The last resort: Cut an inch-long incision into someone’s scalp. Then drill a hole into the skull that’s no bigger than a dime. Insert an electrode directly into the brain that targets the reward center, the nucleus accumbens. Then thread a wire beneath the skin to a pacemaker implanted in the patient’s chest.
That’s the latest—and most controversial—proposal for battling the nation’s opioid crisis. It’s called deep brain stimulation.
The problem: Who wants to go through that? That’s exactly what’s facing Ali Rezai, MD, a 52-year-old neurosurgeon at West Virginia University who’s been charged with testing new technologies for tackling opioid addiction. He wants to perform a clinical trial on 20 patients later this year.
Rezai and his team will look for addicts for which every other treatment has failed. Deep brain stimulation carries with it significant risks, including infection, and emotional, cognitive, and behavioral disturbances.
He intends to start with a handful of volunteers who’ve survived an opioid overdose and couldn’t quit despite undergoing various treatments.
That, Rezai hopes, will be followed by a larger trial in which half of participants will be given deep brain stimulation, and the other half a sham device. Selection will be crucial, says Rezai, not only in finding the right kinds of patients who have failed previous attempts at treatment, but also finding patients who won’t bail out of the study, a problem that has hampered previous trials. For instance, a 2010 study of deep brain stimulation for opioid addiction at the University of Amsterdam’s Academic Medical Center was only able to recruit two participants.
Judy Luigjes, who conducted that study, told Stat that “few people wanted to go through with it. A lot of it has to do with fear of the procedure.”
“Patient compliance and sticking with the trial are important,” says Rezai.
He doesn’t see deep brain stimulation becoming a widely available treatment for opioid addiction for some years. But there may be pressure to go faster, given that an estimated 115 Americans die from opioid addiction every day.
When West Virginia University announced Rezai’s effort last month, some of the coverage pointed to a 2011 article by two Australian researchers, Wayne Hall and Adrian Carter, in the journal F1000 Medicine Reports titled, “Is Deep Brain Stimulation a Prospective ‘Cure’ for Addiction?”
They come out against it, to say the least. They argue that deep brain stimulation had been effective in some Parkinson’s disease patients for treating tremor but that there are important differences between the case for deep brain stimulation in Parkinson’s disease and that for addiction.
On the other hand, Hall and Carter said that addiction does not necessarily lead to disability and death, and is more amenable to pharmacological treatment. “In fact,” they wrote, “many of the failures of addiction treatment are due to inadequate access to well-run and optimally provided forms of existing treatments, a situation that could be exacerbated by an increased use of deep brain stimulation to treat drug addiction.”
Rezai said that the operation costs about $50,000, with maintenance over the following few years coming to about $10,000 a year.
“Costs are initially covered by the clinical trial and if the trials are successful, it can lead to approval and coverage by Medicare,” Rezai says.