All of a sudden we're finding out medical marijuana might not be the only hope for the estimated 400,000 Americans with intractable epilepsy.
Just approved by the Food and Drug Administration is a long-awaited device implanted into the skull called an RNS System. Its sole purpose is to reduce seizures and improve the lives of epileptic patients -- especially adult patients -- who can't be treated with drugs or brain surgery.
The New York Times last week reported the work of Dr. Dileep R. Nair, head of adult epilepsy at the Cleveland Clinic and an investigator in the trial for the RNS System, a product of the NeuroPace Company in Mountain View, Calif. ("Easing epilepsy with battery power," by Catherine Saint Louis.)
This is the first in what I believe is a new generation of therapy for epilepsy, said Nair. Its delivering local therapy. Its not taking tissue out; the brain is left intact. And its unlike a drug, which is a shotgun approach.
Nair explains it as a novel battery-powered device implanted in the patient's skull, its wires threaded into his brain. The device tracks the brain's electrical activity and quells impending seizures. At night, the patient holds a sort of wand to his head and downloads brain data from the device to a laptop for his doctors to review.
The New York Times story reports that until he received a stimulator in 2008, Andrew Stocksdale, 32, of Mansfield, Ohio, experienced up to 20 seizures a day. Now he has about three a month. Since the implant he has 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 couldnt do things. I was afraid of falling. I couldnt hold him.
Understand that there are definite hurdles, chief among them cost. The RNS, with the equipment required to download data, can cost up to $40,000. That figure doesnt include $10,000 to $20,000 for the surgery, or diagnostic testing. So far, insurers have paid most of the expenses for five or so cases since FDA approval, including one covered byMedicare.
There is nothing simple about this device, either. Before the RNS is turned on, a patients unique seizure patterns must be detected.
It's 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.
Rep. Katie Edwards, D-Plantation, who is working with Rep. Matt Gaetz on a bill (HB 843) to make CBD medical marijuana available in a nonsmokable form to children who are suffering from intractable epilepsy, said it's all good news. "I know about it and it's worth writing a story about," she said. "People should know it's out there."
Word has gotten around. Nair has 70 people on a waiting list for the device. Some 110 epilepsy centers with sophisticated diagnostic testing have filed paperwork to be able to offer it, according to Dr. Martha J. Morrell, chief medical officer at NeuroPace. She said that represents most of the estimated 130 Level 4 centers that treat adults with epilepsy.
Epileptic children were not described as RNS System participants. The importance of medical marijuana, and the House and Senate bills now proposed in Florida, is to keep child-epilepsy sufferers alive and well enough to be able to receive an implant, if one is necessary, as they grow to adulthood.
Reach Nancy Smith at nsmith@sunshinestatenews.com or at 228-282-2423.
