Friday, July 11, 2014

New device, new lease on life


DRAMATIC DISCOVERY: The Responsive Neurostimulator System as it appears inside the brain

When Rhode Island resident Ashley Sherman, 25, 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 one night more than five years later. Sherman began having violent convulsions and turned blue. Her father brought her to the hospital where they learned that the tingling sensations she experienced during childhood were not acid reflux episodes. They were epileptic seizures.

Sherman underwent a brain resection surgery in 2001, which temporarily stopped her seizures. But they returned
six years later – in full force.

“Everything went to shambles in 2007,” Sherman says. She was forced to quit her job. She lost her license. Friends had to drive her everywhere.

“I did not go out as much because I was afraid I was going to have seizures in public. I felt it was embarrassing. That is not something I wanted.”

Despite the resection, Sherman was having nearly 300 seizures per month. These were mostly grand mal seizures that cause violent muscle contractions and loss of consciousness. Her quality of life greatly diminished, but joining an MGH study in 2008 brought hope. A newly developed implantable device aimed at treating adults with epilepsy gave Sherman back her life.

“Before, in 2007, I was on just meds and I was having tons and tons of seizures. Now that I have the device, I have not had any,” Sherman says. “I am able to work, drive and 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 2013, is an implantable device designed to help treat adults with partial-onset seizures. Developed by a company called NeuroPace, the device detects abnormal brain activity, and sends out small bursts of electrical stimulation to normalize that activity before a person has a seizure. Patients implanted with the device can download all brain activity with a four-inch wand, which connects to computers and devices through a USB cord. All Sherman has to do is place the wand over the location of the implanted device. The data is then downloaded onto her computer and automatically sent to NeuroPace for analysis.

“The important point here is that this is a novel treatment approach,” says Andrew Cole, MD, director of the MGH Epilepsy Center, and lead coordinator of the study. “It took a tremendous amount of energy and effort to get this device – develop this device, create a clinically useful tool, and do the rigorous testing to demonstrate its benefit. Here is a treatment that can react to the actual problem.”



Despite having a bout of seizures on a Saturday night in June 2012, Sherman says she has had ample success with the RNS device.

“Obviously it was a blind study, so they couldn’t tell me if it was on or off,” Sherman says. “But it was obvious. It happened instantaneously. My seizures went down and down; I knew it. 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.’”

The RNS device has lessened her anxiety about seizures and strengthened her independence. She says she hopes one day to work in the medical field, either as a medical assistant or certified nurse’s assistant.

Along with the other study participants, Sherman comes to the hospital every six months for a checkup and will have the device replaced every three years. During the six-month checkup, doctors and patients discuss the data downloaded by their patients.

Cole says there is a running list of 15 to 20 people at the MGH who are in different stages of evaluation for the RNS. There is no limitation to the number of devices at the hospital, and it is available to a wide number of patients.

I think we have to call the study a success,” Cole says. “The goal was to test the efficacy of the device. It had a statistically meaningful result. By every criteria it was a success, and certainly by the FDA’s criteria it was a success.”

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