Sunday, November 26, 2006

Calming The Storm of Epilepsy: Is Miracle Implant the Future?

Imagine a device that monitors a patient's brainwaves. Imagine it predicts a seizure is about to occur. Imagine it stops the seizure before it begins. Imagine...

If you could have imagined such a device 10 years ago your name may have been Robert Fischell. A physicist and prolific inventor, Fischell's revolutionary firsts include the implantable insulin pump and the rechargeable pacemaker. In a 2005 article in Fortune magazine, he had this to say about the typical path of his inventive genius: "Stage one - everyone says it's impossible. Stage two - they say the solution was obvious all along."

In 1997 Fischell pursued the next "obvious" step in epilepsy treatment and founded NeuroPace, the maker of the Responsive Neurostimulator (RNS). The RNS, currently in Phase III clinical trials, is a device implanted in a patient's skull that stops seizures by delivering small electrical charges to the brain through thin wires known as electrodes. What makes the RNS so special?

The name says it all - Responsive Neurostimulator...

The Responsive Neurostimulator is the first device to respond, in real time, to the brains epileptic activity and immediately intervene to return the brain to its normal state. The RNS assesses the brain's activity, determines when pre-seizure brainwaves occur and delivers therapy to stop the impending seizure. It's remarkable technology, on the cutting edge of what scientists call "closed-loop stimulation," a treatment mechanism that relies on individualized feedback derived from implanted sensors.

Here's how it works:

The matchbook-size RNS (roughly 1.6 by 2.4 inches) is the "control center" of the process - monitoring, assessing, and treating. It is implanted in the patient's skull just below the scalp and, having a contour that matches the curvature of the skull, is undetectable once the hair has regrown. In the most common configuration, the device is connected to two thin electrodes that have been positioned in the area of the brain identified as the focal point, the point of origination, of the seizure activity. Each of the implanted electrodes contains four contact points used to deliver small electrical charges.

As in all high-tech applications, once the hardware is in place, the focus turns to fine-tuning the software. Neurologists begin by establishing a baseline of "normal" brainwave patterns based on data collected by the RNS. When the brainwaves spike beyond the normal range, the RNS shows its stuff - within less than a second it analyzes the feedback, predicts a seizure is about to occur and sends a series of tiny electrical charges that disrupt the seizure and calm the brain - without the patient feeling even the slightest tingle. A simple wireless device allows patients to record data captured by the Responsive Neurostimulator to a laptop and then email the results to their neurologist. This data is analyzed and becomes the basis for future refinements to the RNS settings - settings uniquely established for each individual patient.

This evolving technology is especially important for people whose epilepsy is resistant to medications or for whom surgery is too risky. The Responsive Neurostimulator is a welcome alternative, and a fresh breeze of new hope, to patients who had previously exhausted their treatment options. It takes a page from the Dreamer's Handbook, refines it in the still of neurological wizardry, swirls in just a touch of medical mystery and holds forth the promise of a normal life. ... Sounds like just what the doctor ordered.