Deep brain stimulus big help to patients

Study shows risks as well

By ASSOCIATED PRESS | Wednesday, January 7, 2009

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CHICAGO

Parkinson's disease victims who had electrodes implanted in their brains improved substantially more than those who took only medicine, according to the biggest test yet of deep brain stimulation.

The study, which followed patients for six months, offers the most hopeful news to date for Parkinson's sufferers. The new technique reduced tremors, rigidity and flailing of the limbs and allowed people to move freely for nearly five extra hours a day.

But the research also revealed higher-than-expected risks. About 40 percent of the patients who received these "brain pacemakers" suffered serious side effects, including a surprising number of falls with injuries.

"We had one patient who felt so good he went up to repair his roof, fell down and broke both his legs," said lead author Fran Weaver of Hines Veterans Affairs Hospital, outside Chicago. "Patients are feeling so much better, they forget they still have Parkinson's."

There is no cure for Parkinson's disease, which affects more than 1 million Americans. Patients experience increasingly severe tremors and periodically rigid limbs as their brains stop making dopamine, a chemical needed for movement. They can have trouble walking, speaking and writing, and often struggle with depression.

Standard treatments include drugs to stimulate dopamine. But over time, the medicines can produce flailing movements that are as troubling as Parkinson's tremors.

With deep brain stimulation, which was approved by the Food and Drug Administration in 2002 for advanced Parkinson's and has been performed on thousands of patients, a surgeon implants electrodes in the brain, which are then connected to a pacemakerlike device that can be adjusted and turned on and off. That device, implanted under the collarbone or in the abdomen, sends tiny electrical pulses to the brain, disabling overactive nerve cells.

The latest findings were published in Wednesday's Journal of the American Medical Association. The researchers studied 255 people with advanced Parkinson's at seven VA and six university hospitals. Patients were randomly assigned to have surgery plus the standard medication, or medication alone.

After six months, patients visited neurologists who did not know whether they had had surgery or medication. In the surgery group, 86 out of 121 (71 percent) saw meaningful improvements in movement, as scored by the neurologists. In the medication group, 43 out of 134 patients (32 percent) showed meaningful improvements.

In the surgery group, 49 had serious problems, including infections, falls and one death because of complications from the surgery. In the control group, only 15 people encountered serious problems.

Another way to measure gains for Parkinson's patients is the amount of "on" time - good quality movement time. Recording these times during the day in diaries, patients who had surgery gained, on average, nearly five hours of "on" time each day. Patients who didn't have surgery made no gains in that area.

Surgery to implant the electrodes and pacemaker costs about $60,000 and is covered by Medicare and some insurance companies. Medications can cost $5,000 a year. After surgery, patients were able to cut their medications by 23 percent on average.

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