BOSTON, Aug. 30 (UPI) -- Surgically placing electrodes in the brain appears to significantly improve conditions for Parkinson's disease patients -- even more so than maintaining those patients on the best available medicinal treatment.
About 60 percent of patients undergoing deep brain stimulation achieved significant improvement compared to no change for those patients on medicine in the randomized, controlled clinical trial, German doctors reported in the New England Journal of Medicine, to be published Thursday.
"This procedure shows we can actually 'turn back the clock' and improve our patients quality of life. We have to thank our European colleagues for this excellent trial and impressive results," Michele Tagliati, associate professor of neurology at the Mt. Sinai School of Medicine, New York, said Wednesday.
Tagliati told United Press International that the study is "the first to provide scientific evidence to support what we all are seeing in our clinical practices; that deep brain stimulation does, in fact, improve patients' outcomes."
Gunther Deuschl, professor of neurology at Christian Albrechts University, Kiel, Germany, reporting for a collaborative group of physicians under a grant from the German Federal Ministry of Education and Research, took matched pairs of patient's with advanced Parkinson's disease and assigned one person to receive either the brain surgery plus medicine and the second individual to receive just medical treatment.
After six months, the patients were compared on standardized function tests. "The patients who received neurostimulation had longer periods and better quality of mobility with less dyskinesia (involuntary tremors)," Deuschl said. "These changes in motor functioning led to improvement in measurements of activities of daily living, emotional well-being, stigma, and bodily discomfort."
In one test of the ability to move arms and legs, the initial score of 48 for patients undergoing surgery declined to 28 after six months, while patients on medication had no change in their initial average score of 46. The 41 percent decline represents substantial improvement, Tagliati, who did not participate in the study, told UPI.
"The best we hope for with medicine is to stabilize a patient's condition," Tagliati said. "With deep brain stimulation, we actually see improvements. We see home runs. People go back to work."
Tagliati said the study indicated that the level of disability caused by Parkinson's disease decreased from 7.5 hours a day to two hours a day for those receiving the surgery. "That makes a tremendous difference in a patient's quality of life," he said.
In the study, three people died in the surgery group, including one person who died due to complications during the procedures in which the electrode is implanted. Tagliati said the surgical fatality rate of between one and two percent is what occurs in clinical practice.
"The surgery really isn't that big of a deal," he said, "when you have experienced physicians. The patient goes into the operating room about 8 a.m. and usually everything is finished by noon. The patient typically returns home the next day. We tell them to take it easy for a couple of days and then resume normal activities."
The German researchers implanted Medtronic model 3389 DBS permanent electrodes in the patient's brains. The electrodes are controlled with implanted pulse generators. The final position of the electrode was confirmed by neuroimaging. Postoperatively, the optimal stimulation settings and anti-parkinsonian medication were progressively adjusted according to the patient's response. The patient is awake during the surgery in order to be able to test electrode placement and level of stimulation required.
Tagliati said that, in his experience, no one declines after the surgery, although in some patients there is minimal improvement. He said selecting patients who are likely to undergo the procedure without complications and the experience of the operating team could improve the success rate, or those showing marked improvement, from the 60 percent seen in the study to around 80 percent.
"What I found remarkable about this study," Tagliati told UPI, "is that adverse events actually occurred more often -- 64 percent -- in the patients receiving medical treatment than among the patients undergoing surgery, who had a 50 percent rate of adverse events."
He said long-term studies indicate that the improvement gained with deep brain stimulation are likely to be effective for five years or longer in the majority of patients.