Brain Pacemaker may help control seizures

Sidelined by unpredictable epilepsy, Stephanie Tolle does not drive. So Monday, the 35-year-old Southeastside resident had a device implanted in her brain that could one day put her behind the wheel.

Indiana University School of Medicine surgeons inserted a small responsive neurostimulator system, or RNS, under Tolle's scalp as part of a clinical trial. Tolle is the second participant in the Indiana wing of the multi-center trial.

The trial tests the efficacy of the RNS for patients like Tolle who have not responded well to traditional epilepsy medications or treatments. Similar to what a pacemaker does for the heart, the RNS monitors brain waves for abnormal activity. When the device detects the start of a seizure -- before a patient knows it -- it delivers a brief, mild electrical stimulation to suppress the attack.
While the government already has approved the RNS for use in patients like Tolle, IU researchers along with colleagues at other medical centers around the country are conducting a study to see how well the device performs over time.

"The thinking is that, by controlling the patient's seizures, we can control their quality of life," said Dr. Vicenta Salanova, IU professor of neurology and principal investigator for the trial here.
That's certainly Tolle's hope. Since she was 14, she has had several petit mal seizures a month. Unlike many other people with epilepsy, though, she does not sense a warning "aura" before the symptoms strike. And her condition has not responded well to medication, making her an ideal candidate for this surgery.

Her frequent seizures -- currently she has about six or seven a month -- derailed her dreams of pursuing a career in nursing. She remains dependent on others for transportation, but if this new device keeps her seizure-free for six months to a year, she plans to start driving.

"This could really change my life quite a bit. I could end up with lots of freedoms I have never been able to experience," she said.

About 1 percent of the U.S. population has epilepsy, says Salanova, and about a third of those patients do not respond well to medication.

Only those who have seizures originating from two parts of the brain or from an area that cannot be surgically removed are candidates for the RNS.

Potential candidates must also undergo extensive neurological evaluation, have an average of three or more partial seizures a month that are uncontrolled by medicine, and be between the ages of 18 and 70.

Once the device is implanted, the investigators will be able to monitor participants' seizure history. That information will assist researchers in determining how best to program the devices.

Researchers hope to enroll about 200 patients across the country, Salanova says. IU hopes to enroll about 10 in the coming year.

Tolle, for one, is delighted to be among that number.

"I'm nervous about this," she said a few days before her Monday surgery, "but I feel like this could be my miracle. This could be what I've been waiting for forever."