Parkinson's disease was rapidly crippling Karen Stephani: She had to use a wheelchair, and muscle spasms in her neck left her head bobbing so wildly that "in a restaurant, food would fall out of my mouth."
Exhausted and embarrassed, the once-active 55-year-old seldom left her Minnesota home - until, desperate, she tried an experimental brain implant. Now Stephani is suddenly so healthy that she's stored away her wheelchair and is dusting off her water skis."I was instantly better," said Stephani, four months after surgeons drilled a hole in her skull and implanted a device that essentially blocked the motor-control symptoms of Parkinson's disease. "It was the most exhilarating experience to all of a sudden feel your life isn't over; it's just beginning."
Doctors don't know just why a device that sends small, continual electrical shocks to deep brain tissue would fight Parkinson's - it doesn't stop the brain-cell death that characterizes the devastating and incurable disease.
But European doctors are reporting dramatic effects. And although this new procedure has not yet won Food and Drug Administration approval, Americans are beginning to clamor for it.
"I don't want to be gushy, but it's very exciting," said Dr. Mark Stacy, director of the Muhammad Ali Parkinson's Research Center in Phoenix, who advises the National Parkinson Foundation.
The implant already is sold for another brain operation. The FDA has approved placing Medtronic Inc.'s Activa device inside the thalamus to stop uncontrollable tremors, including some caused by Parkinson's.
But French surgeons discovered that putting the implant into deeper, more delicate brain tissue worked far better: It could block the rigidity, slow movement, impaired balance and even the uncontrollable muscle jerks that imprison advanced Parkinson's patients inside alternately frozen and robot-like bodies.
"The results were truly spectacular," said Dr. Alim-Louis Benabid of the University of Grenoble, France, who developed the surgery and has operated on about 250 people. "Cured would mean the disease is gone and the disease is not gone, of course. But . . . the suppression of symptoms is so strong they look like they're almost cured."
Last month, Medtronic won European Union approval to implant its pacemaker-like device into the subthalamic nucleus or the globus pallidus, regions that control the worst Parkinson's symptoms.
Next month, Medtronic will meet with the FDA to discuss approving Activa Parkinson's therapy here. Without FDA approval, insurance will not pay for the operation - even though doctors already can offer the surgery since the same device is sold for FDA-approved tremor therapy. That means patients like Stephani, who can pay for the $25,000 to $35,000 surgery themselves, can try the procedure today.
Parkinson's drugs initially control the disease, but their effectiveness quickly wanes. Since the 1950s, neurosurgeons have offered a risky alternative: burning lesions into parts of the brain to destroy the defective tissue that caused certain symptoms.
But it didn't control Parkinson's worst problems.
A study of 76 advanced patients from Europe and the United States found the amount of time their bodies functioned normally doubled after the implant. Many are out of wheelchairs and able to live independently again; some have returned to work, Benabid said.
The relief "appears to last a very long time," said Dr. Warren Olanow of New York's Mount Sinai Medical Center, who helped Benabid develop the surgery.