Getting Her Life Back
Tina Nichols sits on the exam table and jokes that she’s
about to get “turned on” as the nurse programs a hand-held
keypad, shooting five volts of electricity through a stimulator
and into Nichols’ brain stem.
“I didn’t feel a thing. Guess we’ll eventually
know how well this thing works,” says the 35-year-old patient,
tapping her head slightly.
Nichols is hopeful the slight continuous jolts she receives from
the stimulator will jump-start a quality of life that has been short
circuited by epilepsy for more than two decades. Nearly a year ago,
she enrolled in a new clinical trial conducted by IU School of Medicine
neurologists to determine if a deep brain stimulator can disrupt
the circuits thought to cause epileptic seizures.
“This is a promising study for patients with severe partial
epilepsy who are not candidates for epilepsy surgery,” says
the trial’s principal investigator Vicenta Salanova, MD, associate
professor and director of the of IUSM’s Epilepsy Monitoring
and Epilepsy Surgery programs. “Preliminary data show that
patients with temporal or frontal lobe epilepsy have an 80 percent
seizure reduction rate.”
IUSM is one of 12 sites in the nation participating in the trial,
which is expected to enroll 125 patients nationally. Seven patients
have been enrolled at IU; Nichols was the first in Indiana to undergo
the procedure. Candidates for the trial are adults with partial-onset
epilepsy for whom at least three antiepileptic drugs have proven
ineffective. They continue to receive their epilepsy medications
while participating in the trial.
Patient Has Control
The technology used is a deep brain stimulator, the Intercept Epilepsy
Control System developed by Medtronic Inc. It begins in the operating
room with Robert M. Worth, MD, professor of neurological surgery.
He and his team implant a small neurostimulator into the patient’s
chest – a device Dr. Worth and other neurosurgeons have used
to treat Parkinson’s disease. Insulated leads from the stimulator
are routed through the neck, behind the ear and beneath the scalp
and fed into two small holes at the top of the skull. From there,
two fine-gauge leads are delicately snaked into the brain and attached
to the thalamus.
The transmitter is then activated, delivering continuous pulses
of low-voltage electricity. These pulses can be non-invasively adjusted
by a clinician from a programming device and transmitted via telemetry
to the transmitter. Patients also receive a hand-held remote control
they can place on their chest above the neurostimulator to increase
voltage if they sense the onset of a seizure.
Nichols was diagnosed with epilepsy when she was 16 and was able
to control the seizures with medications. She pressed on and earned
a bachelor’s degree in 1991 and later went to work as a massage
therapist. But things went downhill in her 20s when the drugs lost
their effectiveness. She gave up an active schedule of sports and
became a sideline spectator. She quit driving her car and was forced
to collect disability when she could no longer work as a massage
therapist.
“One of the most tragic consequences for people having epileptic
seizures that cannot be controlled is that they lose their independence,”
observes Dr. Salanova.
The brain stimulator trial is a double-blind study. Patients in
the active group, who receive neurostimulation, will be monitored
for a reduction in seizure rates compared to the control group,
who do not receive neurostimulation. Neither Nichols nor Dr. Salanova
knows if her stimulator was activated after implantation.
All patients accepted into the trial visit IU Hospital for exams
every month for three months before surgery. After surgery they
are seen regularly for 13 months by Dr. Salanova and her staff,
and continue to be monitored for the duration of the three-year
trial. Four months after receiving the device, all trial patients
visit IU Hospital and have the stimulators calibrated and set to
deliver voltage to the brain.
Tina Nichols went “live” with her stimulator late last
summer and initially did not notice significant changes in seizure
levels; however, she recently reported they seem to have lessened
in recent months. And the Richmond, Ind., resident remains cautiously
optimistic.
“One of these days – and I don’t know when that
will be – the seizures won’t be the focus of my existence,”
she says. “I will get my life back again.”
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