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FDA OKs electrode implants for brain as Parkinson's disease treatment Parkinson's patients on waiting lists expected to benefit Saturday, February 17, 2001 By Anita Srikameswaran, Post-Gazette Staff Writer
Officials of the Food and Drug Administration yesterday said the words that could offer many people with Parkinson's disease new hope when they gave oral approval for using tiny implanted electrodes called deep brain stimulators to treat the disorder.
The devices, made by Medtronic Inc., have been used for the disorder in Canada and Europe, but American patients were able to get them only by participating in experimental protocols.
Many local patients have been waiting months for the federal approval, which will lead Medicare and other insurers to cover the $30,000 cost of the device and its implantation.
"We've already got about 30 people on a list who were just waiting for the approval, and that's just the ones who really, really need it," said Dr. Donald Whiting, surgical director of Allegheny General Hospital's movement disorder center. As many as 400 people in the area could be candidates, he added.
Most patients who have received the stimulators thus far report substantial improvement in their ability to walk or otherwise control movement. Patients also say they have been able to cut back on their use of medication.
That's been the experience of Clifford Baguley, 62, of Leetsdale, who was implanted with deep brain stimulators in December 1999 by Whiting. An avid runner, Baguley's body had gradually been slowed to a near stop by Parkinson's disease, which is caused by the mysterious disappearance of brain cells that produce the neurotransmitter called dopamine.
For years, he took dopamine-replacing medications. As is typical, the drugs became less effective as time passed.
Prior to surgery, Baguley would often slide out of the chair he was sitting in because he couldn't stop the twitches in his right leg. He couldn't guide a cup or fork smoothly to his mouth because his hands shook.
The stimulators helped immediately, loosening up Baguley's rigid limbs and allowing his shuffling gait to turn into a more normal stride.
But they weren't perfect. During the past year, adjustments were made to the voltages the electrodes delivered to his subthalamus, a brain area that controls motion.
"It's played havoc with me," Baguley said earlier this week. "The trouble is my body received the gift so late."
People who get the implants earlier in the course of Parkinson's disease will probably do better, he added. Baguley's first symptoms began more than 15 years ago.
But the stimulators have made a difference even for him.
Now Baguley can sit relaxed and still. He hasn't been able to run a mile as he might have wished, but he has been able to walk for long stretches, including the distance from Downtown to the office of his neurologist, Dr. Susan Baser, at Allegheny General Hospital. He has also been able to take his medication less frequently.
The people who will get the implants in the near future will likely have the most severe symptoms. But as experience grows, doctors should learn when is the best time to offer the surgery to individual patients and more quickly adjust the device to its optimal settings, said Dr. Douglas Kondziolka, a neurosurgeon at the University of Pittsburgh Medical Center.
For now, Parkinson's patients who still benefit from medication are not candidates for the stimulators, and neither are people who are taking blood thinners or who have active infections. The procedure is not considered first-line treatment, said Allegheny General's Whiting.
The stimulators may replace other surgical interventions for the disease, such as pallidotomy, because the older techniques require removal of brain tissue and thus cannot be reversed.
"It's just like a whole new era for people with Parkinson's disease in the U.S.," Whiting said.
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