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Thursday, June 19, 2014
When Rhode Island resident Ashley Sherman was in second grade, she had a tingling sensation in her mouth that would occur twice a day. Doctors at a local hospital thought it was acid reflux.
Fast forward to a night about six years later when Sherman started having violent convulsions and turned blue. Her father immediately brought her to a nearby hospital, and that’s when she was diagnosed with epilepsy, a neurological disorder characterized by seizures.
The tingling sensations weren’t acid reflux episodes. They were seizures.
Sherman, now 25, underwent a brain resection surgery in 2001 which stopped her seizures, but they came back six years later, and in full force.
“Everything went to shambles in 2007,” Sherman said.
She had to quit her job, she lost her license and friends had to pick her up and drive her everywhere.
“I didn’t go out as much because I was afraid I was going to have seizures in public, and it’s embarrassing,” Sherman said. “That’s not something I wanted.”
At that time she was having up to 300 seizures per month, despite having had a resection. They were mostly grand mal seizures, which entail violent muscle contractions and loss of consciousness.
Sherman’s quality of life greatly diminished, but after joining a Mass General Hospital study in 2008 that examined a one-of-a-kind implantable device aiming to treat adults with epilepsy, Sherman got her life back.
“Before, in 2007, I was on just meds and I was having tons and tons of seizures, and now that I have the NeuroPace, I haven’t had any,” Sherman said. “I’m able to work, drive, and I volunteer at my local ambulance and fire department.”
The Responsive Neurostimulator System (RNS), which was approved by the Food and Drug Administration (FDA) in November, is an implantable device to help treat adults with partial onset seizures.
Created by a company called NeuroPace, the device detects abnormal brain activity, and sends out small bursts of electrical stimulation to normalize that brain activity before a person has a full-blown seizure. Patients implanted with the device can download all brain activity using a four-inch-wand, that connects to computers and devices through a USB cord.
All Sherman has to do is place the wand over where the device is implanted and the data is then downloaded onto her computer through the USB cord. The data is also automatically sent to NeuroPace.
“The important point here is that this is a novel treatment approach,” said Dr. Andrew Cole, MD, professor of Neurology and director of the Mass General Epilepsy Service, and the lead investigator of the study. “It took a tremendous amount of energy and effort to develop this device, to create a clinically useful tool, and to do the rigorous testing required to demonstrate its benefit. Here’s a treatment that can react to the actual problem.”
The goal of the initial trial, was “to assess the safety and to demonstrate that the RNS device is effective as an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures that are refractory to two or more antiepileptic medications.”
“It’s a really great advancement for us, and it’s going to make a big change,” said Sherman’s doctor, Sydney Cash, MD, PhD, assistant in the department Neurology at Mass General. “It has created a new treatment modality that hasn’t existed before. It goes beyond the other surgical approaches we’ve had and beyond the medicines we’ve had, and it’s going to be able to help a lot of people who had no other options before.”
The study was initiated in 2008 with seven participants recruited at Mass General, according to Samantha Donovan, a clinical research coordinator in neurology, epilepsy service. Five of the seven participants are still actively involved in the study.
“One patient moved away and is continuing participation at another trial site,” Donovan said. “Another patient decided to opt for a resective surgical treatment for epilepsy and had the device removed.”
Prior to doctors implanting the device, the seven trial patients documented every detail of their seizures for six months in a small journal.
After Sherman had the device implanted into her skull in December 2008, Sherman and the other participants entered a blind portion of the trial, where they were not told whether the device was on or off.
“Obviously it was a blind study, so they couldn’t tell me if it was on or off,” Sherman said. “But it was obvious. It happened instantaneously. My seizures went down and down. I knew it, and I would say to the doctors, ‘Guys, I know it’s on.’ And they would laugh at me and say, ‘Sorry we can’t tell you.’”
Despite having a bout of seizures on a Saturday night in June 2012, Sherman has had ample success with the RNS device, she said.
The RNS System has lessened Sherman’s anxiety about having seizures, and strengthened her independence, she said. She has goals of breaking into the medical field, becoming a medical assistant or certified nurse’s assistant.
Sherman, along with the other study participants, comes to the hospital every six months for a checkup, and to have the device battery replaced every three years. During the six-month checkup, doctors and patients discuss data that their patients download with their wands.
Cole said there is a running list of about 15 to 20 people at Mass General that are in different stages of evaluation for the RNS system. There is no limitation to the number of devices at the hospital, and it is available to a wide number of patients, Cole added.
“I think we have to call the study a success,” Cole said. “The goal was to test the efficacy of the device. It had a statistically and meaningful result. By every criteria it was a success, and certainly by the FDA’s criteria it was a success.”
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