Amid a wide-ranging effort to curb opioid misuse, medical device manufacturers are "racing" to develop new, more comfortable neuromodulation devices to treat pain, Emily Mullin writes for MIT Technology Review.
An effort to combat the opioid epidemic
According to CDC, the amount of opioids prescribed per person in 2015 was three times higher than in 1999—even as the overall level of pain reported by Americans remained stable. Meanwhile, in 2015, an estimated two million people in the United States misused prescription opioids, Mullin writes.
In response, medical device manufacturers are exploring neuromodulation, or neurostimulation, therapy, which scientists believe can treat pain by interrupting the pain signals that nerves send to the brain. While the technology's been around since the 1960s, it's become the center of rapid innovation in recent years, Mullin writes, as medical device makers and other health care industry stakeholders search for nonaddictive methods of controlling pain.
The spinal cord stimulator
According to Mullin, one such device is the spinal cord stimulator—an experimental device implanted under the skin near the base of the spine. When the patient activates the device via an external remote, it emits a mild electric current to nerves in the patient's spine.
FDA approved the first spinal cord simulator in 1989, and they have since then become smaller and more comfortable for patients, Mullin writes. However, despite these comfort improvements, the devices are often viewed as a last resort for patients suffering from chronic pain, according to Nagy Mekhail, a pain physician at the Cleveland Clinic—and that shouldn't be the process. "In some patients, it should be the first choice," he said, noting that patients with pain caused by nerve damage would be the most likely to benefit from the devices.
But Michael Leong, a pain specialist at the Stanford University School of Medicine, said he understood why providers might hesitate on recommending the surgery as a first option, given concerns about paresthesia (a tingling sensation linked to the device in some patients), the risk of infection, and the potential that the device won't effectively treat a patient's pain.
Overall, Boston Scientific—who manufactures such spinal cord stimulators—reports that about 50,000 to 60,000 patients in the United States get the device each year.
Acknowledging that some patients may be wary of an implanted device, many manufacturers are also designing less invasive options that stimulate peripheral nerves—the network of nerves connecting the brain and spinal cord, Mullin writes.
For instance, SPR Therapeutics recently received FDA approval to market its peripheral nerve stimulation device. The device is small, coiled wire—nonsurgically placed under the skin near a nerve—that connects to a matchbox-sized external simulator which patients can place anywhere on their body. According to a small, NIH-funded study, the device was linked to a 72 percent reduction in painamong amputation patients.
Meanwhile, opioid clinics in 30 states are using a new device from Innovative Health Solutions, called the Neuro-Stim System Bridge, to help people who misuse drugs manage withdrawal symptoms, Mullin writes. According to Mullin, the device— a battery-operated chip, located on the skin behind the patient's ear—emits electrical pulses that stimulates the parts of the brain associated with processing pain information.
Jeff Mathews, who operates the Indiana-based Union County Opiate Treatment Center, said the clinic has used the device with more than 100 patients—roughly 85 percent of whom haven't resumed opioids since using the Bridge. While the device is not a long-term option, as it's designed to treat patients during withdrawal, the results are "miraculous," Mathews said. "This could be a game changer in terms of treatment of addiction."
Will the devices see wider use—and should they?
Edward Michna, a pain management specialist at Brigham and Women's Hospital, said while these pain management tools are useful, they shouldn't be considered a cure-all for every type of pain. "Have I seen patients do well on it? Yes. But I've also seen patients lose the relief over time," he said.
Michna called for more research on such devices to see just how long the benefits last, given that most clinical trials of neuromodulation devices have only studied their effects for two years or less.
Part of the issue, according to Mullin, is that medical device manufacturers often just have to demonstrate a product's safety—not its effectiveness—to get FDA approval. As a result, Michna expressed concern that some manufacturers will capitalize on the opioid crisis and put ineffective devices on the market.
According to Michna, cost could be another barrier to wide-spread adoption. Neuromodulation devices can cost between several hundred to several thousand dollars, Mullin writes, and insurance only covers the cost of some therapies.
But obstacles to access shouldn't deter providers and patients from considering the devices, Leong said, adding, "We need to stop thinking of pain control as just being about opioid medications" (Mullin, MIT Technology Review, 7/31).
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