Deep brain electrical stimulation appears to be more effective than the best medical treatment in reducing motor symptoms and improving quality of life in patients with advanced Parkinson's disease, according to the results of a clinical trial.
Several drugs are used initially to reduce symptoms of Parkinson's disease, but their efficacy wanes over time, Dr. Gunther Deuschl and colleagues note in this week's New England Journal of Medicine.
Deuschl, a neurologist at Christian Albrechts University in Kiel, Germany, and his team wanted to compare deep brain stimulation, which has been in use for several years, with optimal medical care.
Neurostimulation is delivered by a pacemaker-like device, and requires an electrode implanted in the subthalamic nucleus region of the brain. The researchers' goal was to see if the benefits of neurostimulation outweigh the risks, and if it is better than medication in reducing the burden of disease.
In a 6-month trial, the investigators randomly assigned one member of 78 pairs of patients to optimal medical treatment and one to surgery. The participants were younger than 75 years of age, had had Parkinson's for at least 5 years, and their symptoms were severe.
"Patients' diaries showed profound and significant changes from baseline to 6 months in the neurostimulation group," Deuschl's team writes. Improvements included decreased severity and duration of periods of immobility and severity of uncontrolled movement.
The medication group showed little change.
There were ten severe adverse events in the neurostimulation group, including three deaths. Other serious events included worsening of mobility, infection at the stimulator insertion site, erroneous stimulator shut-off, and vertebral fracture from a fall.
Three severe adverse effects in the medically treated group included one death from a car accident while driving during a psychotic episode, worsening mobility, and hip fracture from fall.
Otherwise, adverse events, primarily related to advanced Parkinson's disease, were similar in the two groups.
"In carefully selected patients," Deuschl and his associates conclude, "neurostimulation of the subthalamic nucleus is a powerful treatment that alleviates the burden of advanced Parkinson's disease." Still, they add, patients will have to weigh the prospect of an improved quality of life against the risk of complications related to surgery.
SOURCE: New England Journal of Medicine, August 31, 2006.
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