Neuropace device for epilepsy up for FDA approval
Anne Marie Tiernon/Eyewitness News
Indianapolis - A small device to treat epilepsy was tested in Indianapolis, and it's now up for FDA approval. Neuropace is implanted in the brain to detect and defuse seizures.
Stephanie Tolle of Franklin Township routinely visits a team of clinical trial doctors at IU Hospital to download data and get a tweak. It happens through a laptop, which views Stephanie's seizure activity via a trial device implanted in her brain.
"When electrical stimulation is applied, there is suppression. You no longer see the seizure after that," said Dr. Robert Worth, IU neurosurgeon.
Eyewitness News was there in operating room in August 2006 when Stephanie, with head shaved, became one of seven Hoosiers enrolled in the clinical trial to test the new Neuropace technology.
"The use of electrode to stimulate the brain and control seizures is brand new," said Dr. Worth.
Surgeons precisely implanted the thin wire with four electrodes deep in her brain where her brain-scarring seizures are generated. Once the guide wires were in place, they were attached to a transmitter. That was implanted into Stephanie's skull. Now, when it detects the beginning of a seizure, it will deliver an electronic charge to suppress it.
"Everybody is happy. Everyone is amazed at what its done for her and she is able to go and do more activities than she was before," said David Jones, Stephanie's partner.
She still can't drive, but Jones says her clusters of 16 seizures are now down to two to three in a four-day time period.
Published results show of the 171 patients nationally enrolled in the trial at 31 site, 47 percent experienced a 50 percent or greater reduction in their seizure frequency over 12 weeks of long term data.
"The longer the device is in place, the better the patients do," said Dr. Vicenta Salanova, Clarian Neuroscience.
The demand on the device means Stephanie is up for a second battery change.
"That is so easy compared to the brain surgery," she said.
It's an outpatient procedure set for early August.
The Neuropace trial is now closed. However, Clarian is now enrolling patients for a new National Institutes of Health sponsored trial called the ROSE trial. For further information call 1-800-210-7123 or 317-944-0184.