For most of his life, Kevin Ramsey has lived with epileptic seizures that drugs cannot control.
At least once a month, he would collapse, unconscious and shaking violently, sometimes injuring himself. Nighttime seizures left him exhausted at dawn, his tongue a bloody mess. After episodes at work, he struggled to stay employed. Driving became too risky. At 28, he sold his truck and moved into his mother’s spare bedroom.
Cases of intractable epilepsy rarely have happy endings, but today Mr. Ramsey is seizure-free. A novel battery-powered device implanted in his skull, its wires threaded into his brain, tracks its electrical activity and quells impending seizures. At night, he holds a sort of wand to his head and downloads brain data from the device to a laptop for his doctors to review.
“I’m still having seizures on the inside, but my stimulator is stopping all of them,” said Mr. Ramsey, 36, whose hands shake because of one of the three anti-seizure drugs he still must take. “I can do things on my own I couldn’t do before. I can go to the store on my own, and get my groceries. Before, I wouldn’t have been able to drive.”
Just approved by the Food and Drug Administration, the long-awaited device, called the RNS System, aims to reduce seizures and to improve the lives of an estimated 400,000 Americans whose epilepsy cannot be treated with drugs or brain surgery. “This is the first in what I believe is a new generation of therapy for epilepsy,” said Dr. Dileep R. Nair, head of adult epilepsy at the Cleveland Clinic and an investigator in the pivotal trial for NeuroPace’s RNS. “It’s delivering local therapy. It’s not taking tissue out; the brain is left intact. And it’s unlike a drug, which is a shotgun approach.”
Already, Dr. Nair’s center has 70 people on a waiting list for the device. Roughly 110 epilepsy centers with sophisticated diagnostic testing have filed paperwork to be able to offer it, said Dr. Martha J. Morrell, the chief medical officer at NeuroPace, based in Mountain View, Calif. That represents most of the estimated 130 Level 4 centers that treat adults with epilepsy.
Unfortunately, many patients are not referred to these centers by their doctors until they have spent years, even decades, grappling with their condition.
“We want this yesterday,” said Dr. Orrin Devinsky, director of theComprehensive Epilepsy Center at NYU Langone Medical Center. Next month, pending insurance approval, the center plans to implant the device in its first patient.
An estimated 2.3 million adults nationwide have epilepsy, and in a third of them, seizures are not controlled by drugs. Brain surgery can relieve seizures completely, but many patients aren’t candidates because their seizures start in parts of the brain that can’t be removed, such as those needed for language or memory.
Without treatment options, people with intractable epilepsy often find it difficult to hold jobs or to find spouses. They can suffer repeated injuries from falls and burns; their mortality rate is two to three times higher than that of the general population. “There are people out there who are just desperate for the next treatment,” said Janice Buelow, the vice president of research for the Epilepsy Foundation.
With his neurostimulator, Mr. Ramsey, who is partial to ice fishing and wisecracks, is living on his own in a patched-up trailer heated by an indoor wood stove. Inside is the mounted head of a deer he shot. He drives his purple Ford Ranger to appointments at Dartmouth-Hitchcock Medical Center.
Lately, he’s started to look for part-time work. But he’s cautious. “Because of my epilepsy, a lot of people don’t want to take the risk,” he said.
His treatment has been more successful than most. In a randomized clinical trial of 191 people at 32 sites, patients received stimulators but did not know whether they were activated or not. Those with stimulators activated reported a 38 percent reduction in seizures over three months, compared to a 17 percent decrease among those whose stimulators were not, according to the results published in Neurology. Over two years, 90 subjects with the devices turned on experienced a 50 percent or greater reduction in seizures.
Until he received a stimulator in 2008, Andrew Stocksdale, 32, of Mansfield, Ohio, experienced up to 20 seizures a day. By contrast, in the past month, he’s had three. He is now married, holds a full-time job, and has a newborn son.
“My life fell together like a jigsaw puzzle,” Mr. Stocksdale said. “I was afraid to have a son before. I couldn’t do things. I was afraid of falling. I couldn’t hold him.”
Implantation surgery requires two days in the hospital, but extensive evaluation is necessary beforehand, including days of monitoring without anti-seizure drugs.
The device, which requires a battery change every two to three years, works only for people whose seizures start in one or two places in their brain. Electrical stimulation delivered through thin wires placed precisely at those places helps prevent an incipient seizure from spreading.
By contrast, another treatment, a vagus nerve device — which is a stimulator implanted in the chest to prevent seizures — fires “on a preprogrammed basis with no relationship to what’s happening in the brain,” said Dr. Devinsky of the NYU Langone epilepsy center.
Before the RNS is turned on, a patient’s unique seizure patterns must be detected, a process that takes months and multiple clinic visits. Then comes a period of trial and error, when the intensity of stimulation is increased or decreased, or the number of pulses altered, to see if the patient experiences fewer seizures.
“I like to call it a smart device,” said Dr. Christianne Heck, an investigator in the RNS study who is the medical director of the comprehensive epilepsy program at the University of Southern California. “We actually teach the device to detect specific patterns that represent a seizure for each particular patient.”
Soon after Mr. Ramsey’s stimulator was turned on, his major convulsive seizures stopped, said Dr. Barbara C. Jobst, the director of the epilepsy program at Dartmouth-Hitchcock, who was also an investigator in the study. But it took three years of tweaking to stop another kind of seizure that resulted in his simply staring.
Mr. Ramsey’s case was in some ways exceptional, she warned: “It’s not always as clear where the seizures are coming from as it is in him.”
The size of the area where seizures start also affects how well the neurostimulator works, said Dr. David W. Roberts, a neurosurgeon at Dartmouth-Hitchcock. “If a patient’s seizures are confined to thehippocampus, you have a good chance of helping him,” he said, noting that the hippocampus is small.
But if seizures originate over the whole frontal lobe, Dr. Roberts said, the same number of electrical leads are “much less likely to have the same effect.”
Even for patients who are good candidates, access to the new device may be difficult if patients aren’t referred to Level 4 epilepsy centers. Such centers tend to be near universities or larger cities. New York City has eight, while no Level 4 centers exist in Montana, Arkansas or the Dakotas.
Dr. David M. Labiner, the president of the National Association of Epilepsy Centers, said the “lag time” between diagnosis and referral to a comprehensive center “is still up to 20 years.”
Another hurdle is cost. The RNS, with the equipment required to download data, is up to $40,000. That figure doesn’t include $10,000 to $20,000 for the surgery, or diagnostic testing. Thus far, insurers have paid most of the expenses for five or so cases since F.D.A. approval, including one covered by Medicare.
In the long run, seizure reduction is cost-effective, some experts argued.
“Even if seizures are only cut in half, insurers’ costs are cut in half,” said Dr. Labiner, who also heads the epilepsy program at the University of Arizona.
RNS may reduce seizure frequency, but it won’t cure memory loss or repair a difficult marriage. “Psychosocial problems aren’t necessarily better if your seizures are well controlled,” said Dr. Gregory L. Barkley, co-founder of the epilepsy program at Henry Ford Hospital in Detroit.
Mr. Ramsey still has cognitive issues. “I forget people’s names all the time,” he said. At a restaurant in January, he kept forgetting he had decided to order the seafood pie moments before.
As much as his neurostimulator has changed his life, he’s hoping for another sea change: “Finding a really nice girl,” he said. “I would like to have a baby so I can raise a family.”