incorporated],” says Alataris about Nēsos. “In the long run will it be enough? We don’t know yet. I think this is an area that continues to evolve.”